Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT02065557
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2014-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy', 'Sweden']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'See time frame specifics detailed for each reporting group in their respective descriptions below.', 'description': 'Treatment-emergent adverse events (TEAEs) are presented.', 'eventGroups': [{'id': 'EG000', 'title': 'Integrated Study (Main + Japan Sub- Study): I-SD', 'description': 'Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.\n\nTEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 52.8 days.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 13, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Integrated Study (Main + Japan Sub- Study): I-HD', 'description': 'Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.\n\nTEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 55.4 days.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 16, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Integrated Study (Main + Japan Sub- Study): I-HD-OL', 'description': '(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.\n\nTEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 53.8 days.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 14, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Integrated Study (Main + Japan Sub- Study): M-SD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \\[maximum dose of 40 mg\\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.\n\nTEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and prior to re-randomization due to first disease flare if applicable and up to 70 days after the last dose date of the study drug in maintenance period. Events with an onset date on or after the first dose date in long-term follow-up study M10-870 (NCT02632175) are excluded. Mean duration of treatment was 226.8 days.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 15, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Integrated Study (Main + Japan Sub- Study): M-HD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \\[maximum dose of 40 mg\\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.\n\nTEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and prior to re-randomization due to first disease flare if applicable and up to 70 days after the last dose date of the study drug in maintenance period. Events with an onset date on or after the first dose date in long-term follow-up study M10-870 (NCT02632175) are excluded. Mean duration of treatment was 241.0 days.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 20, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG005', 'title': 'Integrated Study (Main + Japan Sub- Study): M-PL', 'description': '(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.\n\nTEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and prior to re-randomization due to first disease flare if applicable and up to 70 days after the last dose date of the study drug in maintenance period. Events with an onset date on or after the first dose date in long-term follow-up study M10-870 (NCT02632175) are excluded. Mean duration of treatment was 184.2 days.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Integrated Study (Main + Japan Sub- Study): Any Adalimumab', 'description': 'Participants receiving any adalimumab during Induction or Maintenance Phase.\n\nAny Adalimumab TEAEs: events with an onset date on or after first dose date of adalimumab and up to 70 days after the last dose date of adalimumab and prior to the first dose date in M10-870 if applicable, whichever comes first. For participants who received placebo during the maintenance period, TEAE collection period ends 70 days after last induction dose of adalimumab and re-starts with their next adalimumab dose, if applicable. Mean duration of treatment was 256.3 days.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 65, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'THROMBOCYTOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'NONINFECTIVE CONJUNCTIVITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'COLITIS ULCERATIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'PERIPHERAL SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 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'MedDRA 22.0'}, {'term': 'PERICARDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'COLITIS ULCERATIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'ENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'PANCREATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'ENTERITIS INFECTIOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'MENINGITIS ASEPTIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'PHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'HAND FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'WRIST FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'LOSS OF CONSCIOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'ERYTHEMA NODOSUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'PSORIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}, {'value': '83', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: I-SD', 'description': 'Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.'}, {'id': 'OG001', 'title': 'Main Study: I-HD', 'description': 'Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.'}, {'id': 'OG002', 'title': 'Main Study: I-SD + I-HD', 'description': 'Combined I-SD + I-HD arms (see above).'}, {'id': 'OG003', 'title': 'Main Study: I-HD-OL', 'description': '(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.'}, {'id': 'OG004', 'title': 'Integrated Study (Main + Japan Sub-Study): I-SD', 'description': 'Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.'