Viewing Study NCT00783718

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Ignite Creation Date: 2025-12-25 @ 4:59 AM

Ignite Modification Date: 2025-12-26 @ 4:00 AM

Study NCT ID: NCT00783718

Status: COMPLETED

Last Update Posted: 2014-07-18

First Post: 2008-10-31

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis

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'}], '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'}, {'id': 'C438271', 'term': 'LDP-02'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialregistry@tpna.com', 'phone': '800-778-2860', 'title': 'Medical Director', 'organization': 'Millennium Pharmaceuticals Inc'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants who received double-blind placebo intravenous infusions in the Induction Phase and continued to receive placebo during the Maintenance Phase.', 'otherNumAtRisk': 149, 'otherNumAffected': 67, 'seriousNumAtRisk': 149, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Vedolizumab Then Placebo', 'description': 'Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase.', 'otherNumAtRisk': 126, 'otherNumAffected': 69, 'seriousNumAtRisk': 126, 'seriousNumAffected': 20}, {'id': 'EG002', 'title': 'Vedolizumab', 'description': 'Participants who received vedolizumab during the Induction Phase and continued to receive vedolizumab during the Maintenance Phase. This includes participants who had a clinical response at Week 6 and were randomized to vedolizumab every 4 weeks or every 8 weeks in the Maintenance Phase, participants who did not achieve a clinical response at Week 6 and continued to receive vedolizumab every 4 weeks for the duration of the study, and participants who withdrew during the Induction phase.', 'otherNumAtRisk': 620, 'otherNumAffected': 321, 'seriousNumAtRisk': 620, 'seriousNumAffected': 77}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 80}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 52}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 57}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 80}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 56}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 36}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 35}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 47}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Peritoneal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Colon dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cholangitis suppurative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Klebsiella infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pulpitis dental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pericoronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Accidental poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gastrointestinal stoma complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pubis fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cholangitis sclerosing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hepatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pemphigoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Haemoglobin decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arteriosclerosis obliterans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 620, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Induction Phase: Percentage of Participants With a Clinical Response at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.'}, {'id': 'OG001', 'title': 'DB Vedolizumab', 'description': 'Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'groupId': 'OG000', 'lowerLimit': '18.5', 'upperLimit': '32.5'}, {'value': '47.1', 'groupId': 'OG001', 'lowerLimit': '40.6', 'upperLimit': '53.6'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.7', 'ciLowerLimit': '11.6', 'ciUpperLimit': '31.7', 'groupDescription': 'The primary comparison of the Induction Phase was tested using the Cochran-Mantel-Haenszel (CMH) chi-square test at a 5% significance level, with stratification according to the stratification factors (concomitant use of oral corticosteroids and previous exposure to tumor necrosis factor alpha (TNFα) antagonists or concomitant immunomodulator \\[6-mercaptopurine or azathioprine\\] use).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 6', 'description': 'Clinical response is defined as a reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.\n\nThe Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving clinical response.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Induction Study Intent-to-treat (ITT) population which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug.'}, {'type': 'PRIMARY', 'title': 'Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.'