Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-04-16 @ 1:57 PM
Study NCT ID:
NCT02038920
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2014-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase III Study of MLN0002 (300 mg) in Treatment of 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '877-825-3327', 'title': 'Medical Director', 'phoneExt': '+1', 'organization': 'Takeda'}, '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 Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Induction Phase: Vedolizumab, 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 17, 'seriousNumAtRisk': 79, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Induction Phase: Placebo', 'description': 'Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 19, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Maintenance Phase: Vedolizumab 300 mg', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Maintenance Phase: Placebo', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Maintenance Phase: Placebo Continuation', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 12, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Open-Label: Vedolizumab 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 113, 'seriousNumAtRisk': 134, 'deathsNumAffected': 0, 'seriousNumAffected': 70}], 'otherEvents': [{'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 55}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Allergy to metals', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Dermatophytosis of nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Bone contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Heat illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Glucose urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Ocular neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Cervicobrachial syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG005', 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{'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Mesenteric abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Mycotic endophthalmitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Periumbilical abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Intestinal anastomosis complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Post lumbar puncture syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Dyslalia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Intracranial hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}, {'term': 'Mediastinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA: 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Induction Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response", 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction Phase: Vedolizumab, 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'OG001', 'title': 'Induction Phase: Placebo', 'description': 'Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000', 'lowerLimit': '17.268', 'upperLimit': '37.720'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '9.184', 'upperLimit': '26.813'}]}]}], 'analyses': [{'pValue': '0.1448', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.80', 'ciLowerLimit': '0.816', 'ciUpperLimit': '3.958', 'estimateComment': 'MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10', 'description': "A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) in the induction phase included participants who were randomized and received at least one dose of the study drug in induction phase.'}, {'type': 'PRIMARY', 'title': 'Maintenance Phase: Percentage of Participants With Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Phase: Vedolizumab 300 mg', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.'}, {'id': 'OG001', 'title': 'Maintenance Phase: Placebo', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000', 'lowerLimit': '15.165', 'upperLimit': '72.333'}, {'value': '16.7', 'groupId': 'OG001', 'lowerLimit': '2.086', 'upperLimit': '48.414'}]}]}], 'analyses': [{'pValue': '0.1779', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.57', 'ciLowerLimit': '0.532', 'ciUpperLimit': '23.953', 'estimateComment': 'MLN0002 group/placebo group', 'statisticalMethod': "Pearson's Chi-square Test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 60', 'description': "Clinical remission is defined as the CDAI score ≤150. CDAI is scoring system for the assessment of Crohn's disease activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS in the maintenance phase included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '134', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction Phase: Vedolizumab, 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'OG001', 'title': 'Induction Phase: Placebo', 'description': 'Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'OG002', 'title': 'Maintenance Phase: Vedolizumab 300 mg', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.'}, {'id': 'OG003', 'title': 'Maintenance Phase: Placebo', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.'}, {'id': 'OG004', 'title': 'Maintenance Phase: Placebo Continuation', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.'}, {'id': 'OG005', 'title': 'Open-Label: Vedolizumab 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '130', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)', 'description': 'An Adverse event (AE) is defined as any untoward medical occurrence in a study participant who received a drug (including a study drug); it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With TEAE Related to Body Weight (Weight Decreased)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '134', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction Phase: Vedolizumab, 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'OG001', 'title': 'Induction Phase: Placebo', 'description': 'Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'OG002', 'title': 'Maintenance Phase: Vedolizumab 300 mg', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.'}, {'id': 'OG003', 'title': 'Maintenance Phase: Placebo', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.'