Viewing Study NCT02435992

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Ignite Creation Date: 2025-12-24 @ 3:22 PM
Ignite Modification Date: 2026-02-20 @ 10:08 PM
Study NCT ID: NCT02435992
Status: COMPLETED
Last Update Posted: 2021-09-01
First Post: 2015-04-24
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607776', 'term': 'ozanimod'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please Email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately up to 52 Weeks', 'description': 'Participant overlap due to re randomization occuring before maintenance phase', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1 (Induction Period): RPC1063 1mg', 'description': 'Cohort 1 (Induction Period): RPC1063 1mg', 'otherNumAtRisk': 429, 'deathsNumAtRisk': 429, 'otherNumAffected': 15, 'seriousNumAtRisk': 429, 'deathsNumAffected': 0, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Cohort 1: Placebo', 'description': 'Cohort 1: Placebo', 'otherNumAtRisk': 216, 'deathsNumAtRisk': 216, 'otherNumAffected': 13, 'seriousNumAtRisk': 216, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Cohort 2 (Induction Period): RPC1063 1mg', 'description': 'Cohort 2 (Induction Period): RPC1063 1mg', 'otherNumAtRisk': 367, 'deathsNumAtRisk': 367, 'otherNumAffected': 15, 'seriousNumAtRisk': 367, 'deathsNumAffected': 1, 'seriousNumAffected': 23}, {'id': 'EG003', 'title': 'Intervention (Maintenance Period): RPC1063 1mg', 'description': 'Intervention (Maintenance Period): RPC1063 1mg', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 230, 'otherNumAffected': 2, 'seriousNumAtRisk': 230, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG004', 'title': 'Placebo (Maintenance Period): Placebo', 'description': 'Placebo (Maintenance Period): Placebo', 'otherNumAtRisk': 227, 'deathsNumAtRisk': 227, 'otherNumAffected': 4, 'seriousNumAtRisk': 227, 'deathsNumAffected': 0, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Diarrhoea haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Proctitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Complicated appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gastroenteritis norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Large intestine infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Measles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pneumonia influenzal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vestibular neuronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Yersinia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Neck injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Respiratory syncytial virus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Cervix carcinoma stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 367, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 230, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants in Clinical Remission at 10 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPC1063 Cohort 1(Induction Period)', 'description': '* Blinded\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG001', 'title': 'Placebo Cohort 1 (Induction Period)', 'description': '-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.'}, {'id': 'OG002', 'title': 'RPC1063 Cohort 2 (Induction Period)', 'description': '* Open Label\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG003', 'title': 'RPC1063 (Maintenance Period)', 'description': '\\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)'}, {'id': 'OG004', 'title': 'Placebo (Maintenance Period)', 'description': '\\- Blinded Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}, {'value': '21.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.586', 'ciLowerLimit': '1.938', 'ciUpperLimit': '6.636', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 10 Weeks', 'description': 'Percentage of participants that are in Clinical remission at 10 weeks', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants in Clinical Remission at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '230', 'groupId': 'OG003'}, {'value': '227', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPC1063 Cohort 1(Induction Period)', 'description': '* Blinded\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG001', 'title': 'Placebo Cohort 1 (Induction Period)', 'description': '-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.'}, {'id': 'OG002', 'title': 'RPC1063 Cohort 2 (Induction Period)', 'description': '* Open Label\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG003', 'title': 'RPC1063 (Maintenance Period)', 'description': '\\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)'}, {'id': 'OG004', 'title': 'Placebo (Maintenance Period)', 'description': '\\- Blinded Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG001'}, {'value': '37.0', 'groupId': 'OG003'}, {'value': '18.5', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.755', 'ciLowerLimit': '1.767', 'ciUpperLimit': '4.294', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At 52 Weeks', 'description': 'Percentage of participants that are in Clinical remission at 52 weeks', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Response at 10 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPC1063 Cohort 1(Induction Period)', 'description': '* Blinded\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG001', 'title': 'Placebo Cohort 1 (Induction Period)', 'description': '-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.'