Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-27 @ 2:56 PM
Study NCT ID:
NCT00783692
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2008-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System 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': 148, 'otherNumAffected': 96, 'seriousNumAtRisk': 148, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'VDZ/PBO', 'description': 'Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase.', 'otherNumAtRisk': 153, 'otherNumAffected': 96, 'seriousNumAtRisk': 153, 'seriousNumAffected': 23}, {'id': 'EG002', 'title': 'VDZ/VDZ', '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': 814, 'otherNumAffected': 476, 'seriousNumAtRisk': 814, 'seriousNumAffected': 199}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 88}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 84}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 79}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 48}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 100}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 54}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 102}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 53}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 110}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 97}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 99}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ileal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Enterovesical fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Small intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Colon dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Colonic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Colonic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ileitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Jejunal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ileal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Periproctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cytolytic hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Carcinoid tumour of the appendix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Sacroiliitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and 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'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Clostridium test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Skin mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Toxic epidermal necrolysis', 'notes': 'This event occurred while the participant was receiving placebo.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 814, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '220', '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': '6.8', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '10.8'}, {'value': '14.5', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '19.2'}]}]}], 'analyses': [{'pValue': '0.0206', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.8', 'ciLowerLimit': '1.2', 'ciUpperLimit': '14.3', 'pValueComment': 'P-value is based on the Cochran-Mantel-Haenszel (CMH) chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no).', 'estimateComment': 'Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo', 'groupDescription': 'The Hochberg method was applied to control the overall Type I error rate at a 5% significance level for the multiple comparisons of the primary endpoints. If both p-values were ≤ 0.05, both primary endpoints were to be declared significant. If 1 of the p-values for the primary endpoints 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 primary was declared significant, no further testing was to be conducted.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 6', 'description': "Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.\n\nThe CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:\n\n* Number of liquid or soft stools each day for 7 days;\n* Abdominal pain (graded from 0-3 on severity) each day for 7 days;\n* General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;\n* Presence of complications;\n* Taking Lomotil or opiates for diarrhea;\n* Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);\n* Hematocrit of \\< 0.47 in men and \\< 0.42 in women;\n* Percentage deviation from standard weight.\n\nThe total score ranges from 0 to approximately 600 and with higher scores indicating 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 Intention to Treat (ITT) Population, which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug.'}, {'type': 'PRIMARY', 'title': 'Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '220', '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': '25.7', 'groupId': 'OG000', 'lowerLimit': '18.6', 'upperLimit': '32.7'}, {'value': '31.4', 'groupId': 'OG001', 'lowerLimit': '25.2', 'upperLimit': '37.5'}]}]}], 'analyses': [{'pValue': '0.2322', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.7', 'ciLowerLimit': '-3.6', 'ciUpperLimit': '15.0', 'pValueComment': 'P-value is based on the Cochran-Mantel-Haenszel (CMH) chi-square test, with stratification according to: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no).', 'estimateComment': 'Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo', 'groupDescription': 'The Hochberg method was applied to control the overall Type I error rate at a 5% significance level for the multiple comparisons of the primary endpoints. If both p-values were ≤ 0.05, both primary endpoints were to be declared significant. If 1 of the p-values for the primary endpoints 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 primary was declared significant, no further testing was to be conducted.