}, {'id': 'OG001', 'title': 'Vedolizumab Q8W', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab Q4W', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '22.3'}, {'value': '41.8', 'groupId': 'OG001', 'lowerLimit': '33.1', 'upperLimit': '50.6'}, {'value': '44.8', 'groupId': 'OG002', 'lowerLimit': '36.1', 'upperLimit': '53.5'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.1', 'ciLowerLimit': '14.9', 'ciUpperLimit': '37.2', 'pValueComment': 'P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.', 'groupDescription': 'The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was \\> 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.1', 'ciLowerLimit': '17.9', 'ciUpperLimit': '40.4', 'pValueComment': 'P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.', 'groupDescription': 'The Hochberg method was applied to control the overall Type I error rate at a 5% significance level. If both P-values were ≤ 0.05, both dose regimens were to be declared significant. If 1 of the P-values for the 2 dose comparisons was \\> 0.05, the other P-value was to be tested at the 0.025 level and declared significant only if the P-value was ≤ 0.025. If neither dose was declared significant for the primary endpoint, no further testing was to be conducted.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore \\> 1 point.\n\nThe Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving clinical remission.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maintenance Study ITT Population, defined as all randomized participants who received vedolizumab during the Induction Phase and met the protocol definition of clinical response at Week 6, as assessed by the investigator, were randomized, and received any amount of double-blind study drug in the Maintenance Phase.'}, {'type': 'SECONDARY', 'title': 'Induction Phase: Percentage of Participants in Clinical Remission at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.'}, {'id': 'OG001', 'title': 'DB Vedolizumab', 'description': 'Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '9.0'}, {'value': '16.9', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '21.8'}]}]}], 'analyses': [{'pValue': '0.0009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.5', 'ciLowerLimit': '4.7', 'ciUpperLimit': '18.3', 'pValueComment': 'P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).', 'groupDescription': 'To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': 'Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore \\> 1 point.\n\nThe Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving clinical remission.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Induction Study ITT Population'}, {'type': 'SECONDARY', 'title': 'Induction Phase: Percentage of Participants With Mucosal Healing at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants in Cohort 1 received double-blind placebo intravenous infusions at Week 0 and Week 2 in the Induction Phase.'}, {'id': 'OG001', 'title': 'DB Vedolizumab', 'description': 'Participants in Cohort 1 received double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 in the Induction Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '31.8'}, {'value': '40.9', 'groupId': 'OG001', 'lowerLimit': '34.5', 'upperLimit': '47.3'}]}]}], 'analyses': [{'pValue': '0.0012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '16.1', 'ciLowerLimit': '6.4', 'ciUpperLimit': '25.9', 'pValueComment': 'P-value is based on the CMH chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); and 2) previous exposure to TNFα antagonists or concomitant immunomodulator use (yes/no).', 'groupDescription': 'To maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially (closed sequential method). The first secondary endpoint was to be tested only if the primary comparison was significant and the second key secondary endpoint was to be tested only if the first secondary endpoint was significant for vedolizumab.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': 'Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.\n\nThe Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:\n\n0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving mucosal healing.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Induction Study ITT Population'}, {'type': 'SECONDARY', 'title': 'Maintenance Phase: Percentage of Participants With Durable Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.'}, {'id': 'OG001', 'title': 'Vedolizumab Q8W', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab Q4W', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.8', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '31.2'}, {'value': '56.6', 'groupId': 'OG001', 'lowerLimit': '47.8', 'upperLimit': '65.4'}, {'value': '52.0', 'groupId': 'OG002', 'lowerLimit': '43.2', 'upperLimit': '60.8'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.8', 'ciLowerLimit': '20.8', 'ciUpperLimit': '44.7', 'pValueComment': 'P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.', 'groupDescription': 'To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.5', 'ciLowerLimit': '16.7', 'ciUpperLimit': '40.3', 'pValueComment': 'P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.', 'groupDescription': 'To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 6 and Week 52', 'description': 'Durable clinical response is defined as reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving durable clinical response.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maintenance Study ITT Population'}, {'type': 'SECONDARY', 'title': 'Maintenance Phase: Percentage of Participants With Mucosal Healing at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.'