Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2026-03-01 @ 9:33 AM
Study NCT ID:
NCT00622700
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2008-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Italy', 'Slovakia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527525', 'term': 'teriflunomide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact-us@sanofi.com', 'title': 'Trial Transparency Team', 'organization': 'Sanofi'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product.', 'description': "Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \\[or up to 1st intake in extension period, whichever occurred first\\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.", 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Core treatment period: Placebo matched to teriflunomide tablet once daily orally.', 'otherNumAtRisk': 191, 'otherNumAffected': 117, 'seriousNumAtRisk': 191, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Teriflunomide 7 mg', 'description': 'Core treatment period: Teriflunomide 7 mg tablet once daily orally.', 'otherNumAtRisk': 207, 'otherNumAffected': 129, 'seriousNumAtRisk': 207, 'seriousNumAffected': 18}, {'id': 'EG002', 'title': 'Teriflunomide 14 mg', 'description': 'Core treatment period: Teriflunomide 14 mg tablet once daily orally.', 'otherNumAtRisk': 216, 'otherNumAffected': 135, 'seriousNumAtRisk': 216, 'seriousNumAffected': 24}, {'id': 'EG003', 'title': 'Placebo/Teriflunomide 7 mg', 'description': 'Core treatment period: Placebo matched to teriflunomide tablet once daily orally.\n\nExtension treatment period: Teriflunomide 7 mg tablet once daily orally.', 'otherNumAtRisk': 62, 'otherNumAffected': 33, 'seriousNumAtRisk': 62, 'seriousNumAffected': 8}, {'id': 'EG004', 'title': 'Teriflunomide 7 mg/7 mg', 'description': 'Core treatment period: Teriflunomide 7 mg tablet once daily orally.\n\nExtension treatment period: Teriflunomide 7 mg tablet once daily orally.', 'otherNumAtRisk': 145, 'otherNumAffected': 66, 'seriousNumAtRisk': 145, 'seriousNumAffected': 17}, {'id': 'EG005', 'title': 'Placebo/Teriflunomide 14 mg', 'description': 'Core treatment period: Placebo matched to teriflunomide tablet once daily orally.\n\nExtension treatment period: Teriflunomide 14 mg tablet once daily orally.', 'otherNumAtRisk': 66, 'otherNumAffected': 38, 'seriousNumAtRisk': 66, 'seriousNumAffected': 8}, {'id': 'EG006', 'title': 'Teriflunomide 14 mg/14 mg', 'description': 'Core treatment period: Teriflunomide 14 mg tablet once daily orally.\n\nExtension treatment period: Teriflunomide 14 mg tablet once daily orally.', 'otherNumAtRisk': 150, 'otherNumAffected': 70, 'seriousNumAtRisk': 150, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}], 'seriousEvents': [{'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 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'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 207, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 145, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 150, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA-18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Core Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '214', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg', 'description': 'Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg', 'description': 'Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'title': 'Percent Probability of Conversion at 24 weeks', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '19.4'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '12.8'}, {'value': '9.0', 'groupId': 'OG002', 'lowerLimit': '5.0', 'upperLimit': '13.0'}]}]}, {'title': 'Percent Probability of Conversion at 48 weeks', 'categories': [{'measurements': [{'value': '26.0', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '32.8'}, {'value': '14.2', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '19.6'}, {'value': '13.7', 'groupId': 'OG002', 'lowerLimit': '8.6', 'upperLimit': '18.7'}]}]}, {'title': 'Percent Probability of Conversion at 108 weeks', 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000', 'lowerLimit': '27.8', 'upperLimit': '43.9'}, {'value': '27.6', 'groupId': 'OG001', 'lowerLimit': '19.9', 'upperLimit': '35.4'}, {'value': '24.0', 'groupId': 'OG002', 'lowerLimit': '17.0', 'upperLimit': '31.0'}]}]}], 'analyses': [{'pValue': '0.0087', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.574', 'ciLowerLimit': '0.379', 'ciUpperLimit': '0.869', 'pValueComment': 'P value was derived using Wald chi-squared test in the Cox proportional hazard model.', 'groupDescription': 'A step-down hierarchical testing procedure, starting with the test of teriflunomide 14 mg versus placebo was used. Time to conversion to CDMS was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.', 'statisticalMethod': 'Wald chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0271', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.628', 'ciLowerLimit': '0.416', 'ciUpperLimit': '0.949', 'pValueComment': 'P value was derived using Wald chi-squared test in the Cox proportional hazard model.', 'groupDescription': 'A step-down hierarchical testing procedure was used. The second step was the test of teriflunomide 7 mg versus placebo for time to conversion to CDMS. Time to conversion to CDMS was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.', 'statisticalMethod': 'Wald chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of 108 weeks depending on time of enrollment', 