Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-27 @ 11:17 AM
Study NCT ID:
NCT02294058
Status:
COMPLETED
Last Update Posted:
2020-11-25
First Post:
2014-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Austria', 'Colombia', 'Mexico', 'Peru']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, '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': 'AMcClain@celgene.com', 'phone': '888-260-1599', 'title': 'Anne McClain, Senior Manager', 'organization': 'Celgene Corporation'}, '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. Celgene may remove confidential and/or proprietary information before publication', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study drug until 28 days following the last dose of study drug; mean exposure to study drug was 13.5 months for interferon beta-1a and 13.6 months for each ozanimod group.', 'description': 'The Safety population included all participants who received at least 1 dose of randomized study drug. All participants in the Safety population were analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.', 'eventGroups': [{'id': 'EG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.', 'otherNumAtRisk': 445, 'otherNumAffected': 273, 'seriousNumAtRisk': 445, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.', 'otherNumAtRisk': 453, 'otherNumAffected': 88, 'seriousNumAtRisk': 453, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.', 'otherNumAtRisk': 448, 'otherNumAffected': 57, 'seriousNumAtRisk': 448, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 227}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sinus Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Supraventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Duodenal Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gallbladder Polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Appendiceal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lyme Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Postoperative Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyelonephritis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Subcutaneous Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Ankle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Eye Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Facial Bones Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Subdural Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fibrin D Dimer Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intervertebral Disc Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Benign Ovarian Tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fibroadenoma Of Breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, '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': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Testicular Seminoma (Pure) Stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Uterine Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cervical Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Multiple Sclerosis Relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vascular Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abortion Spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Renal Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Menometrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Postmenopausal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 445, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 453, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 448, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adjusted Annualized Relapse Rate (ARR) During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}, {'value': '447', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.350', 'groupId': 'OG000', 'lowerLimit': '0.279', 'upperLimit': '0.440'}, {'value': '0.241', 'groupId': 'OG001', 'lowerLimit': '0.188', 'upperLimit': '0.308'}, {'value': '0.181', 'groupId': 'OG002', 'lowerLimit': '0.140', 'upperLimit': '0.236'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.518', 'ciLowerLimit': '0.405', 'ciUpperLimit': '0.663', 'pValueComment': 'To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.', 'statisticalMethod': 'Poisson regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, Baseline age, number of gadolinium enhancing (GdE) lesions and included the natural log transformation of time as an offset term.'}, {'pValue': '0.0013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.688', 'ciLowerLimit': '0.547', 'ciUpperLimit': '0.864', 'pValueComment': 'To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.025 level.', 'statisticalMethod': 'Poisson Regression Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, Baseline age and the number of GdE lesions, and included the natural log transformation of time on study as an offset term.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 months', 'description': 'The relapse rate was based on confirmed relapses. 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 relapses divided by the total number of days in the study \\* 365.25.