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 6', 'description': "Enhanced clinical response is defined as a CDAI score at least 100 points lower than Baseline. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:\n\n* Number of liquid or soft stools each day for 7 days;\n* Abdominal pain (graded from 0-3 on severity) each day for 7 days;\n* General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;\n* Presence of complications;\n* Taking Lomotil or opiates for diarrhea;\n* Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);\n* Hematocrit of \\< 0.47 in men and \\< 0.42 in women;\n* Percentage deviation from standard weight.\n\nThe total score ranges from 0 to 600 with higher scores indicating greater disease activity.\n\nAll participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Induction Study ITT Population'}, {'type': 'PRIMARY', 'title': 'Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '154', '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 then 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 then 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 then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '28.1'}, {'value': '39.0', 'groupId': 'OG001', 'lowerLimit': '31.3', 'upperLimit': '46.7'}, {'value': '36.4', 'groupId': 'OG002', 'lowerLimit': '28.8', 'upperLimit': '44.0'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.4', 'ciLowerLimit': '7.3', 'ciUpperLimit': '27.5', 'pValueComment': 'CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.', 'estimateComment': 'Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo', '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': '0.0042', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.7', 'ciLowerLimit': '4.6', 'ciUpperLimit': '24.7', 'pValueComment': 'CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.', 'estimateComment': 'Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo', '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 CDAI score ≤ 150. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:\n\n* Number of liquid or soft stools each day for 7 days;\n* Abdominal pain (graded from 0-3 on severity) each day for 7 days;\n* General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;\n* Presence of complications;\n* Taking Lomotil or opiates for diarrhea;\n* Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);\n* Hematocrit of \\< 0.47 in men and \\< 0.42 in women;\n* Percentage deviation from standard weight.\n\nThe total score ranges from 0 to 600 with higher scores indicating 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: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '220', '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': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-27.6', 'upperLimit': '12.1'}, {'value': '-0.9', 'groupId': 'OG001', 'lowerLimit': '-20.6', 'upperLimit': '10.3'}]}]}], 'analyses': [{'pValue': '0.9288', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Wilcoxon Rank Sum test on the CRP change from baseline values (two-sided).', 'groupDescription': 'If at least 1 of the primary endpoints was significant, the sequential Hochberg procedure was to be used to test the secondary endpoint for significance at the 0.05% level.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 6', 'description': 'C-reactive protein (CRP) is a protein found in the blood, the levels of which rise in response to inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age. Higher levels indicate mild inflammation (10-40 mg/L) and active inflammation (40-200 mg/L).', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Induction Study ITT Population; last observation carried forward (LOCF) imputation was used. Baseline CRP was missing for one participant in the placebo group.'}, {'type': 'SECONDARY', 'title': 'Maintenance Phase: Percentage of Participants With Enhanced Clinical Response at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '154', '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 then 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 then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.1', 'groupId': 'OG000', 'lowerLimit': '22.8', 'upperLimit': '37.3'}, {'value': '43.5', 'groupId': 'OG001', 'lowerLimit': '35.7', 'upperLimit': '51.3'}, {'value': '45.5', 'groupId': 'OG002', 'lowerLimit': '37.6', 'upperLimit': '53.3'}]}]}], 'analyses': [{'pValue': '0.0132', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.4', 'ciLowerLimit': '2.8', 'ciUpperLimit': '24.0', 'pValueComment': 'CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.', 'estimateComment': 'Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo', 'groupDescription': 'To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0053', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.3', 'ciLowerLimit': '4.6', 'ciUpperLimit': '26.0', 'pValueComment': 'CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.', 'estimateComment': 'Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo', 'groupDescription': 'To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 52', 'description': "Enhanced clinical response is defined as a CDAI score at least 100 points lower than the Baseline value. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:\n\n* Number of liquid or soft stools each day for 7 days;\n* Abdominal pain (graded from 0-3 on severity) each day for 7 days;\n* General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;\n* Presence of complications;\n* Taking Lomotil or opiates for diarrhea;\n* Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);\n* Hematocrit of \\< 0.47 in men and \\< 0.42 in women;\n* Percentage deviation from standard weight.\n\nThe total score ranges from 0 to 600 with higher scores indicating greater disease activity.\n\nAll participants who prematurely discontinued for any reason were considered as not achieving enhanced 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 in Corticosteroid-free Clinical Remission at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '80', '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': '7.9', 'upperLimit': '23.8'}, {'value': '31.7', 'groupId': 'OG001', 'lowerLimit': '21.6', 'upperLimit': '41.8'}, {'value': '28.8', 'groupId': 'OG002', 'lowerLimit': '18.8', 'upperLimit': '38.7'}]}]}], 'analyses': [{'pValue': '0.0154', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.9', 'ciLowerLimit': '3.0', 'ciUpperLimit': '28.7', 'pValueComment': 'P-value is based on the CMH chi-square test, with stratification according to: 1) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 2) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.', 'estimateComment': 'Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo', 'groupDescription': 'To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0450', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.9', 'ciLowerLimit': '0.3', 'ciUpperLimit': '25.5', 'pValueComment': 'P-value is based on the CMH chi-square test, with stratification according to: 1) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 2) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.', 'estimateComment': 'Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo', 'groupDescription': 'To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "Participants using oral corticosteroids at Baseline, who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 52 achieved corticosteroid-free clinical remission. The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity.\n\nAll participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free clinical remission.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Maintenance Study ITT Population, participants who were on corticosteroids at Baseline.'}, {'type': 'SECONDARY', 'title': 'Maintenance Phase: Percentage of Participants With Durable Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '154', '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': '14.4', 'groupId': 'OG000', 'lowerLimit': '8.8', 'upperLimit': '19.9'}, {'value': '21.4', 'groupId': 'OG001', 'lowerLimit': '14.9', 'upperLimit': '27.9'}, {'value': '16.2', 'groupId': 'OG002', 'lowerLimit': '10.4', 'upperLimit': '22.1'}]}]}], 'analyses': [{'pValue': '0.1036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.2', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '16.0', 'pValueComment': 'CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.', 'estimateComment': 'Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo', 'groupDescription': 'To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.6413', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-6.3', 'ciUpperLimit': '10.2', 'pValueComment': 'CMH chi-square test, stratified by: 1) concomitant use of oral corticosteroids (yes/no); 2) previous exposure to TNFα antagonists and/or concomitant immunomodulator use (yes/no); 3) enrollment in Cohort 1 or Cohort 2 in the Induction Phase.', 'estimateComment': 'Risk Difference = adjusted (for stratification factors) percent vedolizumab - adjusted percent placebo', 'groupDescription': 'To maintain the overall Type I error rate at 5% in the multiple-dose comparisons in each key secondary endpoint, the Hochberg method was used. To further maintain the overall Type I error rate at 5%, the key secondary assessments were performed sequentially. The first key secondary endpoint was tested only if 1 or both of the primary comparisons were significant and the next key secondary endpoint was to be tested only if the previous key secondary endpoint was significant for at least 1 dose.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Assessed every 4 weeks from Week 6 to Week 50, and at Week 52', 'description': "Durable clinical remission is defined as CDAI score ≤ 150 points at 80% or more of study visits during the Maintenance Phase, including the Week 52 visit (11 of 13 study visits). The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating 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'}]}, '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': '148'}, {'groupId': 'FG001', 'numSubjects': '220'}, {'groupId': 'FG002', 'numSubjects': '748'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '220'}, {'groupId': 'FG002', 'numSubjects': '747'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '199'}, {'groupId': 'FG002', 