}, {'id': 'OG005', 'title': 'Integrated Study (Main + Japan Sub-Study): I-HD', 'description': 'Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.'}, {'id': 'OG006', 'title': 'Integrated Study (Main + Japan Sub-Study): I-SD + I-HD', 'description': 'Combined I-SD + I-HD arms (see above).'}, {'id': 'OG007', 'title': 'Integrated Study (Main + Japan Sub-Study): I-HD-OL', 'description': '(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000', 'lowerLimit': '25.46', 'upperLimit': '62.57'}, {'value': '59.6', 'groupId': 'OG001', 'lowerLimit': '44.27', 'upperLimit': '73.63'}, {'value': '53.2', 'groupId': 'OG002', 'lowerLimit': '41.52', 'upperLimit': '64.71'}, {'value': '68.8', 'groupId': 'OG003', 'lowerLimit': '41.34', 'upperLimit': '88.98'}, {'value': '40.6', 'groupId': 'OG004', 'lowerLimit': '23.70', 'upperLimit': '59.36'}, {'value': '58.8', 'groupId': 'OG005', 'lowerLimit': '44.17', 'upperLimit': '72.42'}, {'value': '51.8', 'groupId': 'OG006', 'lowerLimit': '40.56', 'upperLimit': '62.92'}, {'value': '66.7', 'groupId': 'OG007', 'lowerLimit': '40.99', 'upperLimit': '86.66'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG002'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)', 'groupDescription': 'Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '< 0.001', 'groupIds': ['OG001'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)', 'groupDescription': 'Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '0.382', 'groupIds': ['OG000'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)', 'groupDescription': 'Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '< 0.001', 'groupIds': ['OG006'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)', 'groupDescription': 'Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '< 0.001', 'groupIds': ['OG005'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)', 'groupDescription': 'Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '0.344', 'groupIds': ['OG004'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for I-SD+I-HD, then for individual adalimumab dose groups (I-HD, I-SD) against the respective external placebo rate (19.83%)', 'groupDescription': 'Efficacy analysis was based on the Intent-To-Treat-Efficacy (ITT-E) population for the induction period. The ITT-E population was a subpopulation of the ITT population, which consisted of all participants who received at least one SC injection of the study medication during the induction period. Participants who received open-label high induction dose, because they enrolled after Protocol Amendment 4 was released, were excluded from the ITT-E population.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': "The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 sub scores (stool frequency, rectal bleeding and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in PMS indicates improvement. Clinical remission was defined as a PMS ≤ 2 and no individual subscore \\> 1.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT): all participants who received at least 1 dose of study drug during the Induction period; analyzed as enrolled/randomized. Non-responder imputation (NRI): missing data is imputed as not having met the endpoint.'}, {'type': 'PRIMARY', 'title': 'Co-Primary Endpoint 2: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 52 in Week 8 Responders Per PMS - Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '68', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: M-PL', 'description': '(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.'}, {'id': 'OG001', 'title': 'Main Study: M-SD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \\[maximum dose of 40 mg\\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG002', 'title': 'Main Study: M-HD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \\[maximum dose of 40 mg\\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG003', 'title': 'Main Study: M-SD + M-HD', 'description': 'Combined M-SD + M-HD arms (see above).'}, {'id': 'OG004', 'title': 'Integrated Study (Main + Japan Sub-Study): M-PL', 'description': '(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.'}, {'id': 'OG005', 'title': 'Integrated Study (Main + Japan Sub-Study): M-SD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \\[maximum dose of 40 mg\\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG006', 'title': 'Integrated Study (Main + Japan Sub-Study): M-HD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \\[maximum dose of 40 mg\\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG007', 'title': 'Integrated Study (Main + Japan Sub-Study): M-SD + M-HD', 'description': 'Combined M-SD + M-HD arms (see above).'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '9.92', 'upperLimit': '65.11'}, {'value': '29.0', 'groupId': 'OG001', 'lowerLimit': '14.22', 'upperLimit': '48.04'}, {'value': '45.2', 'groupId': 'OG002', 'lowerLimit': '27.32', 'upperLimit': '63.97'}, {'value': '37.1', 'groupId': 'OG003', 'lowerLimit': '25.16', 'upperLimit': '50.31'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '9.92', 'upperLimit': '65.11'}, {'value': '27.3', 'groupId': 'OG005', 'lowerLimit': '13.30', 'upperLimit': '45.52'}, {'value': '42.9', 'groupId': 'OG006', 'lowerLimit': '26.32', 'upperLimit': '60.65'}, {'value': '35.3', 'groupId': 'OG007', 'lowerLimit': '24.08', 'upperLimit': '47.83'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG003'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '< 0.001', 'groupIds': ['OG002'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '0.382', 'groupIds': ['OG001'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '< 0.001', 'groupIds': ['OG007'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '< 0.001', 'groupIds': ['OG006'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '0.344', 'groupIds': ['OG005'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (18.37%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \\> 1.