Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 5:40 AM
Study NCT ID:
NCT01628393
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2012-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'otherDetails': 'The investigator shall have the right to publish and/or present study data provided that the investigator shall (i) furnish the sponsor a copy of any proposed publication or presentation generally thirty (30) days in advance of the submission, (ii) delete any confidential information of the sponsor, and (iii) delay submission for generally up to ninety (90) days to permit the preparation and filing of intellectual property applications or until sponsor gives its consent in a timely manner.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Placebo-controlled period: From first dose of study drug up to Week 24, or up to 28 days after the last dose for participants who did not enter the extension period. Extension period: From the first dose of ozanimod in the blinded extension period, up to 4 weeks after the last dose; up to 96 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo-Controlled Period: Placebo', 'description': 'Participants received placebo capsules PO daily during the 24-week placebo-controlled period.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 24, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo-Controlled Period: Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled period.', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 24, 'seriousNumAtRisk': 87, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Placebo-Controlled Period: Ozanimod 1.0 mg', 'description': 'Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled period.', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 10, 'seriousNumAtRisk': 83, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Extension Period: Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg capsules PO daily during the blinded extension period (Weeks 25 to 120).', 'otherNumAtRisk': 126, 'deathsNumAtRisk': 126, 'otherNumAffected': 52, 'seriousNumAtRisk': 126, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG004', 'title': 'Extension Period: Ozanimod 1.0 mg', 'description': 'Participants received ozanimod 1 mg capsules PO daily during the blinded extension period (Weeks 25 to 120).', 'otherNumAtRisk': 123, 'deathsNumAtRisk': 123, 'otherNumAffected': 43, 'seriousNumAtRisk': 123, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gamma-Glutamyltransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Irritable Bowel Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Proctitis Infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Clavicle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lower Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cauda Equina Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intracranial Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Optic Neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Somatoform Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urethral Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Menometrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Uterine Cervical Squamous Metaplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Uterine Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Stasis Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 83, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules PO daily during the 24-week placebo-controlled period.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'spread': '29.87', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '4.77', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '3.44', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.04944 level of significance to keep the overall level of significance at 0.05.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.04944 level of significance to keep the overall level of significance at 0.05.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.'}], 'paramType': 'MEAN', 'timeFrame': 'From Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24', 'description': 'The cumulative number of total GdE lesions on MRI from Week 12 to Week 24. MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population is defined as all randomized participants who received at least 1 dose of study drug.\n\nMissing data were imputed using the last valid non-missing, post-baseline observation which was carried forward if the participant was only missing 1 or 2 consecutive post-baseline scans. If there were no post-baseline data or the participant was missing \\> 2 consecutive scans, the mean number of lesions from participants in the same treatment group and visit was used as the imputed value.'}, {'type': 'SECONDARY', 'title': 'The Number of Gadolinium-Enhancing Lesions on Brain MRI Scan at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules PO daily during the 24-week placebo-controlled period.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '9.81', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.59', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population is defined as all randomized participants who received at least 1 dose of study drug. Missing GdE data values were imputed using the mean number of lesions from participants in the same treatment group at the same visit.'}, {'type': 'SECONDARY', 'title': 'The Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions From Week 12 to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules PO daily during the 24-week placebo-controlled period.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'spread': '20.87', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '3.21', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '1.86', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Wilcoxon-Mann-Whitney test stratified by absence or presence of gadolinium-enhancing lesions at Baseline.