Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-02 @ 3:42 PM
Study NCT ID:
NCT02047734
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2014-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607776', 'term': 'ozanimod'}, {'id': 'D000068556', 'term': 'Interferon beta-1a'}], 'ancestors': [{'id': 'D016899', 'term': 'Interferon-beta'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please email:', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': 'Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than one (1) year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene sixty (60) days prior to submission. Investigator must delete confidential information before submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose of study drug to 28 days following the last dose of study drug; median duration of treatment was 24 months in each treatment group.', 'description': 'The Safety Population included all participants who received at least 1 dose of study drug, analyzed according to the highest dose of ozanimod treatment actually received, not according to the treatment they were randomized to receive, if different.', 'eventGroups': [{'id': 'EG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received IFN β-1a 30 µg intramuscular injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.', 'otherNumAtRisk': 440, 'deathsNumAtRisk': 440, 'otherNumAffected': 275, 'seriousNumAtRisk': 440, 'deathsNumAffected': 0, 'seriousNumAffected': 28}, {'id': 'EG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.', 'otherNumAtRisk': 439, 'deathsNumAtRisk': 439, 'otherNumAffected': 185, 'seriousNumAtRisk': 439, 'deathsNumAffected': 1, 'seriousNumAffected': 31}, {'id': 'EG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.', 'otherNumAtRisk': 434, 'deathsNumAtRisk': 434, 'otherNumAffected': 199, 'seriousNumAtRisk': 434, 'deathsNumAffected': 0, 'seriousNumAffected': 28}], 'otherEvents': [{'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 215}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 68}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 26}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gamma-Glutamyltransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 44}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 30}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Keratoconus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal Wall Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Large Intestine Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Umbilical Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholecystitis Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperplastic Cholecystopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chronic Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyelonephritis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ankle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Carbon Monoxide Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Clavicle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Comminuted Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Craniocerebral Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intentional Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Jaw Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Joint Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ligament Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lower Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lumbar Vertebral Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Traumatic Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hepatic Enzyme Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intervertebral Disc Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Osteitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pseudarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chronic Lymphocytic Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Invasive Breast Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Keratoacanthoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Malignant Melanoma In Situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Medulloblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ovarian Fibroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acoustic Neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Autonomic Nervous System Imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Central Nervous System Lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebral Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cervical Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Generalised Tonic-Clonic Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Guillain-Barre Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lumbar Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Multiple Sclerosis Relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Speech Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Foetal Growth Restriction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Placental Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vanishing Twin Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Suicide Attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Calculus Urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chronic Kidney Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Renal Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urethral Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Breast Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cervical Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dysfunctional Uterine Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ovarian Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Uterine Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 440, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 434, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adjusted Annualized Relapse Rate (ARR) at the End of Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}, {'value': '433', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received IFN β-1a 30 µg intramuscular injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.276', 'groupId': 'OG000', 'lowerLimit': '0.234', 'upperLimit': '0.324'}, {'value': '0.218', 'groupId': 'OG001', 'lowerLimit': '0.183', 'upperLimit': '0.259'}, {'value': '0.172', 'groupId': 'OG002', 'lowerLimit': '0.142', 'upperLimit': '0.208'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.623', 'ciLowerLimit': '0.506', 'ciUpperLimit': '0.768', 'pValueComment': 'To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.', 'estimateComment': 'Rate Ratio = Ozanimod / IFN β-1a', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, age, and Baseline number of GdE lesions, and Included the natural log transformation of time on study as an offset term.'