\n\nARR was adjusted for region (Eastern Europe vs rest of world), Baseline age, and Baseline number of gadolinium-enhancing lesions; the natural log transformation of time on study was included as an offset term.', 'unitOfMeasure': 'relapses/year', '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': 'Adjusted Mean Number of New or Enlarging Hyperintense T2-Weighted Brain Magnetic Resonance Imaging (MRI) Lesions Per Scan Over 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}, {'value': '388', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.836', 'groupId': 'OG000', 'lowerLimit': '2.331', 'upperLimit': '3.451'}, {'value': '2.139', 'groupId': 'OG001', 'lowerLimit': '1.777', 'upperLimit': '2.575'}, {'value': '1.465', 'groupId': 'OG002', 'lowerLimit': '1.203', 'upperLimit': '1.784'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.517', 'ciLowerLimit': '0.427', 'ciUpperLimit': '0.625', 'pValueComment': 'To account for multiple comparisons, each of the 2 treatment comparisons 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, Baseline age and GdE lesions; included the natural log transformation of available MRI scans over 12 months as an offset term.'}, {'pValue': '0.0032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.754', 'ciLowerLimit': '0.625', 'ciUpperLimit': '0.910', 'pValueComment': 'To account for multiple comparisons, each of the 2 treatment comparisons 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, Baseline age and GdE lesions; included the natural log transformation of available MRI scans over 12 months as an offset term.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '12 month treatment period; MRI scans were assessed at Month 6 and Month 12', 'description': 'The 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 treatment period.', 'unitOfMeasure': 'T2 lesions/scan', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; participants with non-missing MRI results.'}, {'type': 'SECONDARY', 'title': 'Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '382', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}, {'value': '388', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.433', 'groupId': 'OG000', 'lowerLimit': '0.295', 'upperLimit': '0.635'}, {'value': '0.287', 'groupId': 'OG001', 'lowerLimit': '0.197', 'upperLimit': '0.418'}, {'value': '0.160', 'groupId': 'OG002', 'lowerLimit': '0.106', 'upperLimit': '0.242'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.370', 'ciLowerLimit': '0.256', 'ciUpperLimit': '0.536', 'pValueComment': 'To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.', 'statisticalMethod': 'Negative Binomial Regression Model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans as an offset term.'}, {'pValue': '0.0182', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.662', 'ciLowerLimit': '0.471', 'ciUpperLimit': '0.932', 'pValueComment': 'To account for multiple comparisons, each of the 2 treatment comparisons was tested at the alpha = 0.05 level.', 'statisticalMethod': 'Negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, Baseline age and GdE lesions; included the natural log transformation of available MRI scans as an offset term.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 12', 'unitOfMeasure': 'lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population; participants with non-missing MRI results.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Disability Progression Confirmed After 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}, {'value': '447', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 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': '0.3055', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.690', 'ciLowerLimit': '0.340', 'ciUpperLimit': '1.402', 'estimateComment': 'Hazard Ratio (Ozanimod / IFN β-1a)', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age, and Baseline EDSS score'}, {'pValue': '0.7163', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.886', 'ciLowerLimit': '0.460', 'ciUpperLimit': '1.705', 'estimateComment': 'Hazard Ratio (Ozanimod / IFN β-1a)', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score'}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the end of the 12-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': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Disability Progression Confirmed After 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}, {'value': '447', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 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': '0.6725', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.238', 'ciLowerLimit': '0.460', 'ciUpperLimit': '3.337', 'estimateComment': 'Hazard Ratio (Ozanimod / IFN β-1a)', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score'}, {'pValue': '0.3755', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.535', 'ciLowerLimit': '0.595', 'ciUpperLimit': '3.963', 'estimateComment': 'Hazard Ratio (Ozanimod / IFN β-1a)', 'statisticalMethod': 'Cox proportional hazard model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the Cox proportional hazard model with factors for treatment group, adjusted for region, Baseline age and Baseline EDSS score'}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose to the end of the 12-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 6 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': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were Gadolinium Enhancing Lesion-Free