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24', 'description': 'The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions from Week 12 to Week 24.\n\nMRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population is defined as all randomized participants who received at least 1 dose of study drug. Missing new or enlarging T2 data values were imputed using the mean from participants of the same treatment group at the same visit.'}, {'type': 'SECONDARY', 'title': 'Adjusted Annualized Relapse Rate (ARR) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules PO daily during the 24-week placebo-controlled period.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '1.15'}, {'value': '0.35', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.82'}, {'value': '0.24', 'groupId': 'OG002', 'lowerLimit': '0.09', 'upperLimit': '0.61'}]}]}], 'analyses': [{'pValue': '0.0531', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.22', 'ciUpperLimit': '1.01', 'estimateComment': 'Rate ratio = Ozanimod / Placebo', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, the number of relapses within 24 months prior to the study, and the absence or presence of GdE lesions at Baseline.'}, {'pValue': '0.2714', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.36', 'ciUpperLimit': '1.34', 'estimateComment': 'Rate ratio = Ozanimod / Placebo', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, the number of relapses within 24 months prior to the study, and the absence or presence of GdE lesions at Baseline.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'A relapse was defined as new or worsening neurological symptoms attributable to MS and preceded by a relatively stable or improving neurological state for at least 30 days. Symptoms must have persisted for \\> 24 hours and not be attributable to confounding clinical factors. Relapses were confirmed when accompanied by objective neurological worsening based on examination by the blinded evaluator, consistent with an increase of ≥ 0.5 on the overall EDSS score relative to the most recent EDSS assessment, or 2 points on one of the functional system scale scores, or 1 point on ≥ two functional system scale scores.\n\nRelapse rate was calculated as the total number of confirmed relapses divided by the total number of days in the study \\* 365.\n\nARR was based on a Poisson regression model, adjusted for region, relapses within 24 months before the study, and presence of gadolinium-enhancing lesions at Baseline.', 'unitOfMeasure': 'relapses/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population is defined as all randomized participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules PO daily during the 24-week placebo-controlled period.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Any moderate or severe TEAE', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Any severe TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE related to study drug', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any serious TEAE related to study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE leading to discontinuation of study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any death related to study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug up to Week 24, or up to 28 days after the last dose for participants who did not enter the extension period.', 'description': 'An adverse event (AE) is any untoward medical occurrence that does not necessarily have a causal relationship with the investigational product (IP), including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. Serious AEs were events that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, were congenital abnormalities/birth defects, or important medical events which may have required medical intervention to prevent one of the above outcomes.\n\nThe investigator assessed the severity of AEs as mild, moderate, or severe, and the relationship of each AE to treatment as unrelated, unlikely, possible, probable, or related based on timing and other known factors such as clinical state, environment, or other therapies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo / Ozanimod 0.5 mg', 'description': 'Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg capsules PO daily during the blinded extension period for 96 weeks.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks.'}, {'id': 'OG002', 'title': 'Placebo / Ozanimod 1 mg', 'description': 'Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg capsules PO daily during the blinded extension period for 96 weeks.'}, {'id': 'OG003', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}]}, {'title': 'Any moderate or severe TEAE', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}]}, {'title': 'Any severe TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE related to study drug', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Any serious TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Any serious TEAE related to study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE leading to discontinuation of study drug', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any death related to study drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of ozanimod, either in the placebo-controlled or the blinded extension period, up to 4 weeks after the last dose; mean duration of exposure was 25.4, 30.9, 24.6, and 32.3 months in each treatment group respectively.', 'description': 'AEs are reported from the start of the placebo-controlled period for participants originally assigned to ozanimod and from the start of the extension period for participants who switched to ozanimod after Week 24.