}, {'pValue': '0.0167', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.791', 'ciLowerLimit': '0.652', 'ciUpperLimit': '0.958', 'pValueComment': 'To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.', 'estimateComment': 'Rate Ratio = Ozanimod / IFN β-1a', 'statisticalMethod': 'Poisson Regression Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, age, and Baseline number of GdE lesions, and Included the natural log transformation of time on study as an offset term.'}], 'paramType': 'NUMBER', 'timeFrame': 'At the end of month 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 \\* 365.25.\n\nARR was based on a Poisson regression model, adjusted for region (Eastern Europe vs Rest of the World), age, and the Baseline number of gadolinium-enhancing lesions, and included the natural log transformation of time on study as an offset term.', 'unitOfMeasure': 'relapses/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included 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.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '327', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received IFN β-1a 30 µg intramuscular injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.183', 'groupId': 'OG000', 'lowerLimit': '2.640', 'upperLimit': '3.838'}, {'value': '2.092', 'groupId': 'OG001', 'lowerLimit': '1.741', 'upperLimit': '2.514'}, {'value': '1.835', 'groupId': 'OG002', 'lowerLimit': '1.523', 'upperLimit': '2.211'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.576', 'ciLowerLimit': '0.465', 'ciUpperLimit': '0.714', 'pValueComment': 'To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.', 'estimateComment': 'Rate Ratio = Ozanimod / IFN β-1a', 'statisticalMethod': 'Negative Binomial Regression Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, age, and Baseline GdE lesions, and included the natural log transformation of available number of MRI scans as an offset term.'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.657', 'ciLowerLimit': '0.531', 'ciUpperLimit': '0.813', 'pValueComment': 'To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.', 'estimateComment': 'Rate Ratio = Ozanimod / IFN β-1a', 'statisticalMethod': 'Negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, age, and Baseline GdE lesions and included the natural log transformation of available number of MRI scans as an offset term.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 month treatment period; MRI scans were performed at Months 12 and 24', 'description': 'The adjusted mean number of new or enlarging hyperintense T2-weighted brain MRI lesions per scan was based on the cumulative number of new or enlarging T2 lesions since Baseline over 24 months. MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.\n\nThe adjusted mean per scan over 24 months was based based on a negative binomial regression model using observed data, adjusted for region (Eastern Europe vs. Rest of the World), age at Baseline, and Baseline number of GdE lesions. The natural log transformation of the number of available MRI scans over 24 months is used as an offset term.', 'unitOfMeasure': 'lesions/scan', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants who received at least 1 dose of study drug. Includes participants with non-missing MRI results.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}, {'value': '327', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received IFN β-1a 30 µg intramuscular injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.373', 'groupId': 'OG000', 'lowerLimit': '0.256', 'upperLimit': '0.543'}, {'value': '0.197', 'groupId': 'OG001', 'lowerLimit': '0.131', 'upperLimit': '0.296'}, {'value': '0.176', 'groupId': 'OG002', 'lowerLimit': '0.116', 'upperLimit': '0.266'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.471', 'ciLowerLimit': '0.306', 'ciUpperLimit': '0.725', 'pValueComment': 'To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.', 'estimateComment': 'Rate ratio = Ozanimod / IFN β-1a', 'statisticalMethod': 'Negative Binomial Regression Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, age, and Baseline GdE lesions with the natural log transformation of available MRI scans at Month 24 as an offset term.'}, {'pValue': '0.0030', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.528', 'ciLowerLimit': '0.346', 'ciUpperLimit': '0.805', 'pValueComment': 'To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.', 'estimateComment': 'Rate ratio = Ozanimod / IFN β-1a', 'statisticalMethod': 'Negative binomial regression model,', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, age, and Baseline GdE lesions with the natural log transformation of available MRI scans at Month 24 as an offset term.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 24', 'description': 'MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.\n\nThe number of gadolinium-enhancing (GdE) lesions at 24 months was analyzed based on observed data using a negative binomial regression model adjusted for region (Eastern Europe vs Rest of World), Baseline age, and Baseline number of GdE lesions, with natural log transformation of number of available MRI scans over 24 months as an offset term (1 scan for per participant).', 'unitOfMeasure': 'lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants who received at least 1 dose of study medication. Includes participants with non-missing GdE MRI results at Month 24.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Disability Progression Confirmed After 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}, {'value': '433', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received IFN β-1a 30 µg intramuscular injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable as there were insufficient disability events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable as there were insufficient disability events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable as there were insufficient disability events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.8224', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.045', 'ciLowerLimit': '0.711', 'ciUpperLimit': '1.537', 'pValueComment': 'To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.', 'estimateComment': 'Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region (Eastern Europe vs Rest of World) age at Baseline, and Baseline EDSS score'}, {'pValue': '0.2849', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.798', 'ciLowerLimit': '0.528', 'ciUpperLimit': '1.206', 'pValueComment': 'To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.', 'estimateComment': 'Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score'}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the end of the 24-month treatment period', 'description': 'EDSS is used to quantify disability and disability progression over time in MS. Based on a neurological examination, 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \\& bladder, cerebral, and other functions) are scored from 0 (no disability) to 5 or 6 (more severe disability). Ambulation is assessed based on distance the patient is able to walk, whether assistance is required or restrictions are present.