}, {'id': 'OG002', 'title': 'RPC1063 Cohort 2 (Induction Period)', 'description': '* Open Label\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG003', 'title': 'RPC1063 (Maintenance Period)', 'description': '\\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)'}, {'id': 'OG004', 'title': 'Placebo (Maintenance Period)', 'description': '\\- Blinded Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000'}, {'value': '25.9', 'groupId': 'OG001'}, {'value': '52.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 10 Weeks', 'description': 'Percentage of participants that are in Clinical response at 10 weeks', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Endoscopic Improvement at 10 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPC1063 Cohort 1(Induction Period)', 'description': '* Blinded\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG001', 'title': 'Placebo Cohort 1 (Induction Period)', 'description': '-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.'}, {'id': 'OG002', 'title': 'RPC1063 Cohort 2 (Induction Period)', 'description': '* Open Label\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG003', 'title': 'RPC1063 (Maintenance Period)', 'description': '\\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)'}, {'id': 'OG004', 'title': 'Placebo (Maintenance Period)', 'description': '\\- Blinded Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000'}, {'value': '11.6', 'groupId': 'OG001'}, {'value': '27.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 10 Weeks', 'description': 'Percentage of participants with endoscopic improvement at 10 weeks', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mucosal Healing at 10 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '367', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPC1063 Cohort 1(Induction Period)', 'description': '* Blinded\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG001', 'title': 'Placebo Cohort 1 (Induction Period)', 'description': '-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.'}, {'id': 'OG002', 'title': 'RPC1063 Cohort 2 (Induction Period)', 'description': '* Open Label\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG003', 'title': 'RPC1063 (Maintenance Period)', 'description': '\\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)'}, {'id': 'OG004', 'title': 'Placebo (Maintenance Period)', 'description': '\\- Blinded Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}, {'value': '11.4', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 10 Weeks', 'description': 'Percentage of participants with mucosal healing at 10 weeks', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Clinical Response at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '230', 'groupId': 'OG003'}, {'value': '227', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPC1063 Cohort 1(Induction Period)', 'description': '* Blinded\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG001', 'title': 'Placebo Cohort 1 (Induction Period)', 'description': '-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.'}, {'id': 'OG002', 'title': 'RPC1063 Cohort 2 (Induction Period)', 'description': '* Open Label\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG003', 'title': 'RPC1063 (Maintenance Period)', 'description': '\\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)'}, {'id': 'OG004', 'title': 'Placebo (Maintenance Period)', 'description': '\\- Blinded Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '39.1', 'groupId': 'OG001'}, {'value': '60.0', 'groupId': 'OG003'}, {'value': '41.0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 52 Weeks', 'description': 'Percentage of participants that are in Clinical response at 52 weeks', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Endoscopic Improvement at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '230', 'groupId': 'OG003'}, {'value': '227', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPC1063 Cohort 1(Induction Period)', 'description': '* Blinded\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG001', 'title': 'Placebo Cohort 1 (Induction Period)', 'description': '-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.'}, {'id': 'OG002', 'title': 'RPC1063 Cohort 2 (Induction Period)', 'description': '* Open Label\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG003', 'title': 'RPC1063 (Maintenance Period)', 'description': '\\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)'}, {'id': 'OG004', 'title': 'Placebo (Maintenance Period)', 'description': '\\- Blinded Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG001'}, {'value': '45.7', 'groupId': 'OG003'}, {'value': '26.4', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 52 Weeks', 'description': 'Percentage of participants with endoscopic improvement at 52 weeks', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPC1063 Cohort 1(Induction Period)', 'description': '* Blinded\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG001', 'title': 'Placebo Cohort 1 (Induction Period)', 'description': '-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.'