}, {'id': 'OG004', 'title': 'Maintenance Phase: Placebo Continuation', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.'}, {'id': 'OG005', 'title': 'Open-Label: Vedolizumab 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)', 'description': 'Reported events on this outcome measure were "Weight Decreased".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With TEAE Related to Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '134', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction Phase: Vedolizumab, 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'OG001', 'title': 'Induction Phase: Placebo', 'description': 'Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'OG002', 'title': 'Maintenance Phase: Vedolizumab 300 mg', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.'}, {'id': 'OG003', 'title': 'Maintenance Phase: Placebo', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.'}, {'id': 'OG004', 'title': 'Maintenance Phase: Placebo Continuation', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.'}, {'id': 'OG005', 'title': 'Open-Label: Vedolizumab 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.'}], 'classes': [{'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}]}, {'title': 'Body Temperature Increased', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Hypertension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Orthostatic Hypotension', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)', 'description': 'Vital signs included body temperature (axilla), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). Reported events on this outcome measure were "Pyrexia", "Body temperature increased", "Hypertension", and "Orthostatic hypotension".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '134', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction Phase: Vedolizumab, 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'OG001', 'title': 'Induction Phase: Placebo', 'description': 'Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'OG002', 'title': 'Maintenance Phase: Vedolizumab 300 mg', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.'}, {'id': 'OG003', 'title': 'Maintenance Phase: Placebo', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.'}, {'id': 'OG004', 'title': 'Maintenance Phase: Placebo Continuation', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.'}, {'id': 'OG005', 'title': 'Open-Label: Vedolizumab 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)', 'description': 'Reported events on this outcome measure were "Bundle Branch Block Right".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}, {'value': '134', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction Phase: Vedolizumab, 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'OG001', 'title': 'Induction Phase: Placebo', 'description': 'Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'OG002', 'title': 'Maintenance Phase: Vedolizumab 300 mg', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.'}, {'id': 'OG003', 'title': 'Maintenance Phase: Placebo', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.'}, {'id': 'OG004', 'title': 'Maintenance Phase: Placebo Continuation', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.'}, {'id': 'OG005', 'title': 'Open-Label: Vedolizumab 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.'}], 'classes': [{'title': 'Hemoglobin (g/dL) <=7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Lymphocytes (/uL) <500', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}, {'title': 'WBC (/uL) <2000', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Platelets (10^4/uL) <7.5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Neutrophils (/uL) <1000', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'ALT (GPT) (U/L) >3.0 x ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'AST (GOT) (U/L) >3.0 x ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Total Bilirubin (mg/dL) >2.0 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Amylase (U/L) >2.0 x ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)', 'description': 'The laboratory values outside the range (Hemoglobin \\<=7 g/dL, Lymphocytes \\<500 /microL, White Blood Cell (WBC) \\<2000 /microL, Platelets \\<7.5 10\\^4/microL, Neutrophils \\<1000 /microL, Alanine Aminotransferase (ALT) (Glutamic Pyruvic Transaminase; GPT) \\>3.0 U/L x upper limit of normal (ULN), Aspartate Aminotransferase (AST) (Glutamic Oxaloacetic Transaminase; GOT) \\>3.0 U/L x ULN, Total Bilirubin \\>2.0 mg/dL x ULN, Amylase \\>2.0 (U/L) x ULN are considered markedly abnormal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.'}, {'type': 'SECONDARY', 'title': 'Induction Phase: Percentage of Participants With Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction Phase: Vedolizumab, 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'OG001', 'title': 'Induction Phase: Placebo', 'description': 'Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000', 'lowerLimit': '10.041', 'upperLimit': '27.942'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '4.533', 'upperLimit': '19.213'}]}]}], 'analyses': [{'pValue': '0.1963', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.83', 'ciLowerLimit': '0.720', 'ciUpperLimit': '4.673', 'estimateComment': 'MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10', 'description': "Clinical remission is defined as the CDAI score ≤150. CDAI is scoring system for the assessment of Crohn's disease activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS in the induction phase included participants who were randomized and received at least one dose of the study drug in induction phase.'}, {'type': 'SECONDARY', 'title': 'Induction Phase: Change From Baseline in C-reactive Protein (CRP) Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction Phase: Vedolizumab, 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'OG001', 'title': 'Induction Phase: Placebo', 'description': 'Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.'