\n\nThe EDSS score ranges from 0 (normal) to 10 (death due to MS) in 0.5 unit increments.\n\nDisability progression is defined by a sustained worsening in EDSS score of 1.0 point or more confirmed after 3 months. Time to onset of disability progression was calculated from the date of first dose to the date of the first visit at which the 1.0 point increase in EDSS was met using Kaplan-Meier methods. Participants without a sustained disease progression event were censored on the date of their last assessment or last dose of study drug, whichever was later.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Disability Progression Confirmed After 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}, {'value': '433', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received IFN β-1a 30 µg intramuscular injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable as there were insufficient disability events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable as there were insufficient disability events', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable as there were insufficient disability events', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.1353', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.435', 'ciLowerLimit': '0.893', 'ciUpperLimit': '2.305', 'pValueComment': 'To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.', 'estimateComment': 'Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.', 'statisticalMethod': 'Cox proportional hazard model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score'}, {'pValue': '0.7154', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.098', 'ciLowerLimit': '0.664', 'ciUpperLimit': '1.815', 'pValueComment': 'To control for type 1 error, the key secondary endpoints were tested in order in a sequential, closed hierarchical testing procedure. Each comparison was tested at the alpha = 0.05 level.', 'estimateComment': 'Hazard ratio (Ozanimod / IFN β-1a) based on Cox proportional hazard model with factors for treatment group, adjusted for region, age at Baseline, and Baseline EDSS score.', 'statisticalMethod': 'Cox proportional hazard model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region (Eastern Europe vs Rest of World), age at Baseline, and Baseline EDSS score'}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the end of the 24-month treatment period', 'description': 'EDSS is used to quantify disability and disability progression over time in MS. Based on a neurological examination, 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \\& bladder, cerebral, and other functions) are scored from 0 (no disability) to 5 or 6 (more severe disability). Ambulation is assessed based on distance the patient is able to walk, whether assistance is required or restrictions are present.\n\nThe EDSS score ranges from 0 (normal) to 10 (death due to MS) in 0.5 unit increments.\n\nDisability progression is defined by a sustained worsening in EDSS score of 1.0 point or more confirmed after 3 months. Time to onset of disability progression was calculated from the date of first dose to the date of the first visit at which the 1.0 point increase in EDSS was met using Kaplan-Meier methods. Participants without a sustained disease progression event were censored on the date of their last assessment or last dose of study drug, whichever was later.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were Gadolinium Enhancing (GdE) Lesion-Free at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}, {'value': '433', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received IFN β-1a 30 µg intramuscular injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.2', 'groupId': 'OG000', 'lowerLimit': '51.6', 'upperLimit': '60.9'}, {'value': '63.3', 'groupId': 'OG001', 'lowerLimit': '58.8', 'upperLimit': '67.8'}, {'value': '65.6', 'groupId': 'OG002', 'lowerLimit': '61.1', 'upperLimit': '70.1'}]}]}], 'analyses': [{'pValue': '0.0047', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.4', 'ciLowerLimit': '2.9', 'ciUpperLimit': '15.8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by region (Eastern Europe vs Rest of the World) and Baseline EDSS category'}, {'pValue': '0.0320', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.1', 'ciLowerLimit': '0.6', 'ciUpperLimit': '13.6', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by region (Eastern Europe vs Rest of the World) and Baseline EDSS category'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 24', 'description': 'Participants were considered lesion free at Month 24 if they did not show evidence of GdE lesions at the Month 24 MRI scan.\n\nMRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all randomized participants who received at least 1 dose of study drug; participants with missing data at Month 24 were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were New or Enlarging T2 Lesion-Free at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}, {'value': '433', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received IFN β-1a 30 µg intramuscular injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000', 'lowerLimit': '14.8', 'upperLimit': '22.0'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '27.4'}, {'value': '23.8', 'groupId': 'OG002', 'lowerLimit': '19.8', 'upperLimit': '27.8'}]}]}], 'analyses': [{'pValue': '0.0466', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.4', 'ciLowerLimit': '0.0', 'ciUpperLimit': '10.8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the Cochran-Mantel-Haenszel test stratified by region (Eastern Europe vs. rest of the world) and Baseline EDSS category'}, {'pValue': '0.0581', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '10.5', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the Cochran-Mantel-Haenszel