}, {'id': 'OG001', 'title': 'Vedolizumab Q8W', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab Q4W', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.8', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '26.8'}, {'value': '51.6', 'groupId': 'OG001', 'lowerLimit': '42.8', 'upperLimit': '60.5'}, {'value': '56.0', 'groupId': 'OG002', 'lowerLimit': '47.3', 'upperLimit': '64.7'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.0', 'ciLowerLimit': '20.3', 'ciUpperLimit': '43.8', 'pValueComment': 'P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.', 'groupDescription': 'To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '36.3', 'ciLowerLimit': '24.4', 'ciUpperLimit': '48.3', 'pValueComment': 'P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.', 'groupDescription': 'To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.\n\nThe Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:\n\n0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving mucosal healing.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maintenance Study ITT Population'}, {'type': 'SECONDARY', 'title': 'Maintenance Phase: Percentage of Participants With Durable Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.'}, {'id': 'OG001', 'title': 'Vedolizumab Q8W', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab Q4W', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '13.7'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '27.7'}, {'value': '24.0', 'groupId': 'OG002', 'lowerLimit': '16.5', 'upperLimit': '31.5'}]}]}], 'analyses': [{'pValue': '0.0079', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.8', 'ciLowerLimit': '3.1', 'ciUpperLimit': '20.5', 'pValueComment': 'P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.', 'groupDescription': 'To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.3', 'ciLowerLimit': '6.2', 'ciUpperLimit': '24.4', 'pValueComment': 'P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.', 'groupDescription': 'To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6 and Week 52', 'description': 'Durable clinical remission is defined as complete Mayo score of ≤ 2 points and no individual subscore \\> 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maintenance Study ITT Population'}, {'type': 'SECONDARY', 'title': 'Maintenance Phase: Percentage of Participants With Corticosteroid-free Remission at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.'}, {'id': 'OG001', 'title': 'Vedolizumab Q8W', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) from Week 6 to Week 50.'}, {'id': 'OG002', 'title': 'Vedolizumab Q4W', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '21.9'}, {'value': '31.4', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '42.3'}, {'value': '45.2', 'groupId': 'OG002', 'lowerLimit': '33.8', 'upperLimit': '56.6'}]}]}], 'analyses': [{'pValue': '0.0120', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.6', 'ciLowerLimit': '3.9', 'ciUpperLimit': '31.3', 'pValueComment': 'P-value based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.', 'groupDescription': 'To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.4', 'ciLowerLimit': '16.6', 'ciUpperLimit': '46.2', 'pValueComment': 'P-value is based on the CMH chi-square test, with 3 stratification factors: concomitant use of oral corticosteroids; previous exposure to TNFα antagonists or concomitant immunomodulator use; enrollment in Cohort 1 or 2 in the Induction Phase.', 'groupDescription': 'To maintain the overall Type I error rate at 5% for the 2 dose regimen comparisons for each key secondary endpoint, the Hochberg method was used as described for the primary outcome measure. To further maintain the overall Type I error rate at 5%, the key secondary endpoints were also performed sequentially. The first was tested only if 1 or both of the primary comparisons were significant and the next endpoint was tested only if the previous endpoint was significant for at least 1 dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore \\> 1 point. Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission at Week 52.\n\nThe Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free remission.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maintenance Study ITT Population, participants who were on corticosteroids at Baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.'}, {'id': 'FG001', 'title': 'Induction Phase: DB Vedolizumab', 'description': 'In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.'}, {'id': 'FG002', 'title': 'Induction Phase: OL Vedolizumab', 'description': 'In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.'}, {'id': 'FG003', 'title': 'Maintenance Phase: Placebo', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase.'}, {'id': 'FG004', 'title': 'Maintenance Phase: Vedolizumab Q8W', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) at Weeks 6, 14, 22, 30, 38, and 46, and, to maintain blinding, placebo infusions at Weeks 10, 18, 26, 34, 42, and 50.'}, {'id': 'FG005', 'title': 'Maintenance Phase: Vedolizumab Q4W', 'description': 'Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.'}, {'id': 'FG006', 'title': 'Maintenance Phase: Non-responders', 'description': 'Participants who received vedolizumab during the Induction Phase who did not demonstrate a clinical response at Week 6 received open-label treatment with vedolizumab 300 mg every 4 weeks from Week 6 to Week 50.'