}, {'id': 'OG002', 'title': 'RPC1063 Cohort 2 (Induction Period)', 'description': '* Open Label\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG003', 'title': 'RPC1063 (Maintenance Period)', 'description': '\\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)'}, {'id': 'OG004', 'title': 'Placebo (Maintenance Period)', 'description': '\\- Blinded Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG001'}, {'value': '51.9', 'groupId': 'OG003'}, {'value': '29.3', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 52 Weeks', 'description': 'Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population who were in remission at week 10'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Corticosteroid Free Remission at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '230', 'groupId': 'OG003'}, {'value': '227', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPC1063 Cohort 1(Induction Period)', 'description': '* Blinded\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG001', 'title': 'Placebo Cohort 1 (Induction Period)', 'description': '-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.'}, {'id': 'OG002', 'title': 'RPC1063 Cohort 2 (Induction Period)', 'description': '* Open Label\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG003', 'title': 'RPC1063 (Maintenance Period)', 'description': '\\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)'}, {'id': 'OG004', 'title': 'Placebo (Maintenance Period)', 'description': '\\- Blinded Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'groupId': 'OG001'}, {'value': '31.7', 'groupId': 'OG003'}, {'value': '16.7', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 52 Weeks', 'description': 'Percentage of participants with corticosteroid free remission at 52 weeks', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mucosal Healing at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '230', 'groupId': 'OG003'}, {'value': '227', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPC1063 Cohort 1(Induction Period)', 'description': '* Blinded\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG001', 'title': 'Placebo Cohort 1 (Induction Period)', 'description': '-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.'}, {'id': 'OG002', 'title': 'RPC1063 Cohort 2 (Induction Period)', 'description': '* Open Label\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG003', 'title': 'RPC1063 (Maintenance Period)', 'description': '\\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)'}, {'id': 'OG004', 'title': 'Placebo (Maintenance Period)', 'description': '\\- Blinded Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG001'}, {'value': '29.6', 'groupId': 'OG003'}, {'value': '14.1', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 52 Weeks', 'description': 'Percentage of participants with Mucosal Healing at 52 weeks', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Durable Clinical Remission at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '230', 'groupId': 'OG003'}, {'value': '227', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'RPC1063 Cohort 1(Induction Period)', 'description': '* Blinded\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG001', 'title': 'Placebo Cohort 1 (Induction Period)', 'description': '-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.'}, {'id': 'OG002', 'title': 'RPC1063 Cohort 2 (Induction Period)', 'description': '* Open Label\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'OG003', 'title': 'RPC1063 (Maintenance Period)', 'description': '\\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)'}, {'id': 'OG004', 'title': 'Placebo (Maintenance Period)', 'description': '\\- Blinded Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG001'}, {'value': '17.8', 'groupId': 'OG003'}, {'value': '9.7', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 52 Weeks', 'description': 'Percentage of participants with durable clinical remission at 52 weeks', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RPC1063 Cohort 1 (Induction Period)', 'description': '* Blinded\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'FG001', 'title': 'Placebo Cohort 1 (Induction Period)', 'description': '-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.'}, {'id': 'FG002', 'title': 'RPC1063 Cohort 2 (Induction Period)', 'description': '* Open Label\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'FG003', 'title': 'RPC1063 (Maintenance Period)', 'description': '\\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)'}, {'id': 'FG004', 'title': 'Placebo (Maintenance Period)', 'description': '\\- Blinded Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '429'}, {'groupId': 'FG001', 'numSubjects': '216'}, {'groupId': 'FG002', 'numSubjects': '367'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Transition to Maintenance Period', 'comment': 'Completed Induction Week 10, continuing into MP', 'achievements': [{'groupId': 'FG000', 'numSubjects': '233'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '224'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Treated in Maintenance Period', 'comment': 'Subjects who entered Maintenance Period from Induction period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Randomized from cohort 1 and 2 RCP1063 treatment', 'groupId': 'FG003', 