test stratified by region (Eastern Europe vs. rest of the world) and Baseline EDSS category'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 24', 'description': 'MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants who received at least 1 dose of study medication; Participants with missing data at Month 24 were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Normalized Brain Volume to Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}, {'value': '390', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received IFN β-1a 30 µg intramuscular injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.937', 'spread': '0.944', 'groupId': 'OG000'}, {'value': '-0.707', 'spread': '0.746', 'groupId': 'OG001'}, {'value': '-0.707', 'spread': '0.878', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.244', 'ciLowerLimit': '0.125', 'ciUpperLimit': '0.363', 'pValueComment': 'Based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline', 'estimateComment': 'Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.224', 'ciLowerLimit': '0.106', 'ciUpperLimit': '0.342', 'pValueComment': 'Based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.', 'estimateComment': 'Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs. rest of the world), Baseline EDSS category, and brain volume at Baseline.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 24', 'description': 'Brain volume (a measure of brain atrophy) was measured by brain MRI scans that were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; last observation carried forward was used for participants with missing data at Month 24 (only post-baseline MRI scans were carried forward)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 24 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '437', 'groupId': 'OG000'}, {'value': '435', 'groupId': 'OG001'}, {'value': '428', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received IFN β-1a 30 µg intramuscular injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.052', 'spread': '0.601', 'groupId': 'OG000'}, {'value': '0.036', 'spread': '0.440', 'groupId': 'OG001'}, {'value': '-0.010', 'spread': '0.622', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2480', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.043', 'ciLowerLimit': '-0.030', 'ciUpperLimit': '0.116', 'estimateComment': 'Difference in means are based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and the Baseline MSFC Z-score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline MSFC Z-score'}, {'pValue': '0.0123', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.093', 'ciLowerLimit': '0.020', 'ciUpperLimit': '0.165', 'estimateComment': 'Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and the Baseline MSFC Z-score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline MSFC Z-score'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 24', 'description': "The MSFC-LCLA is a battery including the following 4 individual scales:\n\n* Timed 25-Foot Walk is an ambulation measure of walking 25 feet with time taken recorded in seconds\n* 9-Hole Peg Test (9HPT) is a quantitative measure of upper extremity (arm and hand) function\n* Symbol Digit Modalities Test (SDMT) is a measure of executive cognitive function that assesses processing speed, flexibility, and calculation ability\n* Low-Contrast Letter Acuity Test (LCLA) used a standardized set of charts to assess low contrast visual acuity, charts are scored according to the number of letters that are identified correctly\n\nZ-scores were calculated for for each component and averaged to create an overall composite score, using the study population as the reference population. A Z-score represents the number of standard deviations a patient's test result is higher (Z \\> 0) or lower (Z \\< 0) than the average test result (Z = 0) of the reference population. A positive change indicates improvement.", 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population with available MSFC Z-scores'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}, {'value': '433', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received IFN β-1a 30 µg intramuscular injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.'}], 'classes': [{'title': 'Physical Health Composite Summary', 'categories': [{'measurements': [{'value': '-1.526', 'spread': '12.319', 'groupId': 'OG000'}, {'value': '0.609', 'spread': '12.315', 'groupId': 'OG001'}, {'value': '0.209', 'spread': '12.321', 'groupId': 'OG002'}]}]}, {'title': 'Mental Health Composite Summary', 'categories': [{'measurements': [{'value': '-1.831', 'spread': '16.422', 'groupId': 'OG000'}, {'value': '-1.182', 'spread': '14.379', 'groupId': 'OG001'}, {'value': '-1.517', 'spread': '15.544', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0988', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.345', 'ciLowerLimit': '-0.252', 'ciUpperLimit': '2.943', 'estimateComment': 'Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.', 'groupDescription': 'Analysis of Physical Health Composite Summary Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score'}, {'pValue': '0.0228', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.849', 'ciLowerLimit': '0.258', 'ciUpperLimit': '3.440', 'estimateComment': 'Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.', 'groupDescription': 'Analysis of Physical Health Composite Summary Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score.'}, {'pValue': '0.6997', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.380', 'ciLowerLimit': '-1.553', 'ciUpperLimit': '2.313', 'estimateComment': 'Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.', 'groupDescription': 'Analysis of Mental Health Composite Summary Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and Baseline summary score'}, {'pValue': '0.5501', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.587', 'ciLowerLimit': '-1.339', 'ciUpperLimit': '2.513', 'estimateComment': 'Difference in means based on the analysis of covariance model, adjusted for region (Eastern Europe vs Rest of the World), Baseline EDSS category, and Baseline summary score.', 'groupDescription': 'Analysis of Mental Health Composite Summary Score', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the analysis of covariance model, adjusted for region, Baseline EDSS category, and the Baseline summary score'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 24', 'description': 'The MSQOL-54 is a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument. The instrument includes 12 subscales, two summary scores, and two single-item measures.