at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}, {'value': '447', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.17', 'groupId': 'OG000', 'lowerLimit': '58.70', 'upperLimit': '67.64'}, {'value': '68.29', 'groupId': 'OG001', 'lowerLimit': '64.00', 'upperLimit': '72.59'}, {'value': '74.05', 'groupId': 'OG002', 'lowerLimit': '69.99', 'upperLimit': '78.11'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.88', 'ciLowerLimit': '4.84', 'ciUpperLimit': '16.92', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the CMH test stratified by region and EDSS category per Interactive Voice Response System (IVRS)'}, {'pValue': '0.1130', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.12', 'ciLowerLimit': '-1.07', 'ciUpperLimit': '11.32', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the CMH test stratified by region and EDSS category per IVRS.'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'MRI scans were analyzed by blinded centralized reading facility.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population; Participants who were missing the Month 12 MRI data were considered non-responders; ie, as not being lesion-free (non-responder imputation).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Were T2 Lesion-Free at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}, {'value': '447', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.44', 'groupId': 'OG000', 'lowerLimit': '19.51', 'upperLimit': '27.36'}, {'value': '26.39', 'groupId': 'OG001', 'lowerLimit': '22.32', 'upperLimit': '30.45'}, {'value': '27.96', 'groupId': 'OG002', 'lowerLimit': '23.80', 'upperLimit': '32.12'}]}]}], 'analyses': [{'pValue': '0.1180', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.53', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '10.24', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the CMH test stratified by region and EDSS Scale category per IVRS.'}, {'pValue': '0.3023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.95', 'ciLowerLimit': '-2.70', 'ciUpperLimit': '8.60', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Based on the CMH test stratified by region and EDSS Scale category per IVRS.'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'MRI scans were analyzed by blinded centralized reading facility.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population; participants who were missing the Month 12 MRI data were considered non-responders, ie, as not being lesion-free.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Normalized Brain Volume at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}, {'value': '338', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.57', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '1.1'}, {'value': '-0.50', 'groupId': 'OG001', 'lowerLimit': '-2.7', 'upperLimit': '1.4'}, {'value': '-0.39', 'groupId': 'OG002', 'lowerLimit': '-2.8', 'upperLimit': '2.1'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Due to the non-normal distribution of the data for brain volume loss, the analyses for percent change from baseline in normalized brain volume were compared using rank-ANCOVA, adjusted for region (Eastern Europe vs Rest of World), and EDSS category per IVRS, with the dependent variable as the residual of the rank of brain volume at Baseline regressed on rank of percent change.', 'statisticalMethod': 'Rank ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region and EDSS category per IVRS'}, {'pValue': '0.0615', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Due to the non-normal distribution of the data for brain volume loss, the analyses for percent change from baseline in normalized brain volume were compared using rank-ANCOVA, adjusted for region (Eastern Europe vs Rest of World), and EDSS category per IVRS, with the dependent variable as the residual of the rank of brain volume at Baseline regressed on rank of percent change.', 'statisticalMethod': 'Rank ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region and EDSS Scale per IVRS'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Month 12', 'description': 'Brain volume (a measure of brain atrophy) was analyzed by MRI.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population with available MRI data at Baseline and Month 12'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '447', 'groupId': 'OG000'}, {'value': '450', 'groupId': 'OG001'}, {'value': '447', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.022', 'spread': '0.334', 'groupId': 'OG000'}, {'value': '-0.007', 'spread': '0.351', 'groupId': 'OG001'}, {'value': '0.003', 'spread': '0.328', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1290', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.034', 'ciLowerLimit': '-0.010', 'ciUpperLimit': '0.077', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, EDSS category per IVRS and the Baseline MSFC score.'