Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT00879658
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2009-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D009471', 'term': 'Neuromyelitis Optica'}, {'id': 'D002549', 'term': 'Diffuse Cerebral Sclerosis of Schilder'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009188', 'term': 'Myelitis, Transverse'}, {'id': 'D009902', 'term': 'Optic Neuritis'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C578989', 'term': 'siponimod'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 2.5 years.', 'eventGroups': [{'id': 'EG000', 'title': 'BAF312 10 mg', 'description': '10 mg of BAF given orally o.d.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 46, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'BAF312 2 mg', 'description': '2 mg of BAF given orally o.d.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 42, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'BAF312 1.25 mg', 'description': '1.25 mg of BAF given orally o.d.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 26, 'seriousNumAtRisk': 42, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 34, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG004', 'title': 'BAF312 0.25 mg', 'description': '0.25 mg of BAF given orally o.d.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 34, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo', 'description': 'Placebo given orally o.d.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 45, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Temperature intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 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'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Benign intracranial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Optic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Schizophreniform disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 43, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 61, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dose Responsiveness of BAF312 Based on the Number of Combined Unique Active MRI Lesions (CUAL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312/Placebo', 'description': 'The dose response relationship among five doses of BAF312 and placebo during 3 months of treatment in patients with RRMS, as measured by the number of combined unique active \\[MRI\\] lesions (CUAL).'}], 'classes': [{'title': 'Dose achieving 50% reduction', 'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000', 'lowerLimit': '0.19', 'upperLimit': '1.34'}]}]}, {'title': 'ED50', 'categories': [{'measurements': [{'value': '0.83', 'groupId': 'OG000', 'lowerLimit': '0.30', 'upperLimit': '2.27'}]}]}, {'title': 'ED90', 'categories': [{'measurements': [{'value': '7.46', 'groupId': 'OG000', 'lowerLimit': '2.72', 'upperLimit': '20.47'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months of treatment', 'description': 'Combined unique active lesions (CUAL) were defined as new gadolinium \\[Gd\\]-enhanced lesions on T1-weighted MRI scans or new or enlarging lesions on T2-weighted MRI scans, without double-counting of lesions.\n\nED50 is the dose that gives half of the asymptotic maximum change over placebo. ED90 is the dose that gives 90% of the asymptotic maximum change over placebo.', 'unitOfMeasure': 'mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) consisted of all patients who received at least one dose of study medication and had no protocol deviation with severity code 0 or 8. Following the intent-to-treat principle, patients were analyzed according to the treatment they were assigned to at randomization.'}, {'type': 'SECONDARY', 'title': 'Number of Confirmed Relapses - Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312 10mg', 'description': '10 mg of BAF given orally o.d.'}, {'id': 'OG001', 'title': 'BAF312 2 mg', 'description': '2 mg of BAF given orally o.d.'}, {'id': 'OG002', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo given orally o.d.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.148', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Negative binomial regression model', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.524', 'ciLowerLimit': '0.219', 'ciUpperLimit': '1.257', 'pValueComment': 'Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \\<1 favors active treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.', 'otherAnalysisDescription': 'An ARR-ratio \\<1 favors active treatment.'}, {'pValue': '0.041', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Negative binomial regression model', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.340', 'ciLowerLimit': '0.121', 'ciUpperLimit': '0.956', 'pValueComment': 'Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \\<1 favors active treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.'}, {'pValue': '0.899', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Negative binomial regression model', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.051', 'ciLowerLimit': '0.486', 'ciUpperLimit': '2.273', 'pValueComment': 'Pairwise comparison and p-values refer to ARR on active treatment compared to placebo. An ARR-ratio \\<1 favors active treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment compared to placebo based on negative binomial regression model, adjusted for treatment group and baseline number of relapses in prev 2 yrs.'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'confirmed relapse: A relapse was to be confirmed by the Independent Evaluating Physician (examining neurologist) performing the EDSS. It was recommended that this occurred within 7 days of the onset of symptoms. A relapse was confirmed when it was accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the Expanded Disability Status Scale (EDSS) or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS).', 'unitOfMeasure': 'Confirmed relapses', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set in period I'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Relapse-free Patients - Period 1 + 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312 10mg', 'description': '10 mg of BAF given orally o.d.'