\n\nThe two summary scores - physical health and mental health - are derived from a weighted combination of scale scores.\n\nThe physical health composite score includes Physical function, Health perceptions, Energy/fatigue, Role limitations - physical, Pain, Sexual function, Social function, and Health distress.\n\nThe mental health composite score includes Health distress, Overall quality of life, Emotional well-being, Role limitations - emotional, and Cognitive function.\n\nEach composite summary score has a range from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants who received at least 1 dose of study medication. Missing data were imputed using a mixed-effects regression model.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '440', 'groupId': 'OG000'}, {'value': '439', 'groupId': 'OG001'}, {'value': '434', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received IFN β-1a 30 µg intramuscular injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '365', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}]}]}, {'title': 'Any Moderate or Severe TEAE', 'categories': [{'measurements': [{'value': '235', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}]}]}, {'title': 'Any Severe TEAE', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Any Related TEAE', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Any Serious TEAE', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Any Related Serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE Leading to discontinuation of Study Drug', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE Leading to Study Withdrawal', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Any Death on Study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study drug up to the first dose of the open-label extension study RPC01-3001, or up to 28 days after last dose for participants who did not continue into the open-label extension study; median duration of treatment was 24 months.', '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 included all participants who received at least 1 dose of study drug, analyzed according to the highest dose of ozanimod treatment actually received, not according to the treatment they were randomized to receive, if different.'}, {'type': 'POST_HOC', 'title': 'Percent Change From Baseline in Normalized Brain Volume to Month 24 Based on Rank ANCOVA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received IFN β-1a 30 µg intramuscular injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.940', 'groupId': 'OG000', 'lowerLimit': '-5.33', 'upperLimit': '1.44'}, {'value': '-0.710', 'groupId': 'OG001', 'lowerLimit': '-5.21', 'upperLimit': '1.36'}, {'value': '-0.690', 'groupId': 'OG002', 'lowerLimit': '-5.65', 'upperLimit': '0.85'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Rank ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region and Baseline EDSS category, with the dependent variable as the residual of the rank of brain volume at Baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Rank ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region and Baseline EDSS category, with the dependent variable as the residual of the rank of brain volume at Baseline'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Month 24', 'description': 'Brain volume (a measure of brain atrophy) was measured by brain MRI scans that were read at a centralized MRI reading facility by a blinded reader.\n\nDue to the non-normal distribution of the data for brain volume loss, the analyses for percent change from Baseline in normalized brain volume was repeated using rank-analysis of covariance (ANCOVA) and observed values.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population; participants with available data at Baseline and Month 24'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interferon Beta-1a (IFN β-1a)', 'description': 'Participants received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.'}, {'id': 'FG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.'}, {'id': 'FG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '443'}, {'groupId': 'FG001', 'numSubjects': '443'}, {'groupId': 'FG002', 'numSubjects': '434'}]}, {'type': 'Received Treatment', 'achievements': [{'comment': 'One participant received ozanimod 0.5 mg in error', 'groupId': 'FG000', 'numSubjects': '441'}, {'comment': 'One participant received ozanimod 1.0 mg in error', 'groupId': 'FG001', 'numSubjects': '439'}, {'groupId': 'FG002', 'numSubjects': '433'}]}, {'type': 'COMPLETED', 'comment': 'Completed study drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '376'}, {'groupId': 'FG001', 'numSubjects': '374'}, {'groupId': 'FG002', 'numSubjects': '388'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '46'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Did Not Receive Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 147 academic medical centers and clinical practices in 21 countries in North America, Europe, and South Africa. Between December 2013 and March 2015, 1695 participants were screened, of which 375 did not meet inclusion criteria. One thousand, three hundred and twenty participants with relapsing multiple sclerosis (MS) were enrolled and randomly assigned to a treatment group.', 'preAssignmentDetails': 'Participants were randomized in a 1:1:1 ratio to one of three treatment groups. Randomization was stratified by Baseline Expanded Disability Status Scale (EDSS) score (≤ 3.5, \\> 3.5) and by country.\n\nParticipants who completed the 24-month study were eligible to enroll in a long-term, open-label extension study (RPC01-3001; NCT02576717).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}, {'value': '1313', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Interferon Beta-1a (IFN β-1a)', 'description': 'Participants received IFN β-1a 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.'}, {'id': 'BG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to Interferon) weekly for 24 months.'}, {'id': 'BG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg oral capsules daily and an intramuscular placebo injection (identical in appearance to interferon) weekly for 24 months.