}], 'periods': [{'title': 'Induction Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '225'}, {'groupId': 'FG002', 'numSubjects': '521'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '218'}, {'groupId': 'FG002', 'numSubjects': '485'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Maintenance Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '126'}, {'groupId': 'FG004', 'numSubjects': '122'}, {'groupId': 'FG005', 'numSubjects': '125'}, {'groupId': 'FG006', 'numSubjects': '330'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '48'}, {'groupId': 'FG004', 'numSubjects': '77'}, {'groupId': 'FG005', 'numSubjects': '84'}, {'groupId': 'FG006', 'numSubjects': '135'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '78'}, {'groupId': 'FG004', 'numSubjects': '45'}, {'groupId': 'FG005', 'numSubjects': '41'}, {'groupId': 'FG006', 'numSubjects': '195'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '16'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '61'}, {'groupId': 'FG004', 'numSubjects': '31'}, {'groupId': 'FG005', 'numSubjects': '33'}, {'groupId': 'FG006', 'numSubjects': '155'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '20'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 211 investigative sites worldwide. The Induction Phase contained 2 cohorts. The eligibility criteria for both cohorts were identical. The purpose of Cohort 2 was to provide enough responders to power the Maintenance Phase primary efficacy analysis.', 'preAssignmentDetails': 'In Cohort 1, eligible patients who met entry criteria were randomized to treatment with double-blind vedolizumab 300 mg or placebo in a 3:2 ratio. All Cohort 2 patients were treated with open-label vedolizumab. In the Maintenance Phase participants were assigned to treatment groups based on their Induction Phase treatment and response to therapy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'BG000'}, {'value': '225', 'groupId': 'BG001'}, {'value': '521', 'groupId': 'BG002'}, {'value': '895', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction.'}, {'id': 'BG001', 'title': 'Induction Phase: DB Vedolizumab', 'description': 'In the Induction Phase participants in Cohort 1 were randomized to receive double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.'}, {'id': 'BG002', 'title': 'Induction Phase: OL Vedolizumab', 'description': 'In the Induction Phase participants in Cohort 2 received open-label vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'spread': '12.50', 'groupId': 'BG000'}, {'value': '40.1', 'spread': '13.11', 'groupId': 'BG001'}, {'value': '40.1', 'spread': '13.27', 'groupId': 'BG002'}, {'value': '40.3', 'spread': '13.09', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 35', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}, {'value': '353', 'groupId': 'BG003'}]}]}, {'title': '≥ 35', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '307', 'groupId': 'BG002'}, {'value': '542', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '503', 'groupId': 'BG002'}, {'value': '862', 'groupId': 'BG003'}]}]}, {'title': '≥ 65', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}, {'value': '370', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}, {'value': '525', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '183', 'groupId': 'BG001'}, {'value': '436', 'groupId': 'BG002'}, {'value': '734', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}, {'value': '832', 'groupId': 'BG003'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Estonia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'Iceland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}, {'title': 'Ireland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}, {'title': 'Latvia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Malaysia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Norway', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}, {'title': 'Singapore', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}, {'value': '238', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '72.4', 'spread': '17.65', 'groupId': 'BG000'}, {'value': '72.4', 'spread': '17.11', 'groupId': 'BG001'}, {'value': '74.2', 'spread': '19.32', 'groupId': 'BG002'}, {'value': '73.4', 'spread': '18.51', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Body weight data only available for 148 participants in the placebo arm.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'spread': '5.11', 'groupId': 'BG000'}, {'value': '24.9', 'spread': '4.85', 'groupId': 'BG001'}, {'value': '25.3', 'spread': '6.05', 'groupId': 'BG002'}, {'value': '25.1', 'spread': '5.62', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'BMI data only available for 148 participants in the placebo arm.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Ulcerative Colitis', 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'spread': '7.25', 'groupId': 'BG000'}, {'value': '6.1', 'spread': '5.08', 'groupId': 'BG001'}, {'value': '7.2', 'spread': '6.61', 'groupId': 'BG002'}, {'value': '6.9', 'spread': '6.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Duration of ulcerative colitis data only available for 519 participants in the Induction Phase: OL Vedolizumab arm.