'description': 'Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants who had at least 1 day study medication exposure. Participants were analyzed in the treatment group to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Core Treatment Period: Time to Conversion to Definite Multiple Sclerosis (DMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '214', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg', 'description': 'Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg', 'description': 'Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'title': 'Percent Probability of Conversion at 24 weeks', 'categories': [{'measurements': [{'value': '58.2', 'groupId': 'OG000', 'lowerLimit': '51.0', 'upperLimit': '65.4'}, {'value': '45.7', 'groupId': 'OG001', 'lowerLimit': '38.5', 'upperLimit': '52.9'}, {'value': '46.0', 'groupId': 'OG002', 'lowerLimit': '39.0', 'upperLimit': '53.0'}]}]}, {'title': 'Percent Probability of Conversion at 48 weeks', 'categories': [{'measurements': [{'value': '72.4', 'groupId': 'OG000', 'lowerLimit': '65.7', 'upperLimit': '79.1'}, {'value': '57.3', 'groupId': 'OG001', 'lowerLimit': '49.8', 'upperLimit': '64.7'}, {'value': '57.8', 'groupId': 'OG002', 'lowerLimit': '50.6', 'upperLimit': '64.9'}]}]}, {'title': 'Percent Probability of Conversion at 108 weeks', 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000', 'lowerLimit': '81.2', 'upperLimit': '92.7'}, {'value': '73.3', 'groupId': 'OG001', 'lowerLimit': '66.0', 'upperLimit': '80.7'}, {'value': '71.5', 'groupId': 'OG002', 'lowerLimit': '64.5', 'upperLimit': '78.4'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.651', 'ciLowerLimit': '0.515', 'ciUpperLimit': '0.822', 'pValueComment': 'P value was derived using Wald chi-squared test in the Cox proportional hazard model.', 'groupDescription': 'A step-down hierarchical testing procedure was used. The third step was the test of teriflunomide 14 mg versus placebo for time to conversion to DMS. This was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.', 'statisticalMethod': 'Wald chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.0020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.686', 'ciLowerLimit': '0.540', 'ciUpperLimit': '0.871', 'pValueComment': 'P value was derived using Wald chi-squared test in the Cox proportional hazard model.', 'groupDescription': 'A step-down hierarchical testing procedure was used. The fourth step was the test of teriflunomide 7 mg versus placebo for time to conversion to DMS. This was analyzed using the Cox proportional hazard model with treatment, region, and baseline monofocal/multifocal status as covariates.', 'statisticalMethod': 'Wald chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of 108 weeks depending on time of enrollment', 'description': "Conversion to DMS was demonstrated by dissemination of MRI lesions in time (as per McDonald criteria) or a relapse, whichever occurs first. MRI Imaging criteria were detection of Gadolinium (Gd) enhancement at least 3 months after onset of initial clinical event, if not at site corresponding to initial event; detection of new T2 lesion if it appears at any time compared with reference scan (done at time of screening) done at least 30 days after onset of the initial clinical event. Occurrence of relapse was defined as new neurological abnormality separated by at least 30 days from onset of preceding clinical event, present for at least 24 hours and occurring in absence of fever or known infection. New clinical abnormality (neurological sign) that is consistent with participant's symptoms with increase in at least one Functional System (FS) or EDSS score compared to last EDSS assessment. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.", 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Core Treatment Period: Annualized Relapse Rate (ARR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '214', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg', 'description': 'Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg', 'description': 'Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.284', 'groupId': 'OG000', 'lowerLimit': '0.214', 'upperLimit': '0.378'}, {'value': '0.190', 'groupId': 'OG001', 'lowerLimit': '0.139', 'upperLimit': '0.260'}, {'value': '0.194', 'groupId': 'OG002', 'lowerLimit': '0.143', 'upperLimit': '0.263'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of 108 weeks depending on time of enrollment', 'description': 'ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. Each episode of relapse (appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever) was to be confirmed by an increase in EDSS score or Functional System scores. ARR was assessed using Poisson regression model with robust error variance. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses onset between randomization date and last dose date as the response variable, treatment, region and baseline monofocal/multifocal status as covariates, and log-transformed treatment duration as an offset variable).', 'unitOfMeasure': 'relapses per patient year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Core Treatment Period: Brain Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Lesion Volume at Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg', 'description': 'Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg', 'description': 'Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.053', 'spread': '0.033', 'groupId': 'OG000'}, {'value': '0.041', 'spread': '0.032', 'groupId': 'OG001'}, {'value': '-0.038', 'spread': '0.029', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 108', 'description': 'The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.', 'unitOfMeasure': 'milliliter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, but including only participants who had post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Core Treatment Period: Brain MRI Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan (Poisson Regression Estimates)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg', 'description': 'Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg', 'description': 'Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.953', 'groupId': 'OG000', 'lowerLimit': '0.708', 'upperLimit': '1.284'}, {'value': '0.749', 'groupId': 'OG001', 'lowerLimit': '0.433', 'upperLimit': '1.294'}, {'value': '0.395', 'groupId': 'OG002', 'lowerLimit': '0.262', 'upperLimit': '0.598'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of 108 weeks depending on time of enrollment', 'description': 'Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).', 'unitOfMeasure': 'lesions per scan', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, but including only participants who had post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Core Treatment Period: Brain MRI Assessment: Volume of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg', 'description': 'Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg', 'description': 'Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.079', 'groupId': 'OG000'}, {'value': '0.058', 'groupId': 'OG001'}, {'value': '0.034', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of 108 weeks depending on time of enrollment', 'description': 'Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).', 'unitOfMeasure': 'milliliters per scan', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, but including only participants who had post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of Hypointense Post-Gadolinium T1 Lesion Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg', 'description': 'Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg', 'description': 'Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.028', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.025', 'spread': '0.018', 'groupId': 'OG001'}, {'value': '-0.033', 'spread': '0.016', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 108', 'description': 'Volume of hypointense post-gadolinium T1 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction', 'unitOfMeasure': 'milliliter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, but including only participants who had post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of T2 Lesion Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg', 'description': 'Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg', 'description': 'Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.052', 'spread': '0.033', 'groupId': 'OG000'}, {'value': '0.036', 'spread': '0.032', 'groupId': 'OG001'}, {'value': '-0.035', 'spread': '0.029', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 108', 'description': 'Volume of T2 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction.', 'unitOfMeasure': 'milliliter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, but including only participants who had post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Core Treatment Period: Brain MRI Assessment: Percent Change From Baseline in Atrophy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg', 'description': 'Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg', 'description': 'Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.386', 'spread': '1.326', 'groupId': 'OG000'}, {'value': '-0.197', 'spread': '1.218', 'groupId': 'OG001'}, {'value': '-0.366', 'spread': '1.151', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 108', 'description': 'Atrophy was measured by MRI scan.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, but including only participants who had post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Core Treatment Period: Time to 12-Week Sustained Disability Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '214', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg', 'description': 'Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg', 'description': 'Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'title': 'Percent Probability at 24 weeks', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'OG000', 'lowerLimit': '93.0', 'upperLimit': '98.9'}, {'value': '94.3', 'groupId': 'OG001', 'lowerLimit': '90.9', 'upperLimit': '97.8'}, {'value': '97.9', 'groupId': 'OG002', 'lowerLimit': '95.9', 'upperLimit': '99.9'}]}]}, {'title': 'Percent Probability at 48 weeks', 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '87.3', 'upperLimit': '96.1'}, {'value': '90.1', 'groupId': 'OG001', 'lowerLimit': '85.4', 'upperLimit': '94.7'}, {'value': '93.9', 'groupId': 'OG002', 'lowerLimit': '90.2', 'upperLimit': '97.6'}]}]}, {'title': 'Percent Probability at 108 weeks', 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000', 'lowerLimit': '79.2', 'upperLimit': '91.8'}, {'value': '86.5', 'groupId': 'OG001', 'lowerLimit': '80.8', 'upperLimit': '92.1'}, {'value': '89.2', 'groupId': 'OG002', 'lowerLimit': '84.1', 'upperLimit': '94.