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Ignite Creation Date: 2025-12-25 @ 2:58 AM

Ignite Modification Date: 2026-01-01 @ 12:58 AM

Study NCT ID: NCT00790933

Status: COMPLETED

Last Update Posted: 2022-05-24

First Post: 2008-11-05

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543529', 'term': 'vedolizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': "In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Vedolizumab 300 mg', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13006, C13007 and C13011.', 'otherNumAtRisk': 2243, 'deathsNumAtRisk': 2243, 'otherNumAffected': 1820, 'seriousNumAtRisk': 2243, 'deathsNumAffected': 10, 'seriousNumAffected': 825}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 594}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 379}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 235}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 216}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 216}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 208}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 175}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 393}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 333}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 333}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 284}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 251}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 227}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 139}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 482}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 239}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 125}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 121}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 452}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 162}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 277}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 229}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 148}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 251}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 168}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 181}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 153}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 122}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}], 'seriousEvents': [{'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 225}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Epiploic appendagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pouchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 120}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Ileal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Small intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Enterocolonic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Enterocutaneous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Enterovesical fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Colonic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Colonic obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Colon dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Abdominal hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Anal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Rectal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Megacolon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Periproctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 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'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Clostridial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Clostridium colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Asymptomatic bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Vaginal cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Sepsis', 'notes': 'One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Abdominal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Blister infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cytomegalovirus colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Oesophageal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Klebsiella infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Klebsiella sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Abscess jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Campylobacter intestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cryptosporidiosis infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Infectious mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Vulval abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'West Nile viral infection', 'notes': 'One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Giardiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cholangitis suppurative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Psoas abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Gastroenteritis salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Infusion site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Intestinal anastomosis complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Gastrointestinal stoma complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Abdominal wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Gastrointestinal anastomotic 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'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Anastomotic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Procedural site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Post procedural discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pneumothorax traumatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Traumatic lung injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dislocation of vertebra', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Acetabulum fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pubis fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Accidental poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Splenic rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Traumatic intracranial haemorrhage', 'notes': 'One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Tendon injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Urethral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Carcinoid tumour of the appendix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Glioblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hepatic neoplasm malignant', 'notes': 'One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Haemangioma of liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Leiomyosarcoma', 'notes': 'One treatment-emergent death occurred during treatment with vedolizumab 300 mg and is not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Spinal meningioma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Metastases to peritoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Neurilemmoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Thyroid adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Fistula discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Ankylosing spondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Spondyloarthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Muscle disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': "Dupuytren's contracture", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 7}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cholangitis sclerosing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pseudopolyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'No therapeutic response', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pulmonary embolism', 'notes': 'One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hydropneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Respiratory failure', 'notes': 'One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cerebrovascular accident', 'notes': 'One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'VIIth nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Transient global amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Nervous system 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'MedDRA, Version 14.0'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Bladder hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Bladder prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Ureteric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Urethral prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dysfunctional uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Uterine cervical erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Ovarian adhesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Ovarian mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Female genital tract fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Breast haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Myopericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Homicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Completed suicide', 'notes': 'One treatment-emergent death occurred during treatment with vedolizumab 300 mg and was not related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Axillary vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Systemic lupus erythematosus rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pyoderma gangrenosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Vitello-intestinal duct remnant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Skeletal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Chondropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Polymyalgia rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Cervicobrachial syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Intracranial hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Colon cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Spinal cord neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Haemorrhagic ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Arteriospasm coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Femoral arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Serum sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Thyroid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Multiple myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Bladder papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Intestinal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Rectourethral fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Small intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Inguinal hernia strangulated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Anal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Umbilical hernia, obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Vulval cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Enterocolitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Vestibular neuronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Postoperative abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Incision site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Peridiverticular abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Herpes zoster ophthalmic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}, {'term': 'Mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2243, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA, Version 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'OG000'}, {'value': '1349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004 and C13006 with a diagnosis of Ulcerative colitis (UC).'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13007 and C13011 with a diagnosis of Crohn's disease."}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Markedly Abnormal Safety Laboratory Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'OG000'}, {'value': '1349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004 and C13006 with a diagnosis of Ulcerative colitis (UC).'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13007 and C13011 with a diagnosis of Crohn's disease."}], 'classes': [{'title': 'Hemoglobin <= 70 g/L', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Lymphocyte Count <0.5 X 10^9/L', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes <2.0 X 10^9/L (Absolute Value)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Platelets <75.0 X 10^9/L', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Absolute Neutrophil Count <1.0 X 10^9/L', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Prothrombin Time >1.25 x ULN', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'ALT >3.0 x ULN', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'AST >3.0 x ULN', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin >2.0 x ULN', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Amylase >2.0 x ULN', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Lipase >2.0 x ULN', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)', 'description': 'A laboratory value was considered a marked abnormality if it met the predefined criteria or parameters and the on-treatment value was more extreme than the Baseline value for the following parameters: hemoglobin \\<= 70 g/L, absolute lymphocyte count \\<0.5 X 10\\^9/L, leukocytes \\<2.0 X 10\\^9/L (absolute value), platelets \\<75.0 X 10\\^9/L, absolute neutrophil Count \\<1.0 X 10\\^9/L, prothrombin time \\>1.25 x upper limit of normal (ULN), alanine aminotransferase (ALT) \\>3.0 x ULN, aspartate aminotransferase (AST) \\>3.0 x ULN, bilirubin \\>2.0 x ULN, amylase \\>2.0 x ULN, lipase \\>2.0 x ULN.