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Categorical Duration of Ulcerative Colitis', 'classes': [{'title': '< 1 year', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}]}, {'title': '≥1 - < 3 years', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '228', 'groupId': 'BG003'}]}]}, {'title': '≥ 3 - < 7 years', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}, {'value': '279', 'groupId': 'BG003'}]}]}, {'title': '≥ 7 years', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}, {'value': '322', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Mayo Score', 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '1.68', 'groupId': 'BG000'}, {'value': '8.5', 'spread': '1.78', 'groupId': 'BG001'}, {'value': '8.6', 'spread': '1.76', 'groupId': 'BG002'}, {'value': '8.6', 'spread': '1.75', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Disease Activity', 'classes': [{'title': 'Complete Mayo score < 6', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}]}, {'title': 'Complete Mayo score of 6 to 8 (inclusive)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}, {'value': '424', 'groupId': 'BG003'}]}]}, {'title': 'Complete Mayo score of 9 to 12 (inclusive)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}, {'value': '446', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Fecal Calprotectin', 'classes': [{'categories': [{'measurements': [{'value': '2369.9', 'spread': '3258.82', 'groupId': 'BG000'}, {'value': '2552.2', 'spread': '3800.36', 'groupId': 'BG001'}, {'value': '1442.7', 'spread': '1855.61', 'groupId': 'BG002'}, {'value': '1868.8', 'spread': '2753.28', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Number of participants for whom baseline fecal calprotectin data were available were 139, 213, and 505, respectively.', 'unitOfMeasure': 'μg/g', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Categorical Baseline Fecal Calprotectin', 'classes': [{'title': '≤ 250 μg/g', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}]}]}, {'title': '> 250 to ≤ 500 μg/g', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '122', 'groupId': 'BG003'}]}]}, {'title': '> 500 μg/g', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '156', 'groupId': 'BG001'}, {'value': '329', 'groupId': 'BG002'}, {'value': '577', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease Localization', 'classes': [{'title': 'Proctosigmoiditis', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}]}, {'title': 'Left-sided colitis', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}, {'value': '339', 'groupId': 'BG003'}]}]}, {'title': 'Extensive colitis', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}]}, {'title': 'Pancolitis', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking Status', 'classes': [{'title': 'Current smoker', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}, {'title': 'Nonsmoker', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}, {'value': '555', 'groupId': 'BG003'}]}]}, {'title': 'Former smoker', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}, {'value': '285', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of Extraintestinal Manifestations', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}, {'value': '298', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '341', 'groupId': 'BG002'}, {'value': '597', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Baseline characteristics are provided for the Induction Phase Safety Population, defined as all participants, in both Cohort 1 and Cohort 2, who received any amount of study drug in the Induction Phase (Weeks 0-6), according to the actual study drug received.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 895}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'dispFirstSubmitDate': '2013-01-14', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-19', 'studyFirstSubmitDate': '2008-10-31', 'dispFirstSubmitQcDate': '2013-01-14', 'resultsFirstSubmitDate': '2014-06-19', 'studyFirstSubmitQcDate': '2008-10-31', 'dispFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-19', 'studyFirstPostDateStruct': {'date': '2008-11-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Induction Phase: Percentage of Participants With a Clinical Response at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'Clinical response is defined as a reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.\n\nThe Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving clinical response.'}, {'measure': 'Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52', 'timeFrame': 'Week 52', 'description': 'Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore \\> 1 point.\n\nThe Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving clinical remission.'}], 'secondaryOutcomes': [{'measure': 'Induction Phase: Percentage of Participants in Clinical Remission at Week 6', 'timeFrame': 'Week 6', 'description': 'Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore \\> 1 point.\n\nThe Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving clinical remission.'}, {'measure': 'Induction Phase: Percentage of Participants With Mucosal Healing at Week 6', 'timeFrame': 'Week 6', 'description': 'Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.\n\nThe Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:\n\n0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving mucosal healing.'