}], 'classes': [{'title': 'Change from Baseline at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.022', 'spread': '2.1421', 'groupId': 'OG000'}, {'value': '-0.125', 'spread': '2.8417', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.089', 'spread': '2.0266', 'groupId': 'OG000'}, {'value': '0.130', 'spread': '2.1674', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.164', 'spread': '2.2729', 'groupId': 'OG000'}, {'value': '0.077', 'spread': '2.8690', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 10', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Participants from 'FAS in the induction phase' with CRP value exceeding 0.30 mg/dL at Baseline were analyzed at given time point. Number analyzed is the number of participants with evaluable data at the given time-point."}, {'type': 'SECONDARY', 'title': "Maintenance Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response", 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Phase: Vedolizumab 300 mg', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.'}, {'id': 'OG001', 'title': 'Maintenance Phase: Placebo', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000', 'lowerLimit': '27.667', 'upperLimit': '84.835'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '0.211', 'upperLimit': '38.480'}]}]}], 'analyses': [{'pValue': '0.0094', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.40', 'ciLowerLimit': '1.473', 'ciUpperLimit': '160.972', 'statisticalMethod': "Pearson's Chi-square Test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 60', 'description': "A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS in the maintenance phase included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.'}, {'type': 'SECONDARY', 'title': 'Maintenance Phase: Percentage of Participants With Durable Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Phase: Vedolizumab 300 mg', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.'}, {'id': 'OG001', 'title': 'Maintenance Phase: Placebo', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '9.925', 'upperLimit': '65.112'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '5.486', 'upperLimit': '57.186'}]}]}], 'analyses': [{'pValue': '0.6534', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '0.254', 'ciUpperLimit': '8.844', 'estimateComment': 'MLN0002 group/placebo group.', 'statisticalMethod': "Pearson's Chi-square Test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 14 and Week 60', 'description': "Durable clinical remission is defined as participants with CDAI score ≤ 150 at both Weeks 14 and 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS in the maintenance phase included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.'}, {'type': 'SECONDARY', 'title': 'Maintenance Phase: Percentage of Participants With Corticosteroid-free Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Phase: Vedolizumab 300 mg', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.'}, {'id': 'OG001', 'title': 'Maintenance Phase: Placebo', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '5.274', 'upperLimit': '85.337'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '70.760'}]}]}], 'analyses': [{'pValue': '0.2059', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': "Pearson's Chi-square Test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 60', 'description': "Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from FAS in maintenance phase included participants who were randomized and received at least one dose of the study drug in the maintenance phase and administered oral corticosteroids concomitantly at Week 0, were analyzed at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Serum Vedolizumab Concentration in Induction Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction Phase: Vedolizumab, 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.23', 'spread': '11.018', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.01', 'spread': '14.076', 'groupId': 'OG000'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.31', 'spread': '14.049', 'groupId': 'OG000'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.24', 'spread': '10.350', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 6, 10 and 14', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Participants from 'FAS in Induction Phase', who were randomized and received at least one dose of the study drug in the induction phase and for whom samples were available for pharmacokinetic (PK) analysis. Number analyzed is the number of participants with evaluable data at the given time-point."}, {'type': 'SECONDARY', 'title': 'Serum Vedolizumab Concentration in Maintenance Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Phase: Vedolizumab 300 mg', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.'}, {'id': 'OG001', 'title': 'Maintenance Phase: Placebo', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.32', 'spread': '13.880', 'groupId': 'OG000'}, {'value': '30.54', 'spread': '9.7495', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.19', 'spread': '17.054', 'groupId': 'OG000'}, {'value': '24.90', 'spread': '14.490', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.24', 'spread': '15.464', 'groupId': 'OG000'}, {'value': '26.60', 'spread': '15.642', 'groupId': 'OG001'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.20', 'spread': '8.5793', 'groupId': 'OG000'}, {'value': '13.72', 'spread': '13.072', 'groupId': 'OG001'}]}]}, {'title': 'Week 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.102', 'spread': '6.1809', 'groupId': 'OG000'}, {'value': '1.502', 'spread': '2.8285', 'groupId': 'OG001'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.013', 'spread': '6.8774', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'OG001'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.68', 'spread': '4.2659', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.0000', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 6, 10, 14, 22, 30 and 60', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Participants from 'FAS in Maintenance Phase', who were randomized and received at least one dose of the study drug in the maintenance phase and for whom samples were available for PK analysis. Number analyzed is the number of participants with evaluable data at the given time-point."