\n\nSerious AEs were events that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, were congenital abnormalities/birth defects, or important medical events which may have required medical intervention to prevent one of the above outcomes.\n\nThe investigator assessed the severity of AEs as mild, moderate, or severe, and the relationship of each AE to treatment based on timing and other known factors such as clinical state, environment, or other therapies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population was defined as all participants who received at least one dose of study drug in the blinded extension phase'}, {'type': 'POST_HOC', 'title': 'Number of Gadolinium-Enhancing (GdE) Lesions During the Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo / Ozanimod 0.5 mg', 'description': 'Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg capsules PO daily during the blinded extension period for 96 weeks.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks.'}, {'id': 'OG002', 'title': 'Placebo / Ozanimod 1 mg', 'description': 'Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg capsules PO daily during the blinded extension period for 96 weeks.'}, {'id': 'OG003', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks.'}], 'classes': [{'title': 'Week 24 (start of extension period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '13.02', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '5.93', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.60', 'groupId': 'OG003'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.30', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '1.35', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.56', 'groupId': 'OG003'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.28', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.56', 'groupId': 'OG003'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.49', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.37', 'groupId': 'OG002'}, {'value': '0.2', 'spread': '0.51', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 24, 48, 72, and 120', 'description': 'MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who entered the blinded extension period, received at least 1 dose of study drug, and had any post-baseline assessment in the blinded extension period. Includes participants with non-missing MRI results at each time point.'}, {'type': 'POST_HOC', 'title': 'Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions In the Extension Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo / Ozanimod 0.5 mg', 'description': 'Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg capsules PO daily during the blinded extension period for 96 weeks.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks.'}, {'id': 'OG002', 'title': 'Placebo / Ozanimod 1 mg', 'description': 'Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg capsules PO daily during the blinded extension period for 96 weeks.'}, {'id': 'OG003', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension period and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks.'}], 'classes': [{'title': 'Week 12 to 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '81', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '3.58', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '7.3', 'spread': '3.07', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '0.21', 'groupId': 'OG003'}]}]}, {'title': 'Week 24 to 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.72', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '0.84', 'groupId': 'OG003'}]}]}, {'title': 'Week 72 to 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '74', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '0.48', 'groupId': 'OG002'}, {'value': '0.7', 'spread': '0.16', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 12 to 24 of the placebo-controlled period and Week 24 to 72 (first year) and Week 72 - 120 (second year) in the extension period', 'description': 'The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions from Week 12 to Week 24 in the placebo controlled period (reference) and during the first and second years of the extension period.\n\nMRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who entered the blinded extension period, received at least 1 dose of study drug, and had any post-baseline assessment in the blinded extension period. Includes participants with non-missing MRI results in each time period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules by mouth (PO) daily during the 24-week placebo-controlled treatment period.'}, {'id': 'FG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension phase and continued to receive ozanimod 0.5 mg capsules PO daily for an additional 96 weeks of treatment.'}, {'id': 'FG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period. Participants were given the option to enter into a blinded extension phase and continued to receive ozanimod 1 mg capsules PO daily for an additional 96 weeks of treatment.'}, {'id': 'FG003', 'title': 'Placebo / Ozanimod 0.5 mg', 'description': 'Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 0.5 mg PO daily during the blinded extension period for 96 weeks.'}, {'id': 'FG004', 'title': 'Placebo / Ozanimod 1 mg', 'description': 'Participants initially randomized to placebo during the 24-week placebo controlled treatment period were re-randomized to receive ozanimod 1 mg PO daily during the blinded extension period for 96 weeks.'