'numSubjects': '674'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '74'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'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': '9'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'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': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'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': '137'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '153'}, {'groupId': 'FG004', 'numSubjects': '154'}, {'groupId': 'FG005', 'numSubjects': '154'}, {'groupId': 'FG006', 'numSubjects': '412'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '64'}, {'groupId': 'FG004', 'numSubjects': '73'}, {'groupId': 'FG005', 'numSubjects': '82'}, {'groupId': 'FG006', 'numSubjects': '163'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '89'}, {'groupId': 'FG004', 'numSubjects': '81'}, {'groupId': 'FG005', 'numSubjects': '72'}, {'groupId': 'FG006', 'numSubjects': '249'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '38'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '64'}, {'groupId': 'FG004', 'numSubjects': '58'}, {'groupId': 'FG005', 'numSubjects': '48'}, {'groupId': 'FG006', 'numSubjects': '177'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 285 investigative sites worldwide from 23 December 2008 to 08 May 2012. 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': '148', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '747', 'groupId': 'BG002'}, {'value': '1115', '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.'}, {'id': 'BG001', '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': 'BG002', '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': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '13.16', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '11.57', 'groupId': 'BG001'}, {'value': '35.6', 'spread': '12.01', 'groupId': 'BG002'}, {'value': '36.1', 'spread': '12.12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 35 years', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '404', 'groupId': 'BG002'}, {'value': '582', 'groupId': 'BG003'}]}]}, {'title': '≥ 35 years', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}, {'value': '533', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '732', 'groupId': 'BG002'}, {'value': '1092', 'groupId': 'BG003'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}, {'value': '595', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}, {'value': '520', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '712', 'groupId': 'BG002'}, {'value': '1065', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '689', 'groupId': 'BG002'}, {'value': '995', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'Estonia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}, {'title': 'Iceland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}, {'title': 'Ireland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'Latvia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Malaysia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Norway', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Singapore', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Turkey', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '68.7', 'spread': '18.90', 'groupId': 'BG000'}, {'value': '67.1', 'spread': '19.07', 'groupId': 'BG001'}, {'value': '70.8', 'spread': '19.56', 'groupId': 'BG002'}, {'value': '69.8', 'spread': '19.42', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '23.7', 'spread': '5.77', 'groupId': 'BG000'}, {'value': '23.1', 'spread': '5.62', 'groupId': 'BG001'}, {'value': '24.2', 'spread': '6.02', 'groupId': 'BG002'}, {'value': '23.9', 'spread': '5.93', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Duration of Crohn's Disease (CD)", 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '7.80', 'groupId': 'BG000'}, {'value': '9.2', 'spread': '8.18', 'groupId': 'BG001'}, {'value': '9.2', 'spread': '7.63', 'groupId': 'BG002'}, {'value': '9.0', 'spread': '7.77', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Duration of Crohn's Disease - Categorical", 'classes': [{'title': '< 1 year', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}]}, {'title': '≥ 1 to < 3 years', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}]}]}, {'title': '≥ 3 to < 7 years', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}, {'value': '285', 'groupId': 'BG003'}]}]}, {'title': '≥ 7 years', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '385', 'groupId': 'BG002'}, {'value': '560', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Baseline Disease Activity - Crohn's Disease Activity Index (CDAI)", 'classes': [{'categories': [{'measurements': [{'value': '324.6', 'spread': '78.08', 'groupId': 'BG000'}, {'value': '327.3', 'spread': '70.67', 'groupId': 'BG001'}, {'value': '322.2', 'spread': '67.17', 'groupId': 'BG002'}, {'value': '323.6', 'spread': '69.37', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Number of participants for whom baseline CDAI scores were available were 147, 219, and 743, respectively.\n\nThe CDAI is a numerical calculation derived from the sum of products from a list of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to \\~600 points with lower scores indicating disease remission and higher scores indicating disease worsening.