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'OG000'}, {'value': '1349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004 and C13006 with a diagnosis of Ulcerative colitis (UC).'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13007 and C13011 with a diagnosis of Crohn's disease."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)', 'description': 'Vital signs (heart rate, respiratory rate, systolic and diastolic blood pressure, and temperature) measurements were collected throughout the study. Any clinically significant mean change in vital signs over time as assessed by the investigator was reported as a TEAE.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '894', 'groupId': 'OG000'}, {'value': '1349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004 and C13006 with a diagnosis of Ulcerative colitis (UC).'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13007 and C13011 with a diagnosis of Crohn's disease."}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)', 'description': 'A standard 12-lead ECG was performed. Any ECGs assessed by the investigator to be clinically significant were reported as TEAEs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.'}, {'type': 'PRIMARY', 'title': 'Time to Major Inflammatory Bowel Disease (IBD) - Related Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2142', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks.'}], 'classes': [{'title': 'IBD-related events, UC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '845', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not estimable due to the low number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'IBD-related events, CD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1297', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not estimable due to the low number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Prior to first dose of study drug in C13008) up to end of study (approximately up to 8.5 years)', 'description': "IBD-related events included hospitalizations, surgeries, or procedures due to ulcerative colitis and Crohn's disease.", 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy population included participants who received at least one dose of vedolizumab and had at least one postbaseline disease activity measurement.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}, {'value': '71', 'groupId': 'OG005'}, {'value': '127', 'groupId': 'OG006'}, {'value': '134', 'groupId': 'OG007'}, {'value': '150', 'groupId': 'OG008'}, {'value': '161', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '125.34', 'spread': '34.895', 'groupId': 'OG000'}, {'value': '129.12', 'spread': '34.289', 'groupId': 'OG001'}, {'value': '124.37', 'spread': '31.632', 'groupId': 'OG002'}, {'value': '122.33', 'spread': '31.114', 'groupId': 'OG003'}, {'value': '127.56', 'spread': '33.718', 'groupId': 'OG004'}, {'value': '127.11', 'spread': '30.537', 'groupId': 'OG005'}, {'value': '123.88', 'spread': '31.620', 'groupId': 'OG006'}, {'value': '124.35', 'spread': '33.310', 'groupId': 'OG007'}, {'value': '131.44', 'spread': '27.715', 'groupId': 'OG008'}, {'value': '132.14', 'spread': '32.245', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 28', 'categories': [{'measurements': [{'value': '60.00', 'spread': '41.165', 'groupId': 'OG000'}, {'value': '62.71', 'spread': '34.600', 'groupId': 'OG001'}, {'value': '62.53', 'spread': '35.072', 'groupId': 'OG002'}, {'value': '57.17', 'spread': '38.851', 'groupId': 'OG003'}, {'value': '57.52', 'spread': '42.561', 'groupId': 'OG004'}, {'value': '51.48', 'spread': '34.576', 'groupId': 'OG005'}, {'value': '41.71', 'spread': '36.508', 'groupId': 'OG006'}, {'value': '40.49', 'spread': '39.733', 'groupId': 'OG007'}, {'value': '42.90', 'spread': '32.581', 'groupId': 'OG008'}, {'value': '30.84', 'spread': '34.614', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '117', 'groupId': 'OG007'}, {'value': '132', 'groupId': 'OG008'}, {'value': '134', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '123.53', 'spread': '36.160', 'groupId': 'OG000'}, {'value': '131.17', 'spread': '33.675', 'groupId': 'OG001'}, {'value': '125.03', 'spread': '32.560', 'groupId': 'OG002'}, {'value': '120.29', 'spread': '30.894', 'groupId': 'OG003'}, {'value': '129.46', 'spread': '34.799', 'groupId': 'OG004'}, {'value': '128.69', 'spread': '30.461', 'groupId': 'OG005'}, {'value': '125.30', 'spread': '30.075', 'groupId': 'OG006'}, {'value': '125.31', 'spread': '34.140', 'groupId': 'OG007'}, {'value': '130.63', 'spread': '28.446', 'groupId': 'OG008'}, {'value': '132.71', 'spread': '33.108', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 52', 'categories': [{'measurements': [{'value': '66.84', 'spread': '41.733', 'groupId': 'OG000'}, {'value': '59.89', 'spread': '33.170', 'groupId': 'OG001'}, {'value': '61.06', 'spread': '37.386', 'groupId': 'OG002'}, {'value': '59.31', 'spread': '34.837', 'groupId': 'OG003'}, {'value': '58.87', 'spread': '40.707', 'groupId': 'OG004'}, {'value': '52.30', 'spread': '29.385', 'groupId': 'OG005'}, {'value': '44.31', 'spread': '37.923', 'groupId': 'OG006'}, {'value': '47.38', 'spread': '37.687', 'groupId': 'OG007'}, {'value': '47.07', 'spread': '30.463', 'groupId': 'OG008'}, {'value': '37.33', 'spread': '40.232', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}, {'value': '91', 'groupId': 'OG006'}, {'value': '106', 'groupId': 'OG007'}, {'value': '118', 'groupId': 'OG008'}, {'value': '113', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '123.66', 'spread': '36.115', 'groupId': 'OG000'}, {'value': '131.31', 'spread': '33.726', 'groupId': 'OG001'}, {'value': '123.87', 'spread': '31.752', 'groupId': 'OG002'}, {'value': '120.00', 'spread': '29.667', 'groupId': 'OG003'}, {'value': '128.47', 'spread': '34.724', 'groupId': 'OG004'}, {'value': '129.06', 'spread': '31.694', 'groupId': 'OG005'}, {'value': '124.89', 'spread': '31.629', 'groupId': 'OG006'}, {'value': '125.89', 'spread': '34.478', 'groupId': 'OG007'}, {'value': '130.75', 'spread': '28.587', 'groupId': 'OG008'}, {'value': '132.46', 'spread': '33.245', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 76', 'categories': [{'measurements': [{'value': '65.53', 'spread': '40.584', 'groupId': 'OG000'}, {'value': '59.88', 'spread': '35.290', 'groupId': 'OG001'}, {'value': '64.27', 'spread': '32.443', 'groupId': 'OG002'}, {'value': '59.91', 'spread': '34.449', 'groupId': 'OG003'}, {'value': '55.05', 'spread': '47.181', 'groupId': 'OG004'}, {'value': '52.85', 'spread': '36.486', 'groupId': 'OG005'}, {'value': '47.43', 'spread': '35.811', 'groupId': 'OG006'}, {'value': '46.32', 'spread': '36.397', 'groupId': 'OG007'}, {'value': '50.59', 'spread': '30.794', 'groupId': 'OG008'}, {'value': '40.14', 'spread': '39.305', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '84', 'groupId': 'OG006'}, {'value': '96', 'groupId': 'OG007'}, {'value': '112', 'groupId': 'OG008'}, {'value': '104', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '124.70', 'spread': '37.614', 'groupId': 'OG000'}, {'value': '130.90', 'spread': '34.361', 'groupId': 'OG001'}, {'value': '124.52', 'spread': '30.033', 'groupId': 'OG002'}, {'value': '120.89', 'spread': '29.745', 'groupId': 'OG003'}, {'value': '129.53', 'spread': '35.261', 'groupId': 'OG004'}, {'value': '128.25', 'spread': '32.333', 'groupId': 'OG005'}, {'value': '123.50', 'spread': '29.662', 'groupId': 'OG006'}, {'value': '128.35', 'spread': '33.793', 'groupId': 'OG007'}, {'value': '132.41', 'spread': '28.538', 'groupId': 'OG008'}, {'value': '132.48', 'spread': '32.305', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 100', 'categories': [{'measurements': [{'value': '61.83', 'spread': '41.505', 'groupId': 'OG000'}, {'value': '62.46', 'spread': '32.502', 'groupId': 'OG001'}, {'value': '62.83', 'spread': '34.475', 'groupId': 'OG002'}, {'value': '57.04', 'spread': '38.448', 'groupId': 'OG003'}, {'value': '58.53', 'spread': '45.644', 'groupId': 'OG004'}, {'value': '53.40', 'spread': '32.651', 'groupId': 'OG005'}, {'value': '49.89', 'spread': '36.806', 'groupId': 'OG006'}, {'value': '46.95', 'spread': '34.691', 'groupId': 'OG007'}, {'value': '52.50', 'spread': '32.267', 'groupId': 'OG008'}, {'value': '38.52', 'spread': '36.982', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '80', 'groupId': 'OG006'}, {'value': '82', 'groupId': 'OG007'}, {'value': '95', 'groupId': 'OG008'}, {'value': '97', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '127.33', 'spread': '36.470', 'groupId': 'OG000'}, {'value': '130.83', 'spread': '34.399', 'groupId': 'OG001'}, {'value': '123.65', 'spread': '30.180', 'groupId': 'OG002'}, {'value': '119.77', 'spread': '29.963', 'groupId': 'OG003'}, {'value': '132.36', 'spread': '34.573', 'groupId': 'OG004'}, {'value': '130.01', 'spread': '33.454', 'groupId': 'OG005'}, {'value': '122.91', 'spread': '29.869', 'groupId': 'OG006'}, {'value': '129.08', 'spread': '33.576', 'groupId': 'OG007'}, {'value': '132.75', 'spread': '28.131', 'groupId': 'OG008'}, {'value': '131.56', 'spread': '31.567', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 124', 'categories': [{'measurements': [{'value': '63.94', 'spread': '44.480', 'groupId': 'OG000'}, {'value': '60.94', 'spread': '37.769', 'groupId': 'OG001'}, {'value': '63.71', 'spread': '34.542', 'groupId': 'OG002'}, {'value': '61.91', 'spread': '36.288', 'groupId': 'OG003'}, {'value': '53.91', 'spread': '44.023', 'groupId': 'OG004'}, {'value': '53.74', 'spread': '34.514', 'groupId': 'OG005'}, {'value': '46.62', 'spread': '38.435', 'groupId': 'OG006'}, {'value': '47.60', 'spread': '40.634', 'groupId': 'OG007'}, {'value': '54.47', 'spread': '29.636', 'groupId': 'OG008'}, {'value': '40.35', 'spread': '41.543', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '76', 'groupId': 'OG006'}, {'value': '83', 'groupId': 'OG007'}, {'value': '93', 'groupId': 'OG008'}, {'value': '92', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '127.33', 'spread': '36.470', 'groupId': 'OG000'}, {'value': '131.95', 'spread': '34.649', 'groupId': 'OG001'}, {'value': '123.02', 'spread': '29.685', 'groupId': 'OG002'}, {'value': '119.07', 'spread': '30.344', 'groupId': 'OG003'}, {'value': '132.23', 'spread': '35.877', 'groupId': 'OG004'}, {'value': '130.25', 'spread': '34.108', 'groupId': 'OG005'}, {'value': '122.01', 'spread': '28.967', 'groupId': 'OG006'}, {'value': '128.66', 'spread': '34.624', 'groupId': 'OG007'}, {'value': '133.36', 'spread': '28.616', 'groupId': 'OG008'}, {'value': '132.38', 'spread': '32.172', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 148', 'categories': [{'measurements': [{'value': '60.66', 'spread': '41.786', 'groupId': 'OG000'}, {'value': '62.72', 'spread': '33.786', 'groupId': 'OG001'}, {'value': '65.81', 'spread': '33.232', 'groupId': 'OG002'}, {'value': '60.41', 'spread': '36.074', 'groupId': 'OG003'}, {'value': '54.53', 'spread': '48.036', 'groupId': 'OG004'}, {'value': '56.08', 'spread': '32.954', 'groupId': 'OG005'}, {'value': '52.30', 'spread': '39.123', 'groupId': 'OG006'}, {'value': '49.40', 'spread': '36.880', 'groupId': 'OG007'}, {'value': '54.50', 'spread': '32.874', 'groupId': 'OG008'}, {'value': '42.13', 'spread': '40.030', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '71', 'groupId': 'OG006'}, {'value': '76', 'groupId': 'OG007'}, {'value': '89', 'groupId': 'OG008'}, {'value': '80', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '130.25', 'spread': '36.650', 'groupId': 'OG000'}, {'value': '132.93', 'spread': '34.216', 'groupId': 'OG001'}, {'value': '123.47', 'spread': '30.141', 'groupId': 'OG002'}, {'value': '120.49', 'spread': '30.221', 'groupId': 'OG003'}, {'value': '131.60', 'spread': '36.013', 'groupId': 'OG004'}, {'value': '132.31', 'spread': '33.860', 'groupId': 'OG005'}, {'value': '120.70', 'spread': '27.535', 'groupId': 'OG006'}, {'value': '127.42', 'spread': '34.779', 'groupId': 'OG007'}, {'value': '133.34', 'spread': '28.981', 'groupId': 'OG008'}, {'value': '131.69', 'spread': '32.229', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 172', 'categories': [{'measurements': [{'value': '58.67', 'spread': '42.513', 'groupId': 'OG000'}, {'value': '62.20', 'spread': '33.187', 'groupId': 'OG001'}, {'value': '62.16', 'spread': '33.969', 'groupId': 'OG002'}, {'value': '65.43', 'spread': '35.350', 'groupId': 'OG003'}, {'value': '54.91', 'spread': '40.758', 'groupId': 'OG004'}, {'value': '53.92', 'spread': '33.132', 'groupId': 'OG005'}, {'value': '51.55', 'spread': '40.714', 'groupId': 'OG006'}, {'value': '47.97', 'spread': '35.121', 'groupId': 'OG007'}, {'value': '56.02', 'spread': '33.863', 'groupId': 'OG008'}, {'value': '41.18', 'spread': '40.805', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '66', 'groupId': 'OG006'}, {'value': '71', 'groupId': 'OG007'}, {'value': '62', 'groupId': 'OG008'}, {'value': '51', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '127.33', 'spread': '36.470', 'groupId': 'OG000'}, {'value': '135.33', 'spread': '33.596', 'groupId': 'OG001'}, {'value': '122.00', 'spread': '30.129', 'groupId': 'OG002'}, {'value': '119.35', 'spread': '31.651', 'groupId': 'OG003'}, {'value': '130.39', 'spread': '36.410', 'groupId': 'OG004'}, {'value': '132.16', 'spread': '34.217', 'groupId': 'OG005'}, {'value': '121.15', 'spread': '28.703', 'groupId': 'OG006'}, {'value': '126.44', 'spread': '34.826', 'groupId': 'OG007'}, {'value': '136.55', 'spread': '27.551', 'groupId': 'OG008'}, {'value': '137.27', 