}, {'id': 'OG001', 'title': 'BAF312 2 mg', 'description': '2 mg of BAF given orally o.d.'}, {'id': 'OG002', 'title': 'BAF312 1.25 mg', 'description': '1.25 mg of BAF given orally o.d.'}, {'id': 'OG003', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.'}, {'id': 'OG004', 'title': 'BAF312 0.25 mg', 'description': '0.25 mg of BAF given orally o.d.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo given orally o.d.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000'}, {'value': '0.93', 'groupId': 'OG001'}, {'value': '0.93', 'groupId': 'OG002'}, {'value': '0.79', 'groupId': 'OG003'}, {'value': '0.86', 'groupId': 'OG004'}, {'value': '0.88', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.879', 'groupIds': ['OG000', 'OG005'], 'paramType': 'Logistic regression model', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.915', 'ciLowerLimit': '0.288', 'ciUpperLimit': '2.925', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Proportions are estimated from the logistic regression model.\n\n\\- An odds ratio of \\> 1 indicates an increased odds in favor of the active treatment.', 'nonInferiorityComment': 'Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.'}, {'pValue': '0.399', 'groupIds': ['OG001', 'OG005'], 'paramType': 'Logistic regression model', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.745', 'ciLowerLimit': '0.484', 'ciUpperLimit': '7.167', 'pValueComment': 'Proportions are estimated from the logistic regression model.\n\n\\- An odds ratio of \\> 1 indicates an increased odds in favor of the active treatment.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.'}, {'pValue': '0.454', 'groupIds': ['OG002', 'OG005'], 'paramType': 'Logistic regression model', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.697', 'ciLowerLimit': '0.438', 'ciUpperLimit': '8.296', 'pValueComment': 'Proportions are estimated from the logistic regression model.\n\n\\- An odds ratio of \\> 1 indicates an increased odds in favor of the active treatment.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.'}, {'pValue': '0.223', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Logistic regression model', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.509', 'ciLowerLimit': '0.166', 'ciUpperLimit': '1.511', 'pValueComment': 'Proportions are estimated from the logistic regression model.\n\n\\- An odds ratio of \\> 1 indicates an increased odds in favor of the active treatment.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.'}, {'pValue': '0.668', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Logistic regression model', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.785', 'ciLowerLimit': '0.253', 'ciUpperLimit': '2.392', 'pValueComment': 'Proportions are estimated from the logistic regression model.\n\n\\- An odds ratio of \\> 1 indicates an increased odds in favor of the active treatment.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.'}], 'paramType': 'NUMBER', 'timeFrame': '3 month', 'description': 'To explore the effect of BAF312 on the proportion of relapse-free patients (confirmed relapses only)', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - Period I and II'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Relapse-free Patients - Period 1 Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312 10mg', 'description': '10 mg of BAF given orally o.d.'}, {'id': 'OG001', 'title': 'BAF312 2 mg', 'description': '2 mg of BAF given orally o.d.'}, {'id': 'OG002', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo given orally o.d.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.84', 'groupId': 'OG000'}, {'value': '0.92', 'groupId': 'OG001'}, {'value': '0.77', 'groupId': 'OG002'}, {'value': '0.72', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.178', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Logistic regression model', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.996', 'ciLowerLimit': '0.731', 'ciUpperLimit': '5.669', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Proportions are estimated from the logistic regression model. - An odds ratio of \\> 1 indicates an increased odds in favor of the active treatment.', 'nonInferiorityComment': 'Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.'}, {'pValue': '0.014', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Logistic regression model', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.120', 'ciLowerLimit': '1.328', 'ciUpperLimit': '14.681', 'pValueComment': 'Proportions are estimated from the logistic regression model. - An odds ratio of \\> 1 indicates an increased odds in favor of the active treatment.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.'}, {'pValue': '0.642', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Logistic regression model', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.266', 'ciLowerLimit': '0.468', 'ciUpperLimit': '3.494', 'pValueComment': 'Proportions are estimated from the logistic regression model. - An odds ratio of \\> 1 indicates an increased odds in favor of the active treatment.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Pairwise comparison of treatments to placebo are based on odds ratios estimated from a logistic regression model adjusted for treatment group and using number of relapses in the previous 2 years as a covariate.'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'To explore the effect of BAF312 on the proportion of relapse-free patients (confirmed relapses only)', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set - Period I One patient in the placebo group was misrandomized and never received study medication.'}, {'type': 'SECONDARY', 'title': 'Number of New [Gd]-Enhanced T1 Lesions Monthly - Period 1 +2 at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312 10mg', 'description': '10 mg of BAF given orally o.d.'}, {'id': 'OG001', 'title': 'BAF312 2 mg', 'description': '2 mg of BAF given orally o.d.'}, {'id': 'OG002', 'title': 'BAF312 1.25 mg', 'description': '1.25 mg of BAF given orally o.d.'