}, {'pValue': '0.4942', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.015', 'ciLowerLimit': '-0.028', 'ciUpperLimit': '0.059', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, EDSS category per IVRS and the Baseline MSFC score'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12', '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 Baseline and Month 12 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': '448', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}], 'classes': [{'title': 'Physical health composite summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '445', 'groupId': 'OG000'}, {'value': '448', 'groupId': 'OG001'}, {'value': '443', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.046', 'spread': '12.578', 'groupId': 'OG000'}, {'value': '1.414', 'spread': '12.343', 'groupId': 'OG001'}, {'value': '1.925', 'spread': '11.870', 'groupId': 'OG002'}]}]}, {'title': 'Mental health composite summary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '451', 'groupId': 'OG001'}, {'value': '446', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.123', 'spread': '15.240', 'groupId': 'OG000'}, {'value': '0.283', 'spread': '15.686', 'groupId': 'OG001'}, {'value': '0.260', 'spread': '15.800', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0364', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.642', 'ciLowerLimit': '0.104', 'ciUpperLimit': '3.180', 'groupDescription': 'Analysis of Physical Health Composite Summary', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, EDSS category per IVRS, and the Baseline summary score.'}, {'pValue': '0.1905', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.024', 'ciLowerLimit': '-0.510', 'ciUpperLimit': '2.559', 'groupDescription': 'Analysis of Physical Health Composite Summary', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, EDSS category per IVRS, and the Baseline summary score.'}, {'pValue': '0.7104', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.356', 'ciLowerLimit': '-1.523', 'ciUpperLimit': '2.234', 'groupDescription': 'Analysis of Mental Health Composite Summary', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, EDSS category per IVRS, and the Baseline summary score.'}, {'pValue': '0.8587', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.170', 'ciLowerLimit': '-2.045', 'ciUpperLimit': '1.705', 'groupDescription': 'Analysis of Mental Health Composite Summary', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for region, EDSS category per IVRS, and the Baseline summary score.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12', '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': 'ITT population with available Baseline data; missing post-baseline data were imputed using a mixed-effects regression model (random slope and intercept).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '445', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}, {'value': '448', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.'}, {'id': 'OG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}, {'id': 'OG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '336', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '268', 'groupId': 'OG002'}]}]}, {'title': 'Any Moderate or Severe TEAE', 'categories': [{'measurements': [{'value': '182', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}]}, {'title': 'Any Severe TEAE', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Any Suspected TEAE', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}]}]}, {'title': 'Any Related TEAE', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Any Serious TEAE', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Any Suspected Serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Any Related Serious TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE Leading to Stopping of Study Drug', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Any TEAE Leading to Study Withdrawal', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Any Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Death related to Study Drug', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study drug until 28 days following the last dose of study drug; mean exposure to study drug was 13.5 months for interferon beta-1a and 13.6 months for each ozanimod group.', 'description': 'An adverse event (AE) is any untoward medical occurrence that does not necessarily have a causal relationship with the investigational product (IP). An AE can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. A serious AE (SAE) is any untoward medical occurrence or effect that results in death, is life-threatening, requires hospitalization or prolongation of existing inpatient hospitalization. The investigator assessed the severity of AEs as mild, moderate, or severe.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population consisted of all participants who received at least 1 dose of randomized study medication, analyzed according to the highest dose of ozanimod treatment actually received (up to 1 mg) and not according to the treatment they were randomized to receive, if different.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received 30 µg interferon beta-1a (IFN β-1a) by intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally once a day until the last participant had been treated for at least 12 months.'}, {'id': 'FG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection (identical in appearance to Interferon) weekly until the last participant had been treated for at least 12 months.'