'spread': '30.844', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 196', 'categories': [{'measurements': [{'value': '63.19', 'spread': '38.061', 'groupId': 'OG000'}, {'value': '59.13', 'spread': '33.318', 'groupId': 'OG001'}, {'value': '68.89', 'spread': '34.578', 'groupId': 'OG002'}, {'value': '64.81', 'spread': '36.563', 'groupId': 'OG003'}, {'value': '58.90', 'spread': '46.107', 'groupId': 'OG004'}, {'value': '55.67', 'spread': '32.453', 'groupId': 'OG005'}, {'value': '52.22', 'spread': '42.363', 'groupId': 'OG006'}, {'value': '49.41', 'spread': '35.662', 'groupId': 'OG007'}, {'value': '49.05', 'spread': '30.390', 'groupId': 'OG008'}, {'value': '36.35', 'spread': '41.424', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '45', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '116.05', 'spread': '31.747', 'groupId': 'OG000'}, {'value': '133.61', 'spread': '32.538', 'groupId': 'OG001'}, {'value': '120.28', 'spread': '30.875', 'groupId': 'OG002'}, {'value': '116.63', 'spread': '32.888', 'groupId': 'OG003'}, {'value': '131.81', 'spread': '35.906', 'groupId': 'OG004'}, {'value': '129.37', 'spread': '31.455', 'groupId': 'OG005'}, {'value': '122.00', 'spread': '27.231', 'groupId': 'OG006'}, {'value': '125.93', 'spread': '35.080', 'groupId': 'OG007'}, {'value': '127.00', 'spread': '63.930', 'groupId': 'OG008'}, {'value': '128.00', 'spread': '35.749', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 248', 'categories': [{'measurements': [{'value': '76.21', 'spread': '38.693', 'groupId': 'OG000'}, {'value': '57.52', 'spread': '31.841', 'groupId': 'OG001'}, {'value': '69.56', 'spread': '38.680', 'groupId': 'OG002'}, {'value': '65.72', 'spread': '34.776', 'groupId': 'OG003'}, {'value': '54.97', 'spread': '41.658', 'groupId': 'OG004'}, {'value': '58.76', 'spread': '35.250', 'groupId': 'OG005'}, {'value': '51.39', 'spread': '45.950', 'groupId': 'OG006'}, {'value': '53.04', 'spread': '38.830', 'groupId': 'OG007'}, {'value': '73.00', 'spread': '48.446', 'groupId': 'OG008'}, {'value': '72.00', 'spread': '32.156', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '100.71', 'spread': '21.831', 'groupId': 'OG000'}, {'value': '137.50', 'spread': '30.478', 'groupId': 'OG001'}, {'value': '120.38', 'spread': '24.401', 'groupId': 'OG002'}, {'value': '119.67', 'spread': '33.463', 'groupId': 'OG003'}, {'value': '134.88', 'spread': '36.957', 'groupId': 'OG004'}, {'value': '121.38', 'spread': '30.133', 'groupId': 'OG005'}, {'value': '120.25', 'spread': '19.085', 'groupId': 'OG006'}, {'value': '162.50', 'spread': '47.376', 'groupId': 'OG007'}]}]}, {'title': 'Change at Week 300', 'categories': [{'measurements': [{'value': '94.29', 'spread': '38.612', 'groupId': 'OG000'}, {'value': '55.43', 'spread': '41.694', 'groupId': 'OG001'}, {'value': '67.54', 'spread': '27.823', 'groupId': 'OG002'}, {'value': '69.00', 'spread': '41.192', 'groupId': 'OG003'}, {'value': '53.00', 'spread': '41.542', 'groupId': 'OG004'}, {'value': '72.00', 'spread': '35.219', 'groupId': 'OG005'}, {'value': '73.50', 'spread': '12.342', 'groupId': 'OG006'}, {'value': '2.00', 'spread': '5.657', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable (NA) for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '89.00', 'spread': 'NA', 'comment': 'Standard deviation (SD) was not calculated for 1 participant.', 'groupId': 'OG000'}, {'value': '120.00', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '118.00', 'spread': '32.047', 'groupId': 'OG002'}, {'value': '70.00', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG003'}, {'value': '137.00', 'spread': '28.284', 'groupId': 'OG004'}, {'value': '126.00', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 352', 'categories': [{'measurements': [{'value': '123.00', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG000'}, {'value': '86.00', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '66.00', 'spread': '33.181', 'groupId': 'OG002'}, {'value': '131.00', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG003'}, {'value': '37.50', 'spread': '28.991', 'groupId': 'OG004'}, {'value': '84.00', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}, {'value': '71', 'groupId': 'OG005'}, {'value': '127', 'groupId': 'OG006'}, {'value': '136', 'groupId': 'OG007'}, {'value': '151', 'groupId': 'OG008'}, {'value': '162', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '39.57', 'spread': '8.599', 'groupId': 'OG000'}, {'value': '41.15', 'spread': '8.313', 'groupId': 'OG001'}, {'value': '40.05', 'spread': '7.634', 'groupId': 'OG002'}, {'value': '37.05', 'spread': '7.522', 'groupId': 'OG003'}, {'value': '37.87', 'spread': '8.113', 'groupId': 'OG004'}, {'value': '39.09', 'spread': '7.771', 'groupId': 'OG005'}, {'value': '37.92', 'spread': '8.355', 'groupId': 'OG006'}, {'value': '36.81', 'spread': '8.274', 'groupId': 'OG007'}, {'value': '40.06', 'spread': '8.631', 'groupId': 'OG008'}, {'value': '39.20', 'spread': '7.306', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 28', 'categories': [{'measurements': [{'value': '10.20', 'spread': '8.792', 'groupId': 'OG000'}, {'value': '8.22', 'spread': '9.015', 'groupId': 'OG001'}, {'value': '8.89', 'spread': '7.110', 'groupId': 'OG002'}, {'value': '9.85', 'spread': '8.789', 'groupId': 'OG003'}, {'value': '12.46', 'spread': '8.900', 'groupId': 'OG004'}, {'value': '9.60', 'spread': '7.620', 'groupId': 'OG005'}, {'value': '6.48', 'spread': '8.514', 'groupId': 'OG006'}, {'value': '7.74', 'spread': '9.310', 'groupId': 'OG007'}, {'value': '7.07', 'spread': '8.752', 'groupId': 'OG008'}, {'value': '5.67', 'spread': '7.695', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}, {'value': '71', 'groupId': 'OG005'}, {'value': '127', 'groupId': 'OG006'}, {'value': '136', 'groupId': 'OG007'}, {'value': '151', 'groupId': 'OG008'}, {'value': '162', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '39.98', 'spread': '11.349', 'groupId': 'OG000'}, {'value': '40.70', 'spread': '11.226', 'groupId': 'OG001'}, {'value': '38.28', 'spread': '11.039', 'groupId': 'OG002'}, {'value': '35.49', 'spread': '11.139', 'groupId': 'OG003'}, {'value': '38.53', 'spread': '10.631', 'groupId': 'OG004'}, {'value': '37.70', 'spread': '12.423', 'groupId': 'OG005'}, {'value': '36.60', 'spread': '11.545', 'groupId': 'OG006'}, {'value': '38.04', 'spread': '12.567', 'groupId': 'OG007'}, {'value': '40.87', 'spread': '11.385', 'groupId': 'OG008'}, {'value': '39.29', 'spread': '11.535', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 28', 'categories': [{'measurements': [{'value': '8.36', 'spread': '13.096', 'groupId': 'OG000'}, {'value': '11.10', 'spread': '11.098', 'groupId': 'OG001'}, {'value': '11.52', 'spread': '12.464', 'groupId': 'OG002'}, {'value': '13.35', 'spread': '11.857', 'groupId': 'OG003'}, {'value': '10.88', 'spread': '12.396', 'groupId': 'OG004'}, {'value': '10.94', 'spread': '12.386', 'groupId': 'OG005'}, {'value': '7.48', 'spread': '12.061', 'groupId': 'OG006'}, {'value': '6.34', 'spread': '13.161', 'groupId': 'OG007'}, {'value': '6.48', 'spread': '10.809', 'groupId': 'OG008'}, {'value': '3.72', 'spread': '12.377', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '118', 'groupId': 'OG007'}, {'value': '133', 'groupId': 'OG008'}, {'value': '135', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '39.94', 'spread': '8.930', 'groupId': 'OG000'}, {'value': '41.72', 'spread': '8.314', 'groupId': 'OG001'}, {'value': '40.12', 'spread': '7.694', 'groupId': 'OG002'}, {'value': '36.75', 'spread': '7.510', 'groupId': 'OG003'}, {'value': '37.82', 'spread': '8.301', 'groupId': 'OG004'}, {'value': '39.23', 'spread': '7.807', 'groupId': 'OG005'}, {'value': '37.87', 'spread': '7.992', 'groupId': 'OG006'}, {'value': '37.40', 'spread': '8.171', 'groupId': 'OG007'}, {'value': '40.51', 'spread': '8.454', 'groupId': 'OG008'}, {'value': '39.27', 'spread': '7.469', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 52', 'categories': [{'measurements': [{'value': '9.55', 'spread': '10.155', 'groupId': 'OG000'}, {'value': '8.57', 'spread': '7.889', 'groupId': 'OG001'}, {'value': '9.77', 'spread': '6.766', 'groupId': 'OG002'}, {'value': '9.43', 'spread': '9.088', 'groupId': 'OG003'}, {'value': '12.97', 'spread': '9.147', 'groupId': 'OG004'}, {'value': '9.98', 'spread': '7.824', 'groupId': 'OG005'}, {'value': '7.48', 'spread': '8.800', 'groupId': 'OG006'}, {'value': '8.97', 'spread': '8.743', 'groupId': 'OG007'}, {'value': '8.37', 'spread': '8.401', 'groupId': 'OG008'}, {'value': '6.72', 'spread': '7.842', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '118', 'groupId': 'OG007'}, {'value': '133', 'groupId': 'OG008'}, {'value': '135', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '39.33', 'spread': '11.878', 'groupId': 'OG000'}, {'value': '41.18', 'spread': '11.150', 'groupId': 'OG001'}, {'value': '38.29', 'spread': '11.062', 'groupId': 'OG002'}, {'value': '35.43', 'spread': '11.445', 'groupId': 'OG003'}, {'value': '39.45', 'spread': '9.910', 'groupId': 'OG004'}, {'value': '38.98', 'spread': '11.963', 'groupId': 'OG005'}, {'value': '36.80', 'spread': '11.052', 'groupId': 'OG006'}, {'value': '38.54', 'spread': '12.379', 'groupId': 'OG007'}, {'value': '40.32', 'spread': '11.333', 'groupId': 'OG008'}, {'value': '39.16', 'spread': '11.518', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 52', 'categories': [{'measurements': [{'value': '10.27', 'spread': '12.895', 'groupId': 'OG000'}, {'value': '10.40', 'spread': '10.777', 'groupId': 'OG001'}, {'value': '12.18', 'spread': '11.506', 'groupId': 'OG002'}, {'value': '12.68', 'spread': '11.843', 'groupId': 'OG003'}, {'value': '10.54', 'spread': '11.719', 'groupId': 'OG004'}, {'value': '8.40', 'spread': '11.598', 'groupId': 'OG005'}, {'value': '8.27', 'spread': '11.770', 'groupId': 'OG006'}, {'value': '7.86', 'spread': '13.129', 'groupId': 'OG007'}, {'value': '6.71', 'spread': '10.363', 'groupId': 'OG008'}, {'value': '6.23', 'spread': '12.306', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}, {'value': '90', 'groupId': 'OG006'}, {'value': '106', 'groupId': 'OG007'}, {'value': '120', 'groupId': 'OG008'}, {'value': '114', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '39.79', 'spread': '8.801', 'groupId': 'OG000'}, {'value': '41.33', 'spread': '8.517', 'groupId': 'OG001'}, {'value': '40.07', 'spread': '7.625', 'groupId': 'OG002'}, {'value': '37.03', 'spread': '7.675', 'groupId': 'OG003'}, {'value': '37.92', 'spread': '8.353', 'groupId': 'OG004'}, {'value': '39.59', 'spread': '7.809', 'groupId': 'OG005'}, {'value': '37.53', 'spread': '8.286', 'groupId': 'OG006'}, {'value': '37.47', 'spread': '8.147', 'groupId': 'OG007'}, {'value': '40.73', 'spread': '8.552', 'groupId': 'OG008'}, {'value': '39.25', 'spread': '7.667', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 76', 'categories': [{'measurements': [{'value': '9.69', 'spread': '9.714', 'groupId': 'OG000'}, {'value': '8.97', 'spread': '8.891', 'groupId': 'OG001'}, {'value': '10.54', 'spread': '6.416', 'groupId': 'OG002'}, {'value': '10.48', 'spread': '7.797', 'groupId': 'OG003'}, {'value': '11.98', 'spread': '9.496', 'groupId': 'OG004'}, {'value': '10.28', 'spread': '7.651', 'groupId': 'OG005'}, {'value': '7.77', 'spread': '8.397', 'groupId': 'OG006'}, {'value': '8.82', 'spread': '8.501', 'groupId': 'OG007'}, {'value': '9.73', 'spread': '8.461', 'groupId': 'OG008'}, {'value': '7.31', 'spread': '8.436', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}, {'value': '90', 'groupId': 'OG006'}, {'value': '106', 'groupId': 'OG007'}, {'value': '120', 'groupId': 'OG008'}, {'value': '114', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '39.41', 'spread': '11.201', 'groupId': 'OG000'}, {'value': '41.30', 'spread': '10.710', 'groupId': 'OG001'}, {'value': '38.26', 'spread': '10.974', 'groupId': 'OG002'}, {'value': '35.50', 'spread': '11.582', 'groupId': 'OG003'}, {'value': '38.86', 'spread': '10.046', 'groupId': 'OG004'}, {'value': '38.52', 'spread': '12.244', 'groupId': 'OG005'}, {'value': '36.68', 'spread': '11.947', 'groupId': 'OG006'}, {'value': '39.03', 'spread': '12.679', 'groupId': 'OG007'}, {'value': '40.32', 'spread': '11.673', 'groupId': 'OG008'}, {'value': '39.16', 'spread': '11.712', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 76', 'categories': [{'measurements': [{'value': '9.64', 'spread': '14.272', 'groupId': 'OG000'}, {'value': '8.52', 'spread': '11.462', 'groupId': 'OG001'}, {'value': '10.51', 'spread': '12.334', 'groupId': 'OG002'}, {'value': '12.92', 'spread': '13.174', 'groupId': 'OG003'}, {'value': '8.02', 'spread': '14.020', 'groupId': 'OG004'}, {'value': '9.13', 'spread': '13.719', 'groupId': 'OG005'}, {'value': '8.27', 'spread': '12.720', 'groupId': 'OG006'}, {'value': '8.26', 'spread': '12.809', 'groupId': 'OG007'}, {'value': '7.77', 'spread': '10.989', 'groupId': 'OG008'}, {'value': '7.16', 'spread': '13.144', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '84', 'groupId': 'OG006'}, {'value': '96', 'groupId': 'OG007'}, {'value': '114', 'groupId': 'OG008'}, {'value': '105', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '41.26', 'spread': '8.825', 'groupId': 'OG000'}, {'value': '41.03', 'spread': '8.260', 'groupId': 'OG001'}, {'value': '40.29', 'spread': '7.480', 'groupId': 'OG002'}, {'value': '36.97', 'spread': '7.677', 'groupId': 'OG003'}, {'value': '38.11', 'spread': '8.169', 'groupId': 'OG004'}, {'value': '39.59', 'spread': '7.989', 'groupId': 'OG005'}, {'value': '37.26', 'spread': '7.974', 'groupId': 'OG006'}, {'value': '37.90', 'spread': '8.297', 'groupId': 'OG007'}, {'value': '41.13', 'spread': '8.579', 'groupId': 'OG008'}, {'value': '39.28', 