}, {'id': 'OG003', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.'}, {'id': 'OG004', 'title': 'BAF312 0.25 mg', 'description': '0.25 mg of BAF given orally o.d.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo-controlled'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.48', 'groupId': 'OG002'}, {'value': '0.9', 'spread': '2.48', 'groupId': 'OG003'}, {'value': '0.6', 'spread': '1.16', 'groupId': 'OG004'}, {'value': '1.4', 'spread': '3.11', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.138', 'ciLowerLimit': '0.047', 'ciUpperLimit': '0.408', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose groups and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model'}, {'pValue': '0.012', 'groupIds': ['OG001'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.307', 'ciLowerLimit': '0.123', 'ciUpperLimit': '0.771', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.113', 'ciLowerLimit': '0.036', 'ciUpperLimit': '0.358', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.021', 'groupIds': ['OG003', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.375', 'ciLowerLimit': '0.163', 'ciUpperLimit': '0.860', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.062', 'groupIds': ['OG004', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.478', 'ciLowerLimit': '0.220', 'ciUpperLimit': '1.037', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Results for Month 1 through Month 3 inclusive include patients from both Period 1 and Period 2. New lesions at a specific visit were assessed relative to the previous scheduled visit scan. The number of lesions of each type was available from the central MRI reader. No derivation was performed. Lesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.', 'unitOfMeasure': 'Lesion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set One patient in the placebo group was misrandomized and never received study medication.'}, {'type': 'SECONDARY', 'title': 'Number of New [Gd]-Enhanced T1 Lesions Monthly - Period 1 Only at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312 10mg', 'description': '10 mg of BAF given orally o.d.'}, {'id': 'OG001', 'title': 'BAF312 2 mg', 'description': '2 mg of BAF given orally o.d.'}, {'id': 'OG002', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-controlled'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '4.17', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '3.09', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.154', 'ciLowerLimit': '0.063', 'ciUpperLimit': '0.376', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'new lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model', 'nonInferiorityComment': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.'}, {'pValue': '0.005', 'groupIds': ['OG001', 'OG003'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.228', 'ciLowerLimit': '0.081', 'ciUpperLimit': '0.641', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.188', 'ciLowerLimit': '0.070', 'ciUpperLimit': '0.509', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Month 4 through Month 6 include patients from Period 1 only. New lesions at a specific visit were assessed relative to the previous scheduled visit scan.\n\nThe number of lesions of each type was available from the central MRI reader. No derivation was performed.\n\nLesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set One patient in the placebo group was misrandomized and never received study medication.'}, {'type': 'SECONDARY', 'title': 'Number of All New Gd-enhanced T1 Lesions - Period 1 +2 at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312 10mg', 'description': '10 mg of BAF given orally o.d.'}, {'id': 'OG001', 'title': 'BAF312 2 mg', 'description': '2 mg of BAF given orally o.d.'}, {'id': 'OG002', 'title': 'BAF312 1.25 mg', 'description': '1.25 mg of BAF given orally o.d.'}, {'id': 'OG003', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.'}, {'id': 'OG004', 'title': 'BAF312 0.25 mg', 'description': '0.25 mg of BAF given orally o.d.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo-controlled'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '1.46', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.68', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '3.92', 'groupId': 'OG003'}, {'value': '1.0', 'spread': '1.54', 'groupId': 'OG004'}, {'value': '2.0', 'spread': '3.78', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.279', 'ciLowerLimit': '0.124', 'ciUpperLimit': '0.628', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.'}, {'pValue': '0.019', 'groupIds': ['OG001', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.396', 'ciLowerLimit': '0.182', 'ciUpperLimit': '0.861', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.154', 'ciLowerLimit': '0.059', 'ciUpperLimit': '0.400', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.035', 'groupIds': ['OG003', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.454', 'ciLowerLimit': '0.219', 'ciUpperLimit': '0.945', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.087', 'groupIds': ['OG004', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '96', 'paramValue': '0.555', 'ciLowerLimit': '0.283', 'ciUpperLimit': '1.090', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The results for Month 1 through Month 3 includes patients from both Period 1 and Period 2. New lesions at a specific visit were assessed relative to the previous scheduled visit scan.\n\nThe number of lesions of each type was available from the central MRI reader. No derivation was performed.\n\nLesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set One patient in the placebo group was misrandomized and never received study medication.'}, {'type': 'SECONDARY', 'title': 'Number of All Gd-enhanced T1 Lesions - Period 1 Only at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312 10mg', 'description': '10 mg of BAF given orally o.d.'}, {'id': 'OG001', 'title': 'BAF312 2 mg', 'description': '2 mg of BAF given orally o.d.'