}, {'measure': 'Maintenance Phase: Percentage of Participants With Durable Clinical Response', 'timeFrame': 'Baseline, Week 6 and Week 52', 'description': 'Durable clinical response is defined as reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving durable clinical response.'}, {'measure': 'Maintenance Phase: Percentage of Participants With Mucosal Healing at Week 52', 'timeFrame': 'Week 52', 'description': 'Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.\n\nThe Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:\n\n0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving mucosal healing.'}, {'measure': 'Maintenance Phase: Percentage of Participants With Durable Clinical Remission', 'timeFrame': 'Week 6 and Week 52', 'description': 'Durable clinical remission is defined as complete Mayo score of ≤ 2 points and no individual subscore \\> 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission.'}, {'measure': 'Maintenance Phase: Percentage of Participants With Corticosteroid-free Remission at Week 52', 'timeFrame': 'Week 52', 'description': 'Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore \\> 1 point. Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission at Week 52.\n\nThe Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).\n\nAll participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free remission.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '23964932', 'type': 'RESULT', 'citation': 'Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734.'}, {'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': '33200296', 'type': 'DERIVED', 'citation': 'Wyant T, Yang L, Rosario M. Comparison of the ELISA and ECL Assay for Vedolizumab Anti-drug Antibodies: Assessing the Impact on Pharmacokinetics and Safety Outcomes of the Phase 3 GEMINI Trials. AAPS J. 2020 Nov 16;23(1):3. doi: 10.1208/s12248-020-00518-0.'}, {'pmid': '32635680', 'type': 'DERIVED', 'citation': "Okamoto H, Dirks NL, Rosario M, Hori T, Hibi T. Population pharmacokinetics of vedolizumab in Asian and non-Asian patients with ulcerative colitis and Crohn's disease. Intest Res. 2021 Jan;19(1):95-105. doi: 10.5217/ir.2019.09167. Epub 2020 Jul 10."}, {'pmid': '32606883', 'type': 'DERIVED', 'citation': 'Loftus EV Jr, Sands BE, Colombel JF, Dotan I, Khalid JM, Tudor D, Geransar P. Sustained Corticosteroid-Free Clinical Remission During Vedolizumab Maintenance Therapy in Patients with Ulcerative Colitis on Stable Concomitant Corticosteroids During Induction Therapy: A Post Hoc Analysis of GEMINI 1. Clin Exp Gastroenterol. 2020 Jun 11;13:211-220. doi: 10.2147/CEG.S248597. eCollection 2020.'}, {'pmid': '32062041', 'type': 'DERIVED', 'citation': 'Dulai PS, Singh S, Vande Casteele N, Meserve J, Winters A, Chablaney S, Aniwan S, Shashi P, Kochhar G, Weiss A, Koliani-Pace JL, Gao Y, Boland BS, Chang JT, Faleck D, Hirten R, Ungaro R, Lukin D, Sultan K, Hudesman D, Chang S, Bohm M, Varma S, Fischer M, Shmidt E, Swaminath A, Gupta N, Rosario M, Jairath V, Guizzetti L, Feagan BG, Siegel CA, Shen B, Kane S, Loftus EV Jr, Sandborn WJ, Sands BE, Colombel JF, Lasch K, Cao C. Development and Validation of Clinical Scoring Tool to Predict Outcomes of Treatment With Vedolizumab in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Dec;18(13):2952-2961.e8. doi: 10.1016/j.cgh.2020.02.010. Epub 2020 Feb 13.'}, {'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': '30285104', 'type': 'DERIVED', 'citation': 'Sandborn WJ, Colombel JF, Panaccione R, Dulai PS, Rosario M, Cao C, Barocas M, Lasch K. Deep Remission With Vedolizumab in Patients With Moderately to Severely Active Ulcerative Colitis: A GEMINI 1 post hoc Analysis. J Crohns Colitis. 2019 Feb 1;13(2):172-181. doi: 10.1093/ecco-jcc/jjy149.'}, {'pmid': '30203005', 'type': 'DERIVED', 'citation': 'Feagan BG, Sandborn WJ, Colombel JF, Byrne SO, Khalid JM, Kempf C, Geransar P, Bhayat F, Rubin DT. Incidence of Arthritis/Arthralgia in Inflammatory Bowel Disease with Long-term Vedolizumab Treatment: Post Hoc Analyses of the GEMINI Trials. J Crohns Colitis. 2019 Jan 1;13(1):50-57. doi: 10.1093/ecco-jcc/jjy125.'}, {'pmid': '29857145', 'type': 'DERIVED', 'citation': 'Feagan BG, Lasch K, Lissoos T, Cao C, Wojtowicz AM, Khalid JM, Colombel JF. Rapid Response to Vedolizumab Therapy in Biologic-Naive Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2019 Jan;17(1):130-138.e7. doi: 10.1016/j.cgh.2018.05.026. Epub 2018 May 29.'}, {'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': '27639327', 'type': 'DERIVED', 'citation': 'Feagan BG, Rubin DT, Danese S, Vermeire S, Abhyankar B, Sankoh S, James A, Smyth M. Efficacy of Vedolizumab Induction and Maintenance Therapy in Patients With Ulcerative Colitis, Regardless of Prior Exposure to Tumor Necrosis Factor Antagonists. Clin Gastroenterol Hepatol. 2017 Feb;15(2):229-239.e5. doi: 10.1016/j.cgh.2016.08.044. Epub 2016 Sep 14.'}, {'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."}, {'pmid': '25996351', 'type': 'DERIVED', 'citation': "Rosario M, Dirks NL, Gastonguay MR, Fasanmade AA, Wyant T, Parikh A, Sandborn WJ, Feagan BG, Reinisch W, Fox I. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease. Aliment Pharmacol Ther. 2015 Jul;42(2):188-202. doi: 10.1111/apt.13243. Epub 2015 May 20."