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Disease Activity - Categorical', 'classes': [{'title': 'CDAI ≤ 330', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '418', 'groupId': 'BG002'}, {'value': '618', 'groupId': 'BG003'}]}]}, {'title': 'CDAI > 330', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}, {'value': '491', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline C-reactive Protein (CRP)', 'classes': [{'categories': [{'measurements': [{'value': '23.6', 'spread': '27.85', 'groupId': 'BG000'}, {'value': '24.1', 'spread': '27.23', 'groupId': 'BG001'}, {'value': '20.4', 'spread': '27.40', 'groupId': 'BG002'}, {'value': '21.5', 'spread': '27.45', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline CRP data was only available for 147 participants in the placebo arm.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline CRP - Categorical', 'classes': [{'title': '≤ 2.87 mg/L', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}]}]}, {'title': '> 2.87 to ≤ 5 mg/L', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}]}, {'title': '> 5 to ≤ 10 mg/L', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}, {'value': '226', 'groupId': 'BG003'}]}]}, {'title': '> 10 mg/L', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}, {'value': '587', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Fecal Calprotectin', 'classes': [{'categories': [{'measurements': [{'value': '1421.2', 'spread': '2076.11', 'groupId': 'BG000'}, {'value': '1839.9', 'spread': '2624.92', 'groupId': 'BG001'}, {'value': '1050.1', 'spread': '1558.93', 'groupId': 'BG002'}, {'value': '1254.2', 'spread': '1908.82', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Number of participants for whom baseline fecal calprotectin data were available were 142, 210, and 719, respectively.', 'unitOfMeasure': 'μg/g', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Fecal Calprotectin - Categorical', 'classes': [{'title': '≤ 250 μg/g', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}, {'value': '286', 'groupId': 'BG003'}]}]}, {'title': '> 250 to ≤ 500 μg/g', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}]}, {'title': '> 500 μg/g', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '406', 'groupId': 'BG002'}, {'value': '621', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease Localization', 'classes': [{'title': 'Ileum only', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}]}]}, {'title': 'Colon only', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}, {'value': '316', 'groupId': 'BG003'}]}]}, {'title': 'Ileocolonic (both ileum and colon)', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '413', 'groupId': 'BG002'}, {'value': '618', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "History of Prior Surgery for Crohn's Disease", 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '314', 'groupId': 'BG002'}, {'value': '466', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}, {'value': '649', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of Fistulizing Disease', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}, {'value': '410', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '483', 'groupId': 'BG002'}, {'value': '705', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Draining Fistula at Baseline', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}, {'value': '165', 'groupId': 'BG003'}]}]}, {'title': 'All Closed', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '635', 'groupId': 'BG002'}, {'value': '939', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Smoking Status', 'classes': [{'title': 'Current smoker', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}, {'value': '298', 'groupId': 'BG003'}]}]}, {'title': 'Nonsmoker (never smoked)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}, {'value': '556', 'groupId': 'BG003'}]}]}, {'title': 'Former smoker', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}, {'value': '260', 'groupId': 'BG003'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Extraintestinal Manifestations', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '456', 'groupId': 'BG002'}, {'value': '696', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}, {'value': '419', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of Extraintestinal Manifestations', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '619', 'groupId': 'BG002'}, {'value': '919', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '196', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '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 to 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': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'dispFirstSubmitDate': '2013-04-08', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-19', 'studyFirstSubmitDate': '2008-10-31', 'dispFirstSubmitQcDate': '2013-04-08', 'resultsFirstSubmitDate': '2014-06-19', 'studyFirstSubmitQcDate': '2008-10-31', 'dispFirstPostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-19', 'studyFirstPostDateStruct': {'date': '2008-11-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6', 'timeFrame': 'Week 6', 'description': "Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.\n\nThe CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:\n\n* Number of liquid or soft stools each day for 7 days;\n* Abdominal pain (graded from 0-3 on severity) each day for 7 days;\n* General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;\n* Presence of complications;\n* Taking Lomotil or opiates for diarrhea;\n* Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);\n* Hematocrit of \\< 0.47 in men and \\< 0.42 in women;\n* Percentage deviation from standard weight.