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT): all Week 8 PMS responders who were re-randomized at Week 8 and received at least 1 dose of study drug during the Maintenance period; analyzed as randomized at the beginning of the Maintenance phase. NRI: missing data is imputed as not having met the endpoint.'}, {'type': 'SECONDARY', 'title': 'Ranked Secondary Endpoint 1: Percentage of Participants With Clinical Response Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '68', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: M-PL', 'description': '(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.'}, {'id': 'OG001', 'title': 'Main Study: M-SD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \\[maximum dose of 40 mg\\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG002', 'title': 'Main Study: M-HD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \\[maximum dose of 40 mg\\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG003', 'title': 'Main Study: M-SD + M-HD', 'description': 'Combined M-SD + M-HD arms (see above).'}, {'id': 'OG004', 'title': 'Integrated Study (Main + Japan Sub-Study): M-PL', 'description': '(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.'}, {'id': 'OG005', 'title': 'Integrated Study (Main + Japan Sub-Study): M-SD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \\[maximum dose of 40 mg\\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG006', 'title': 'Integrated Study (Main + Japan Sub-Study): M-HD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \\[maximum dose of 40 mg\\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG007', 'title': 'Integrated Study (Main + Japan Sub-Study): M-SD + M-HD', 'description': 'Combined M-SD + M-HD arms (see above).'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '9.92', 'upperLimit': '65.11'}, {'value': '61.3', 'groupId': 'OG001', 'lowerLimit': '42.19', 'upperLimit': '78.15'}, {'value': '67.7', 'groupId': 'OG002', 'lowerLimit': '48.63', 'upperLimit': '83.32'}, {'value': '64.5', 'groupId': 'OG003', 'lowerLimit': '51.34', 'upperLimit': '76.26'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '9.92', 'upperLimit': '65.11'}, {'value': '57.6', 'groupId': 'OG005', 'lowerLimit': '39.22', 'upperLimit': '74.52'}, {'value': '65.7', 'groupId': 'OG006', 'lowerLimit': '47.79', 'upperLimit': '80.87'}, {'value': '61.8', 'groupId': 'OG007', 'lowerLimit': '49.18', 'upperLimit': '73.29'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG003'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '< 0.001', 'groupIds': ['OG002'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '0.008', 'groupIds': ['OG001'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '< 0.001', 'groupIds': ['OG007'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '< 0.001', 'groupIds': ['OG006'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '0.038', 'groupIds': ['OG005'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (26.10%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Clinical response per FMS is defined as a decrease in FMS ≥ 3 points and ≥ 30% from Baseline.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT): all Week 8 PMS responders who were re-randomized at Week 8 and received at least 1 dose of study drug during the Maintenance period; analyzed as randomized at the beginning of the Maintenance phase. NRI: missing data is imputed as not having met the endpoint.'}, {'type': 'SECONDARY', 'title': 'Ranked Secondary Endpoint 2: Percentage of Participants With Mucosal Healing at Week 52 in Week 8 Responders Per PMS - Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '33', 'groupId': 'OG005'}, {'value': '35', 'groupId': 'OG006'}, {'value': '68', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: M-PL', 'description': '(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.'}, {'id': 'OG001', 'title': 'Main Study: M-SD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \\[maximum dose of 40 mg\\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG002', 'title': 'Main Study: M-HD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \\[maximum dose of 40 mg\\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG003', 'title': 'Main Study: M-SD + M-HD', 'description': 'Combined M-SD + M-HD arms (see above).'}, {'id': 'OG004', 'title': 'Integrated Study (Main + Japan Sub-Study): M-PL', 'description': '(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.'}, {'id': 'OG005', 'title': 'Integrated Study (Main + Japan Sub-Study): M-SD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \\[maximum dose of 40 mg\\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG006', 'title': 'Integrated Study (Main + Japan Sub-Study): M-HD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \\[maximum dose of 40 mg\\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG007', 'title': 'Integrated Study (Main + Japan Sub-Study): M-SD + M-HD', 'description': 'Combined M-SD + M-HD arms (see above).'