}, {'id': 'OG002', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-controlled'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.37', 'groupId': 'OG001'}, {'value': '1.1', 'spread': '3.78', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '5.88', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.095', 'ciLowerLimit': '0.033', 'ciUpperLimit': '0.273', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.180', 'ciLowerLimit': '0.069', 'ciUpperLimit': '0.470', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.173', 'ciLowerLimit': '0.069', 'ciUpperLimit': '0.434', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The results for Month 4 through Month 6 inclusive includes patients from Period 1 only. New lesions at a specific visit were assessed relative to the previous scheduled visit scan.\n\nThe number of lesions of each type was available from the central MRI reader. No derivation was performed.\n\nLesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set One patient in the placebo group was misrandomized and never received study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Monthly New/Enlarging T2 Lesions - Period 1 +2 at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312 10mg', 'description': '10 mg of BAF given orally o.d.'}, {'id': 'OG001', 'title': 'BAF312 2 mg (Period 1)', 'description': '2 mg of BAF given orally o.d. for a period of 6 months'}, {'id': 'OG002', 'title': 'BAF312 1.25 mg', 'description': '1.25 mg of BAF given orally o.d.'}, {'id': 'OG003', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.'}, {'id': 'OG004', 'title': 'BAF312 0.25 mg', 'description': '0.25 mg of BAF given orally o.d.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo-controlled'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.00', 'groupId': 'OG001'}, {'value': '0.2', 'spread': '0.64', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '3.08', 'groupId': 'OG003'}, {'value': '0.8', 'spread': '1.39', 'groupId': 'OG004'}, {'value': '1.5', 'spread': '3.17', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.259', 'ciLowerLimit': '0.100', 'ciUpperLimit': '0.670', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.'}, {'pValue': '0.005', 'groupIds': ['OG001', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.276', 'ciLowerLimit': '0.112', 'ciUpperLimit': '0.676', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.118', 'ciLowerLimit': '0.034', 'ciUpperLimit': '0.409', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.485', 'groupIds': ['OG003', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.683', 'ciLowerLimit': '0.234', 'ciUpperLimit': '1.991', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.142', 'groupIds': ['OG004', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.591', 'ciLowerLimit': '0.292', 'ciUpperLimit': '1.193', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The results for Month 1 through Month 3 inclusive include patients from both Period 1 and Period 2. New lesions at a specific visit were assessed relative to the previous scheduled visit scan.\n\nThe number of lesions of each type was available from the central MRI reader. No derivation was performed.\n\nLesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set One patient in the placebo group was misrandomized and never received study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Monthly New/Enlarging T2 Lesions - Period 1 Only at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312 10mg', 'description': '10 mg of BAF given orally o.d.'}, {'id': 'OG001', 'title': 'BAF312 2 mg', 'description': '2 mg of BAF given orally o.d.'}, {'id': 'OG002', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-controlled'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '2.97', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '3.66', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.161', 'ciLowerLimit': '0.062', 'ciUpperLimit': '0.421', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.'}, {'pValue': '0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.197', 'ciLowerLimit': '0.074', 'ciUpperLimit': '0.527', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.139', 'groupIds': ['OG002', 'OG003'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.416', 'ciLowerLimit': '0.130', 'ciUpperLimit': '1.331', 'pValueComment': 'new Gd-enhanced T1 lesions was compared between treatment groups using a negative binomial generalized estimating equation regression model.', 'groupDescription': 'Pairwise treatment comparison between different BAF312 dose group and placebo used a two-sided significance level of 5% without adjusting for multiplicity.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Month 4 through Month 6 inclusive include patients from Period 1 only. New lesions at a specific visit were assessed relative to the previous scheduled visit scan.\n\nThe number of lesions of each type was available from the central MRI reader. No derivation was performed.\n\nLesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set One patient in the placebo group was misrandomized and never received study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Without Any New MRI Disease Activity - Period 1 +2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312 10mg', 'description': '10 mg of BAF given orally o.d.'}, {'id': 'OG001', 'title': 'BAF312 2 mg', 'description': '2 mg of BAF given orally o.d.'}, {'id': 'OG002', 'title': 'BAF312 1.25 mg', 'description': '1.25 mg of BAF given orally o.d.'}, {'id': 'OG003', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.'}, {'id': 'OG004', 'title': 'BAF312 0.25 mg', 'description': '0.25 mg of BAF given orally o.d.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo given orally o.d.