}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.', 'detailedDescription': 'This multicenter, phase 3, randomized, blinded, placebo-controlled study in patients with moderately to severely active ulcerative colitis comprises two phases:\n\n* The Induction Phase, designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.\n* The Maintenance Phase, designed to establish the efficacy and safety of vedolizumab for the maintenance of clinical response and remission.\n\nThe 6-week Induction Phase contained 2 cohorts of participants: Cohort 1 participants were randomized and treated with double-blind study drug, and Cohort 2 participants were treated with open-label vedolizumab. The second cohort was enrolled to ensure that the sample size of Induction Phase responders randomized into the Maintenance Study provided sufficient power for the Maintenance Study primary efficacy analysis. These participants did not contribute to the efficacy analyses performed for the Induction Study. Participants in both cohorts were assessed for treatment response at Week 6.\n\nIn the Maintenance Phase vedolizumab-treated participants from both Cohort 1 and Cohort 2 who demonstrated a clinical response were randomized in a 1:1:1 ratio to double-blind treatment with vedolizumab administered every 4 weeks (Q4W), vedolizumab administered every 8 weeks (Q8W), or placebo. Vedolizumab-treated participants who did not demonstrate response at Week 6 continued treatment with open-label vedolizumab, administered Q4W. Participants treated with double-blind placebo in the Induction Phase continued on double-blind placebo during the Maintenance Phase, regardless of treatment response during induction. The Maintenance Phase began at Week 6 and concluded with Week 52 assessments.\n\nAfter the Week 52 assessments, participants meeting protocol-defined criteria were eligible to enroll in Study C13008 (NCT00790933; Long-term Safety) to receive open-label vedolizumab treatment. Participants who withdrew early (prior to Week 52) due to sustained nonresponse, disease worsening, or the need for rescue medications may also have been eligible for Study C13008. Participants who did not enroll into Study C13008 were to complete a final on-study safety assessment at Week 66 (or final safety visit 16 weeks after the last dose) in the Maintenance Phase of Study C13006.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEach patient must meet all of the following inclusion criteria to be enrolled in the study:\n\n1. Diagnosis of moderately to severely active ulcerative colitis\n2. Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance at least 1 of the following agents:\n\n 1. Immunomodulators\n 2. Tumor necrosis factor-alpha (TNFα) antagonists\n 3. Corticosteroids\n3. May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol\n\nExclusion Criteria:\n\n1. Evidence of abdominal abscess at the initial screening visit\n2. Extensive colonic resection, subtotal or total colectomy\n3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine\n4. Have received non permitted IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol\n5. Chronic hepatitis B or C infection\n6. Active or latent tuberculosis'}, 'identificationModule': {'nctId': 'NCT00783718', 'acronym': 'GEMINI I', 'briefTitle': 'Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Millennium Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'C13006'}, 'secondaryIdInfos': [{'id': 'U1111-1156-8422', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': '2008-002782-32', 'type': 'EUDRACT_NUMBER'}, {'id': 'NL25207.096.08', 'type': 'REGISTRY', 'domain': 'CCMO'}, {'id': 'CTRI/2009/091/000128', 'type': 'REGISTRY', 'domain': 'CTRI'}, {'id': 'NMRR-08-1046-2201', 'type': 'REGISTRY', 'domain': 'NMRR'}, {'id': 'C13006CTIL', 'type': 'OTHER', 'domain': 'Israel MoH'}, {'id': '09/H1102/66', 'type': 'REGISTRY', 'domain': 'NRES'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vedolizumab', 'description': 'In the Induction Phase participants received vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 (Days 1 and 15).\n\nIn the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria were randomized in a 1:1:1 ratio to double-blind treatment with vedolizumab administered every 4 weeks, vedolizumab administered every 8 weeks, or placebo for up to Week 50. Participants who did not demonstrate response at Week 6 of the Induction Phase continued treatment with vedolizumab, administered every 4 weeks during the Maintenance Phase.', 'interventionNames': ['Drug: vedolizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'In the Induction Phase participants received placebo intravenous infusion at Week 0 and Week 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'vedolizumab', 'type': 'DRUG', 'otherNames': ['Entyvio', 'MLN0002', 'MLN02', 'LDP-02'], 'description': 'Vedolizumab for intravenous infusion', 'armGroupLabels': ['Vedolizumab']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo intravenous infusion', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35234', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Apex Clinical Trials', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 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