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}, {'value': '1313', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '35.1', 'spread': '9.07', 'groupId': 'BG000'}, {'value': '35.4', 'spread': '8.82', 'groupId': 'BG001'}, {'value': '36.0', 'spread': '8.89', 'groupId': 'BG002'}, {'value': '35.5', 'spread': '8.93', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}, {'value': '1313', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '304', 'groupId': 'BG000'}, {'value': '287', 'groupId': 'BG001'}, {'value': '291', 'groupId': 'BG002'}, {'value': '882', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '431', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}, {'value': '1313', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '436', 'groupId': 'BG000'}, {'value': '433', 'groupId': 'BG001'}, {'value': '423', 'groupId': 'BG002'}, {'value': '1292', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}, {'value': '1313', 'groupId': 'BG003'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '432', 'groupId': 'BG000'}, {'value': '431', 'groupId': 'BG001'}, {'value': '428', 'groupId': 'BG002'}, {'value': '1291', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}, {'value': '1313', 'groupId': 'BG003'}]}], 'categories': [{'title': 'North America', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}, {'title': 'Western Europe', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}, {'title': 'Eastern Europe', 'measurements': [{'value': '379', 'groupId': 'BG000'}, {'value': '378', 'groupId': 'BG001'}, {'value': '374', 'groupId': 'BG002'}, {'value': '1131', 'groupId': 'BG003'}]}, {'title': 'Southern Africa', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Country of Enrollment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}, {'value': '1313', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Belarus', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}]}, {'title': 'Belgium', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Bosnia And Herzegovina', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Bulgaria', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}, {'title': 'Canada', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Croatia', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'Georgia', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Greece', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Hungary', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Italy', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Poland', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}, {'value': '373', 'groupId': 'BG003'}]}, {'title': 'Republic of Moldova', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Romania', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Russian Federation', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}, {'title': 'Serbia', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}, {'title': 'Slovakia', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'South Africa', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': 'Spain', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}, {'title': 'Ukraine', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '233', 'groupId': 'BG003'}]}, {'title': 'United Kingdom', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'United States', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of Multiple Sclerosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}, {'value': '1313', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Relapsing-remitting multiple sclerosis', 'measurements': [{'value': '432', 'groupId': 'BG000'}, {'value': '432', 'groupId': 'BG001'}, {'value': '425', 'groupId': 'BG002'}, {'value': '1289', 'groupId': 'BG003'}]}, {'title': 'Progressive-relapsing multiple sclerosis', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Secondary progressive multiple sclerosis', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age at MS Symptom Onset', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}, {'value': '1313', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '28.9', 'spread': '8.60', 'groupId': 'BG000'}, {'value': '29.3', 'spread': '8.41', 'groupId': 'BG001'}, {'value': '29.2', 'spread': '8.67', 'groupId': 'BG002'}, {'value': '29.1', 'spread': '8.56', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age at MS Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}, {'value': '1313', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '31.6', 'spread': '8.82', 'groupId': 'BG000'}, {'value': '32.0', 'spread': '8.59', 'groupId': 'BG001'}, {'value': '32.1', 'spread': '8.95', 'groupId': 'BG002'}, {'value': '31.9', 'spread': '8.78', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time Since MS Symptom Onset', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}, {'value': '1313', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6.36', 'spread': '6.065', 'groupId': 'BG000'}, {'value': '6.23', 'spread': '5.547', 'groupId': 'BG001'}, {'value': '6.92', 'spread': '6.201', 'groupId': 'BG002'}, {'value': '6.50', 'spread': '5.947', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Expanded Disability Status Scale (EDSS) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}, {'value': '1313', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.49', 'spread': '1.158', 'groupId': 'BG000'}, {'value': '2.48', 'spread': '1.166', 'groupId': 'BG001'}, {'value': '2.55', 'spread': '1.145', 'groupId': 'BG002'}, {'value': '2.51', 'spread': '1.156', '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': 'EDSS Category', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '441', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}, {'value': '1313', 'groupId': 'BG003'}]}], 'categories': [{'title': 'EDSS ≤ 3.5', 'measurements': [{'value': '375', 'groupId': 'BG000'}, {'value': '374', 'groupId': 'BG001'}, {'value': '371', 'groupId': 'BG002'}, {'value': '1120', 'groupId': 'BG003'}]}, {'title': 'EDSS > 3.5', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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 of 0 (no disability) to 5 or 6 (more severe disability). Ambulation is also scored. Based on scores in these 8 functional systems and 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': 'Participants'}, {'title': 'Number of Gadolinium-enhancing (GdE) Lesions', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '440', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '433', 'groupId': 'BG002'}, {'value': '1312', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '3.54', 'groupId': 'BG000'}, {'value': '1.8', 'spread': '3.62', 'groupId': 'BG001'}, {'value': '1.6', 'spread': '3.78', 'groupId': 'BG002'}, {'value': '1.7', 'spread': '3.65', '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': 'Participants with available MRI data'}, {'title': 'Number of T2 Lesions', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '440', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}, {'value': '1311', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '48.7', 