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.227', 'groupIds': ['OG000', 'OG005'], 'pValueComment': 'Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.020', 'groupIds': ['OG001', 'OG005'], 'pValueComment': 'Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG002', 'OG005'], 'pValueComment': 'Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.122', 'groupIds': ['OG003', 'OG005'], 'pValueComment': 'Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.034', 'groupIds': ['OG004', 'OG005'], 'pValueComment': 'Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'The proportion of patients who were free of new Gd-enhanced T1 lesions, and/or free of new or enlarging T2 lesions, i.e. free of new MRI activity (CUAL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Number of Patients Without Any New MRI Disease Activity - Period 1 Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312 10mg', 'description': '10 mg of BAF given orally o.d.'}, {'id': 'OG001', 'title': 'BAF312 2 mg', 'description': '2 mg of BAF given orally o.d.'}, {'id': 'OG002', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'placebo given orally o.d.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.335', 'groupIds': ['OG000', 'OG003'], 'pValueComment': 'Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.022', 'groupIds': ['OG001', 'OG003'], 'pValueComment': 'Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.124', 'groupIds': ['OG002', 'OG003'], 'pValueComment': 'Calculated using weighted logistic regression model adj. for tx group and baseline number of Gd-enhanced T1 lesions. Weight used is equal to 1 if all post-baseline scans up to month 3 are available and (k-x)/k if x scans out of k scans are missing.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'The proportion of patients who were free of new Gd-enhanced T1 lesions, and/or free of new or enlarging T2 lesions, i.e. free of new MRI activity (CUAL).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set One patient in the placebo group was misrandomized and never received study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Monthly New Gd-enhanced T1 Lesions With High Baseline Disease Activity - Period 1 +2 at 3 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '61', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312 10mg', 'description': '10 mg of BAF given orally o.d.'}, {'id': 'OG001', 'title': 'BAF312 2 mg', 'description': '2 mg of BAF given orally o.d.'}, {'id': 'OG002', 'title': 'BAF312 1.25 mg', 'description': '1.25 mg of BAF given orally o.d.'}, {'id': 'OG003', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.'}, {'id': 'OG004', 'title': 'BAF312 0.25 mg', 'description': '0.25 mg of BAF given orally o.d.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Placebo-controlled'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.53', 'groupId': 'OG002'}, {'value': '1.5', 'spread': '3.68', 'groupId': 'OG003'}, {'value': '1.5', 'spread': '1.57', 'groupId': 'OG004'}, {'value': '2.7', 'spread': '4.47', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.129', 'ciLowerLimit': '0.030', 'ciUpperLimit': '0.561', 'pValueComment': 'p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.'}, {'pValue': '0.005', 'groupIds': ['OG001', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.159', 'ciLowerLimit': '0.044', 'ciUpperLimit': '0.578', 'pValueComment': 'p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.'}, {'pValue': '0.005', 'groupIds': ['OG002', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.052', 'ciLowerLimit': '0.007', 'ciUpperLimit': '0.405', 'pValueComment': 'p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.'}, {'pValue': '0.019', 'groupIds': ['OG003', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.271', 'ciLowerLimit': '0.091', 'ciUpperLimit': '0.807', 'pValueComment': 'p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.', 'groupDescription': 'Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.169', 'groupIds': ['OG004', 'OG005'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.504', 'ciLowerLimit': '0.190', 'ciUpperLimit': '1.337', 'pValueComment': 'p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.'}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'In patients with high baseline disease activity, the relative reduction in new Gd-enhanced T1 lesions compared to placebo at Month 3.\n\nHigh baseline disease activity is defined as \\>=2 Gd-enhanced T1 lesions at baseline.\n\nThe number of lesions of each type was available as such from the central MRI reader. No derivation was performed.\n\nLesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set One patient in the placebo group was misrandomized and never received study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Monthly New Gd-enhanced T1 Lesions With High Baseline Disease Activity - Period 1 Only at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312 10mg', 'description': '10 mg of BAF given orally o.d.'}, {'id': 'OG001', 'title': 'BAF312 2 mg', 'description': '2 mg of BAF given orally o.d.'}, {'id': 'OG002', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo-controlled'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.16', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '4.26', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '2.42', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.214', 'ciLowerLimit': '0.091', 'ciUpperLimit': '0.499', 'pValueComment': 'p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.'}, {'pValue': '0.018', 'groupIds': ['OG001', 'OG003'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.240', 'ciLowerLimit': '0.074', 'ciUpperLimit': '0.779', 'pValueComment': 'p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.'}, {'pValue': '0.006', 'groupIds': ['OG002', 'OG003'], 'paramType': 'lesion ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.231', 'ciLowerLimit': '0.081', 'ciUpperLimit': '0.653', 'pValueComment': 'p-value corresponds to the lesion ratio and 95% CI of lesion ratio for active treatment in comparison to placebo.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Pairwise comparison of treatments are based on a negative binomial GEE regression model accounting for repeated measures on each patient, adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month (the month number of each lesion count measurement) interaction, using the log link.'