'spread': '7.458', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 100', 'categories': [{'measurements': [{'value': '10.28', 'spread': '8.418', 'groupId': 'OG000'}, {'value': '9.41', 'spread': '7.934', 'groupId': 'OG001'}, {'value': '9.42', 'spread': '7.556', 'groupId': 'OG002'}, {'value': '11.18', 'spread': '8.322', 'groupId': 'OG003'}, {'value': '12.97', 'spread': '9.396', 'groupId': 'OG004'}, {'value': '10.78', 'spread': '8.926', 'groupId': 'OG005'}, {'value': '8.47', 'spread': '8.096', 'groupId': 'OG006'}, {'value': '9.45', 'spread': '8.747', 'groupId': 'OG007'}, {'value': '9.70', 'spread': '8.869', 'groupId': 'OG008'}, {'value': '7.40', 'spread': '8.473', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '84', 'groupId': 'OG006'}, {'value': '96', 'groupId': 'OG007'}, {'value': '114', 'groupId': 'OG008'}, {'value': '105', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '39.56', 'spread': '11.833', 'groupId': 'OG000'}, {'value': '41.10', 'spread': '11.140', 'groupId': 'OG001'}, {'value': '38.21', 'spread': '10.885', 'groupId': 'OG002'}, {'value': '35.61', 'spread': '11.568', 'groupId': 'OG003'}, {'value': '38.76', 'spread': '10.215', 'groupId': 'OG004'}, {'value': '37.41', 'spread': '11.857', 'groupId': 'OG005'}, {'value': '36.61', 'spread': '11.894', 'groupId': 'OG006'}, {'value': '39.43', 'spread': '12.474', 'groupId': 'OG007'}, {'value': '40.39', 'spread': '11.559', 'groupId': 'OG008'}, {'value': '39.04', 'spread': '11.604', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 100', 'categories': [{'measurements': [{'value': '8.80', 'spread': '14.395', 'groupId': 'OG000'}, {'value': '9.87', 'spread': '10.552', 'groupId': 'OG001'}, {'value': '10.82', 'spread': '12.303', 'groupId': 'OG002'}, {'value': '10.64', 'spread': '13.629', 'groupId': 'OG003'}, {'value': '8.94', 'spread': '13.798', 'groupId': 'OG004'}, {'value': '9.98', 'spread': '11.450', 'groupId': 'OG005'}, {'value': '8.25', 'spread': '12.562', 'groupId': 'OG006'}, {'value': '7.93', 'spread': '11.053', 'groupId': 'OG007'}, {'value': '7.66', 'spread': '10.685', 'groupId': 'OG008'}, {'value': '6.94', 'spread': '13.189', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '80', 'groupId': 'OG006'}, {'value': '83', 'groupId': 'OG007'}, {'value': '97', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '41.75', 'spread': '7.947', 'groupId': 'OG000'}, {'value': '41.08', 'spread': '8.219', 'groupId': 'OG001'}, {'value': '39.88', 'spread': '7.332', 'groupId': 'OG002'}, {'value': '37.00', 'spread': '7.854', 'groupId': 'OG003'}, {'value': '38.58', 'spread': '8.078', 'groupId': 'OG004'}, {'value': '39.31', 'spread': '8.279', 'groupId': 'OG005'}, {'value': '37.09', 'spread': '8.044', 'groupId': 'OG006'}, {'value': '38.36', 'spread': '8.240', 'groupId': 'OG007'}, {'value': '41.10', 'spread': '8.747', 'groupId': 'OG008'}, {'value': '39.01', 'spread': '7.363', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 124', 'categories': [{'measurements': [{'value': '10.12', 'spread': '9.685', 'groupId': 'OG000'}, {'value': '7.91', 'spread': '9.483', 'groupId': 'OG001'}, {'value': '10.15', 'spread': '8.551', 'groupId': 'OG002'}, {'value': '11.79', 'spread': '8.053', 'groupId': 'OG003'}, {'value': '12.87', 'spread': '8.803', 'groupId': 'OG004'}, {'value': '11.01', 'spread': '8.319', 'groupId': 'OG005'}, {'value': '8.36', 'spread': '7.495', 'groupId': 'OG006'}, {'value': '7.77', 'spread': '9.228', 'groupId': 'OG007'}, {'value': '10.56', 'spread': '8.804', 'groupId': 'OG008'}, {'value': '9.27', 'spread': '8.274', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '80', 'groupId': 'OG006'}, {'value': '83', 'groupId': 'OG007'}, {'value': '97', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '40.34', 'spread': '12.065', 'groupId': 'OG000'}, {'value': '40.81', 'spread': '11.132', 'groupId': 'OG001'}, {'value': '37.85', 'spread': '11.106', 'groupId': 'OG002'}, {'value': '35.29', 'spread': '11.668', 'groupId': 'OG003'}, {'value': '38.59', 'spread': '9.956', 'groupId': 'OG004'}, {'value': '38.33', 'spread': '12.409', 'groupId': 'OG005'}, {'value': '39.04', 'spread': '12.421', 'groupId': 'OG006'}, {'value': '36.64', 'spread': '11.938', 'groupId': 'OG007'}, {'value': '40.87', 'spread': '11.156', 'groupId': 'OG008'}, {'value': '38.90', 'spread': '11.427', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 124', 'categories': [{'measurements': [{'value': '9.53', 'spread': '16.289', 'groupId': 'OG000'}, {'value': '10.02', 'spread': '10.734', 'groupId': 'OG001'}, {'value': '9.70', 'spread': '12.781', 'groupId': 'OG002'}, {'value': '11.35', 'spread': '12.681', 'groupId': 'OG003'}, {'value': '9.20', 'spread': '12.521', 'groupId': 'OG004'}, {'value': '10.38', 'spread': '13.230', 'groupId': 'OG005'}, {'value': '8.50', 'spread': '12.808', 'groupId': 'OG006'}, {'value': '8.78', 'spread': '13.283', 'groupId': 'OG007'}, {'value': '7.73', 'spread': '11.048', 'groupId': 'OG008'}, {'value': '6.26', 'spread': '13.274', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '76', 'groupId': 'OG006'}, {'value': '82', 'groupId': 'OG007'}, {'value': '20', 'groupId': 'OG008'}, {'value': '24', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '41.75', 'spread': '7.947', 'groupId': 'OG000'}, {'value': '41.33', 'spread': '8.438', 'groupId': 'OG001'}, {'value': '39.86', 'spread': '7.312', 'groupId': 'OG002'}, {'value': '36.68', 'spread': '8.055', 'groupId': 'OG003'}, {'value': '39.22', 'spread': '7.511', 'groupId': 'OG004'}, {'value': '39.21', 'spread': '8.303', 'groupId': 'OG005'}, {'value': '36.94', 'spread': '8.087', 'groupId': 'OG006'}, {'value': '37.99', 'spread': '8.430', 'groupId': 'OG007'}, {'value': '43.32', 'spread': '10.405', 'groupId': 'OG008'}, {'value': '38.77', 'spread': '7.024', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 148', 'categories': [{'measurements': [{'value': '9.08', 'spread': '9.090', 'groupId': 'OG000'}, {'value': '9.35', 'spread': '8.228', 'groupId': 'OG001'}, {'value': '10.34', 'spread': '6.524', 'groupId': 'OG002'}, {'value': '12.15', 'spread': '9.941', 'groupId': 'OG003'}, {'value': '12.54', 'spread': '9.695', 'groupId': 'OG004'}, {'value': '11.26', 'spread': '7.231', 'groupId': 'OG005'}, {'value': '9.37', 'spread': '8.223', 'groupId': 'OG006'}, {'value': '8.94', 'spread': '8.442', 'groupId': 'OG007'}, {'value': '9.81', 'spread': '8.727', 'groupId': 'OG008'}, {'value': '10.39', 'spread': '6.824', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '76', 'groupId': 'OG006'}, {'value': '82', 'groupId': 'OG007'}, {'value': '20', 'groupId': 'OG008'}, {'value': '24', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '40.34', 'spread': '12.065', 'groupId': 'OG000'}, {'value': '41.20', 'spread': '11.115', 'groupId': 'OG001'}, {'value': '37.48', 'spread': '11.101', 'groupId': 'OG002'}, {'value': '35.05', 'spread': '11.782', 'groupId': 'OG003'}, {'value': '38.56', 'spread': '10.221', 'groupId': 'OG004'}, {'value': '39.21', 'spread': '12.368', 'groupId': 'OG005'}, {'value': '36.71', 'spread': '12.021', 'groupId': 'OG006'}, {'value': '39.36', 'spread': '12.612', 'groupId': 'OG007'}, {'value': '42.40', 'spread': '8.427', 'groupId': 'OG008'}, {'value': '41.67', 'spread': '10.953', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 148', 'categories': [{'measurements': [{'value': '6.89', 'spread': '14.522', 'groupId': 'OG000'}, {'value': '9.79', 'spread': '11.176', 'groupId': 'OG001'}, {'value': '11.09', 'spread': '12.299', 'groupId': 'OG002'}, {'value': '10.47', 'spread': '12.517', 'groupId': 'OG003'}, {'value': '9.27', 'spread': '11.720', 'groupId': 'OG004'}, {'value': '9.81', 'spread': '12.524', 'groupId': 'OG005'}, {'value': '8.91', 'spread': '12.680', 'groupId': 'OG006'}, {'value': '8.26', 'spread': '12.835', 'groupId': 'OG007'}, {'value': '6.44', 'spread': '12.279', 'groupId': 'OG008'}, {'value': '6.85', 'spread': '12.118', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '71', 'groupId': 'OG006'}, {'value': '75', 'groupId': 'OG007'}, {'value': '91', 'groupId': 'OG008'}, {'value': '81', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '42.23', 'spread': '8.073', 'groupId': 'OG000'}, {'value': '41.52', 'spread': '8.401', 'groupId': 'OG001'}, {'value': '40.23', 'spread': '6.713', 'groupId': 'OG002'}, {'value': '37.29', 'spread': '8.057', 'groupId': 'OG003'}, {'value': '38.82', 'spread': '8.231', 'groupId': 'OG004'}, {'value': '39.16', 'spread': '8.177', 'groupId': 'OG005'}, {'value': '36.92', 'spread': '8.023', 'groupId': 'OG006'}, {'value': '37.85', 'spread': '8.538', 'groupId': 'OG007'}, {'value': '41.12', 'spread': '9.029', 'groupId': 'OG008'}, {'value': '39.30', 'spread': '7.264', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 172', 'categories': [{'measurements': [{'value': '10.08', 'spread': '8.996', 'groupId': 'OG000'}, {'value': '9.20', 'spread': '8.324', 'groupId': 'OG001'}, {'value': '9.68', 'spread': '6.804', 'groupId': 'OG002'}, {'value': '11.83', 'spread': '8.042', 'groupId': 'OG003'}, {'value': '13.21', 'spread': '9.194', 'groupId': 'OG004'}, {'value': '10.88', 'spread': '7.837', 'groupId': 'OG005'}, {'value': '9.61', 'spread': '8.461', 'groupId': 'OG006'}, {'value': '9.07', 'spread': '7.519', 'groupId': 'OG007'}, {'value': '10.47', 'spread': '8.921', 'groupId': 'OG008'}, {'value': '8.55', 'spread': '8.546', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '71', 'groupId': 'OG006'}, {'value': '75', 'groupId': 'OG007'}, {'value': '91', 'groupId': 'OG008'}, {'value': '81', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '40.79', 'spread': '12.254', 'groupId': 'OG000'}, {'value': '41.49', 'spread': '11.015', 'groupId': 'OG001'}, {'value': '37.00', 'spread': '10.963', 'groupId': 'OG002'}, {'value': '35.47', 'spread': '11.757', 'groupId': 'OG003'}, {'value': '38.77', 'spread': '10.268', 'groupId': 'OG004'}, {'value': '39.83', 'spread': '12.249', 'groupId': 'OG005'}, {'value': '36.64', 'spread': '11.938', 'groupId': 'OG006'}, {'value': '39.01', 'spread': '12.258', 'groupId': 'OG007'}, {'value': '40.98', 'spread': '11.479', 'groupId': 'OG008'}, {'value': '38.85', 'spread': '11.972', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 172', 'categories': [{'measurements': [{'value': '7.43', 'spread': '12.227', 'groupId': 'OG000'}, {'value': '10.37', 'spread': '10.420', 'groupId': 'OG001'}, {'value': '9.57', 'spread': '12.850', 'groupId': 'OG002'}, {'value': '12.84', 'spread': '12.281', 'groupId': 'OG003'}, {'value': '9.12', 'spread': '14.244', 'groupId': 'OG004'}, {'value': '8.45', 'spread': '13.317', 'groupId': 'OG005'}, {'value': '8.78', 'spread': '13.283', 'groupId': 'OG006'}, {'value': '7.52', 'spread': '12.609', 'groupId': 'OG007'}, {'value': '8.66', 'spread': '10.767', 'groupId': 'OG008'}, {'value': '7.48', 'spread': '12.329', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '40.72', 'spread': '7.823', 'groupId': 'OG000'}, {'value': '40.83', 'spread': '8.135', 'groupId': 'OG001'}, {'value': '40.52', 'spread': '7.242', 'groupId': 'OG002'}, {'value': '35.64', 'spread': '7.862', 'groupId': 'OG003'}, {'value': '36.65', 'spread': '9.250', 'groupId': 'OG004'}, {'value': '39.33', 'spread': '8.136', 'groupId': 'OG005'}, {'value': '39.53', 'spread': '7.830', 'groupId': 'OG006'}, {'value': '38.40', 'spread': '9.680', 'groupId': 'OG007'}]}]}, {'title': 'Change at Week 196', 'categories': [{'measurements': [{'value': '11.82', 'spread': '9.370', 'groupId': 'OG000'}, {'value': '9.98', 'spread': '7.569', 'groupId': 'OG001'}, {'value': '9.31', 'spread': '5.771', 'groupId': 'OG002'}, {'value': '12.35', 'spread': '8.867', 'groupId': 'OG003'}, {'value': '14.10', 'spread': '10.616', 'groupId': 'OG004'}, {'value': '11.75', 'spread': '8.261', 'groupId': 'OG005'}, {'value': '6.94', 'spread': '8.667', 'groupId': 'OG006'}, {'value': '9.83', 'spread': '8.111', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '19', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '39.46', 'spread': '13.424', 'groupId': 'OG000'}, {'value': '42.74', 'spread': '10.517', 'groupId': 'OG001'}, {'value': '40.40', 'spread': '9.771', 'groupId': 'OG002'}, {'value': '36.17', 'spread': '12.536', 'groupId': 'OG003'}, {'value': '39.07', 'spread': '10.804', 'groupId': 'OG004'}, {'value': '37.63', 'spread': '12.199', 'groupId': 'OG005'}, {'value': '40.11', 'spread': '10.932', 'groupId': 'OG006'}, {'value': '40.05', 'spread': '13.807', 'groupId': 'OG007'}]}]}, {'title': 'Change at Week 196', 'categories': [{'measurements': [{'value': '9.37', 'spread': '12.087', 'groupId': 'OG000'}, {'value': '9.43', 'spread': '9.349', 'groupId': 'OG001'}, {'value': '9.79', 'spread': '11.516', 'groupId': 'OG002'}, {'value': '12.62', 'spread': '14.386', 'groupId': 'OG003'}, {'value': '10.05', 'spread': '15.471', 'groupId': 'OG004'}, {'value': '9.26', 'spread': '12.732', 'groupId': 'OG005'}, {'value': '8.59', 'spread': '14.645', 'groupId': 'OG006'}, {'value': '9.75', 'spread': '14.824', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '45', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '39.99', 'spread': '7.219', 'groupId': 'OG000'}, {'value': '40.71', 'spread': '7.605', 'groupId': 'OG001'}, {'value': '39.33', 'spread': '6.820', 'groupId': 'OG002'}, {'value': '37.54', 'spread': '8.054', 'groupId': 'OG003'}, {'value': '38.32', 'spread': '8.047', 'groupId': 'OG004'}, {'value': '40.28', 'spread': '8.878', 'groupId': 'OG005'}, {'value': '37.95', 'spread': '8.232', 'groupId': 'OG006'}, {'value': '37.77', 'spread': '8.654', 'groupId': 'OG007'}, {'value': '39.17', 'spread': '13.987', 'groupId': 'OG008'}, {'value': '38.79', 'spread': '7.735', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 248', 