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-vedolizumab Antibodies (AVA) in Induction Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction Phase: Vedolizumab, 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '16 Weeks After Last Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Participants who underwent proper AVA test out of 'the FAS in the induction phase' were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-vedolizumab Antibodies (AVA) in Maintenance Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Phase: Vedolizumab 300 mg', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.'}, {'id': 'OG001', 'title': 'Maintenance Phase: Placebo', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '16 Weeks After Last Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Participants who underwent proper AVA test out of the 'FAS in Maintenance Phase', the participants who received at least one dose of study drug in the maintenance phase were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-vedolizumab Antibodies (AVA) in Open Label Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label: Vedolizumab 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 94', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '16 Weeks After Last Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Participants who underwent proper AVA test out of the 'FAS in Open Label Cohort', the participants who received at least one dose of study drug in the open label cohort were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Induction Phase: Vedolizumab, 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '16 Weeks After Last Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Participants who underwent proper AVA test out of 'the FAS in the induction phase' were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maintenance Phase: Vedolizumab 300 mg', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.'}, {'id': 'OG001', 'title': 'Maintenance Phase: Placebo', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '16 Weeks After Last Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Participants who underwent proper AVA test out of the 'FAS in Maintenance Phase', the participants who received at least one dose of study drug in the maintenance phase were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label: Vedolizumab 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 62', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 94', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '16 Weeks After Last Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Participants who underwent proper AVA test out of the 'FAS in Open Label Cohort', the participants who received at least one dose of study drug in the open label cohort were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Induction Phase: Vedolizumab, 300 mg', 'description': 'Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'FG001', 'title': 'Induction Phase: Placebo', 'description': 'Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'FG002', 'title': 'Maintenance Phase: Vedolizumab 300 mg', 'description': "Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved Crohn's Disease Activity Index (CDAI)-70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase."}, {'id': 'FG003', 'title': 'Maintenance Phase: Placebo', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.'}, {'id': 'FG004', 'title': 'Maintenance Phase: Placebo Continuation', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.'}, {'id': 'FG005', 'title': 'Open-Label: Vedolizumab 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.'}], 'periods': [{'title': 'Induction Phase (Week 0 to 14)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Pretreatment Event/Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Voluntary Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Maintenance Phase (Week 14 to 60)', 'milestones': [{'type': 'STARTED', 'comment': 'Participants who achieved clinical response at Week 10 entered into the maintenance phase.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '17'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Pretreatment Event/Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', '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'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Open Label Cohort (Week 10 to 154)', 'milestones': [{'type': 'STARTED', 'comment': '23 out of 157 participants from induction/maintenance phase did not enter the open-label cohort.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '134'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '77'}]}], 'dropWithdraws': [{'type': 'Pretreatment Event/Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '43'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Voluntary Withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '23'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 77 investigative sites in Japan from 28 Jan 2014 to 21 May 2019.', 'preAssignmentDetails': "Participants with moderate to severe Crohn's disease were enrolled. 157 participants enrolled in induction phase, 41 participants entered maintenance phase and 134 participants entered open-label cohort and received placebo or vedolizumab 300 mg. Open-label cohort occurred between Week 10 and 154 through study with maximum of 94 weeks of treatment."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Induction Phase: Vedolizumab, 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'BG001', 'title': 'Induction Phase: Placebo', 'description': 'Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '33.9', 'spread': '12.25', 'groupId': 'BG000'}, {'value': '32.6', 'spread': '10.93', 'groupId': 'BG001'}, {'value': '33.3', 'spread': '11.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '166.3', 'spread': '8.73', 'groupId': 'BG000'}, {'value': '166.4', 'spread': '7.97', 'groupId': 'BG001'}, {'value': '166.4', 'spread': '8.