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'In patients with high baseline disease activity, the relative reduction in new Gd-enhanced T1 lesions compared to placebo at Month 6. High baseline disease activity is defined as \\>=2 Gd-enhanced T1 lesions at baseline.\n\nThe number of lesions of each type was available from the central MRI reader. No derivation was performed.\n\nLesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set One patient in the placebo group was misrandomized and never received study medication.'}, {'type': 'SECONDARY', 'title': 'Number of CUAL - Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312 10mg', 'description': '10 mg of BAF given orally o.d.'}, {'id': 'OG001', 'title': 'BAF312 2 mg', 'description': '2 mg of BAF given orally o.d.'}, {'id': 'OG002', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo given orally o.d.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '3.42', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '2.71', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Combined unique active lesions (CUAL) are defined as new Gd-enhanced T1 lesions or new or enlarging T2 lesions, withput double counting of lesions at any specific point in time.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set One patient in the placebo group was misrandomized and never received study medication.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean BAF312 Plasma Trough Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BAF312 10mg', 'description': '10 mg of BAF given orally o.d.'}, {'id': 'OG001', 'title': 'BAF312 2 mg', 'description': '2 mg of BAF given orally o.d.'}, {'id': 'OG002', 'title': 'BAF312 1.2.5 mg', 'description': '1.25 mg of BAF given orally o.d.'}, {'id': 'OG003', 'title': 'BAF312 0.5 mg', 'description': '0.5 mg of BAF given orally o.d.'}, {'id': 'OG004', 'title': 'BAF312 0.25 mg', 'description': '0.25 mg of BAF given orally o.d.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '127.9732', 'spread': '65.53329', 'groupId': 'OG000'}, {'value': '25.1777', 'spread': '15.05116', 'groupId': 'OG001'}, {'value': '14.0450', 'spread': '6.61030', 'groupId': 'OG002'}, {'value': '6.9490', 'spread': '4.97572', 'groupId': 'OG003'}, {'value': '2.8167', 'spread': '1.17863', 'groupId': 'OG004'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '127.4595', 'spread': '74.96856', 'groupId': 'OG000'}, {'value': '23.5143', 'spread': '12.51344', 'groupId': 'OG001'}, {'value': '11.8270', 'spread': '6.53977', 'groupId': 'OG002'}, {'value': '6.1075', 'spread': '3.89391', 'groupId': 'OG003'}, {'value': '2.4897', 'spread': '1.64555', 'groupId': 'OG004'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '104.0332', 'spread': '75.60951', 'groupId': 'OG000'}, {'value': '23.4480', 'spread': '19.27251', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Dose was not analyze at month 6.', 'groupId': 'OG002'}, {'value': '5.307', 'spread': '2.75235', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Dose was not analyze at month 6.', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1, Month 3, Month 6', 'description': 'Geometric mean BAF312 plasma concentrations by treatment and by visit', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis Set consisted of all patients who received at least one dose of active BAF 312 study medication. Patients were analyzed according to the treatment received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BAF312 10mg (Period 1)', 'description': '10 mg of BAF given orally o.d. for a period of 6 months'}, {'id': 'FG001', 'title': 'BAF312 2 mg (Period 1)', 'description': '2 mg of BAF given orally o.d. for a period of 6 months'}, {'id': 'FG002', 'title': 'BAF312 0.5 mg (Period 1)', 'description': '0.5 mg of BAF given orally o.d. for a period of 6 months'}, {'id': 'FG003', 'title': 'Placebo (Period 1)', 'description': 'Placebo given orally o.d. for a period of 6 months'}, {'id': 'FG004', 'title': 'BAF312 1.25 mg (Period 2)', 'description': '1.25 mg of BAF given orally o.d. for a period of 3 months'}, {'id': 'FG005', 'title': 'BAF312 0.25 mg (Period 2)', 'description': '0.25 mg of BAF given orally o.d. for a period of 3 months'}, {'id': 'FG006', 'title': 'Placebo (Period 2)', 'description': 'Placebo given orally o.d. for a period of 3 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '46'}, {'groupId': 'FG004', 'numSubjects': '42'}, {'groupId': 'FG005', 'numSubjects': '51'}, {'groupId': 'FG006', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '42'}, {'groupId': 'FG004', 'numSubjects': '40'}, {'groupId': 'FG005', 'numSubjects': '50'}, {'groupId': 'FG006', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'misrandomized (never received study med)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was performed in 297 patients at 73 centers in 12 countries.', 'preAssignmentDetails': 'One patient was misrandomized and never received study drug. Patient was included in Participant Flow and Baseline Characteristics but not included in actual enrollment count or Full Analysis Set..'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '51', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}, {'value': '297', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'BAF312 10mg (Period 1)', 'description': '10 mg of BAF given orally o.d. for a period of 6 months'}, {'id': 'BG001', 'title': 'BAF312 2 mg (Period 1)', 'description': '2 mg of BAF given orally o.d. for a period of 6 months'}, {'id': 'BG002', 'title': 'BAF312 0.5 mg (Period 1)', 'description': '0.5 mg of BAF given orally o.d. for a period of 6 months'}, {'id': 'BG003', 'title': 'Placebo (Period 1)', 'description': 'Placebo given orally o.d. for a period of 3 months'}, {'id': 'BG004', 'title': 'BAF312 1.25 mg (Period 2)', 'description': '1.25 mg of BAF given orally o.d. for a period of 3 months'}, {'id': 'BG005', 'title': 'BAF312 0.25 mg (Period 2)', 'description': '0.25 mg of BAF given orally o.d. for a period of 3 months'}, {'id': 'BG006', 'title': 'Placebo (Period 2)', 'description': 'Placebo given orally o.d. for a period of 6 months'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'spread': '8.43', 'groupId': 