\n\nThe total score ranges from 0 to approximately 600 and with higher scores indicating 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 Enhanced Clinical Response at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': "Enhanced clinical response is defined as a CDAI score at least 100 points lower than Baseline. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:\n\n* Number of liquid or soft stools each day for 7 days;\n* Abdominal pain (graded from 0-3 on severity) each day for 7 days;\n* General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;\n* Presence of complications;\n* Taking Lomotil or opiates for diarrhea;\n* Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);\n* Hematocrit of \\< 0.47 in men and \\< 0.42 in women;\n* Percentage deviation from standard weight.\n\nThe total score ranges from 0 to 600 with higher scores indicating greater disease activity.\n\nAll participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."}, {'measure': 'Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52', 'timeFrame': 'Week 52', 'description': "Clinical remission is defined as a CDAI score ≤ 150. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:\n\n* Number of liquid or soft stools each day for 7 days;\n* Abdominal pain (graded from 0-3 on severity) each day for 7 days;\n* General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;\n* Presence of complications;\n* Taking Lomotil or opiates for diarrhea;\n* Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);\n* Hematocrit of \\< 0.47 in men and \\< 0.42 in women;\n* Percentage deviation from standard weight.\n\nThe total score ranges from 0 to 600 with higher scores indicating greater disease activity.\n\nAll participants who prematurely discontinued for any reason were considered as not achieving clinical remission."}], 'secondaryOutcomes': [{'measure': 'Induction Phase: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6', 'timeFrame': 'Baseline and Week 6', 'description': 'C-reactive protein (CRP) is a protein found in the blood, the levels of which rise in response to inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age. Higher levels indicate mild inflammation (10-40 mg/L) and active inflammation (40-200 mg/L).'}, {'measure': 'Maintenance Phase: Percentage of Participants With Enhanced Clinical Response at Week 52', 'timeFrame': 'Baseline and Week 52', 'description': "Enhanced clinical response is defined as a CDAI score at least 100 points lower than the Baseline value. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:\n\n* Number of liquid or soft stools each day for 7 days;\n* Abdominal pain (graded from 0-3 on severity) each day for 7 days;\n* General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;\n* Presence of complications;\n* Taking Lomotil or opiates for diarrhea;\n* Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);\n* Hematocrit of \\< 0.47 in men and \\< 0.42 in women;\n* Percentage deviation from standard weight.\n\nThe total score ranges from 0 to 600 with higher scores indicating greater disease activity.\n\nAll participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response."}, {'measure': 'Maintenance Phase: Percentage of Participants in Corticosteroid-free Clinical Remission at Week 52', 'timeFrame': 'Week 52', 'description': "Participants using oral corticosteroids at Baseline, who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 52 achieved corticosteroid-free clinical remission. The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity.\n\nAll participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free clinical remission."}, {'measure': 'Maintenance Phase: Percentage of Participants With Durable Clinical Remission', 'timeFrame': 'Assessed every 4 weeks from Week 6 to Week 50, and at Week 52', 'description': "Durable clinical remission is defined as CDAI score ≤ 150 points at 80% or more of study visits during the Maintenance Phase, including the Week 52 visit (11 of 13 study visits). The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity.\n\nAll participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'referencesModule': {'references': [{'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': '30615117', 'type': 'DERIVED', 'citation': "Sands BE, Van Assche G, Tudor D, Akhundova-Unadkat G, Curtis RI, Tan T. Vedolizumab in Combination With Corticosteroids for Induction Therapy in Crohn's Disease: A Post Hoc Analysis of GEMINI 2 and 3. Inflamm Bowel Dis. 2019 Jul 17;25(8):1375-1382. doi: 10.1093/ibd/izy384."}, {'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': '29471381', 'type': 'DERIVED', 'citation': "Feagan BG, Schwartz D, Danese S, Rubin DT, Lissoos TW, Xu J, Lasch K. Efficacy of Vedolizumab in Fistulising Crohn's Disease: Exploratory Analyses of Data from GEMINI 2. J Crohns Colitis. 2018 Apr 27;12(5):621-626. doi: 10.1093/ecco-jcc/jjy019."}, {'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."}, {'pmid': '23964933', 'type': 'DERIVED', 'citation': "Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel JF, Sands BE, Lukas M, Fedorak RN, Lee S, Bressler B, Fox I, Rosario M, Sankoh S, Xu J, Stephens K, Milch C, Parikh A; GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013 Aug 22;369(8):711-21. doi: 10.1056/NEJMoa1215739."}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response and remission at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.', 'detailedDescription': 'Study C13007 comprised 2 randomized, double-blind, placebo-controlled studies conducted under 1 protocol which, operationally, consisted of 2 phases.