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58.53', 'spread': '14.095', 'groupId': 'BG000'}, {'value': '55.03', 'spread': '8.928', 'groupId': 'BG001'}, {'value': '56.79', 'spread': '11.906', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21.15', 'spread': '4.942', 'groupId': 'BG000'}, {'value': '19.81', 'spread': '2.567', 'groupId': 'BG001'}, {'value': '20.48', 'spread': '3.989', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index = weight(kg)/\\[height(m)\\^2\\]', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Duration of Crohn's Disease", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7.20', 'groupId': 'BG000', 'lowerLimit': '0.3', 'upperLimit': '27.8'}, {'value': '8.35', 'groupId': 'BG001', 'lowerLimit': '0.3', 'upperLimit': '32.0'}, {'value': '7.90', 'groupId': 'BG002', 'lowerLimit': '0.3', 'upperLimit': '32.0'}]}]}], 'paramType': 'MEDIAN', 'description': "Duration between the first diagnosis of Crohn's disease and the start of the study was reported.", 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'C-Reactive Protein (CRP)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.234', 'spread': '2.1763', 'groupId': 'BG000'}, {'value': '2.848', 'spread': '3.2303', 'groupId': 'BG001'}, {'value': '2.539', 'spread': '2.7593', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CDAI Score at Week 0', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '303.9', 'spread': '63.19', 'groupId': 'BG000'}, {'value': '295.0', 'spread': '64.81', 'groupId': 'BG001'}, {'value': '299.5', 'spread': '63.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "CDAI is scoring system for the Assessment of Crohn's Disease Activity. The total CDAI score ranges from 0 to approximately 600 , where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Disease Localization', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Small Intestine Type', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Large Intestine Type', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Small/large Intestine Type', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking Classification', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Never Smoked', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Current Smoker', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Ex-smoker', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Extraintestinal Manifestations (Based on CDAI subscore)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Had No Extraintestinal Manifestations', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Had Extraintestinal Manifestations', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "CDAI is scoring system for the Assessment of Crohn's Disease Activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.", 'unitOfMeasure': 'Participants'}, {'title': 'Extraintestinal Manifestations (Based on Case Report Form)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Had No Extraintestinal Manifestations', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Had Extraintestinal Manifestations', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "History of Prior Surgery for Crohn's Disease (CD)", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Had No Surgical History', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}, {'title': 'Had Surgical History', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Current Medical Condition Related to Fistula', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Had No Current Medical Condition', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': 'Had Current Medical Condition', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who entered in the induction phase.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-11-11', 'size': 1471246, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-11-20T19:46', 'hasProtocol': True}, {'date': '2018-01-25', 'size': 3239052, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-11-20T19:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-20', 'studyFirstSubmitDate': '2014-01-15', 'resultsFirstSubmitDate': '2019-11-20', 'studyFirstSubmitQcDate': '2014-01-15', 'lastUpdatePostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-20', 'studyFirstPostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Induction Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response", 'timeFrame': 'Week 10', 'description': "A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease."}, {'measure': 'Maintenance Phase: Percentage of Participants With Clinical Remission', 'timeFrame': 'Week 60', 'description': "Clinical remission is defined as the CDAI score ≤150. CDAI is scoring system for the assessment of Crohn's disease activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease."}, {'measure': 'Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)', 'description': 'An Adverse event (AE) is defined as any untoward medical occurrence in a study participant who received a drug (including a study drug); it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.'}, {'measure': 'Number of Participants With TEAE Related to Body Weight (Weight Decreased)', 'timeFrame': 'From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)', 'description': 'Reported events on this outcome measure were "Weight Decreased".'}, {'measure': 'Number of Participants With TEAE Related to Vital Signs', 'timeFrame': 'From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)', 'description': 'Vital signs included body temperature (axilla), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). Reported events on this outcome measure were "Pyrexia", "Body temperature increased", "Hypertension", and "Orthostatic hypotension".'}, {'measure': 'Number of Participants With TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right]', 'timeFrame': 'From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)', 'description': 'Reported events on this outcome measure were "Bundle Branch Block Right".'