'BG000'}, {'value': '37.4', 'spread': '8.94', 'groupId': 'BG001'}, {'value': '36.0', 'spread': '8.79', 'groupId': 'BG002'}, {'value': '35.2', 'spread': '8.75', 'groupId': 'BG003'}, {'value': '35.4', 'spread': '8.87', 'groupId': 'BG004'}, {'value': '37.4', 'spread': '8.39', 'groupId': 'BG005'}, {'value': '35.9', 'spread': '8.24', 'groupId': 'BG006'}, {'value': '36.3', 'spread': '8.62', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Randomized set'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '42', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}, {'value': '212', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '85', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Randomized set'}], 'populationDescription': 'The Randomized Set (RAN) consisted of all patients who were assigned a randomization number. The RAN set was used for a summary of patient disposition and demographics and baseline characteristics. One patient was misrandomized and never received study drug. Demographic data was collected and the patient was included in the randomized set.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 297}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'dispFirstSubmitDate': '2012-07-24', 'completionDateStruct': {'date': '2011-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-26', 'studyFirstSubmitDate': '2009-04-09', 'dispFirstSubmitQcDate': '2012-07-24', 'resultsFirstSubmitDate': '2018-10-30', 'studyFirstSubmitQcDate': '2009-04-09', 'dispFirstPostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-26', 'studyFirstPostDateStruct': {'date': '2009-04-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Responsiveness of BAF312 Based on the Number of Combined Unique Active MRI Lesions (CUAL)', 'timeFrame': '3 months of treatment', 'description': 'Combined unique active lesions (CUAL) were defined as new gadolinium \\[Gd\\]-enhanced lesions on T1-weighted MRI scans or new or enlarging lesions on T2-weighted MRI scans, without double-counting of lesions.\n\nED50 is the dose that gives half of the asymptotic maximum change over placebo. ED90 is the dose that gives 90% of the asymptotic maximum change over placebo.'}], 'secondaryOutcomes': [{'measure': 'Number of Confirmed Relapses - Period 1', 'timeFrame': '6 months', 'description': 'confirmed relapse: A relapse was to be confirmed by the Independent Evaluating Physician (examining neurologist) performing the EDSS. It was recommended that this occurred within 7 days of the onset of symptoms. A relapse was confirmed when it was accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the Expanded Disability Status Scale (EDSS) or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS).'}, {'measure': 'Proportion of Participants With Relapse-free Patients - Period 1 + 2', 'timeFrame': '3 month', 'description': 'To explore the effect of BAF312 on the proportion of relapse-free patients (confirmed relapses only)'}, {'measure': 'Proportion of Participants With Relapse-free Patients - Period 1 Only', 'timeFrame': '6 months', 'description': 'To explore the effect of BAF312 on the proportion of relapse-free patients (confirmed relapses only)'}, {'measure': 'Number of New [Gd]-Enhanced T1 Lesions Monthly - Period 1 +2 at Month 3', 'timeFrame': '3 months', 'description': 'Results for Month 1 through Month 3 inclusive include patients from both Period 1 and Period 2. New lesions at a specific visit were assessed relative to the previous scheduled visit scan. The number of lesions of each type was available from the central MRI reader. No derivation was performed. Lesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.'}, {'measure': 'Number of New [Gd]-Enhanced T1 Lesions Monthly - Period 1 Only at 6 Months', 'timeFrame': '6 months', 'description': 'Month 4 through Month 6 include patients from Period 1 only. New lesions at a specific visit were assessed relative to the previous scheduled visit scan.\n\nThe number of lesions of each type was available from the central MRI reader. No derivation was performed.\n\nLesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.'}, {'measure': 'Number of All New Gd-enhanced T1 Lesions - Period 1 +2 at Month 3', 'timeFrame': '3 months', 'description': 'The results for Month 1 through Month 3 includes patients from both Period 1 and Period 2. New lesions at a specific visit were assessed relative to the previous scheduled visit scan.\n\nThe number of lesions of each type was available from the central MRI reader. No derivation was performed.\n\nLesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.'}, {'measure': 'Number of All Gd-enhanced T1 Lesions - Period 1 Only at 6 Months', 'timeFrame': '6 months', 'description': 'The results for Month 4 through Month 6 inclusive includes patients from Period 1 only. New lesions at a specific visit were assessed relative to the previous scheduled visit scan.\n\nThe number of lesions of each type was available from the central MRI reader. No derivation was performed.\n\nLesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.'}, {'measure': 'Number of Monthly New/Enlarging T2 Lesions - Period 1 +2 at 3 Months', 'timeFrame': '3 months', 'description': 'The results for Month 1 through Month 3 inclusive include patients from both Period 1 and Period 2. New lesions at a specific visit were assessed relative to the previous scheduled visit scan.\n\nThe number of lesions of each type was available from the central MRI reader. No derivation was performed.\n\nLesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.'}, {'measure': 'Number of Monthly New/Enlarging T2 Lesions - Period 1 Only at 6 Months', 'timeFrame': '6 months', 'description': 'Month 4 through Month 6 inclusive include patients from Period 1 only. New lesions at a specific visit were assessed relative to the previous scheduled visit scan.\n\nThe number of lesions of each type was available from the central MRI reader. No derivation was performed.\n\nLesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.'