\n\n* The Induction Phase, designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and clinical remission, and\n* The Maintenance Phase, designed to establish the efficacy and safety of vedolizumab for the maintenance of clinical response and clinical 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 may have been eligible to enroll in Study C13008 (NCT00790933; Long-term Safety Study) 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 have been eligible to enroll in 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 C13007.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 to 80\n2. Diagnosis of moderately to severely active Crohn's disease (CD)\n3. CD involvement of the ileum and/or colon\n4. Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents, within protocol-specified parameters:\n\n 1. Immunomodulators\n 2. Tumor necrosis factor-alpha (TNFα) antagonists\n 3. Corticosteroids\n5. May be receiving a therapeutic dose of conventional therapies for irritable bowel disease (IBD) defined by the protocol\n\nExclusion Criteria\n\n1. Evidence of abdominal abscess at the initial screening visit, other than a minimum of 10 aphthous ulcerations involving a minimum of 10 contiguous cm of intestine\n2. Extensive colonic resection, subtotal or total colectomy\n3. History of \\>3 small bowel resections or diagnosis of short bowel syndrome\n4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine\n5. Have received non permitted IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol\n6. Chronic hepatitis B or C infection\n7. Active or latent tuberculosis"}, 'identificationModule': {'nctId': 'NCT00783692', 'acronym': 'GEMINI II', 'briefTitle': "Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease", '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 Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease", 'orgStudyIdInfo': {'id': 'C13007'}, 'secondaryIdInfos': [{'id': '2008-002783-33', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1157-7675', 'type': 'REGISTRY', 'domain': 'WHO'}, {'id': 'CTRI/2009/091/000135', 'type': 'REGISTRY', 'domain': 'CTRI'}, {'id': 'NMRR-08-1047-2202', 'type': 'REGISTRY', 'domain': 'NMRR'}, {'id': '09/H1102/65', 'type': 'REGISTRY', 'domain': 'NRES'}, {'id': 'NL25208.096.08', 'type': 'REGISTRY', 'domain': 'CCMO'}, {'id': 'C13007CTIL', 'type': 'OTHER', 'domain': 'Israel MoH'}]}, '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': '90067', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Gastrointestinal Bioscience', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90640', 'city': 'Montebello', 'state': 'California', 'country': 'United States', 'facility': 'Paramount Medical Specialty', 'geoPoint': {'lat': 34.00946, 'lon': -118.10535}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Capital Gastroenterology Consultants Medical Group', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Applications Laboratories Inc.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92114', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Desta Digestive Disease Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health Sciences Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80401', 'city': 'Golden', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Clinical Research, LLC', 'geoPoint': {'lat': 39.75554, 'lon': -105.2211}}, {'zip': '80026', 'city': 'Lafayette', 'state': 'Colorado', 'country': 'United States', 'facility': 'Gastroenterology of the Rockies', 'geoPoint': {'lat': 39.9936, 'lon': -105.08971}}, {'zip': '80120', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Arapahoe Gastroenterology Associates P.C.', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'country': 'United States', 'facility': 'South Denver Gastroenterology', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}, {'zip': '81007', 'city': 'Pueblo', 'state': 'Colorado', 'country': 'United States', 'facility': 'Lynn Institute of Pueblo', 'geoPoint': {'lat': 38.25445, 'lon': -104.60914}}, {'zip': '06010', 'city': 'Bristol', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Connecticut Gastroenterology Institute', 'geoPoint': {'lat': 41.67176, 'lon': -72.94927}}, {'zip': '06518', 'city': 'Hamden', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Gastroenterology Center of Connecticut, P.C.', 'geoPoint': {'lat': 41.39593, 'lon': -72.89677}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida, Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32223', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'East Coast Institute for Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Borland-Groover Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Advanced Gastroenterology', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '32901', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Osler Clinical Research', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Miller School of Medicine', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32168', 'city': 'New Smyrna Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'United Medical Research Institute', 'geoPoint': {'lat': 29.02582, 'lon': -80.927}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research LLC', 'geoPoint': {'lat': 28.53834, 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