'numSubjects': '230'}, {'comment': 'Randomized from cohort 1 and 2 RCP1063 treatment', 'groupId': 'FG004', 'numSubjects': '227'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '401'}, {'groupId': 'FG001', 'numSubjects': '192'}, {'groupId': 'FG002', 'numSubjects': '324'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'non compliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '1012 Participants randomized and treated'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}, {'value': '227', 'groupId': 'BG004'}, {'value': '1469', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'RPC1063 Cohort 1(Induction Period)', 'description': '* Blinded\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'BG001', 'title': 'Placebo Cohort 1 (Induction Period)', 'description': '-Blinded Placebo Participants started in induction period and some continued to receive placebo in the Maintenance Period in a double blind manner.'}, {'id': 'BG002', 'title': 'RPC1063 Cohort 2 (Induction Period)', 'description': '* Open Label\n* On Days 1 to 4, RPC1063/ozanimod HCl 0.25 mg (equivalent to ozanimod 0.23 mg) or matching placebo once daily (one 0.25 mg capsule)\n* On Days 5 to 7, RPC1063/ozanimod HCl 0.5 mg (equivalent to ozanimod 0.46 mg) or matching placebo once daily (two 0.25 mg capsules)\n* On Day 8, patients will receive the final dose RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) or matching placebo once daily for 9 weeks (one 1 mg capsule)'}, {'id': 'BG003', 'title': 'RPC1063 (Maintenance Period)', 'description': '\\- Blinded RPC1063/ozanimod HCl 1 mg (equivalent to ozanimod 0.92 mg) once daily for 42 weeks (one 1 mg capsule)'}, {'id': 'BG004', 'title': 'Placebo (Maintenance Period)', 'description': '\\- Blinded Placebo'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Induction Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1012', 'groupId': 'BG005'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '410', 'groupId': 'BG000'}, {'value': '202', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}, {'value': '958', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG005'}]}]}, {'title': 'Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}, {'value': '227', 'groupId': 'BG004'}, {'value': '457', 'groupId': 'BG005'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '217', 'groupId': 'BG003'}, {'value': '215', 'groupId': 'BG004'}, {'value': '432', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Two different periods'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Induction Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1012', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}, {'value': '410', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '245', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}, {'value': '602', 'groupId': 'BG005'}]}]}, {'title': 'Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}, {'value': '227', 'groupId': 'BG004'}, {'value': '457', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '117', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}, {'value': '239', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '113', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}, {'value': '218', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Two different periods'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Induction Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1012', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '403', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}, {'value': '962', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG005'}]}]}, {'title': 'Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}, {'value': '227', 'groupId': 'BG004'}, {'value': '457', 'groupId': 'BG005'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '221', 'groupId': 'BG003'}, {'value': '214', 'groupId': 'BG004'}, {'value': '435', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Two different periods'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Induction Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '429', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '367', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1012', 'groupId': 'BG005'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '370', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}, {'value': '898', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG005'}]}]}, {'title': 'Maintenance Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '230', 'groupId': 'BG003'}, {'value': '227', 'groupId': 'BG004'}, {'value': '457', 'groupId': 'BG005'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG003'}, 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Clinical remission at 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Clinical Response at 10 Weeks', 'timeFrame': 'At 10 Weeks', 'description': 'Percentage of participants that are in Clinical response at 10 weeks'}, {'measure': 'Percentage of Participants With Endoscopic Improvement at 10 Weeks', 'timeFrame': 'At 10 Weeks', 'description': 'Percentage of participants with endoscopic improvement at 10 weeks'}, {'measure': 'Percentage of Participants With Mucosal Healing at 10 Weeks', 'timeFrame': 'At 10 Weeks', 'description': 'Percentage of participants with mucosal healing at 10 weeks'}, {'measure': 