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '9.92', 'upperLimit': '65.11'}, {'value': '38.7', 'groupId': 'OG001', 'lowerLimit': '21.85', 'upperLimit': '57.81'}, {'value': '51.6', 'groupId': 'OG002', 'lowerLimit': '33.06', 'upperLimit': '69.85'}, {'value': '45.2', 'groupId': 'OG003', 'lowerLimit': '32.48', 'upperLimit': '58.32'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '9.92', 'upperLimit': '65.11'}, {'value': '36.4', 'groupId': 'OG005', 'lowerLimit': '20.40', 'upperLimit': '54.88'}, {'value': '48.6', 'groupId': 'OG006', 'lowerLimit': '31.38', 'upperLimit': '66.01'}, {'value': '42.6', 'groupId': 'OG007', 'lowerLimit': '30.72', 'upperLimit': '55.23'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG003'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '< 0.001', 'groupIds': ['OG002'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '0.382', 'groupIds': ['OG001'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '< 0.001', 'groupIds': ['OG007'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '< 0.001', 'groupIds': ['OG006'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '0.344', 'groupIds': ['OG005'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (22.03%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those participants with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Mucosal healing per Mayo endoscopy subscore is defined as a subscore of ≤ 1.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT): all Week 8 PMS responders who were re-randomized at Week 8 and received at least 1 dose of study drug during the Maintenance period; analyzed as randomized at the beginning of the Maintenance phase. NRI: missing data is imputed as not having met the endpoint.'}, {'type': 'SECONDARY', 'title': 'Ranked Secondary Endpoint 3: Percentage of Participants With Clinical Remission Per FMS at Week 52 in Week 8 Remitters Per PMS - Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '25', 'groupId': 'OG006'}, {'value': '46', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: M-PL', 'description': '(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.'}, {'id': 'OG001', 'title': 'Main Study: M-SD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \\[maximum dose of 40 mg\\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG002', 'title': 'Main Study: M-HD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \\[maximum dose of 40 mg\\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG003', 'title': 'Main Study: M-SD + M-HD', 'description': 'Combined M-SD + M-HD arms (see above).'}, {'id': 'OG004', 'title': 'Integrated Study (Main + Japan Sub-Study): M-PL', 'description': '(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.'}, {'id': 'OG005', 'title': 'Integrated Study (Main + Japan Sub-Study): M-SD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \\[maximum dose of 40 mg\\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG006', 'title': 'Integrated Study (Main + Japan Sub-Study): M-HD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \\[maximum dose of 40 mg\\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG007', 'title': 'Integrated Study (Main + Japan Sub-Study): M-SD + M-HD', 'description': 'Combined M-SD + M-HD arms (see above).'}], 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'groupId': 'OG000', 'lowerLimit': '8.52', 'upperLimit': '75.51'}, {'value': '42.9', 'groupId': 'OG001', 'lowerLimit': '21.82', 'upperLimit': '65.98'}, {'value': '45.5', 'groupId': 'OG002', 'lowerLimit': '24.39', 'upperLimit': '67.79'}, {'value': '44.2', 'groupId': 'OG003', 'lowerLimit': '29.08', 'upperLimit': '60.12'}, {'value': '37.5', 'groupId': 'OG004', 'lowerLimit': '8.52', 'upperLimit': '75.51'}, {'value': '42.9', 'groupId': 'OG005', 'lowerLimit': '21.82', 'upperLimit': '65.98'}, {'value': '44.0', 'groupId': 'OG006', 'lowerLimit': '24.40', 'upperLimit': '65.07'}, {'value': '43.5', 'groupId': 'OG007', 'lowerLimit': '28.93', 'upperLimit': '58.89'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG003'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '< 0.001', 'groupIds': ['OG002'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '0.292', 'groupIds': ['OG001'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '< 0.001', 'groupIds': ['OG007'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '< 0.001', 'groupIds': ['OG006'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '0.292', 'groupIds': ['OG005'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (14.79%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS remitters are defined as those participants with a PMS ≤ 2 and no individual subscore \\> 1. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \\> 1.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT): all Week 8 PMS responders who were re-randomized at Week 8 and received at least 1 dose of study drug during the Maintenance period; analyzed as randomized at the beginning of the Maintenance phase. Participants who were also Week 8 remitters. NRI: missing data is imputed as not having met the endpoint.'}, {'type': 'SECONDARY', 'title': 'Ranked Secondary Endpoint 4: Percentage of Participants With Corticosteroid-Free Clinical Remission Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}, {'value': '32', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Main Study: M-PL', 'description': '(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.'}, {'id': 'OG001', 'title': 'Main Study: M-SD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \\[maximum dose of 40 mg\\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG002', 'title': 'Main Study: M-HD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \\[maximum dose of 40 mg\\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG003', 'title': 'Main Study: M-SD + M-HD', 'description': 'Combined M-SD + M-HD arms (see above).'}, {'id': 'OG004', 'title': 'Integrated Study (Main + Japan Sub-Study): M-PL', 'description': '(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.'}, {'id': 'OG005', 'title': 'Integrated Study (Main + Japan Sub-Study): M-SD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \\[maximum dose of 40 mg\\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG006', 'title': 'Integrated Study (Main + Japan Sub-Study): M-HD', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \\[maximum dose of 40 mg\\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'OG007', 'title': 'Integrated Study (Main + Japan Sub-Study): M-SD + M-HD', 'description': 'Combined M-SD + M-HD arms (see above).'