}], 'periods': [{'title': 'Placebo-controlled Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '83'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '82'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Blinded Active Extension Period', 'milestones': [{'type': 'STARTED', 'comment': 'Three participants who completed the placebo-controlled treatment period declined to enter the blinded extension period.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '81'}, {'groupId': 'FG003', 'numSubjects': '41'}, {'groupId': 'FG004', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '75'}, {'groupId': 'FG003', 'numSubjects': '37'}, {'groupId': 'FG004', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The study was conducted at 55 study centers in 13 countries including the United States, Europe and Russia. Participants with multiple sclerosis (MS) were recruited between September 2012 and October 2013.\n\nThe study consisted of a 24-week placebo-controlled treatment period and an optional 96-week blinded extension period.', 'preAssignmentDetails': 'Participants were randomly assigned in a 1:1:1 ratio to receive one of two daily doses of ozanimod (0.5 mg or 1 mg) or matching placebo for 24 weeks. Those who completed 24 weeks could enter a blinded extension phase and continue on their assigned doses of ozanimod, whereas those assigned to placebo were re-randomized in a 1:1 ratio to ozanimod 0.5 mg or 1 mg. In both periods the randomization was stratified by country.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '258', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo capsules by mouth (PO) daily during the 24-week placebo-controlled treatment period.'}, {'id': 'BG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg capsules PO daily during the 24-week placebo-controlled treatment period.'}, {'id': 'BG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg capsules PO daily during the 24-week placebo-controlled treatment period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.0', 'spread': '8.67', 'groupId': 'BG000'}, {'value': '38.1', 'spread': '9.17', 'groupId': 'BG001'}, {'value': '38.4', 'spread': '9.82', 'groupId': 'BG002'}, {'value': '38.5', 'spread': '9.19', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '254', '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': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Western Europe', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Eastern Europe', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '233', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Country of Enrollment', 'classes': [{'categories': [{'title': 'Poland', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}]}, {'title': 'Serbia', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'Ukraine', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Russia', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'United States', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Romania', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Georgia', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Bulgaria', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Greece', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Spain', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Italy', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Belgium', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Hungary', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age at Multiple Sclerosis Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '33.9', 'spread': '8.30', 'groupId': 'BG000'}, {'value': '34.8', 'spread': '10.01', 'groupId': 'BG001'}, {'value': '34.4', 'spread': '9.51', 'groupId': 'BG002'}, {'value': '34.4', 'spread': '9.27', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time Since Multiple Sclerosis Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '5.12', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '4.98', 'groupId': 'BG001'}, {'value': '3.6', 'spread': '4.43', 'groupId': 'BG002'}, {'value': '3.7', 'spread': '4.90', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Expanded Disability Status Scale (EDSS) Score at Baseline', 'classes': [{'categories': [{'measurements': [{'value': '2.85', 'spread': '1.273', 'groupId': 'BG000'}, {'value': '2.94', 'spread': '1.287', 'groupId': 'BG001'}, {'value': '2.86', 'spread': '1.213', 'groupId': 'BG002'}, {'value': '2.88', 'spread': '1.255', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The EDSS is a scale for quantifying disability in MS. Eight functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \\& bladder, cerebral, and other functions) are scored on a scale from 0 (no disability) to 5 or 6 (more severe disability). Ambulation is also scored. Based on scores in the 8 functional systems plus gait, an overall score ranging from 0 (normal) to 10 (death due to MS) in 0.5 unit increments is assigned. Participants with EDSS scores of 0.0 to 4.5 are fully ambulatory; patients with EDSS scores of 5.0 to 9.5 have impaired ambulation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time Since MS Symptom Onset', 'classes': [{'categories': [{'measurements': [{'value': '8.1', 'spread': '6.97', 'groupId': 'BG000'}, {'value': '6.0', 'spread': '6.41', 'groupId': 'BG001'}, {'value': '6.2', 'spread': '5.79', 'groupId': 'BG002'}, {'value': '6.8', 'spread': '6.47', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Relapses Within the Last 12 months Prior to Screening', 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '0.64', 'groupId': 'BG000'}, {'value': '1.5', 'spread': '1.18', 'groupId': 'BG001'}, {'value': '1.3', 'spread': '0.73', 'groupId': 'BG002'}, {'value': '1.4', 'spread': '0.88', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'relapses', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Relapses Within the Last 24 months Prior to Screening', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '1.01', 'groupId': 'BG000'}, {'value': '2.0', 