}, {'measure': 'Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values', 'timeFrame': 'From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)', 'description': 'The laboratory values outside the range (Hemoglobin \\<=7 g/dL, Lymphocytes \\<500 /microL, White Blood Cell (WBC) \\<2000 /microL, Platelets \\<7.5 10\\^4/microL, Neutrophils \\<1000 /microL, Alanine Aminotransferase (ALT) (Glutamic Pyruvic Transaminase; GPT) \\>3.0 U/L x upper limit of normal (ULN), Aspartate Aminotransferase (AST) (Glutamic Oxaloacetic Transaminase; GOT) \\>3.0 U/L x ULN, Total Bilirubin \\>2.0 mg/dL x ULN, Amylase \\>2.0 (U/L) x ULN are considered markedly abnormal.'}], 'secondaryOutcomes': [{'measure': 'Induction Phase: Percentage of Participants With Clinical Remission', 'timeFrame': 'Week 10', 'description': "Clinical remission is defined as the CDAI score ≤150. CDAI is scoring system for the assessment of Crohn's disease activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease."}, {'measure': 'Induction Phase: Change From Baseline in C-reactive Protein (CRP) Values', 'timeFrame': 'Baseline to Week 10'}, {'measure': "Maintenance Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response", 'timeFrame': 'Week 60', 'description': "A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease."}, {'measure': 'Maintenance Phase: Percentage of Participants With Durable Clinical Remission', 'timeFrame': 'From Week 14 and Week 60', 'description': "Durable clinical remission is defined as participants with CDAI score ≤ 150 at both Weeks 14 and 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease."}, {'measure': 'Maintenance Phase: Percentage of Participants With Corticosteroid-free Clinical Remission', 'timeFrame': 'Week 60', 'description': "Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease."}, {'measure': 'Serum Vedolizumab Concentration in Induction Phase', 'timeFrame': 'Weeks 2, 6, 10 and 14'}, {'measure': 'Serum Vedolizumab Concentration in Maintenance Phase', 'timeFrame': 'Weeks 2, 6, 10, 14, 22, 30 and 60'}, {'measure': 'Number of Participants With Anti-vedolizumab Antibodies (AVA) in Induction Phase', 'timeFrame': 'Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase'}, {'measure': 'Number of Participants With Anti-vedolizumab Antibodies (AVA) in Maintenance Phase', 'timeFrame': 'Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase'}, {'measure': 'Number of Participants With Anti-vedolizumab Antibodies (AVA) in Open Label Cohort', 'timeFrame': 'Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort'}, {'measure': 'Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase', 'timeFrame': 'Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase'}, {'measure': 'Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase', 'timeFrame': 'Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase'}, {'measure': 'Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort', 'timeFrame': 'Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ["Crohn's Disease"]}, 'referencesModule': {'references': [{'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."}]}, 'descriptionModule': {'briefSummary': "This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in Japanese participants with moderately or severely active Crohn's disease.", 'detailedDescription': "This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of intravenous vedolizumab (300 mg) infusion in induction and maintenance therapy in Japanese participants with moderately or severely active Crohn's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. In the opinion of the investigator, participants were capable of understanding and complying with protocol requirements\n2. Participants or, when applicable, participants legally acceptable representative sign and date the informed consent form prior to initiation of any study procedures\n3. Participants aged 15 to 80 years (inclusive) at the time of consent\n4. A nonsterilized male participant who has a female partner of child-bearing potential has to agree to use adequate contraception during the period from the signing of informed consent to 6 months after the last dose of the study drug\n5. A female participant of child-bearing potential (i.e., nonsterilized or whose last regular menses was within previous 2 years) who has a nonsterilized male partner has to agree to use adequate contraception during the period from the signing of informed consent to 6 months after the last dose of the study drug\n6. Participants with a diagnosis of small-intestinal, large-intestinal, or small-/large-intestinal Crohn's disease (CD) established based on the Revised Diagnostic Criteria for Crohn's disease issued by Research Group for Intractable Inflammatory Bowel Disease Designated as Specified Disease by the Ministry of Health, Labor and Welfare of Japan (2012) at least 3 months before the start of administration of study drug\n7. Participants with baseline CDAI score of 220 to 450(inclusive) and meeting at least one of the followings:\n\n * C-reactive protein (CRP) at screening test is above 0.30 mg/dL\n * Participants with irregular or semicircular ulcers or multiple aphthae (10 or more) observed over an extensive area of the small or large intestine on endoscopy or imaging test within the 4 months before the start of administration of study drugs\n * Participants with longitudinal ulcers or a cobblestone appearance observed in the small or large intestine on endoscopy or imaging test within 4 months before the start of administration of study drugs\n8. In case of the participants who meet any of the following criteria; participants with ≥ 8-year history of extensive or limited colitis, participants aged ≥ 50 years, or participants with a first-degree family history of colon cancer, those whom the complication of colon cancer or dysplasia was ruled out by total colonoscopy at the start of study drug administration (or the results from total colonoscopy performed within 1 year before giving consent are available)\n9. Participants meeting the criteria for treatment failure below with at least one of the following agents received within previous 5 year period before giving consent\n\n 