}, {'id': 'FG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection (identical in appearance to Interferon) weekly until the last participant had been treated for at least 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '448'}, {'groupId': 'FG001', 'numSubjects': '451'}, {'groupId': 'FG002', 'numSubjects': '447'}]}, {'type': 'Safety Population', 'comment': 'Three participants randomized to the interferon beta-1a group received ozanimod in error at some visits (2 participants received ozanimod 0.5 mg and 1 participant received ozanimod 1 mg) and are counted in the ozanimod groups in the Safety Population.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '445'}, {'groupId': 'FG001', 'numSubjects': '453'}, {'groupId': 'FG002', 'numSubjects': '448'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '412'}, {'groupId': 'FG001', 'numSubjects': '425'}, {'groupId': 'FG002', 'numSubjects': '418'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 152 sites in 20 countries in Eastern and Western Europe, the United States, and New Zealand. Between December 2014 and November 2015, 1656 participants were screened, of whom 1346 were eligible and enrolled.', 'preAssignmentDetails': 'Participants were randomly assigned to one of three treatment groups in a 1:1:1 ratio. Randomization was stratified by Baseline Expanded Disability Status Scale (EDSS) score (≤ 3.5, \\> 3.5) and country.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'BG000'}, {'value': '451', 'groupId': 'BG001'}, {'value': '447', 'groupId': 'BG002'}, {'value': '1346', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Interferon Beta-1a', 'description': 'Participants received 30 µg interferon beta-1a by IM injection weekly and matching placebo capsules orally once a day until the last participant had been treated for at least 12 months.'}, {'id': 'BG001', 'title': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}, {'id': 'BG002', 'title': 'Ozanimod 1 mg', 'description': 'Participants received ozanimod 1 mg orally once a day and a placebo intramuscular injection weekly until the last participant had been treated for at least 12 months.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.9', 'spread': '9.11', 'groupId': 'BG000'}, {'value': '36.0', 'spread': '9.43', 'groupId': 'BG001'}, {'value': '34.8', 'spread': '9.24', 'groupId': 'BG002'}, {'value': '35.6', 'spread': '9.27', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '311', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}, {'value': '894', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}, {'value': '452', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Black', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '447', 'groupId': 'BG000'}, {'value': '447', 'groupId': 'BG001'}, {'value': '446', 'groupId': 'BG002'}, {'value': '1340', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region', 'classes': [{'title': 'Rest of World', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}, {'title': 'Eastern Europe', 'categories': [{'measurements': [{'value': '419', 'groupId': 'BG000'}, {'value': '419', 'groupId': 'BG001'}, {'value': '415', 'groupId': 'BG002'}, {'value': '1253', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Eastern Europe includes Belarus, Bosnia and Herzegovina, Bulgaria, Croatia, Estonia, Georgia, Latvia, Lithuania, Moldova, Poland, Romania, Russia, Serbia, and Ukraine.\n\nRest of world includes the United States, Germany, Portugal, Spain, Sweden, and New Zealand.', 'unitOfMeasure': 'Participants'}, {'title': 'Expanded Disability Status Scale (EDSS)', 'classes': [{'categories': [{'measurements': [{'value': '2.62', 'spread': '1.138', 'groupId': 'BG000'}, {'value': '2.65', 'spread': '1.135', 'groupId': 'BG001'}, {'value': '2.61', 'spread': '1.160', 'groupId': 'BG002'}, {'value': '2.62', 'spread': '1.144', '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 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': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time Since MS Symptom Onset', 'classes': [{'categories': [{'measurements': [{'value': '6.88', 'spread': '5.877', 'groupId': 'BG000'}, {'value': '7.16', 'spread': '6.255', 'groupId': 'BG001'}, {'value': '6.85', 'spread': '6.449', 'groupId': 'BG002'}, {'value': '6.96', 'spread': '6.195', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time Since MS Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '3.71', 'spread': '4.361', 'groupId': 'BG000'}, {'value': '3.70', 'spread': '4.518', 'groupId': 'BG001'}, {'value': '3.60', 'spread': '4.193', 'groupId': 'BG002'}, {'value': '3.67', 'spread': '4.357', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age at MS Symptom Onset', 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'spread': '8.92', 'groupId': 'BG000'}, {'value': '29.3', 'spread': '9.25', 'groupId': 'BG001'}, {'value': '28.4', 'spread': '8.42', 'groupId': 'BG002'}, {'value': '29.1', 'spread': '8.88', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age at MS Diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '32.7', 'spread': '9.01', 'groupId': 'BG000'}, {'value': '32.7', 'spread': '9.49', 'groupId': 'BG001'}, {'value': '31.6', 'spread': '8.81', 'groupId': 'BG002'}, {'value': '32.4', 'spread': '9.12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The Intent-to-Treat (ITT) population consisted of 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.'