'categories': [{'measurements': [{'value': '11.22', 'spread': '10.562', 'groupId': 'OG000'}, {'value': '9.95', 'spread': '8.355', 'groupId': 'OG001'}, {'value': '11.43', 'spread': '8.047', 'groupId': 'OG002'}, {'value': '11.70', 'spread': '6.541', 'groupId': 'OG003'}, {'value': '13.88', 'spread': '8.511', 'groupId': 'OG004'}, {'value': '9.98', 'spread': '9.027', 'groupId': 'OG005'}, {'value': '9.32', 'spread': '9.261', 'groupId': 'OG006'}, {'value': '10.50', 'spread': '8.803', 'groupId': 'OG007'}, {'value': '15.98', 'spread': '7.868', 'groupId': 'OG008'}, {'value': '9.88', 'spread': '6.977', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '45', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '38.00', 'spread': '12.537', 'groupId': 'OG000'}, {'value': '41.76', 'spread': '10.579', 'groupId': 'OG001'}, {'value': '38.01', 'spread': '10.876', 'groupId': 'OG002'}, {'value': '34.26', 'spread': '12.252', 'groupId': 'OG003'}, {'value': '38.06', 'spread': '10.300', 'groupId': 'OG004'}, {'value': '38.04', 'spread': '11.320', 'groupId': 'OG005'}, {'value': '36.41', 'spread': '13.568', 'groupId': 'OG006'}, {'value': '36.77', 'spread': '12.333', 'groupId': 'OG007'}, {'value': '38.65', 'spread': '18.372', 'groupId': 'OG008'}, {'value': '31.20', 'spread': '4.603', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 248', 'categories': [{'measurements': [{'value': '11.99', 'spread': '13.421', 'groupId': 'OG000'}, {'value': '6.13', 'spread': '9.986', 'groupId': 'OG001'}, {'value': '10.41', 'spread': '13.081', 'groupId': 'OG002'}, {'value': '12.70', 'spread': '12.140', 'groupId': 'OG003'}, {'value': '9.84', 'spread': '11.433', 'groupId': 'OG004'}, {'value': '10.61', 'spread': '11.204', 'groupId': 'OG005'}, {'value': '7.37', 'spread': '16.473', 'groupId': 'OG006'}, {'value': '10.61', 'spread': '12.188', 'groupId': 'OG007'}, {'value': '7.64', 'spread': '18.599', 'groupId': 'OG008'}, {'value': '15.98', 'spread': '13.355', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '36.89', 'spread': '5.913', 'groupId': 'OG000'}, {'value': '38.84', 'spread': '7.720', 'groupId': 'OG001'}, {'value': '39.22', 'spread': '5.469', 'groupId': 'OG002'}, {'value': '36.56', 'spread': '8.514', 'groupId': 'OG003'}, {'value': '34.80', 'spread': '8.431', 'groupId': 'OG004'}, {'value': '39.97', 'spread': '6.626', 'groupId': 'OG005'}, {'value': '41.04', 'spread': '12.016', 'groupId': 'OG006'}, {'value': '34.80', 'spread': '10.515', 'groupId': 'OG007'}]}]}, {'title': 'Change at Week 300', 'categories': [{'measurements': [{'value': '12.03', 'spread': '10.338', 'groupId': 'OG000'}, {'value': '10.58', 'spread': '8.335', 'groupId': 'OG001'}, {'value': '11.15', 'spread': '6.497', 'groupId': 'OG002'}, {'value': '15.47', 'spread': '9.920', 'groupId': 'OG003'}, {'value': '14.42', 'spread': '6.749', 'groupId': 'OG004'}, {'value': '10.69', 'spread': '6.448', 'groupId': 'OG005'}, {'value': '9.10', 'spread': '9.330', 'groupId': 'OG006'}, {'value': '6.41', 'spread': '9.023', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '34.53', 'spread': '12.530', 'groupId': 'OG000'}, {'value': '43.55', 'spread': '9.074', 'groupId': 'OG001'}, {'value': '35.77', 'spread': '8.585', 'groupId': 'OG002'}, {'value': '33.38', 'spread': '11.168', 'groupId': 'OG003'}, {'value': '39.40', 'spread': '11.144', 'groupId': 'OG004'}, {'value': '35.79', 'spread': '12.157', 'groupId': 'OG005'}, {'value': '31.35', 'spread': '13.760', 'groupId': 'OG006'}, {'value': '46.99', 'spread': '7.729', 'groupId': 'OG007'}]}]}, {'title': 'Change at Week 300', 'categories': [{'measurements': [{'value': '21.86', 'spread': '13.935', 'groupId': 'OG000'}, {'value': '4.82', 'spread': '10.738', 'groupId': 'OG001'}, {'value': '9.82', 'spread': '11.463', 'groupId': 'OG002'}, {'value': '13.46', 'spread': '15.324', 'groupId': 'OG003'}, {'value': '6.31', 'spread': '11.916', 'groupId': 'OG004'}, {'value': '14.79', 'spread': '15.281', 'groupId': 'OG005'}, {'value': '19.87', 'spread': '6.588', 'groupId': 'OG006'}, {'value': '-3.67', 'spread': '20.577', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '35.68', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG000'}, {'value': '38.32', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '44.36', 'spread': '0.920', 'groupId': 'OG002'}, {'value': '31.07', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG003'}, {'value': '37.14', 'spread': '3.711', 'groupId': 'OG004'}, {'value': '33.67', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 352', 'categories': [{'measurements': [{'value': '17.97', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG000'}, {'value': '17.87', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '5.06', 'spread': '5.188', 'groupId': 'OG002'}, {'value': '24.06', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG003'}, {'value': '11.18', 'spread': '2.116', 'groupId': 'OG004'}, {'value': '18.02', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '42.19', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG000'}, {'value': '35.34', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '32.72', 'spread': '7.252', 'groupId': 'OG002'}, {'value': '22.18', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG003'}, {'value': '39.80', 'spread': '14.563', 'groupId': 'OG004'}, {'value': '42.98', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 352', 'categories': [{'measurements': [{'value': '17.40', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG000'}, {'value': '19.87', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '14.14', 'spread': '10.114', 'groupId': 'OG002'}, {'value': '25.04', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG003'}, {'value': '8.65', 'spread': '7.463', 'groupId': 'OG004'}, {'value': '13.08', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}, {'value': '71', 'groupId': 'OG005'}, {'value': '126', 'groupId': 'OG006'}, {'value': '136', 'groupId': 'OG007'}, {'value': '151', 'groupId': 'OG008'}, {'value': '162', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.42', 'spread': '1.328', 'groupId': 'OG000'}, {'value': '7.21', 'spread': '1.354', 'groupId': 'OG001'}, {'value': '7.54', 'spread': '1.399', 'groupId': 'OG002'}, {'value': '8.00', 'spread': '1.559', 'groupId': 'OG003'}, {'value': '7.77', 'spread': '1.442', 'groupId': 'OG004'}, {'value': '7.73', 'spread': '1.434', 'groupId': 'OG005'}, {'value': '7.67', 'spread': '1.475', 'groupId': 'OG006'}, {'value': '7.85', 'spread': '1.525', 'groupId': 'OG007'}, {'value': '7.30', 'spread': '1.360', 'groupId': 'OG008'}, {'value': '7.48', 'spread': '1.420', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 28', 'categories': [{'measurements': [{'value': '-1.29', 'spread': '1.873', 'groupId': 'OG000'}, {'value': '-1.03', 'spread': '1.705', 'groupId': 'OG001'}, {'value': '-1.44', 'spread': '1.568', 'groupId': 'OG002'}, {'value': '-1.65', 'spread': '1.867', 'groupId': 'OG003'}, {'value': '-1.82', 'spread': '1.675', 'groupId': 'OG004'}, {'value': '-1.46', 'spread': '1.510', 'groupId': 'OG005'}, {'value': '-0.75', 'spread': '1.648', 'groupId': 'OG006'}, {'value': '-0.90', 'spread': '1.634', 'groupId': 'OG007'}, {'value': '-0.96', 'spread': '1.380', 'groupId': 'OG008'}, {'value': '-0.69', 'spread': '1.493', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}, {'value': '70', 'groupId': 'OG005'}, {'value': '125', 'groupId': 'OG006'}, {'value': '135', 'groupId': 'OG007'}, {'value': '149', 'groupId': 'OG008'}, {'value': '157', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '58.4', 'spread': '20.96', 'groupId': 'OG000'}, {'value': '62.1', 'spread': '16.54', 'groupId': 'OG001'}, {'value': '53.5', 'spread': '17.30', 'groupId': 'OG002'}, {'value': '51.5', 'spread': '17.57', 'groupId': 'OG003'}, {'value': '52.2', 'spread': '18.72', 'groupId': 'OG004'}, {'value': '52.3', 'spread': '18.39', 'groupId': 'OG005'}, {'value': '53.2', 'spread': '18.02', 'groupId': 'OG006'}, {'value': '51.3', 'spread': '19.09', 'groupId': 'OG007'}, {'value': '56.4', 'spread': '19.64', 'groupId': 'OG008'}, {'value': '55.6', 'spread': '16.72', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 28', 'categories': [{'measurements': [{'value': '22.7', 'spread': '24.11', 'groupId': 'OG000'}, {'value': '20.0', 'spread': '18.75', 'groupId': 'OG001'}, {'value': '25.1', 'spread': '22.09', 'groupId': 'OG002'}, {'value': '23.8', 'spread': '23.79', 'groupId': 'OG003'}, {'value': '27.6', 'spread': '22.58', 'groupId': 'OG004'}, {'value': '23.7', 'spread': '22.51', 'groupId': 'OG005'}, {'value': '16.8', 'spread': '22.55', 'groupId': 'OG006'}, {'value': '19.9', 'spread': '22.44', 'groupId': 'OG007'}, {'value': '17.1', 'spread': '21.75', 'groupId': 'OG008'}, {'value': '13.4', 'spread': '19.48', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '63', 'groupId': 'OG005'}, {'value': '107', 'groupId': 'OG006'}, {'value': '118', 'groupId': 'OG007'}, {'value': '133', 'groupId': 'OG008'}, {'value': '135', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.50', 'spread': '1.368', 'groupId': 'OG000'}, {'value': '7.17', 'spread': '1.318', 'groupId': 'OG001'}, {'value': '7.54', 'spread': '1.390', 'groupId': 'OG002'}, {'value': '8.08', 'spread': '1.499', 'groupId': 'OG003'}, {'value': '7.75', 'spread': '1.468', 'groupId': 'OG004'}, {'value': '7.65', 'spread': '1.358', 'groupId': 'OG005'}, {'value': '7.62', 'spread': '1.398', 'groupId': 'OG006'}, {'value': '7.74', 'spread': '1.538', 'groupId': 'OG007'}, {'value': '7.33', 'spread': '1.386', 'groupId': 'OG008'}, {'value': '7.49', 'spread': '1.429', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 52', 'categories': [{'measurements': [{'value': '-1.59', 'spread': '1.775', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '1.571', 'groupId': 'OG001'}, {'value': '-1.43', 'spread': '1.556', 'groupId': 'OG002'}, {'value': '-1.60', 'spread': '1.673', 'groupId': 'OG003'}, {'value': '-1.77', 'spread': '1.640', 'groupId': 'OG004'}, {'value': '-1.46', 'spread': '1.457', 'groupId': 'OG005'}, {'value': '-0.87', 'spread': '1.666', 'groupId': 'OG006'}, {'value': '-1.15', 'spread': '1.703', 'groupId': 'OG007'}, {'value': '-0.95', 'spread': '1.551', 'groupId': 'OG008'}, {'value': '-0.85', 'spread': '1.637', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '62', 'groupId': 'OG005'}, {'value': '105', 'groupId': 'OG006'}, {'value': '118', 'groupId': 'OG007'}, {'value': '129', 'groupId': 'OG008'}, {'value': '133', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '57.5', 'spread': '21.39', 'groupId': 'OG000'}, {'value': '61.9', 'spread': '16.18', 'groupId': 'OG001'}, {'value': '52.3', 'spread': '18.09', 'groupId': 'OG002'}, {'value': '50.8', 'spread': '17.82', 'groupId': 'OG003'}, {'value': '52.6', 'spread': '19.43', 'groupId': 'OG004'}, {'value': '52.7', 'spread': '18.38', 'groupId': 'OG005'}, {'value': '53.3', 'spread': '17.21', 'groupId': 'OG006'}, {'value': '52.2', 'spread': '18.94', 'groupId': 'OG007'}, {'value': '55.9', 'spread': '20.51', 'groupId': 'OG008'}, {'value': '56.3', 'spread': '16.21', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 52', 'categories': [{'measurements': [{'value': '22.9', 'spread': '27.46', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '20.31', 'groupId': 'OG001'}, {'value': '27.0', 'spread': '21.87', 'groupId': 'OG002'}, {'value': '27.9', 'spread': '20.70', 'groupId': 'OG003'}, {'value': '30.8', 'spread': '21.59', 'groupId': 'OG004'}, {'value': '25.0', 'spread': '18.85', 'groupId': 'OG005'}, {'value': '19.9', 'spread': '22.83', 'groupId': 'OG006'}, {'value': '23.5', 'spread': '23.03', 'groupId': 'OG007'}, {'value': '20.8', 'spread': '21.93', 'groupId': 'OG008'}, {'value': '17.6', 'spread': '22.69', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '58', 'groupId': 'OG005'}, {'value': '89', 'groupId': 'OG006'}, {'value': '106', 'groupId': 'OG007'}, {'value': '120', 'groupId': 'OG008'}, {'value': '113', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.48', 'spread': '1.379', 'groupId': 'OG000'}, {'value': '7.18', 'spread': '1.337', 'groupId': 'OG001'}, {'value': '7.56', 'spread': '1.267', 'groupId': 'OG002'}, {'value': '8.11', 'spread': '1.434', 'groupId': 'OG003'}, {'value': '7.72', 'spread': '1.420', 'groupId': 'OG004'}, {'value': '7.64', 'spread': '1.385', 'groupId': 'OG005'}, {'value': '7.69', 'spread': '1.489', 'groupId': 'OG006'}, {'value': '7.74', 'spread': '1.545', 'groupId': 'OG007'}, {'value': '7.28', 'spread': '1.348', 'groupId': 'OG008'}, {'value': '7.52', 'spread': '1.464', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 76', 'categories': [{'measurements': [{'value': '-1.38', 'spread': '1.498', 'groupId': 'OG000'}, {'value': '-1.05', 'spread': '1.583', 'groupId': 'OG001'}, {'value': '-1.33', 'spread': '1.513', 'groupId': 'OG002'}, {'value': '-1.67', 'spread': '1.430', 'groupId': 'OG003'}, {'value': '-1.50', 'spread': '1.724', 'groupId': 'OG004'}, {'value': '-1.52', 'spread': '1.466', 'groupId': 'OG005'}, {'value': '-1.11', 'spread': '1.518', 'groupId': 'OG006'}, {'value': '-1.14', 'spread': '1.496', 'groupId': 'OG007'}, {'value': '-1.26', 'spread': '1.481', 'groupId': 'OG008'}, {'value': '-1.05', 'spread': '1.546', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '57', 'groupId': 'OG005'}, {'value': '88', 'groupId': 'OG006'}, {'value': '106', 'groupId': 'OG007'}, {'value': '119', 'groupId': 'OG008'}, {'value': '113', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '58.8', 'spread': '21.93', 'groupId': 'OG000'}, {'value': '62.3', 'spread': '17.01', 'groupId': 'OG001'}, {'value': '52.0', 'spread': '18.47', 'groupId': 'OG002'}, {'value': '50.7', 'spread': '16.81', 'groupId': 'OG003'}, {'value': '52.0', 