'spread': '1.79', 'groupId': 'BG001'}, {'value': '1.9', 'spread': '1.05', 'groupId': 'BG002'}, {'value': '1.9', 'spread': '1.33', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'relapses', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Gadolinium Enhancing (GdE) Lesions', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '3.36', 'groupId': 'BG000'}, {'value': '0.9', 'spread': '1.42', 'groupId': 'BG001'}, {'value': '1.3', 'spread': '2.75', 'groupId': 'BG002'}, {'value': '1.2', 'spread': '2.64', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'A lesion appearing on magnetic resonance imagery (MRI), following injection of the chemical compound gadolinium, that reveals a breakdown in the blood-brain barrier. This breakdown of the blood-brain barrier indicates either a newly active lesion or the re-activation of an old one.', 'unitOfMeasure': 'lesions', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-treat (ITT) population is defined as all randomized participants who received at least 1 dose of study drug; participants were analyzed according to the treatment they were randomized to receive and not according to what they actually received, if different.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-05-20', 'size': 1754245, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-04-19T17:26', 'hasProtocol': False}, {'date': '2014-10-01', 'size': 4843575, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-19T17:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 258}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'dispFirstSubmitDate': '2016-05-04', 'completionDateStruct': {'date': '2016-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2012-06-22', 'dispFirstSubmitQcDate': '2016-06-07', 'resultsFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2012-06-22', 'dispFirstPostDateStruct': {'date': '2016-06-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-25', 'studyFirstPostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Number of Gadolinium-Enhancing (GdE) Lesions Assessed on Brain Magnetic Resonance Imaging (MRI) From Week 12 to Week 24', 'timeFrame': 'From Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24', 'description': 'The cumulative number of total GdE lesions on MRI from Week 12 to Week 24. MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.'}], 'secondaryOutcomes': [{'measure': 'The Number of Gadolinium-Enhancing Lesions on Brain MRI Scan at Week 24', 'timeFrame': 'Week 24', 'description': 'MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.'}, {'measure': 'The Total Number of New or Enlarging Hyperintense T2-Weighted Brain MRI Lesions From Week 12 to Week 24', 'timeFrame': 'Week 12 to Week 24; MRI was performed at Weeks 12, 16, 20, and 24', 'description': 'The cumulative number of new or enlarging hyperintense T2-weighted brain MRI lesions from Week 12 to Week 24.\n\nMRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.'}, {'measure': 'Adjusted Annualized Relapse Rate (ARR) at Week 24', 'timeFrame': 'Week 24', 'description': 'A relapse was defined as new or worsening neurological symptoms attributable to MS and preceded by a relatively stable or improving neurological state for at least 30 days. Symptoms must have persisted for \\> 24 hours and not be attributable to confounding clinical factors. Relapses were confirmed when accompanied by objective neurological worsening based on examination by the blinded evaluator, consistent with an increase of ≥ 0.5 on the overall EDSS score relative to the most recent EDSS assessment, or 2 points on one of the functional system scale scores, or 1 point on ≥ two functional system scale scores.\n\nRelapse rate was calculated as the total number of confirmed relapses divided by the total number of days in the study \\* 365.\n\nARR was based on a Poisson regression model, adjusted for region, relapses within 24 months before the study, and presence of gadolinium-enhancing lesions at Baseline.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) During the Placebo-Controlled Treatment Period', 'timeFrame': 'From first dose of study drug up to Week 24, or up to 28 days after the last dose for participants who did not enter the extension period.', 'description': 'An adverse event (AE) is any untoward medical occurrence that does not necessarily have a causal relationship with the investigational product (IP), including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. Serious AEs were events that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, were congenital abnormalities/birth defects, or important medical events which may have required medical intervention to prevent one of the above outcomes.\n\nThe investigator assessed the severity of AEs as mild, moderate, or severe, and the relationship of each AE to treatment as unrelated, unlikely, possible, probable, or related based on timing and other known factors such as clinical state, environment, or other therapies.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAE) During Ozanimod Exposure', 'timeFrame': 'From the first dose of ozanimod, either in the placebo-controlled or the blinded extension period, up to 4 weeks after the last dose; mean duration of exposure was 25.4, 30.9, 24.6, and 32.3 months in each treatment group respectively.', 'description': 'AEs are reported from the start of the placebo-controlled period for participants originally assigned to ozanimod and from the start of the extension period for participants who switched to ozanimod after Week 24.\n\nSerious AEs were events that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability or incapacity, were congenital abnormalities/birth defects, or important medical events which may have required medical intervention to prevent one of the above outcomes.