}, {'measure': 'Number of Patients Without Any New MRI Disease Activity - Period 1 +2', 'timeFrame': '3 months', 'description': 'The proportion of patients who were free of new Gd-enhanced T1 lesions, and/or free of new or enlarging T2 lesions, i.e. free of new MRI activity (CUAL).'}, {'measure': 'Number of Patients Without Any New MRI Disease Activity - Period 1 Only', 'timeFrame': '6 months', 'description': 'The proportion of patients who were free of new Gd-enhanced T1 lesions, and/or free of new or enlarging T2 lesions, i.e. free of new MRI activity (CUAL).'}, {'measure': 'Number of Monthly New Gd-enhanced T1 Lesions With High Baseline Disease Activity - Period 1 +2 at 3 Months', 'timeFrame': '3 months', 'description': 'In patients with high baseline disease activity, the relative reduction in new Gd-enhanced T1 lesions compared to placebo at Month 3.\n\nHigh baseline disease activity is defined as \\>=2 Gd-enhanced T1 lesions at baseline.\n\nThe number of lesions of each type was available as such from the central MRI reader. No derivation was performed.\n\nLesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.'}, {'measure': 'Number of Monthly New Gd-enhanced T1 Lesions With High Baseline Disease Activity - Period 1 Only at 6 Months', 'timeFrame': '6 months', 'description': 'In patients with high baseline disease activity, the relative reduction in new Gd-enhanced T1 lesions compared to placebo at Month 6. High baseline disease activity is defined as \\>=2 Gd-enhanced T1 lesions at baseline.\n\nThe number of lesions of each type was available from the central MRI reader. No derivation was performed.\n\nLesion ratio (and 95% CI) is set between the estimated number of lesions on active treatment compared to placebo. Estimates are computed at Month 3 and Month 6. New lesions at a specific visit were assessed relative to the previous visit. The computation was based upon the mean number of monthly new \\[Gd\\]- enhanced lesions. Month 3 and Month 6 results are based on two negative binomial GEE regression models accounting for repeated measures on a patient. Both models were adjusted for baseline number of Gd-enhanced T1 lesions and treatment group x month interaction, using the log link.'}, {'measure': 'Number of CUAL - Period 1', 'timeFrame': '6 months', 'description': 'Combined unique active lesions (CUAL) are defined as new Gd-enhanced T1 lesions or new or enlarging T2 lesions, withput double counting of lesions at any specific point in time.'}, {'measure': 'Geometric Mean BAF312 Plasma Trough Concentrations', 'timeFrame': 'Month 1, Month 3, Month 6', 'description': 'Geometric mean BAF312 plasma concentrations by treatment and by visit'}]}, 'conditionsModule': {'keywords': ['Multiple Sclerosis (MS)', 'Relapsing-Remitting', 'Demyelinating Autoimmune Diseases', 'Disseminated sclerosis', 'Encephalomyelitis disseminate', 'Inflammatory disease', 'Demyelination', 'Auto-inflammatory disease', "Devic's disease", 'Balo concentric sclerosis', "Schilder's diffuse sclerosis"], 'conditions': ['Relapsing-remitting Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '26083135', 'type': 'DERIVED', 'citation': 'Mercier F, Bornkamp B, Ohlssen D, Wallstroem E. Characterization of dose-response for count data using a generalized MCP-Mod approach in an adaptive dose-ranging trial. Pharm Stat. 2015 Jul-Aug;14(4):359-67. doi: 10.1002/pst.1693. Epub 2015 Jun 17.'}, {'pmid': '23764350', 'type': 'DERIVED', 'citation': 'Selmaj K, Li DK, Hartung HP, Hemmer B, Kappos L, Freedman MS, Stuve O, Rieckmann P, Montalban X, Ziemssen T, Auberson LZ, Pohlmann H, Mercier F, Dahlke F, Wallstrom E. Siponimod for patients with relapsing-remitting multiple sclerosis (BOLD): an adaptive, dose-ranging, randomised, phase 2 study. Lancet Neurol. 2013 Aug;12(8):756-67. doi: 10.1016/S1474-4422(13)70102-9. Epub 2013 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the dose-response curve for the MRI-based efficacy of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), and to characterize its safety and tolerability for the selection of an optimal dose in a later phase III study.\n\nStudy Design Rationale An adaptive design was chosen to characterize the dose response curve of BAF312. In a first period of study ("Period 1"), three doses of BAF312 and placebo were tested for MRI efficacy. Based on an interim analysis (IA) after 3 months of treatment, two additional active doses for period 2 wereselected , thus allowing to optimize the overall determination of the dose response curve with 5 data points of active treatment, and placebo. The doses were kept blinded. The use of Modeling and Simulation allowed to establish the full range and dynamics of the dose-response curve in silico, and hence the definition of the optimal dose for later phase III studies.\n\nThe choice of placebo as treatment control was essential to obtain information on the specific compared to non-specific effects of active treatment and provides the best way of evaluating the efficacy and of assessing the true safety and tolerability profile of BAF312. Short-term placebo exposure (6 (Period 1) or 3 (Period 2) months, respectively) was unlikely to lead to longer term differences in outcomes \\[Polman, 2008\\]. The use of an adaptive design strategy contributed to a significant reduction of placebo exposure, both in terms of the number of patients and duration, as compared to conventional trial models.\n\nPatients having completed the study within the protocol might be eligible for the Extension Phase study where they receive long-term BAF312 treatment (a separate protocol).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key inclusion Criteria:\n\n* Diagnosis of Multiple Sclerosis (MS) as defined by revised McDonald criteria.\n* A relapsing-remitting course of disease with at least 1 documented relapse during the previous year, or 2 documented relapses during the previous 2 years, or a positive gadolinium (Gd)-enhanced MRI scan at screening (in case the first MRI scan obtained at screening is negative, a second scan may be obtained 1 month later.)\n* An Expanded Disability 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