1. Corticosteroids\n\n * Resistance\n * Dependence\n * Intolerance\n 2. Immunomodulators (azathioprine, 6-mercaptopurine or methotrexate)\n\n * Refractory\n * Intolerance\n 3. Anti-tumor necrosis factor alpha (TNFα) antibodies\n\n * Inadequate response\n * Loss of response\n * Intolerance\n\nExclusion Criteria:\n\n1. Participants with an evidence of or suspected abdominal abscess\n2. Participants with a history of subtotal or total colectomy\n3. Participants who have had a resection of the small intestine in at least 3 locations or have a diagnosis of short bowel syndrome\n4. Participants with ileostomy, colostomy, or internal fistula, or severe intestinal stenosis\n5. Participants who have a treatment history with natalizumab, efalizumab or rituximab\n6. Participants who started 5-aminosalicylic acid oral drug or probiotics treatment, antimicrobials to treat Crohn's disease, or 30 mg/day or less of oral corticosteroids within 13 days before initiation of study drug administration. If these drugs were used within 14 days before initiation of study drug administration, the dosage must have been changed or their use discontinued within 13 days before the initiation of study drug administration\n7. Participants who had received 5-aminosalicylic acid or corticosteroid enemas/suppositories, intravenous corticosteroid injections, or more than 30 mg/day of oral corticosteroids, medications for diarrhea-predominant irritable bowel syndrome, or Chinese herbal medicine for the treatment of Crohn's disease (e.g., Daikenchuto) within 13 days before initiation of study drug administration\n8. Participants who had received azathioprine, 6-mercaptopurine, or methotrexate within 27 days before initiation of study drug administration. However, this shall not apply to participants who have received these drugs for 83 or more days before initiation of the study drug administration and continued the steady dose administration of the drugs for 27 or more days before initiation of the study drug administration\n9. Participants who had received cyclosporin, tacrolimus, tofacitinib or any study drugs for treatment of ulcerative colitis within 27 days before initiation of the study drug administration\n10. Participants who had received adalimumab within 27 days before initiation of study drug administration or any biological drugs other than adalimumab within 55 days before initiation of study drug administration. Topical administration (such as intraocular implantation for treatment of age-related maculopacy) is allowed\n11. Participants who had received any live vaccinations within 27 days before initiation of study drug administration\n12. Participants who had undergone intestinal resection within 27 days before initiation of study drug administration or those anticipated to require intestinal resection during the study\n13. Participants who had received leukocytapheresis or granulocyte apheresis within 27 days before initiation of the study drug administration\n14. Participants who had received intravenous hyperalimentation or total enteral nutrition within the 20 days before initiation of the study drug administration or participants who are fasted\n15. Participants who had received enteral nutrition at \\> 900 kcal/day or started enteral nutrition at \\<= 900 kcal/day within the 20 days before initiation of the study drug administration. Participants receiving 900 kcal/day or less of enteral nutrition for at least 21 days before initiation of the study drug administration whom these dosage was changed or the medications were discontinued within 20 days before initiation of the study drug administration\n16. Participants who had been infected with Clostridium difficile, cytomegalovirus, or any other intestinal pathogen within 27 days before the first dose of the study drug\n17. Participants with evidence of adenomatous colonic polyps that need to be removed at the start of study drug administration\n18. Participants with a history or an complication of dysplasia of the small or large intestine\n19. Participants who were suspected to have enteritis other than CD\n20. Participants who were hepatitis B surface (HBs) antigen-positive or hepatitis C virus (HCV) antibody-positive at the screening. Or participants who are hepatitis B core (HBc) antibodypositive or HBs antibody positive, even though HBs antigen-negative. However, this does not apply to participants who are only HBs antibody-positive due to hepatitis B virus (HBV) vaccination, HBV-DNA-negative, HCV antigen-negative, or HCV-RNA-negative\n21. Participants who had an evidence of history of tuberculosis or a suspected history of tuberculosis (including those who have findings suggesting previous tuberculosis on chest imaging procedure at the screening). However, this does not apply to participants who had completed prophylactic isoniazid, or participants who had been receiving prophylactic isoniazid for more than 21 days before the first dose of the study drug (in the latter case, the screening period are allowed to extend up to 28 days to ensure at least 21-day prophylactic isoniazid and then the study treatment is allowed to start)\n22. Participants who had positive T-SPOT test or QuantiFERON test at the screening\n23. Participants who had a history or complication of identified congenital or acquire immunodeficiency syndrome (eg, not-classifiable immunodeficiency, human immunodeficiency virus \\[HIV\\] infection or organ transplantation)\n24. Participants who had been affected by extraintestinal infection (eg, pneumonia, sepsis, active hepatitis or pyelonephritis) within 27 days before the first dose of the study drug\n25. Participants who had a treatment history with MLN0002\n26. Female participants who are lactating at the screening, or have positive urine pregnancy test either at the screening or baseline\n27. Participants who had serious complications in the heart, lung, liver, kidney, metabolism, gastrointestinal system, urinary system, endocrine system or blood\n28. Participants who had a history of a surgery requiring general anesthesia within 27 days