'Percentage of Participants in Clinical Response at 52 Weeks', 'timeFrame': 'At 52 Weeks', 'description': 'Percentage of participants that are in Clinical response at 52 weeks'}, {'measure': 'Percentage of Participants With Endoscopic Improvement at 52 Weeks', 'timeFrame': 'At 52 Weeks', 'description': 'Percentage of participants with endoscopic improvement at 52 weeks'}, {'measure': 'Percentage of Participants in Clinical Remission at Week 52 Who Were in Remission at Week 10', 'timeFrame': 'At 52 Weeks', 'description': 'Percentage of participants in clinical remission at week 52 who were in clinical remission at week 10'}, {'measure': 'Percentage of Participants With Corticosteroid Free Remission at 52 Weeks', 'timeFrame': 'At 52 Weeks', 'description': 'Percentage of participants with corticosteroid free remission at 52 weeks'}, {'measure': 'Percentage of Participants With Mucosal Healing at 52 Weeks', 'timeFrame': 'At 52 Weeks', 'description': 'Percentage of participants with Mucosal Healing at 52 weeks'}, {'measure': 'Percentage of Participants With Durable Clinical Remission at 52 Weeks', 'timeFrame': 'At 52 Weeks', 'description': 'Percentage of participants with durable clinical remission at 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '41003640', 'type': 'DERIVED', 'citation': 'Yarur A, Irving P, Siegmund B, Dubinsky MC, Ananthakrishnan AN, Regueiro M, Ungaro RC, Ritter T, Nakase H, Liu Z, Mehra D, Osterman MT, Jain A, Rubin DT, Hibi T. Long-Term Ozanimod Therapy in Patients With Moderately Active Ulcerative Colitis After Failure of 5-Aminosalicylic Acid. Inflamm Bowel Dis. 2025 Sep 26:izaf195. doi: 10.1093/ibd/izaf195. Online ahead of print.'}, {'pmid': '39773524', 'type': 'DERIVED', 'citation': "Sands BE, Rubin DT, Loftus EV Jr, Wolf DC, Panaccione R, Colombel JF, Dignass A, Regueiro M, Vermeire S, Afzali A, Lawlor G, Ahmad HA, Wu H, Osterman MT, Jain A, D'Haens G. Impact of Prior Biologic Exposure on Ozanimod Efficacy and Safety in the Phase 3 True North Clinical Trial. Am J Gastroenterol. 2025 Oct 1;120(10):2339-2349. doi: 10.14309/ajg.0000000000003310. Epub 2025 Jan 8."}, {'pmid': '39018016', 'type': 'DERIVED', 'citation': "Regueiro M, Siegmund B, Horst S, Moslin R, Charles L, Petersen A, Tatosian D, Wu H, Lawlor G, Fischer M, D'Haens G, Colombel JF. Concomitant Administration of Ozanimod and Serotonergic Antidepressants in Patients With Ulcerative Colitis or Relapsing Multiple Sclerosis. Inflamm Bowel Dis. 2025 Apr 10;31(4):1010-1017. doi: 10.1093/ibd/izae136."}, {'pmid': '38723981', 'type': 'DERIVED', 'citation': "Sands BE, D'Haens G, Panaccione R, Regueiro M, Ghosh S, Hudesman D, Ahmad HA, Mehra D, Wu H, Jain A, Petersen A, Osterman MT, Afzali A, Danese S. Ozanimod in Patients With Moderate to Severe Ulcerative Colitis Naive to Advanced Therapies. Clin Gastroenterol Hepatol. 2024 Oct;22(10):2084-2095.e4. doi: 10.1016/j.cgh.2024.03.042. Epub 2024 May 8."}, {'pmid': '38040274', 'type': 'DERIVED', 'citation': 'Armuzzi A, Cross RK, Lichtenstein GR, Hou J, Deepak P, Regueiro M, Wolf DC, Akukwe L, Ahmad HA, Jain A, Kozinn M, Wu H, Petersen A, Charles L, Long M. Cardiovascular Safety of Ozanimod in Patients With Ulcerative Colitis: True North and Open-Label Extension Analyses. Clin Gastroenterol Hepatol. 2024 May;22(5):1067-1076.e3. doi: 10.1016/j.cgh.2023.11.018. Epub 2023 Nov 30.'}, {'pmid': '34587385', 'type': 'DERIVED', 'citation': "Sandborn WJ, Feagan BG, D'Haens G, Wolf DC, Jovanovic I, Hanauer SB, Ghosh S, Petersen A, Hua SY, Lee JH, Charles L, Chitkara D, Usiskin K, Colombel JF, Laine L, Danese S; True North Study Group. Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2021 Sep 30;385(14):1280-1291. doi: 10.1056/NEJMoa2033617."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether RPC1063 is effective in the treatment of Ulcerative Colitis (UC).', 'detailedDescription': 'The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP), patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort 2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 to 75 years (at screening for Cohort 1 and 2)\n* UC confirmed on endoscopy\n* Moderately to severely active UC (May score 6-12)\n* Currently receiving treatment with aminosalisylate, prednisone, or budesonide\n* Can be receiving azathioprine, mercaptopurine, or methotrexate, but treatment will be stopped prior to randomization\n\nExclusion Criteria:\n\n* Have severe extensive colitis as evidence by:\n* Physician judgment that the patient is likely to require colectomy or ileostomy within 12 weeks of baseline.\n* Current or recent (within 3 months) evidence of fulminant colitis, toxic megacolon, or bowel perforation.\n* Diagnosis of CD, indeterminate colitis, or the presence of fistula consistent with CD or microscopic colitis, radiation colitis, or ischemic colitis\n* Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk\n* History of uveitis or unknown macular edema\n* Pregnancy, lactation, or a positive serum β-human chorionic gonadotropin (β-hCG) measured during screening'}, 'identificationModule': {'nctId': 'NCT02435992', 'briefTitle': 'Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'RPC01-3101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RPC1063 (Ozanimod)', 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