'spread': '19.38', 'groupId': 'OG004'}, {'value': '52.4', 'spread': '18.88', 'groupId': 'OG005'}, {'value': '52.5', 'spread': '17.18', 'groupId': 'OG006'}, {'value': '51.4', 'spread': '18.99', 'groupId': 'OG007'}, {'value': '56.1', 'spread': '20.36', 'groupId': 'OG008'}, {'value': '55.8', 'spread': '16.19', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 76', 'categories': [{'measurements': [{'value': '20.9', 'spread': '25.66', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '20.65', 'groupId': 'OG001'}, {'value': '25.1', 'spread': '19.62', 'groupId': 'OG002'}, {'value': '27.3', 'spread': '18.87', 'groupId': 'OG003'}, {'value': '30.3', 'spread': '23.68', 'groupId': 'OG004'}, {'value': '27.0', 'spread': '21.49', 'groupId': 'OG005'}, {'value': '22.2', 'spread': '20.82', 'groupId': 'OG006'}, {'value': '23.3', 'spread': '21.40', 'groupId': 'OG007'}, {'value': '19.2', 'spread': '25.10', 'groupId': 'OG008'}, {'value': '17.8', 'spread': '22.04', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}, {'value': '84', 'groupId': 'OG006'}, {'value': '96', 'groupId': 'OG007'}, {'value': '114', 'groupId': 'OG008'}, {'value': '105', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.48', 'spread': '1.451', 'groupId': 'OG000'}, {'value': '7.22', 'spread': '1.325', 'groupId': 'OG001'}, {'value': '7.55', 'spread': '1.391', 'groupId': 'OG002'}, {'value': '8.04', 'spread': '1.507', 'groupId': 'OG003'}, {'value': '7.69', 'spread': '1.446', 'groupId': 'OG004'}, {'value': '7.67', 'spread': '1.375', 'groupId': 'OG005'}, {'value': '7.71', 'spread': '1.428', 'groupId': 'OG006'}, {'value': '7.71', 'spread': '1.507', 'groupId': 'OG007'}, {'value': '7.28', 'spread': '1.360', 'groupId': 'OG008'}, {'value': '7.53', 'spread': '1.401', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 100', 'categories': [{'measurements': [{'value': '-1.48', 'spread': '1.602', 'groupId': 'OG000'}, {'value': '-1.26', 'spread': '1.528', 'groupId': 'OG001'}, {'value': '-1.43', 'spread': '1.452', 'groupId': 'OG002'}, {'value': '-1.64', 'spread': '1.773', 'groupId': 'OG003'}, {'value': '-1.73', 'spread': '1.741', 'groupId': 'OG004'}, {'value': '-1.62', 'spread': '1.394', 'groupId': 'OG005'}, {'value': '-1.04', 'spread': '1.609', 'groupId': 'OG006'}, {'value': '-1.16', 'spread': '1.538', 'groupId': 'OG007'}, {'value': '-1.37', 'spread': '1.477', 'groupId': 'OG008'}, {'value': '-0.98', 'spread': '1.473', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '54', 'groupId': 'OG005'}, {'value': '82', 'groupId': 'OG006'}, {'value': '95', 'groupId': 'OG007'}, {'value': '112', 'groupId': 'OG008'}, {'value': '103', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '59.2', 'spread': '22.81', 'groupId': 'OG000'}, {'value': '61.3', 'spread': '16.80', 'groupId': 'OG001'}, {'value': '52.9', 'spread': '16.94', 'groupId': 'OG002'}, {'value': '50.7', 'spread': '16.81', 'groupId': 'OG003'}, {'value': '53.8', 'spread': '18.76', 'groupId': 'OG004'}, {'value': '51.9', 'spread': '19.02', 'groupId': 'OG005'}, {'value': '51.9', 'spread': '16.53', 'groupId': 'OG006'}, {'value': '52.2', 'spread': '19.18', 'groupId': 'OG007'}, {'value': '56.5', 'spread': '20.68', 'groupId': 'OG008'}, {'value': '55.3', 'spread': '16.49', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 100', 'categories': [{'measurements': [{'value': '20.4', 'spread': '27.47', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '17.45', 'groupId': 'OG001'}, {'value': '26.4', 'spread': '21.82', 'groupId': 'OG002'}, {'value': '26.9', 'spread': '22.39', 'groupId': 'OG003'}, {'value': '29.4', 'spread': '23.09', 'groupId': 'OG004'}, {'value': '26.9', 'spread': '21.76', 'groupId': 'OG005'}, {'value': '22.3', 'spread': '20.11', 'groupId': 'OG006'}, {'value': '23.1', 'spread': '21.82', 'groupId': 'OG007'}, {'value': '19.4', 'spread': '26.78', 'groupId': 'OG008'}, {'value': '16.6', 'spread': '21.92', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '80', 'groupId': 'OG006'}, {'value': '83', 'groupId': 'OG007'}, {'value': '97', 'groupId': 'OG008'}, {'value': '98', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.33', 'spread': '1.271', 'groupId': 'OG000'}, {'value': '7.24', 'spread': '1.329', 'groupId': 'OG001'}, {'value': '7.61', 'spread': '1.406', 'groupId': 'OG002'}, {'value': '8.14', 'spread': '1.457', 'groupId': 'OG003'}, {'value': '7.62', 'spread': '1.423', 'groupId': 'OG004'}, {'value': '7.69', 'spread': '1.446', 'groupId': 'OG005'}, {'value': '7.73', 'spread': '1.441', 'groupId': 'OG006'}, {'value': '7.65', 'spread': '1.510', 'groupId': 'OG007'}, {'value': '7.28', 'spread': '1.223', 'groupId': 'OG008'}, {'value': '7.54', 'spread': '1.401', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 124', 'categories': [{'measurements': [{'value': '-1.52', 'spread': '1.805', 'groupId': 'OG000'}, {'value': '-1.07', 'spread': '1.566', 'groupId': 'OG001'}, {'value': '-1.52', 'spread': '1.539', 'groupId': 'OG002'}, {'value': '-1.70', 'spread': '1.655', 'groupId': 'OG003'}, {'value': '-1.60', 'spread': '1.690', 'groupId': 'OG004'}, {'value': '-1.69', 'spread': '1.560', 'groupId': 'OG005'}, {'value': '-0.85', 'spread': '1.662', 'groupId': 'OG006'}, {'value': '-1.05', 'spread': '1.637', 'groupId': 'OG007'}, {'value': '-1.34', 'spread': '1.560', 'groupId': 'OG008'}, {'value': '-1.07', 'spread': '1.639', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}, {'value': '79', 'groupId': 'OG006'}, {'value': '82', 'groupId': 'OG007'}, {'value': '96', 'groupId': 'OG008'}, {'value': '95', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '61.2', 'spread': '21.60', 'groupId': 'OG000'}, {'value': '61.6', 'spread': '16.98', 'groupId': 'OG001'}, {'value': '52.0', 'spread': '16.58', 'groupId': 'OG002'}, {'value': '50.0', 'spread': '16.87', 'groupId': 'OG003'}, {'value': '54.8', 'spread': '17.87', 'groupId': 'OG004'}, {'value': '52.4', 'spread': '19.58', 'groupId': 'OG005'}, {'value': '51.8', 'spread': '16.77', 'groupId': 'OG006'}, {'value': '52.8', 'spread': '19.62', 'groupId': 'OG007'}, {'value': '56.1', 'spread': '20.59', 'groupId': 'OG008'}, {'value': '55.6', 'spread': '15.81', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 124', 'categories': [{'measurements': [{'value': '24.0', 'spread': '25.45', 'groupId': 'OG000'}, {'value': '19.7', 'spread': '18.12', 'groupId': 'OG001'}, {'value': '23.8', 'spread': '21.39', 'groupId': 'OG002'}, {'value': '29.4', 'spread': '21.15', 'groupId': 'OG003'}, {'value': '28.1', 'spread': '20.71', 'groupId': 'OG004'}, {'value': '24.5', 'spread': '28.36', 'groupId': 'OG005'}, {'value': '21.1', 'spread': '21.77', 'groupId': 'OG006'}, {'value': '23.8', 'spread': '21.41', 'groupId': 'OG007'}, {'value': '22.2', 'spread': '26.13', 'groupId': 'OG008'}, {'value': '18.1', 'spread': '24.00', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}, {'value': '76', 'groupId': 'OG006'}, {'value': '83', 'groupId': 'OG007'}, {'value': '94', 'groupId': 'OG008'}, {'value': '93', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.33', 'spread': '1.271', 'groupId': 'OG000'}, {'value': '7.20', 'spread': '1.337', 'groupId': 'OG001'}, {'value': '7.64', 'spread': '1.415', 'groupId': 'OG002'}, {'value': '8.17', 'spread': '1.447', 'groupId': 'OG003'}, {'value': '7.60', 'spread': '1.450', 'groupId': 'OG004'}, {'value': '7.65', 'spread': '1.370', 'groupId': 'OG005'}, {'value': '7.75', 'spread': '1.434', 'groupId': 'OG006'}, {'value': '7.72', 'spread': '1.541', 'groupId': 'OG007'}, {'value': '7.31', 'spread': '1.376', 'groupId': 'OG008'}, {'value': '7.52', 'spread': '1.396', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 148', 'categories': [{'measurements': [{'value': '-1.30', 'spread': '1.589', 'groupId': 'OG000'}, {'value': '-1.26', 'spread': '1.544', 'groupId': 'OG001'}, {'value': '-1.62', 'spread': '1.417', 'groupId': 'OG002'}, {'value': '-1.66', 'spread': '1.559', 'groupId': 'OG003'}, {'value': '-1.74', 'spread': '1.774', 'groupId': 'OG004'}, {'value': '-1.67', 'spread': '1.175', 'groupId': 'OG005'}, {'value': '-1.11', 'spread': '1.740', 'groupId': 'OG006'}, {'value': '-1.36', 'spread': '1.679', 'groupId': 'OG007'}, {'value': '-1.47', 'spread': '1.591', 'groupId': 'OG008'}, {'value': '-1.24', 'spread': '1.644', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}, {'value': '75', 'groupId': 'OG006'}, {'value': '83', 'groupId': 'OG007'}, {'value': '92', 'groupId': 'OG008'}, {'value': '91', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '61.2', 'spread': '21.60', 'groupId': 'OG000'}, {'value': '61.5', 'spread': '17.24', 'groupId': 'OG001'}, {'value': '51.4', 'spread': '16.62', 'groupId': 'OG002'}, {'value': '49.4', 'spread': '17.04', 'groupId': 'OG003'}, {'value': '54.3', 'spread': '18.04', 'groupId': 'OG004'}, {'value': '52.1', 'spread': '19.63', 'groupId': 'OG005'}, {'value': '51.5', 'spread': '16.66', 'groupId': 'OG006'}, {'value': '52.0', 'spread': '19.73', 'groupId': 'OG007'}, {'value': '56.2', 'spread': '20.93', 'groupId': 'OG008'}, {'value': '55.6', 'spread': '16.31', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 148', 'categories': [{'measurements': [{'value': '23.4', 'spread': '27.31', 'groupId': 'OG000'}, {'value': '21.9', 'spread': '18.53', 'groupId': 'OG001'}, {'value': '28.7', 'spread': '19.43', 'groupId': 'OG002'}, {'value': '28.2', 'spread': '20.56', 'groupId': 'OG003'}, {'value': '28.2', 'spread': '21.30', 'groupId': 'OG004'}, {'value': '24.7', 'spread': '22.11', 'groupId': 'OG005'}, {'value': '24.9', 'spread': '25.63', 'groupId': 'OG006'}, {'value': '24.6', 'spread': '22.24', 'groupId': 'OG007'}, {'value': '23.9', 'spread': '23.40', 'groupId': 'OG008'}, {'value': '21.1', 'spread': '22.50', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '43', 'groupId': 'OG005'}, {'value': '70', 'groupId': 'OG006'}, {'value': '75', 'groupId': 'OG007'}, {'value': '91', 'groupId': 'OG008'}, {'value': '81', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.28', 'spread': '1.308', 'groupId': 'OG000'}, {'value': '7.17', 'spread': '1.326', 'groupId': 'OG001'}, {'value': '7.67', 'spread': '1.449', 'groupId': 'OG002'}, {'value': '8.03', 'spread': '1.385', 'groupId': 'OG003'}, {'value': '7.65', 'spread': '1.446', 'groupId': 'OG004'}, {'value': '7.70', 'spread': '1.337', 'groupId': 'OG005'}, {'value': '7.71', 'spread': '1.436', 'groupId': 'OG006'}, {'value': '7.81', 'spread': '1.548', 'groupId': 'OG007'}, {'value': '7.33', 'spread': '1.407', 'groupId': 'OG008'}, {'value': '7.62', 'spread': '1.428', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 172', 'categories': [{'measurements': [{'value': '-1.24', 'spread': '1.535', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '1.665', 'groupId': 'OG001'}, {'value': '-1.45', 'spread': '1.569', 'groupId': 'OG002'}, {'value': '-1.76', 'spread': '1.747', 'groupId': 'OG003'}, {'value': '-1.74', 'spread': '1.747', 'groupId': 'OG004'}, {'value': '-1.72', 'spread': '1.098', 'groupId': 'OG005'}, {'value': '-1.07', 'spread': '1.722', 'groupId': 'OG006'}, {'value': '-1.27', 'spread': '1.695', 'groupId': 'OG007'}, {'value': '-1.52', 'spread': '1.546', 'groupId': 'OG008'}, {'value': '-1.23', 'spread': '1.653', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '42', 'groupId': 'OG005'}, {'value': '70', 'groupId': 'OG006'}, {'value': '75', 'groupId': 'OG007'}, {'value': '90', 'groupId': 'OG008'}, {'value': '80', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '61.6', 'spread': '22.40', 'groupId': 'OG000'}, {'value': '62.1', 'spread': '16.84', 'groupId': 'OG001'}, {'value': '51.3', 'spread': '16.87', 'groupId': 'OG002'}, {'value': '49.7', 'spread': '17.87', 'groupId': 'OG003'}, {'value': '54.2', 'spread': '17.79', 'groupId': 'OG004'}, {'value': '52.4', 'spread': '20.42', 'groupId': 'OG005'}, {'value': '51.3', 'spread': '16.58', 'groupId': 'OG006'}, {'value': '50.9', 'spread': '19.40', 'groupId': 'OG007'}, {'value': '55.9', 'spread': '20.95', 'groupId': 'OG008'}, {'value': '55.4', 'spread': '15.90', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 172', 'categories': [{'measurements': [{'value': '19.8', 'spread': '27.91', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '21.59', 'groupId': 'OG001'}, {'value': '25.9', 'spread': '21.53', 'groupId': 'OG002'}, {'value': '29.2', 'spread': '22.92', 'groupId': 'OG003'}, {'value': '29.4', 'spread': '21.40', 'groupId': 'OG004'}, {'value': '25.9', 'spread': '25.70', 'groupId': 'OG005'}, {'value': '26.0', 'spread': '20.30', 'groupId': 'OG006'}, {'value': '23.9', 'spread': '23.72', 'groupId': 'OG007'}, {'value': '25.2', 'spread': '22.04', 'groupId': 'OG008'}, {'value': '22.2', 'spread': '21.21', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '66', 'groupId': 'OG006'}, {'value': '71', 'groupId': 'OG007'}, {'value': '62', 'groupId': 'OG008'}, {'value': '51', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.33', 'spread': '1.271', 'groupId': 'OG000'}, {'value': '7.14', 'spread': '1.325', 'groupId': 'OG001'}, {'value': '7.54', 'spread': '1.312', 'groupId': 'OG002'}, {'value': '8.11', 'spread': '1.487', 'groupId': 'OG003'}, {'value': '7.68', 'spread': '1.474', 'groupId': 'OG004'}, {'value': '7.66', 'spread': '1.389', 'groupId': 'OG005'}, {'value': '7.71', 'spread': '1.476', 'groupId': 'OG006'}, {'value': '7.82', 'spread': '1.579', 'groupId': 'OG007'}, {'value': '7.34', 'spread': '1.292', 'groupId': 'OG008'}, {'value': '7.61', 'spread': '1.297', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 196', 'categories': [{'measurements': [{'value': '-1.30', 'spread': '1.436', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '1.490', 'groupId': 'OG001'}, {'value': '-1.52', 'spread': '1.426', 'groupId': 