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '5.27', 'upperLimit': '85.34'}, {'value': '30.8', 'groupId': 'OG001', 'lowerLimit': '9.09', 'upperLimit': '61.43'}, {'value': '31.3', 'groupId': 'OG002', 'lowerLimit': '11.02', 'upperLimit': '58.66'}, {'value': '31.0', 'groupId': 'OG003', 'lowerLimit': '15.28', 'upperLimit': '50.83'}, {'value': '40.0', 'groupId': 'OG004', 'lowerLimit': '5.27', 'upperLimit': '85.34'}, {'value': '26.7', 'groupId': 'OG005', 'lowerLimit': '7.79', 'upperLimit': '55.10'}, {'value': '35.3', 'groupId': 'OG006', 'lowerLimit': '14.21', 'upperLimit': '61.67'}, {'value': '31.3', 'groupId': 'OG007', 'lowerLimit': '16.12', 'upperLimit': '50.01'}]}]}], 'analyses': [{'pValue': '0.382', 'groupIds': ['OG003'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '1.000', 'groupIds': ['OG002'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '1.000', 'groupIds': ['OG001'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '0.344', 'groupIds': ['OG007'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '0.559', 'groupIds': ['OG006'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}, {'pValue': '0.815', 'groupIds': ['OG005'], 'pValueComment': 'Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)', 'groupDescription': 'Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.', 'statisticalMethod': 'rejective multiple test procedure', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'controlling familywise Type I error of 5% in a strong sense', 'nonInferiorityComment': 'one-sample two-sided Chi-square test'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': "The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from baseline. Among participants receiving systemic corticosteroids at Baseline, corticosteroid-free clinical remission per FMS at Week 52 is defined as having discontinued systemic corticosteroids prior to Week 52 and being in FMS clinical remission at Week 52 (defined as Mayo Score ≤ 2 and no individual subscore \\> 1).", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT: all Week 8 PMS responders who were re-randomized at Week 8 and received at least 1 dose of study drug during the Maintenance period; analyzed as randomized at the beginning of the Maintenance phase. Participants receiving systemic corticosteroids at baseline. NRI: missing data is imputed as not having met the endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Integrated Study: Induction Standard Dose (I-SD)', 'description': 'Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.'}, {'id': 'FG001', 'title': 'Integrated Study: Induction High Dose (I-HD)', 'description': 'Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.'}, {'id': 'FG002', 'title': 'Integrated Study: Induction High Dose Open Label (I-HD-OL)', 'description': '(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.'}, {'id': 'FG003', 'title': 'Integrated Study: Maintenance Placebo (M-PL)', 'description': '(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'FG004', 'title': 'Integrated Study: Maintenance Standard Dose (M-SD)', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \\[maximum dose of 40 mg\\] every other week \\[eow\\]). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}, {'id': 'FG005', 'title': 'Integrated Study: Maintenance High Dose (M-HD)', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \\[maximum dose of 40 mg\\] every week \\[ew\\]). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.'}], 'periods': [{'title': 'Induction Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Enrolled in Main Study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Enrolled in Japan Sub-study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Requires Alternative/Prohibited Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Non-Responder at Week 8', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', '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 Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '33'}, {'groupId': 'FG005', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'comment': 'Completed Week 52', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '25'}, {'groupId': 'FG005', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Requires Alternative/Prohibited Therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'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': '5'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Subject Non-Compliance', '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'}]}]}], 'recruitmentDetails': 'Prior to Protocol Amendment 4, participants were randomized 3:2 at baseline to adalimumab induction high dose or adalimumab induction standard dose. At Week 8, those demonstrating a clinical response per Partial Mayo Score (PMS) were randomized 2:2:1 to adalimumab maintenance standard dose, adalimumab maintenance high dose, or maintenance placebo.', 'preAssignmentDetails': 'After Protocol Amendment 4, participants received adalimumab induction high dose open-label. At Week 8, those demonstrating a clinical response per PMS were randomized in a 1:1 ratio to adalimumab maintenance standard dose or adalimumab maintenance high dose. "Integrated Study" data includes data from both the Main Study and the Japan Sub-Study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '101', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Integrated Study (Main + Japan Sub- Study): I-SD', 'description': 'Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.'}, {'id': 'BG001', 'title': 'Integrated Study (Main + Japan Sub- Study): I-HD', 'description': 'Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.'