'spread': '32.62', 'groupId': 'BG000'}, {'value': '48.7', 'spread': '36.27', 'groupId': 'BG001'}, {'value': '47.9', 'spread': '32.37', 'groupId': 'BG002'}, {'value': '48.4', 'spread': '33.78', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'A T2-weighted MRI scan shows the number of old and new lesions in a specific part of the brain or spinal cord.', 'unitOfMeasure': 'lesions', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available MRI data'}, {'title': 'Normalized Brain Volume', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '439', 'groupId': 'BG000'}, {'value': '437', 'groupId': 'BG001'}, {'value': '432', 'groupId': 'BG002'}, {'value': '1308', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1449.581', 'spread': '77.156', 'groupId': 'BG000'}, {'value': '1452.852', 'spread': '71.978', 'groupId': 'BG001'}, {'value': '1441.949', 'spread': '79.228', 'groupId': 'BG002'}, {'value': '1448.153', 'spread': '76.250', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Measured using MRI', 'unitOfMeasure': 'cm³', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}], 'populationDescription': 'Intent-to-treat (ITT) population included 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': '2014-10-04', 'size': 4842962, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-15T23:27', 'hasProtocol': True}, {'date': '2015-06-05', 'size': 2362766, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-12-16T00:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'dispFirstSubmitDate': '2018-04-04', 'completionDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2014-01-26', 'dispFirstSubmitQcDate': '2018-04-04', 'resultsFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2014-01-26', 'dispFirstPostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-25', 'studyFirstPostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjusted Annualized Relapse Rate (ARR) at the End of Month 24', 'timeFrame': 'At the end of month 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 \\* 365.25.\n\nARR was based on a Poisson regression model, adjusted for region (Eastern Europe vs Rest of the World), age, and the Baseline number of gadolinium-enhancing lesions, and included the natural log transformation of time on study as an offset term.'}], 'secondaryOutcomes': [{'measure': 'Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 24 Months', 'timeFrame': '24 month treatment period; MRI scans were performed at Months 12 and 24', 'description': 'The adjusted mean number of new or enlarging hyperintense T2-weighted brain MRI lesions per scan was based on the cumulative number of new or enlarging T2 lesions since Baseline over 24 months. MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.\n\nThe adjusted mean per scan over 24 months was based based on a negative binomial regression model using observed data, adjusted for region (Eastern Europe vs. Rest of the World), age at Baseline, and Baseline number of GdE lesions. The natural log transformation of the number of available MRI scans over 24 months is used as an offset term.'}, {'measure': 'Adjusted Mean Number of Gadolinium Enhancing Brain Lesions at Month 24', 'timeFrame': 'Month 24', 'description': 'MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.\n\nThe number of gadolinium-enhancing (GdE) lesions at 24 months was analyzed based on observed data using a negative binomial regression model adjusted for region (Eastern Europe vs Rest of World), Baseline age, and Baseline number of GdE lesions, with natural log transformation of number of available MRI scans over 24 months as an offset term (1 scan for per participant).'}, {'measure': 'Time to Onset of Disability Progression Confirmed After 3 Months', 'timeFrame': 'From first dose to the end of the 24-month treatment period', 'description': 'EDSS is used to quantify disability and disability progression over time in MS. Based on a neurological examination, 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \\& bladder, cerebral, and other functions) are scored from 0 (no disability) to 5 or 6 (more severe disability). Ambulation is assessed based on distance the patient is able to walk, whether assistance is required or restrictions are present.\n\nThe EDSS score ranges from 0 (normal) to 10 (death due to MS) in 0.5 unit increments.\n\nDisability progression is defined by a sustained worsening in EDSS score of 1.0 point or more confirmed after 3 months. Time to onset of disability progression was calculated from the date of first dose to the date of the first visit at which the 1.0 point increase in EDSS was met using Kaplan-Meier methods. Participants without a sustained disease progression event were censored on the date of their last assessment or last dose of study drug, whichever was later.'}, {'measure': 'Time to Onset of Disability Progression Confirmed After 6 Months', 'timeFrame': 'From first dose to the end of the 24-month treatment period', 'description': 'EDSS is used to quantify disability and disability progression over time in MS. Based on a neurological examination, 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \\& bladder, cerebral, and other functions) are scored from 0 (no disability) to 5 or 6 (more severe disability). Ambulation is assessed based on distance the patient is able to walk, whether assistance is required or restrictions are present.\n\nThe EDSS score ranges from 0 (normal) to 10 (death due to MS) in 0.5 unit increments.\n\nDisability progression is defined by a sustained worsening in EDSS score of 1.0 point or more confirmed after 3 months. Time to onset of disability progression was calculated from the date of first dose to the date of the first visit at which the 1.0 point increase in EDSS was met using Kaplan-Meier methods. Participants without a sustained disease progression event were censored on the date of their last assessment or last dose of study drug, whichever was later.'}, {'measure': 'Percentage of Participants Who Were Gadolinium Enhancing (GdE) Lesion-Free at Month 24', 'timeFrame': 'Month 24', 'description': 'Participants were considered lesion free at Month 24 if they did not show evidence of GdE lesions at the Month 24 MRI scan.\n\nMRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.'}, {'measure': 'Percentage of Participants Who Were New or Enlarging T2 Lesion-Free at Month 24', 'timeFrame': 'Month 24', 'description': 'MRI images were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.'}, {'measure': 'Percent Change From Baseline in Normalized Brain Volume to Month 24', 'timeFrame': 'Baseline and Month 24', 'description': 'Brain volume (a measure of brain atrophy) was measured by brain MRI scans that were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.'