'OG002'}, {'value': '-1.89', 'spread': '1.449', 'groupId': 'OG003'}, {'value': '-1.85', 'spread': '1.783', 'groupId': 'OG004'}, {'value': '-1.90', 'spread': '1.375', 'groupId': 'OG005'}, {'value': '-1.12', 'spread': '1.687', 'groupId': 'OG006'}, {'value': '-1.42', 'spread': '1.555', 'groupId': 'OG007'}, {'value': '-1.44', 'spread': '1.656', 'groupId': 'OG008'}, {'value': '-1.37', 'spread': '1.697', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}, {'value': '66', 'groupId': 'OG006'}, {'value': '71', 'groupId': 'OG007'}, {'value': '62', 'groupId': 'OG008'}, {'value': '51', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '61.2', 'spread': '21.60', 'groupId': 'OG000'}, {'value': '61.3', 'spread': '16.63', 'groupId': 'OG001'}, {'value': '52.5', 'spread': '17.01', 'groupId': 'OG002'}, {'value': '49.0', 'spread': '18.41', 'groupId': 'OG003'}, {'value': '54.2', 'spread': '17.71', 'groupId': 'OG004'}, {'value': '52.8', 'spread': '20.56', 'groupId': 'OG005'}, {'value': '51.5', 'spread': '16.72', 'groupId': 'OG006'}, {'value': '51.5', 'spread': '19.58', 'groupId': 'OG007'}, {'value': '56.7', 'spread': '20.21', 'groupId': 'OG008'}, {'value': '56.5', 'spread': '14.35', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 196', 'categories': [{'measurements': [{'value': '22.9', 'spread': '28.01', 'groupId': 'OG000'}, {'value': '21.6', 'spread': '17.20', 'groupId': 'OG001'}, {'value': '26.4', 'spread': '20.17', 'groupId': 'OG002'}, {'value': '31.9', 'spread': '23.39', 'groupId': 'OG003'}, {'value': '29.1', 'spread': '22.45', 'groupId': 'OG004'}, {'value': '29.2', 'spread': '22.32', 'groupId': 'OG005'}, {'value': '24.6', 'spread': '21.32', 'groupId': 'OG006'}, {'value': '23.3', 'spread': '26.17', 'groupId': 'OG007'}, {'value': '22.1', 'spread': '22.91', 'groupId': 'OG008'}, {'value': '23.2', 'spread': '18.14', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '45', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.48', 'spread': '1.365', 'groupId': 'OG000'}, {'value': '7.21', 'spread': '1.119', 'groupId': 'OG001'}, {'value': '7.69', 'spread': '1.215', 'groupId': 'OG002'}, {'value': '8.09', 'spread': '1.510', 'groupId': 'OG003'}, {'value': '7.66', 'spread': '1.450', 'groupId': 'OG004'}, {'value': '7.84', 'spread': '1.463', 'groupId': 'OG005'}, {'value': '7.63', 'spread': '1.532', 'groupId': 'OG006'}, {'value': '7.89', 'spread': '1.541', 'groupId': 'OG007'}, {'value': '7.33', 'spread': '1.155', 'groupId': 'OG008'}, {'value': '7.75', 'spread': '1.500', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 248', 'categories': [{'measurements': [{'value': '-1.67', 'spread': '1.653', 'groupId': 'OG000'}, {'value': '-1.03', 'spread': '1.619', 'groupId': 'OG001'}, {'value': '-1.58', 'spread': '1.339', 'groupId': 'OG002'}, {'value': '-2.03', 'spread': '1.425', 'groupId': 'OG003'}, {'value': '-1.81', 'spread': '1.554', 'groupId': 'OG004'}, {'value': '-1.97', 'spread': '1.538', 'groupId': 'OG005'}, {'value': '-1.05', 'spread': '2.039', 'groupId': 'OG006'}, {'value': '-1.57', 'spread': '1.521', 'groupId': 'OG007'}, {'value': '-2.00', 'spread': '1.000', 'groupId': 'OG008'}, {'value': '-2.00', 'spread': '1.414', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '31', 'groupId': 'OG005'}, {'value': '38', 'groupId': 'OG006'}, {'value': '45', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'OG008', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - UC)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.'}, {'id': 'OG009', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants - CD)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '57.2', 'spread': '21.28', 'groupId': 'OG000'}, {'value': '61.6', 'spread': '16.17', 'groupId': 'OG001'}, {'value': '52.1', 'spread': '16.63', 'groupId': 'OG002'}, {'value': '47.2', 'spread': '18.17', 'groupId': 'OG003'}, {'value': '52.3', 'spread': '16.40', 'groupId': 'OG004'}, {'value': '53.2', 'spread': '19.72', 'groupId': 'OG005'}, {'value': '50.8', 'spread': '17.39', 'groupId': 'OG006'}, {'value': '49.0', 'spread': '19.37', 'groupId': 'OG007'}, {'value': '61.3', 'spread': '28.11', 'groupId': 'OG008'}, {'value': '47.5', 'spread': '7.33', 'groupId': 'OG009'}]}]}, {'title': 'Change at Week 248', 'categories': [{'measurements': [{'value': '27.5', 'spread': '25.77', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '18.62', 'groupId': 'OG001'}, {'value': '28.0', 'spread': '22.14', 'groupId': 'OG002'}, {'value': '34.9', 'spread': '18.79', 'groupId': 'OG003'}, {'value': '32.1', 'spread': '19.98', 'groupId': 'OG004'}, {'value': '29.9', 'spread': '24.37', 'groupId': 'OG005'}, {'value': '24.7', 'spread': '25.34', 'groupId': 'OG006'}, {'value': '28.9', 'spread': '27.65', 'groupId': 'OG007'}, {'value': '28.7', 'spread': '32.72', 'groupId': 'OG008'}, {'value': '34.3', 'spread': '11.44', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.14', 'spread': '1.069', 'groupId': 'OG000'}, {'value': '7.50', 'spread': '0.941', 'groupId': 'OG001'}, {'value': '8.08', 'spread': '1.115', 'groupId': 'OG002'}, {'value': '8.33', 'spread': '1.803', 'groupId': 'OG003'}, {'value': '7.88', 'spread': '1.356', 'groupId': 'OG004'}, {'value': '7.94', 'spread': '1.063', 'groupId': 'OG005'}, {'value': '7.75', 'spread': '2.062', 'groupId': 'OG006'}, {'value': '7.00', 'spread': '0.000', 'groupId': 'OG007'}]}]}, {'title': 'Change at Week 300', 'categories': [{'measurements': [{'value': '-2.29', 'spread': '1.799', 'groupId': 'OG000'}, {'value': '-1.43', 'spread': '2.065', 'groupId': 'OG001'}, {'value': '-1.77', 'spread': '1.363', 'groupId': 'OG002'}, {'value': '-2.11', 'spread': '1.965', 'groupId': 'OG003'}, {'value': '-2.00', 'spread': '2.138', 'groupId': 'OG004'}, {'value': '-2.25', 'spread': '1.438', 'groupId': 'OG005'}, {'value': '-1.50', 'spread': '1.291', 'groupId': 'OG006'}, {'value': '0.50', 'spread': '2.121', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}, {'id': 'OG006', 'title': 'Vedolizumab 300 mg (C13011 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.'}, {'id': 'OG007', 'title': 'Vedolizumab 300 mg (C13011 Vedolizumab)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '58.1', 'spread': '20.27', 'groupId': 'OG000'}, {'value': '64.9', 'spread': '11.82', 'groupId': 'OG001'}, {'value': '55.7', 'spread': '10.10', 'groupId': 'OG002'}, {'value': '50.4', 'spread': '22.34', 'groupId': 'OG003'}, {'value': '53.1', 'spread': '15.80', 'groupId': 'OG004'}, {'value': '42.9', 'spread': '19.54', 'groupId': 'OG005'}, {'value': '43.5', 'spread': '19.12', 'groupId': 'OG006'}, {'value': '52.0', 'spread': '24.04', 'groupId': 'OG007'}]}]}, {'title': 'Change at Week 300', 'categories': [{'measurements': [{'value': '23.6', 'spread': '29.14', 'groupId': 'OG000'}, {'value': '20.4', 'spread': '17.92', 'groupId': 'OG001'}, {'value': '28.4', 'spread': '14.78', 'groupId': 'OG002'}, {'value': '33.2', 'spread': '25.83', 'groupId': 'OG003'}, {'value': '31.3', 'spread': '17.47', 'groupId': 'OG004'}, {'value': '43.6', 'spread': '23.17', 'groupId': 'OG005'}, {'value': '40.3', 'spread': '9.50', 'groupId': 'OG006'}, {'value': '13.0', 'spread': '11.31', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.00', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG000'}, {'value': '8.00', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '8.33', 'spread': '0.577', 'groupId': 'OG002'}, {'value': '12.00', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG003'}, {'value': '8.00', 'spread': '1.414', 'groupId': 'OG004'}, {'value': '9.00', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 352', 'categories': [{'measurements': [{'value': '-2.00', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG000'}, {'value': '-3.00', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '-1.33', 'spread': '1.528', 'groupId': 'OG002'}, {'value': '-6.00', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG003'}, {'value': '-1.00', 'spread': '0.000', 'groupId': 'OG004'}, {'value': '-4.00', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Vedolizumab 300 mg (C13006 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.'}, {'id': 'OG001', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab 300 mg (C13006 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.'}, {'id': 'OG003', 'title': 'Vedolizumab 300 mg (C13007 Placebo)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.'}, {'id': 'OG004', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q8W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.'}, {'id': 'OG005', 'title': 'Vedolizumab 300 mg (C13007 Vedolizumab Q4W)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '52.0', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG000'}, {'value': '50.0', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '48.0', 'spread': '8.19', 'groupId': 'OG002'}, {'value': '15.0', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG003'}, {'value': '50.0', 'spread': '14.14', 'groupId': 'OG004'}, {'value': '31.0', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG005'}]}]}, {'title': 'Change at Week 352', 'categories': [{'measurements': [{'value': '46.0', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG000'}, {'value': '40.0', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG001'}, {'value': '24.3', 'spread': '20.11', 'groupId': 'OG002'}, {'value': '64.0', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG003'}, {'value': '24.0', 'spread': '8.49', 'groupId': 'OG004'}, {'value': '59.0', 'spread': 'NA', 'comment': 'SD was not calculated for 1 participant.', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vedolizumab 300 mg (C13006)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: participants received either vedolizumab matching placebo or vedolizumab every Q4W or vedolizumab every 8 weeks (Q8W), IV infusion up to Week 52.'}, {'id': 'FG001', 'title': 'Vedolizumab 300 mg (C13007)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: participants received either vedolizumab matching placebo or vedolizumab Q4W or vedolizumab Q8W, IV infusion up to Week 52.'}, {'id': 'FG002', 'title': 'Vedolizumab 300 mg (C13011)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: participants received either vedolizumab matching placebo or vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'FG003', 'title': 'Vedolizumab 300 mg (C13004)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 510 weeks including treatment in the previous study. In study C13004: participants received either vedolizumab 2 mg/kg or 6 mg/kg, IV infusion Q8W up to Week 78.'}, {'id': 'FG004', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 260 weeks in participants with Crohn's disease (CD) or ulcerative colitis (UC) not treated in a previous study."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '675'}, {'groupId': 'FG001', 'numSubjects': '726'}, {'groupId': 'FG002', 'numSubjects': '384'}, {'groupId': 'FG003', 'numSubjects': '37'}, {'groupId': 'FG004', 'numSubjects': '421'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '237'}, {'groupId': 'FG001', 'numSubjects': '246'}, {'groupId': 'FG002', 'numSubjects': '115'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '145'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '438'}, {'groupId': 'FG001', 'numSubjects': '480'}, {'groupId': 'FG002', 'numSubjects': '269'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '276'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '119'}, {'groupId': 'FG002', 'numSubjects': '65'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '69'}]}, {'type': 'Protocol Violation(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '176'}, {'groupId': 'FG002', 'numSubjects': '130'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '121'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '50'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '15'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Participants took part in study at 298 sites in North America, Western/Northern Europe, Central Europe, Eastern Europe, Asia, Australia and Africa from 22 May 2009 to 31 October 2017.', 'preAssignmentDetails': "Participants with a diagnosis of ulcerative colitis and Crohn's disease who participated in previous studies: C13004 (NCT00619489), C13006 (NCT00783718), C13007 (NCT00783692) and C13011 (NCT01224171) and DeNovo participants were enrolled into 1 treatment group, vedolizumab 300 mg, 30-minute intravenous (IV) infusion, every 4 weeks (Q4W)."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Vedolizumab 300 mg (C13006)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: participants received either vedolizumab matching placebo or vedolizumab every Q4W or vedolizumab Q8W, IV infusion up to Week 52.'}, {'id': 'BG001', 'title': 'Vedolizumab 300 mg (C13007)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: participants received either vedolizumab matching placebo or vedolizumab Q4W or vedolizumab Q8W, IV infusion up to Week 52.'}, {'id': 'BG002', 'title': 'Vedolizumab 300 mg (C13011)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: participants received either vedolizumab matching placebo or vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.'}, {'id': 'BG003', 'title': 'Vedolizumab 300 mg (C13004)', 'description': 'Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 510 weeks including treatment in the previous study. In study C13004: participants received either vedolizumab 2 mg/kg or 6 mg/kg, IV infusion Q8W up to Week 78.'}, {'id': 'BG004', 'title': 'Vedolizumab 300 mg (C13008 De Novo Participants)', 'description': "Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 260 weeks in participants with Crohn's disease (CD) or ulcerative colitis (UC) not treated in a previous study."