}, {'id': 'BG002', 'title': 'Integrated Study (Main + Japan Sub- Study): I-HD-OL', 'description': '(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '2.66', 'groupId': 'BG000'}, {'value': '13.8', 'spread': '3.06', 'groupId': 'BG001'}, {'value': '13.8', 'spread': '2.82', 'groupId': 'BG002'}, {'value': '14.1', 'spread': '2.90', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Japanese', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'No Ethnicity', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Full Mayo Score (FMS)', 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '1.22', 'groupId': 'BG000'}, {'value': '7.7', 'spread': '1.25', 'groupId': 'BG001'}, {'value': '7.7', 'spread': '1.09', 'groupId': 'BG002'}, {'value': '7.8', 'spread': '1.20', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Partial Mayo Score (PMS)', 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '1.14', 'groupId': 'BG000'}, {'value': '5.5', 'spread': '1.24', 'groupId': 'BG001'}, {'value': '5.5', 'spread': '1.06', 'groupId': 'BG002'}, {'value': '5.6', 'spread': '1.17', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Endoscopy Subscore', 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0.34', 'groupId': 'BG000'}, {'value': '2.2', 'spread': '0.40', 'groupId': 'BG001'}, {'value': '2.2', 'spread': '0.43', 'groupId': 'BG002'}, {'value': '2.2', 'spread': '0.38', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The endoscopy subscore of the FMS ranges from 0 (normal) to 3 (severe disease).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Rectal Bleeding Subscore', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.93', 'groupId': 'BG000'}, {'value': '1.5', 'spread': '0.88', 'groupId': 'BG001'}, {'value': '1.4', 'spread': '0.97', 'groupId': 'BG002'}, {'value': '1.5', 'spread': '0.91', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The rectal bleeding subscore of the FMS ranges from 0 (normal) to 3 (severe disease).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Physicians Global Assessment Subscore', 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '0.40', 'groupId': 'BG000'}, {'value': '2.2', 'spread': '0.43', 'groupId': 'BG001'}, {'value': '2.2', 'spread': '0.38', 'groupId': 'BG002'}, {'value': '2.2', 'spread': '0.41', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The physicians global assessment subscore of the FMS ranges from 0 (normal) to 3 (severe disease).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stool Frequency Subscore', 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '0.78', 'groupId': 'BG000'}, {'value': '1.8', 'spread': '0.88', 'groupId': 'BG001'}, {'value': '1.9', 'spread': '0.73', 'groupId': 'BG002'}, {'value': '1.9', 'spread': '0.83', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The stool frequency subscore of the FMS ranges from 0 (normal) to 3 (severe disease).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-20', 'size': 3589544, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-09-10T07:21', 'hasProtocol': True}, {'date': '2019-08-08', 'size': 1041270, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-10T07:23', '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': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-10', 'studyFirstSubmitDate': '2014-02-17', 'resultsFirstSubmitDate': '2020-09-10', 'studyFirstSubmitQcDate': '2014-02-17', 'lastUpdatePostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-10', 'studyFirstPostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period', 'timeFrame': 'Week 8', 'description': "The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 sub scores (stool frequency, rectal bleeding and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in PMS indicates improvement. Clinical remission was defined as a PMS ≤ 2 and no individual subscore \\> 1."}, {'measure': 'Co-Primary Endpoint 2: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 52 in Week 8 Responders Per PMS - Maintenance Period', 'timeFrame': 'Week 52', 'description': "The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \\> 1."}], 'secondaryOutcomes': [{'measure': 'Ranked Secondary Endpoint 1: Percentage of Participants With Clinical Response Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period', 'timeFrame': 'Week 52', 'description': "The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Clinical response per FMS is defined as a decrease in FMS ≥ 3 points and ≥ 30% from Baseline."}, {'measure': 'Ranked Secondary Endpoint 2: Percentage of Participants With Mucosal Healing at Week 52 in Week 8 Responders Per PMS - Maintenance Period', 'timeFrame': 'Week 52', 'description': "The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those participants with a decrease in PMS ≥ 2 points and ≥ 30% from Baseline. Mucosal healing per Mayo endoscopy subscore is defined as a subscore of ≤ 1."}, {'measure': 'Ranked Secondary Endpoint 3: Percentage of Participants With Clinical Remission Per FMS at Week 52 in Week 8 Remitters Per PMS - Maintenance Period', 'timeFrame': 'Week 52', 'description': "The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS remitters are defined as those participants with a PMS ≤ 2 and no individual subscore \\> 1. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \\> 1."}, {'measure': 'Ranked Secondary Endpoint 4: Percentage of Participants With Corticosteroid-Free Clinical Remission Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period', 'timeFrame': 'Week 52', 'description': "The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from baseline. Among participants receiving systemic corticosteroids at Baseline, corticosteroid-free clinical remission per FMS at Week 52 is defined as having discontinued systemic corticosteroids prior to Week 52 and being in FMS clinical remission at Week 52 (defined as Mayo Score ≤ 2 and no individual subscore \\> 1)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ulcerative Colitis', 'adalimumab'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '34153231', 'type': 'DERIVED', 'citation': 'Croft NM, Faubion WA Jr, Kugathasan S, Kierkus J, Ruemmele FM, Shimizu T, Mostafa NM, Venetucci M, Finney-Hayward T, Sanchez Gonzalez Y, Bereswill M, Lazar A, Turner D. Efficacy and safety of adalimumab in paediatric patients with moderate-to-severe ulcerative colitis (ENVISION I): a randomised, controlled, phase 3 study. Lancet Gastroenterol Hepatol. 