}}, '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': 1346}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2016-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2014-08-05', 'resultsFirstSubmitDate': '2017-12-22', 'studyFirstSubmitQcDate': '2014-11-14', 'lastUpdatePostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-23', 'studyFirstPostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjusted Annualized Relapse Rate (ARR) During the Treatment Period', 'timeFrame': '12 months', 'description': 'The relapse rate was based on confirmed relapses. 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 relapses divided by the total number of days in the study \\* 365.25.\n\nARR was adjusted for region (Eastern Europe vs rest of world), Baseline age, and Baseline number of gadolinium-enhancing lesions; the natural log transformation of time on study was included 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 12 Months', 'timeFrame': '12 month treatment period; MRI scans were assessed at Month 6 and Month 12', 'description': 'The 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 treatment period.'}, {'measure': 'Adjusted Mean Number of Gadolinium Enhancing (GdE) Brain MRI Lesions at Month 12', 'timeFrame': 'Month 12'}, {'measure': 'Time to Onset of Disability Progression Confirmed After 3 Months', 'timeFrame': 'From first dose to the end of the 12-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 12-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 6 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 Lesion-Free at Month 12', 'timeFrame': 'Month 12', 'description': 'MRI scans were analyzed by blinded centralized reading facility.'}, {'measure': 'Percentage of Participants Who Were T2 Lesion-Free at Month 12', 'timeFrame': 'Month 12', 'description': 'MRI scans were analyzed by blinded centralized reading facility.'}, {'measure': 'Percent Change From Baseline in Normalized Brain Volume at Month 12', 'timeFrame': 'Baseline to Month 12', 'description': 'Brain volume (a measure of brain atrophy) was analyzed by MRI.'}, {'measure': 'Change From Baseline to Month 12 in Multiple Sclerosis Functional Composite (MSFC) Score Including the Low-Contrast Letter Acuity (LCLA) Test', 'timeFrame': 'Baseline to Month 12', '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 12', '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 until 28 days following the last dose of study drug; mean exposure to study drug was 13.5 months for interferon beta-1a and 13.6 months for each ozanimod group.', 'description': 'An adverse event (AE) is any untoward medical occurrence that does not necessarily have a causal relationship with the investigational product (IP). An AE can be any unfavorable or unintended sign, including an abnormal laboratory finding, symptom or disease temporally associated with the use of an IP whether or not considered related to the IP. A serious AE (SAE) is any untoward medical occurrence or effect that results in death, is life-threatening, requires hospitalization or prolongation of existing inpatient hospitalization. The investigator assessed the severity of AEs as mild, moderate, or severe.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MS', 'RMS', 'Multiple Sclerosis', 'Relapsing Multiple Sclerosis'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '31492651', 'type': 'BACKGROUND', 'citation': 'Comi G, Kappos L, Selmaj KW, Bar-Or A, Arnold DL, Steinman L, Hartung HP, Montalban X, Kubala Havrdova E, Cree BAC, Sheffield JK, Minton N, Raghupathi K, Ding N, Cohen JA; SUNBEAM Study Investigators. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial. Lancet Neurol. 2019 Nov;18(11):1009-1020. doi: 10.1016/S1474-4422(19)30239-X. Epub 2019 Sep 3.'}, {'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': '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.'}, {'pmid': '33454584', 'type': 'DERIVED', 'citation': 'DeLuca J, Schippling S, Montalban X, Kappos L, Cree BAC, Comi G, Arnold DL, Hartung HP, Sheffield JK, Liu H, Silva D, Cohen JA. Effect of Ozanimod on Symbol Digit Modalities Test Performance in Relapsing MS. Mult Scler Relat Disord. 2021 Feb;48:102673. doi: 10.1016/j.msard.2020.102673. Epub 2020 Dec 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria\n* EDSS score between 0 and 5.0 at baseline\n\nExclusion Criteria:\n\n• Primary progressive multiple sclerosis'}, 'identificationModule': {'nctId': 'NCT02294058', 'acronym': 'SUNBEAM', 'briefTitle': 'Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis Patients', 'orgStudyIdInfo': {'id': 'RPC01-301'}, 'secondaryIdInfos': [{'id': '2014-002320-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interferon beta-1a', 'description': 'Participants received 30 µg interferon beta-1a by intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally once a day until the last participant had been treated for 12 months.', 'interventionNames': ['Drug: Interferon beta-1a', 'Drug: Placebo to ozanimod']}, {'type': 'EXPERIMENTAL', 'label': 'Ozanimod 0.5 mg', 'description': 'Participants received ozanimod 0.5 mg capsules orally once a day and an intramuscular placebo injection (identical in appearance to Interferon) weekly until the last participant had been treated for 12 months.', 'interventionNames': ['Drug: Ozanimod', 'Drug: Placebo to interferon beta-1a']}, {'type': 'EXPERIMENTAL', 'label': 'Ozanimod 1 mg', 'description': 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