}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '41.2', 'spread': '13.27', 'groupId': 'BG000'}, {'value': '37.3', 'spread': '12.26', 'groupId': 'BG001'}, {'value': '38.3', 'spread': '12.87', 'groupId': 'BG002'}, {'value': '43.9', 'spread': '14.24', 'groupId': 'BG003'}, {'value': '39.3', 'spread': '14.23', 'groupId': 'BG004'}, {'value': '39.1', 'spread': '13.19', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'title': '<65', 'measurements': [{'value': '646', 'groupId': 'BG000'}, {'value': '710', 'groupId': 'BG001'}, {'value': '376', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}, {'value': '2167', 'groupId': 'BG005'}]}, {'title': '>=65', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '76', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '280', 'groupId': 'BG000'}, {'value': '384', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '215', 'groupId': 'BG004'}, {'value': '1115', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '395', 'groupId': 'BG000'}, {'value': '342', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '206', 'groupId': 'BG004'}, {'value': '1128', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '631', 'groupId': 'BG000'}, {'value': '700', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '400', 'groupId': 'BG004'}, {'value': '2139', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '37', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '557', 'groupId': 'BG000'}, {'value': '641', 'groupId': 'BG001'}, {'value': '349', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '398', 'groupId': 'BG004'}, {'value': '1981', 'groupId': 'BG005'}]}, {'title': 'Black', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '187', 'groupId': 'BG005'}]}, {'title': 'American Indian or Alaskan Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Other', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}]}, {'title': 'Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '100', 'groupId': 'BG005'}]}]}, {'title': 'Hong Kong', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}, {'title': 'India', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '63', 'groupId': 'BG005'}]}]}, {'title': 'Malaysia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}]}, {'title': 'New Zealand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}]}]}, {'title': 'Singapore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}, {'title': 'South Africa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}]}]}, {'title': 'Korea, Republic Of', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '59', 'groupId': 'BG005'}]}]}, {'title': 'Taiwan, Province Of China', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}, {'title': 'Czech Republic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}, {'value': '206', 'groupId': 'BG005'}]}]}, {'title': 'Greece', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}, {'title': 'Hungary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '98', 'groupId': 'BG005'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '82', 'groupId': 'BG005'}]}]}, {'title': 'Romania', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}, {'title': 'Serbia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}, {'title': 'Slovakia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}]}]}, {'title': 'Bulgaria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}]}, {'title': 'Estonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}]}]}, {'title': 'Israel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}]}, {'title': 'Latvia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '85', 'groupId': 'BG005'}]}]}, {'title': 'Turkey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}]}, {'title': 'Ukraine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}]}, {'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '87', 'groupId': 'BG004'}, {'value': '355', 'groupId': 'BG005'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '147', 'groupId': 'BG004'}, {'value': '591', 'groupId': 'BG005'}]}]}, {'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '175', 'groupId': 'BG005'}]}]}, {'title': 'Denmark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}]}]}, {'title': 'Iceland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}, {'title': 'Ireland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}]}]}, {'title': 'Netherlands', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}]}]}, {'title': 'Norway', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}, {'title': 'Sweden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}, {'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}, {'value': '2243', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '74.10', 'spread': '17.934', 'groupId': 'BG000'}, {'value': '71.70', 'spread': '19.600', 'groupId': 'BG001'}, {'value': '71.29', 'spread': '18.951', 'groupId': 'BG002'}, {'value': '77.66', 'spread': '18.907', 'groupId': 'BG003'}, {'value': '75.45', 'spread': '18.814', 'groupId': 'BG004'}, {'value': '73.15', 'spread': '18.900', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '675', 'groupId': 'BG000'}, {'value': '726', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1822', 'groupId': 'BG005'}]}], 'categories': [{'measurements': [{'value': '25.39', 'spread': '5.391', 'groupId': 'BG000'}, {'value': '24.61', 'spread': '6.039', 'groupId': 'BG001'}, {'value': '24.56', 'spread': '5.783', 'groupId': 'BG002'}, {'value': '27.11', 'spread': '6.523', 'groupId': 'BG003'}, {'value': '24.94', 'spread': '5.779', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index = weight (kg)/\\[height (m)\\^2\\]. BMI was not calculated for de novo participants as height was not collected for these participants. BMI data was available for only 1822 participants.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'BMI was not calculated for de novo participants due to no collection of height information.'}], 'populationDescription': 'Safety population was defined as all participants who received any amount of vedolizumab in this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-22', 'size': 1126975, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-10-31T09:12', 'hasProtocol': True}, {'date': '2013-01-07', 'size': 595574, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-31T09:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2243}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-02', 'studyFirstSubmitDate': '2008-11-05', 'resultsFirstSubmitDate': '2018-10-31', 'studyFirstSubmitQcDate': '2008-11-13', 'lastUpdatePostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-15', 'studyFirstPostDateStruct': {'date': '2008-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.'}, {'measure': 'Number of Participants With Markedly Abnormal Safety Laboratory Findings', 'timeFrame': 'From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)', 'description': 'A laboratory value was considered a marked abnormality if it met the predefined criteria or parameters and the on-treatment value was more extreme than the Baseline value for the following parameters: hemoglobin \\<= 70 g/L, absolute lymphocyte count \\<0.5 X 10\\^9/L, leukocytes \\<2.0 X 10\\^9/L (absolute value), platelets \\<75.0 X 10\\^9/L, absolute neutrophil Count \\<1.0 X 10\\^9/L, prothrombin time \\>1.25 x upper limit of normal (ULN), alanine aminotransferase (ALT) \\>3.0 x ULN, aspartate aminotransferase (AST) \\>3.0 x ULN, bilirubin \\>2.0 x ULN, amylase \\>2.0 x ULN, lipase \\>2.0 x ULN.'}, {'measure': 'Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements', 'timeFrame': 'From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)', 'description': 'Vital signs (heart rate, respiratory rate, systolic and diastolic blood pressure, and temperature) measurements were collected throughout the study. Any clinically significant mean change in vital signs over time as assessed by the investigator was reported as a TEAE.'}, {'measure': 'Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings', 'timeFrame': 'From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)', 'description': 'A standard 12-lead ECG was performed. Any ECGs assessed by the investigator to be clinically significant were reported as TEAEs.'}, {'measure': 'Time to Major Inflammatory Bowel Disease (IBD) - Related Events', 'timeFrame': 'Baseline (Prior to first dose of study drug in C13008) up to end of study (approximately up to 8.5 years)', 'description': "IBD-related events included hospitalizations, surgeries, or procedures due to ulcerative colitis and Crohn's disease."}, {'measure': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352', 'description': 'The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement."}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352', 'description': 'EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352', 'timeFrame': 'Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug therapy'], 'conditions': ['Ulcerative Colitis', "Crohn's Disease"]}, 'referencesModule': {'references': [{'pmid': '35934286', 'type': 'DERIVED', 'citation': 'Dulai PS, Feagan BG, Sands BE, Chen J, Lasch K, Lirio RA. Prognostic Value of Fecal Calprotectin to Inform Treat-to-Target Monitoring in Ulcerative Colitis. Clin Gastroenterol Hepatol. 2023 Feb;21(2):456-466.e7. doi: 10.1016/j.cgh.2022.07.027. Epub 2022 Aug 4.'}, {'pmid': '33908636', 'type': 'DERIVED', 'citation': 'Wyant T, Yang L, Lirio RA, Rosario M. Vedolizumab Immunogenicity With Long-Term or Interrupted Treatment of Patients With Inflammatory Bowel Disease. J Clin Pharmacol. 2021 Sep;61(9):1174-1181. doi: 10.1002/jcph.1877. Epub 2021 Jul 14.'}, {'pmid': '32876349', 'type': 'DERIVED', 'citation': "Loftus EV Jr, Feagan BG, Panaccione R, Colombel JF, Sandborn WJ, Sands BE, Danese S, D'Haens G, Rubin DT, Shafran I, Parfionovas A, Rogers R, Lirio RA, Vermeire S. Long-term safety of vedolizumab for inflammatory bowel disease. Aliment Pharmacol Ther. 2020 Oct;52(8):1353-1365. doi: 10.1111/apt.16060. Epub 2020 Sep 2."}, {'pmid': '30365009', 'type': 'DERIVED', 'citation': "Feagan BG, Schreiber S, Wolf DC, Axler JL, Kaviya A, James A, Curtis RI, Geransar P, Stallmach A, Ehehalt R, Bokemeyer B, Khalid JM, O'Byrne S. Sustained Clinical Remission With Vedolizumab in Patients With Moderate-to-Severe Ulcerative Colitis. Inflamm Bowel Dis. 2019 May 4;25(6):1028-1035. doi: 10.1093/ibd/izy323."}, {'pmid': '27802155', 'type': 'DERIVED', 'citation': 'Arijs I, De Hertogh G, Lemmens B, Van Lommel L, de Bruyn M, Vanhove W, Cleynen I, Machiels K, Ferrante M, Schuit F, Van Assche G, Rutgeerts P, Vermeire S. Effect of vedolizumab (anti-alpha4beta7-integrin) therapy on histological healing and mucosal gene expression in patients with UC. Gut. 2018 Jan;67(1):43-52. doi: 10.1136/gutjnl-2016-312293. Epub 2016 Oct 7.'}, {'pmid': '26893500', 'type': 'DERIVED', 'citation': "Colombel JF, Sands BE, Rutgeerts P, Sandborn W, Danese S, D'Haens G, Panaccione R, Loftus EV Jr, Sankoh S, Fox I, Parikh A, Milch C, Abhyankar B, Feagan BG. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2017 May;66(5):839-851. doi: 10.1136/gutjnl-2015-311079. Epub 2016 Feb 18."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.', 'detailedDescription': "The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis or Crohn's disease. This study will determine the safety profile of long-term vedolizumab treatment.\n\nThe study enrolled 2243 patients. Participants who received either placebo or vedolizumab 300 mg IV infusion every 4 or 8 weeks in previous vedolizumab studies received:\n\n• Vedolizumab 300 mg\n\nAll participants received vedolizumab intravenous infusion every 4 weeks for approximately up to 510 weeks.\n\nThis multicenter trial is being conducted worldwide. The overall time to participate in this study was up to October 2017 until vedolizumab was available in the country in which the participant resided, or until participant withdrawal, whichever came first. Participants made multiple visits to the clinic up to 16 weeks after receiving their last dose of vedolizumab and were being followed up for 2-years during which a safety questionnaire was administered by telephone for follow-up assessments."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Previous treatment in Study C13004 (NCT00619489), Study C13006 (NCT00783718), Study C13007 (NCT00783692), or Study C13011 (NCT01224171) that, in the opinion of the investigator, was well tolerated OR b. Moderate to severe Crohn's disease or ulcerative colitis which has not been previously treated with vedolizumab (MLN0002)\n2. May be receiving a therapeutic dose of conventional therapies for Crohn's disease or ulcerative colitis as defined by the protocol\n\nExclusion Criteria:\n\n1\\. Development of any new, unstable, or uncontrolled disease"}, 'identificationModule': {'nctId': 'NCT00790933', 'acronym': 'GEMINI LTS', 'briefTitle': "An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': "A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn's Disease", 'orgStudyIdInfo': {'id': 'C13008'}, 'secondaryIdInfos': [{'id': '2008-002784-14', 'type': 'EUDRACT_NUMBER'}, {'id': 'NMRR-08-1040-2195', 'type': 'REGISTRY', 'domain': 'NMRR'}, {'id': 'CTRI/2009/091/000138', 'type': 'REGISTRY', 'domain': 'CTRI'}, {'id': '10/H1102/12', 'type': 'REGISTRY', 'domain': 'NRES'}, {'id': 'NL25209.096.08', 'type': 'REGISTRY', 'domain': 'CCMO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vedolizumab 300 mg', 'description': 'Vedolizumab 300 mg, 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