2021 Aug;6(8):616-627. doi: 10.1016/S2468-1253(21)00142-4. Epub 2021 Jun 19.'}], 'seeAlsoLinks': [{'url': 'http://rxabbvie.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of UC for at least 12 weeks prior to screening, confirmed by endoscopy with biopsy.\n* Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of 2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both.\n\nExclusion Criteria:\n\n* Subject with Crohn's disease (CD) or indeterminate colitis (IC).\n* Current diagnosis of fulminant colitis and/or toxic megacolon.\n* Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.\n* Chronic recurring infections or active tuberculosis (TB)."}, 'identificationModule': {'nctId': 'NCT02065557', 'briefTitle': 'Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'M11-290'}, 'secondaryIdInfos': [{'id': '2013-003032-77', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adalimumab Induction Standard Dose', 'description': 'Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and matching placebo at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.', 'interventionNames': ['Biological: Adalimumab', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Adalimumab Induction High Dose', 'description': 'Participants randomized to receive adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.', 'interventionNames': ['Biological: Adalimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Adalimumab Induction High Dose - Open Label', 'description': '(After Amendment 4) participants assigned to open-label adalimumab 2.4 mg/kg (maximum dose of 160 mg) at Baseline and at Week 1, 1.2 mg/kg (maximum dose of 80 mg) at Week 2, followed by 0.6 mg/kg (maximum dose of 40 mg) at Week 4 and Week 6.', 'interventionNames': ['Biological: Adalimumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Maintenance Placebo', 'description': '(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.', 'interventionNames': ['Biological: Adalimumab', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Adalimumab Maintenance Standard Dose', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \\[maximum dose of 40 mg\\] every other week). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after second flare.', 'interventionNames': ['Biological: Adalimumab']}, {'type': 'EXPERIMENTAL', 'label': 'Adalimumab Maintenance High Dose', 'description': 'Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \\[maximum dose of 40 mg\\] every week). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after second flare.', 'interventionNames': ['Biological: Adalimumab']}], 'interventions': [{'name': 'Adalimumab', 'type': 'BIOLOGICAL', 'otherNames': ['Humira'], 'description': 'Subcutaneous (SC) injection', 'armGroupLabels': ['Adalimumab Induction High Dose', 'Adalimumab Induction High Dose - Open Label', 'Adalimumab Induction Standard Dose', 'Adalimumab Maintenance High Dose', 'Adalimumab Maintenance Standard Dose', 'Maintenance Placebo']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Subcutaneous (SC) injection', 'armGroupLabels': ['Adalimumab Induction Standard Dose', 'Maintenance Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hospital LA /ID# 147452', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143-2204', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Univ California, San Francisco /ID# 120901', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Arnold Palmer Hosp Children /ID# 120898', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital /ID# 121858', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Ctr Digestive, US /ID# 121855", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637-1443', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago /ID# 120904', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Ctr /ID# 120900', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University /ID# 120908', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital /ID# 124551', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Childrens Hospital /ID# 147714', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905-0001', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - Rochester /ID# 121056', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Gastroenterology P.A /ID# 120895', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': "Goryeb Chidlren's Hospital /ID# 121860", 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital /ID# 120905', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Univ Rochester Med Ctr /ID# 127776', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Multicare Institute for Research and Innovation /ID# 147716', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '5006', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Womens and Childrens Hospital /ID# 127538', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universitat Wien /ID# 120802', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'LKH Salzburg and Paracelsus /ID# 123457', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'UZ Brussel /ID# 120798', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'zip': '1200', 'city': 'Woluwe-Saint-Lambert', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint Luc /ID# 120797', 'geoPoint': {'lat': 50.84389, 'lon': 