}, {'measure': 'Change From Baseline to Month 24 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test', 'timeFrame': 'Baseline to Month 24', 'description': "The MSFC-LCLA is a battery including the following 4 individual scales:\n\n* Timed 25-Foot Walk is an ambulation measure of walking 25 feet with time taken recorded in seconds\n* 9-Hole Peg Test (9HPT) is a quantitative measure of upper extremity (arm and hand) function\n* Symbol Digit Modalities Test (SDMT) is a measure of executive cognitive function that assesses processing speed, flexibility, and calculation ability\n* Low-Contrast Letter Acuity Test (LCLA) used a standardized set of charts to assess low contrast visual acuity, charts are scored according to the number of letters that are identified correctly\n\nZ-scores were calculated for for each component and averaged to create an overall composite score, using the study population as the reference population. A Z-score represents the number of standard deviations a patient's test result is higher (Z \\> 0) or lower (Z \\< 0) than the average test result (Z = 0) of the reference population. A positive change indicates improvement."}, {'measure': 'Mean Change From Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Physical Health Composite Summary and Mental Health Composite Summary Scores', 'timeFrame': 'Baseline to Month 24', 'description': 'The MSQOL-54 is a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument. The instrument includes 12 subscales, two summary scores, and two single-item measures.\n\nThe two summary scores - physical health and mental health - are derived from a weighted combination of scale scores.\n\nThe physical health composite score includes Physical function, Health perceptions, Energy/fatigue, Role limitations - physical, Pain, Sexual function, Social function, and Health distress.\n\nThe mental health composite score includes Health distress, Overall quality of life, Emotional well-being, Role limitations - emotional, and Cognitive function.\n\nEach composite summary score has a range from 0 to 100 where higher scores indicate better quality of life. A positive change from Baseline indicates improvement.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events', 'timeFrame': 'From the first dose of study drug up to the first dose of the open-label extension study RPC01-3001, or up to 28 days after last dose for participants who did not continue into the open-label extension study; median duration of treatment was 24 months.', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Relapsing Multiple Sclerosis']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Cree B, et al. The RADIANCE and SUNBEAM phase 3 studies of ozanimod in relapsing multiple sclerosis: study design and baseline characteristics. Presented at the 69th Annual American Academy of Neurology Meeting, April 22-28, 2017, Boston, MA. Abstract No. P6-344'}, {'pmid': '31492652', 'type': 'RESULT', 'citation': 'Cohen JA, Comi G, Selmaj KW, Bar-Or A, Arnold DL, Steinman L, Hartung HP, Montalban X, Kubala Havrdova E, Cree BAC, Sheffield JK, Minton N, Raghupathi K, Huang V, Kappos L; RADIANCE Trial Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial. Lancet Neurol. 2019 Nov;18(11):1021-1033. doi: 10.1016/S1474-4422(19)30238-8. Epub 2019 Sep 3.'}, {'pmid': '40462564', 'type': 'DERIVED', 'citation': 'Harris S, Comi G, Cree BAC, Arnold DL, Steinman L, Sheffield JK, Maddux R, Southworth H, Kappos L, Cohen JA. Glial Fibrillary Acidic Protein as a Marker of Disease in Relapsing Multiple Sclerosis: Post Hoc Analysis of Phase 3 Ozanimod Trials. Eur J Neurol. 2025 Jun;32(6):e70222. doi: 10.1111/ene.70222.'}]}, 'descriptionModule': {'briefSummary': 'This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record.\n\nThe primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).', 'detailedDescription': 'This clinical trial (RPC01-201; RADIANCE) consisted of 2 parts, each reported separately on ClinicalTrials.gov: Part A (NCT01628393) and Part B (this record).\n\nPart A was a phase 2 study in which two doses of ozanimod were administered daily for 24 weeks with an efficacy and safety comparison to a placebo control and is reported separately as ClinicalTrials.gov record NCT01628393.\n\nPart B, reported herein, was a phase 3 study in which two doses of ozanimod were administered daily for a 24 month period compared to an active control, interferon β-1a. Participants were allowed to enroll in the open-label extension study RPC01-3001 (NCT02576717) or complete the study with a safety follow-up visit 28 days after their last dose of study treatment.'}, '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* Primary progressive multiple sclerosis'}, 'identificationModule': {'nctId': 'NCT02047734', 'acronym': 'RADIANCE', 'briefTitle': 'Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis', '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-PartB'}, 'secondaryIdInfos': [{'id': '2012-002714-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ozanimod 0.5 mg', 'description': 'Ozanimod 0.5 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.', 'interventionNames': ['Drug: Ozanimod', 'Drug: Interferon beta-1a placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ozanimod1 mg', 'description': 'Ozanimod 1 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months.', 'interventionNames': ['Drug: Ozanimod', 'Drug: Interferon beta-1a placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interferon β-1a', 'description': 'interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months.', 'interventionNames': ['Drug: Ozanimod placebo', 'Drug: Interferon beta-1a']}], 'interventions': [{'name': 'Ozanimod', 'type': 'DRUG', 'otherNames': ['RPC1063', 'Zeposia®'], 'description': 'Oral capsule, daily for 24 months', 'armGroupLabels': ['Ozanimod 0.5 mg', 'Ozanimod1 mg']}, {'name': 'Ozanimod placebo', 'type': 'DRUG', 'description': 'Oral capsule, daily for 24 months', 'armGroupLabels': ['Interferon β-1a']}, {'name': 'Interferon beta-1a', 'type': 'DRUG', 'otherNames': ['Avonex'], 'description': 'Intramuscular injection, 30 µg, weekly for 24 months', 'armGroupLabels': ['Interferon β-1a']}, {'name': 'Interferon beta-1a placebo', 'type': 'DRUG', 'description': 'Intramuscular injection, weekly for 24 months', 'armGroupLabels': ['Ozanimod 0.5 mg', 'Ozanimod1 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United 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