\n\nThe investigator assessed the severity of AEs as mild, moderate, or severe, and the relationship of each AE to treatment based on timing and other known factors such as clinical state, environment, or other therapies.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Relapsing Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '26879276', 'type': 'RESULT', 'citation': 'Cohen JA, Arnold DL, Comi G, Bar-Or A, Gujrathi S, Hartung JP, Cravets M, Olson A, Frohna PA, Selmaj KW; RADIANCE Study Group. Safety and efficacy of the selective sphingosine 1-phosphate receptor modulator ozanimod in relapsing multiple sclerosis (RADIANCE): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2016 Apr;15(4):373-81. doi: 10.1016/S1474-4422(16)00018-1. Epub 2016 Feb 12.'}, {'pmid': '30043658', 'type': 'RESULT', 'citation': 'Cohen JA, Comi G, Arnold DL, Bar-Or A, Selmaj KW, Steinman L, Havrdova EK, Cree BA, Montalban X, Hartung HP, Huang V, Frohna P, Skolnick BE, Kappos L; RADIANCE Trial Investigators. Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized phase II study. Mult Scler. 2019 Aug;25(9):1255-1262. doi: 10.1177/1352458518789884. Epub 2018 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'This study is a two-part trial consisting of Part A (presented in this record) and Part B (see NCT02047734).\n\nThe primary objective in Part A of this study was to demonstrate the superior efficacy of ozanimod compared to placebo by showing a reduction in the cumulative number of total gadolinium-enhancing (GdE) lesions from Week 12 to Week 24 in patients with relapsing multiple sclerosis (RMS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria\n* Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at Baseline\n\nExclusion Criteria:\n\n* Secondary or primary progressive multiple sclerosis'}, 'identificationModule': {'nctId': 'NCT01628393', 'acronym': 'RADIANCE', 'briefTitle': 'Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 2/3, Multi-center, Randomized, Double-blind, Placebo-controlled (Part A) and Double-blind, Double-dummy, Active-controlled (Part B), Parallel Group Study to Evaluate the Efficacy and Safety of RPC1063 Administered Orally to Relapsing Multiple Sclerosis Patients', 'orgStudyIdInfo': {'id': 'RPC01-201-PartA'}, 'secondaryIdInfos': [{'id': '2012-002714-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and continue to receive ozanimod 0.5 mg weekly for another 96 weeks.', 'interventionNames': ['Drug: Ozanimod']}, {'type': 'EXPERIMENTAL', 'label': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and continue to receive ozanimod 1 mg weekly for another 96 weeks.', 'interventionNames': ['Drug: Ozanimod']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo to ozanimod oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and were randomized to receive ozanimod 0.5 mg or 1 mg weekly for 96 weeks.', 'interventionNames': ['Drug: Ozanimod', 'Drug: Placebo']}], 'interventions': [{'name': 'Ozanimod', 'type': 'DRUG', 'otherNames': ['RPC1063', 'Zeposia®'], 'description': 'Oral capsule taken once a day', 'armGroupLabels': ['Ozanimod 0.5 mg', 'Ozanimod 1 mg', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral capsule taken once a day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Medical Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Neuro Pain Medical Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Neurological Institute PA', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44320', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neurology and Neuroscience Associates Inc.', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'The Polyclinic', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires St-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '4420', 'city': 'Montegnée', 'country': 'Belgium', 'facility': 'Centre Hospitalier Chretien Clinique Saint Joseph', 'geoPoint': {'lat': 50.64576, 'lon': 5.51411}}, {'zip': '1340', 'city': 'Ottignies', 'country': 'Belgium', 'facility': 'Clinique Saint-Pierre', 'geoPoint': {'lat': 50.66535, 'lon': 4.56679}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '0112', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Sarajishvili Institute of Neurology', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0160', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'LTD MediClubGeorgia', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '0179', 'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'Khechinashvili University Hospital', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'zip': '10676', 'city': 'Athens', 'country': 'Greece', 'facility': 'Evaggelismos General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11525', 'city': 'Athens', 'country': 'Greece', 'facility': '401 Military Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '57010', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Georgios Papanikolaou General Hospital of Thessaloniki', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '2500', 'city': 'Esztergom', 'country': 'Hungary', 'facility': 'Vaszary Kolos Korhaz', 'geoPoint': {'lat': 47.7928, 'lon': 18.74148}}, {'zip': '95123', 'city': 'Cantania', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele'}, {'zip': '41-250', 'city': 'Czeladź', 'country': 'Poland', 'facility': 'Powiatowy Zespol Zakladow Opieki Zdrowotnej Szpital w Czeladzi', 'geoPoint': {'lat': 50.31542, 'lon': 19.07824}}, {'zip': '86-300', 'city': 'Grudziądz', 'country': 'Poland', 'facility': 'Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego', 'geoPoint': {'lat': 53.48411, 'lon': 18.75366}}, {'zip': '40-650', 'city': 'Katowice', 'country': 'Poland', 'facility': 'Novo-Med Zielinski i wsp. 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