4.42912}}, {'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hosp Univ Enfants Reine Fabiol /ID# 120795', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre /ID# 127777', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': '779 00', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Palacky University /ID# 131388', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '305 99', 'city': 'Pilsen', 'country': 'Czechia', 'facility': 'Univ Hosp, Plzen, CZ /ID# 120813', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'zip': '9023', 'city': 'Győr', 'country': 'Hungary', 'facility': 'Petz Aladar Megyei Oktato Korh /ID# 124323', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'zip': '7100', 'city': 'Szekszárd', 'country': 'Hungary', 'facility': 'Balassa Janos County Hospital /ID# 128474', 'geoPoint': {'lat': 46.34723, 'lon': 18.71189}}, {'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka Medical Ctr /ID# 147338', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '70300', 'city': 'Be’er Ya‘aqov', 'country': 'Israel', 'facility': 'Assaf Harofeh Medical Center /ID# 147791', 'geoPoint': {'lat': 31.93864, 'lon': 34.83749}}, {'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus /ID# 120827', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '91031', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek Medical Center /ID# 120830', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '4920235', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Schneider Childrens Med Ctr /ID# 120821', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '5262100', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center /ID# 124324', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '76100', 'city': 'Rehovot', 'country': 'Israel', 'facility': 'Kaplan Medical Center /ID# 150245', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'zip': '830-0011', 'city': 'Kurume-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Kurume University Hospital /ID# 125476'}, {'zip': '371-8511', 'city': 'Maebashi', 'state': 'Gunma', 'country': 'Japan', 'facility': 'Gunma University Hospital /ID# 126345', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'zip': '060-0033', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124482', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '663-8501', 'city': 'Nishinomiya-shi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'The Hospital of Hyogo College of Medicine /ID# 131665'}, {'zip': '230-0012', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Saiseikai Yokohamashi Tobu /ID# 124486', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '232-0024', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Yokohama City Univ Medical Ctr /ID# 147763', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '989-3126', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': "Miyagi Children's Hospital /ID# 125475", 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '330-8777', 'city': 'Saitama-shi', 'state': 'Saitama', 'country': 'Japan', 'facility': "Saitama Children's Medical Center /ID# 124485"}, {'zip': '113-8431', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Juntendo University Hospital /ID# 124536'}, {'zip': '157-8535', 'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Center for Child Health and Development /ID# 125203'}, {'zip': '558-8558', 'city': 'Osaka', 'country': 'Japan', 'facility': 'Osaka General Medical Center /ID# 124535', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Canterbury District Health Boa /ID# 120837', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '30-663', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'Uni Szpital Dzieciecy w Krakowie /ID# 120915', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '00-635', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Centrum Zdrowia MDM /ID# 120910', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '35-210', 'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Gabinet Lekarski Bartosz Korcz /ID# 120916', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'zip': '50-369', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpital /ID# 120839', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '93-338', 'city': 'Lodz', 'state': 'Łódź Voivodeship', 'country': 'Poland', 'facility': 'Polish Mothers Memorial Hosp /ID# 148497', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '974 09', 'city': 'Banská Bystrica', 'country': 'Slovakia', 'facility': 'FN s poliklinikou F.D. Rooseve /ID# 120847', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'zip': '821 01', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Univerzitna Nemocnica Bratislava /ID# 120842', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '036 01', 'city': 'Martin', 'state': 'Žilina Region', 'country': 'Slovakia', 'facility': 'Univerzitna nemocnica Martin /ID# 120844', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Univ Vall d'Hebron /ID# 120856", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28009', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infantil Universitario Nino Jesus /ID# 121862', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'E1 1BB', 'city': 'London', 'state': 'London, City of', 'country': 'United Kingdom', 'facility': 'The Royal London Hospital /ID# 120861', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW3 2QG', 'city': 'London', 'state': 'London, City of', 'country': 'United Kingdom', 'facility': 'The Royal Free Hospital /ID# 123142', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'G3 8SJ', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Royal Hosp for Sick Children /ID# 120864', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Manchester Royal Infirmary, Ma /ID# 120862', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}