before the first dose of the study drug, or with a schedule of a surgery requiring hospitalization during the study period\n29. Participants who had a complication or a history of malignancy. However, this does not apply to the following participants:\n\n * Participants who had a curative resection of localized skin basal cell carcinoma or have completed curative radiotherapy\n * Participants who had not experienced recurrence for more than 1 year since completion of a curative resection or curative radiotherapy for skin squamous cell carcinoma\n * Participants who had not experienced recurrence for more than 3 years since completion of a curative resection or curative radiotherapy for intraepithelial carcinoma of uterine cervix For participants who had a substantially distant history of malignancy (eg, 10 years or longer without recurrence since treatment completion), the investigator and the sponsor had a discussion to decide eligibility on the basis of type of malignancy and treatment applied\n30. Participants who had a history or a complication of the central nervous disorder, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.\n31. Participants who had any subjective symptoms in the subjective PML checklist at the screening or baseline\n32. Participants who had any of the following laboratory abnormalities at the screening;\n\n * Hemoglobin ≤8 g/dL\n * White blood cells ≤3,000/μL\n * Lymphocytes ≤500/μL\n * Platelets ≤100,000/μL or ≥1,200,000/μL\n * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3×upper limit of normal (ULN)\n * Alkaline phosphatase (ALP) ≥3×ULN\n * Creatinine ≥2×ULN\n33. Participants who had a history or a complication of alcohol dependence or illicit drug use within one year before the first dose of the study drug\n34. Participants who had a history or a complication of psychotic disorder that could obstruct compliance with the study procedures"}, 'identificationModule': {'nctId': 'NCT02038920', 'briefTitle': "Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': "Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Crohn's Disease", 'orgStudyIdInfo': {'id': 'MLN0002/CCT-001'}, 'secondaryIdInfos': [{'id': 'U1111-1150-2688', 'type': 'OTHER', 'domain': 'WHO'}, {'id': 'JapicCTI-142402', 'type': 'REGISTRY', 'domain': 'JapicCTI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Induction Phase: Vedolizumab, 300 mg', 'description': 'Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.', 'interventionNames': ['Drug: Vedolizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Induction Phase: Placebo', 'description': 'Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.', 'interventionNames': ['Drug: Vedolizumab placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Maintenance Phase: Vedolizumab 300 mg', 'description': "Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved Crohn's Disease Activity Index (CDAI)-70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.", 'interventionNames': ['Drug: Vedolizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Maintenance Phase: Placebo', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.', 'interventionNames': ['Drug: Vedolizumab placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Maintenance Phase: Placebo Continuation', 'description': 'Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.', 'interventionNames': ['Drug: Vedolizumab placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Open-Label: Vedolizumab 300 mg', 'description': 'Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.', 'interventionNames': ['Drug: Vedolizumab']}], 'interventions': [{'name': 'Vedolizumab', 'type': 'DRUG', 'otherNames': ['MLN0002'], 'description': 'Vedolizumab IV injection', 'armGroupLabels': ['Induction Phase: Vedolizumab, 300 mg', 'Maintenance Phase: Vedolizumab 300 mg', 'Open-Label: Vedolizumab 300 mg']}, {'name': 'Vedolizumab placebo', 'type': 'DRUG', 'description': 'Vedolizumab placebo-matching IV infusion', 'armGroupLabels': ['Induction Phase: Placebo', 'Maintenance Phase: Placebo', 'Maintenance Phase: Placebo 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'geoPoint': {'lat': 33.52594, 'lon': 130.4611}}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Takasaki', 'state': 'Gunma', 'country': 'Japan', 'geoPoint': {'lat': 36.33333, 'lon': 139.01667}}, {'city': 'Fukuyama', 'state': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.48333, 'lon': 133.36667}}, {'city': 'Hatsukaichi', 'state': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.35, 'lon': 132.33333}}, {'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Tomakomai', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 42.63694, 'lon': 141.60333}}, {'city': 'Akashi', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.65524, 'lon': 135.00687}}, {'city': 'Nishinomiya', 'state': 'Hyōgo', 'country': 'Japan', 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'Yamaguchi', 'country': 'Japan', 'geoPoint': {'lat': 34.08053, 'lon': 131.82564}}, {'city': 'Kofu', 'state': 'Yamanashi', 'country': 'Japan', 'geoPoint': {'lat': 35.66667, 'lon': 138.56667}}, {'city': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Fukui', 'country': 'Japan', 'geoPoint': {'lat': 34.84214, 'lon': 135.54836}}, {'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Kagoshima', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Nagasaki', 'country': 'Japan', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'city': 'Niigata', 'country': 'Japan', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Okayama', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Okinawa', 'country': 'Japan', 'geoPoint': {'lat': 26.33583, 'lon': 127.80139}}, {'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Ōita', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Saga', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'city': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Wakayama', 'country': 'Japan', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}], 'overallOfficials': [{'name': 'Study Director Clinical Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}