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to a maximum of 108 weeks depending on time of enrollment', 'description': 'The 12-week sustained disability progression was defined as increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score of greater than \\[\\>\\] 5.5) that persisted for at least 12 weeks. Percent probability of participants free of 12-week sustained disability progression at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Core Treatment Period: Change From Baseline in EDSS at Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg', 'description': 'Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg', 'description': 'Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.069', 'spread': '0.087', 'groupId': 'OG000'}, {'value': '-0.191', 'spread': '0.086', 'groupId': 'OG001'}, {'value': '-0.166', 'spread': '0.080', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 108', 'description': 'EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, but including only participants who had post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg', 'description': 'Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg', 'description': 'Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.537', 'spread': '2.794', 'groupId': 'OG000'}, {'value': '-2.524', 'spread': '2.710', 'groupId': 'OG001'}, {'value': '-1.827', 'spread': '2.551', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 108', 'description': 'FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social. FIS total score ranges from 0 (no problem) to 160 (extreme problem). Least-square means were estimated using a Mixed-effect model with repeated measures \\[MMRM\\] on FIS total score data adjusted for or baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, but including only participants who had post-baseline data.'}, {'type': 'SECONDARY', 'title': 'Core Treatment Period: Overview of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg', 'description': 'Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg', 'description': 'Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}]}, {'title': 'Any serious AE', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}]}, {'title': 'Any AE leading to death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any AE leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first', 'description': 'AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population:all randomized participants exposed to study medication; analyzed according to drug actually received. In Placebo arm, 4 received teriflunomide 7mg \\& 2 received teriflunomide 14mg, hence they were included in respective teriflunomide arm. Participants who were randomized but not treated were excluded (2 in each teriflunomide arm).'}, {'type': 'SECONDARY', 'title': 'Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Teriflunomide 7 mg', 'description': 'Core treatment period: Placebo matched to teriflunomide tablet once daily orally.\n\nExtension treatment period: Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg/ 7mg', 'description': 'Core treatment period: Placebo matched to teriflunomide tablet once daily orally.\n\nExtension treatment period: Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Placebo/ Teriflunomide 14 mg', 'description': 'Core treatment period: Placebo matched to teriflunomide tablet once daily orally.\n\nExtension treatment period: Teriflunomide 14 mg tablet once daily orally.'}, {'id': 'OG003', 'title': 'Teriflunomide 14 mg/14 mg', 'description': 'Core treatment period: Teriflunomide 14 mg tablet once daily orally.\n\nExtension treatment period: Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'title': 'Percent Probability of Conversion at 24 Weeks', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.9'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '6.6'}, {'value': '13.5', 'groupId': 'OG002', 'lowerLimit': '5.3', 'upperLimit': '21.6'}, {'value': '4.7', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '8.0'}]}]}, {'title': 'Percent Probability of Conversion at 48 Weeks', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '20.6'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '14.8'}, {'value': '21.2', 'groupId': 'OG002', 'lowerLimit': '11.3', 'upperLimit': '31.0'}, {'value': '8.7', 'groupId': 'OG003', 'lowerLimit': '4.2', 'upperLimit': '13.3'}]}]}, {'title': 'Percent Probability of Conversion at 72 Weeks', 'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '24.6'}, {'value': '17.1', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '23.4'}, {'value': '24.3', 'groupId': 'OG002', 'lowerLimit': '13.9', 'upperLimit': '34.6'}, {'value': '14.8', 'groupId': 'OG003', 'lowerLimit': '9.1', 'upperLimit': '20.6'}]}]}, {'title': 'Percent Probability of Conversion at 96 Weeks', 'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '28.6'}, {'value': '23.9', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': '31.0'}, {'value': '27.4', 'groupId': 'OG002', 'lowerLimit': '16.6', 'upperLimit': '38.2'}, {'value': '16.2', 'groupId': 'OG003', 'lowerLimit': '10.3', 'upperLimit': '22.1'}]}]}, {'title': 'Percent Probability of Conversion at 120 Weeks', 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '32.7'}, {'value': '27.7', 'groupId': 'OG001', 'lowerLimit': '20.2', 'upperLimit': '35.2'}, {'value': '32.2', 'groupId': 'OG002', 'lowerLimit': '20.8', 'upperLimit': '43.6'}, {'value': '18.3', 'groupId': 'OG003', 'lowerLimit': '12.1', 'upperLimit': '24.6'}]}]}, {'title': 'Percent Probability of Conversion at 144 Weeks', 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '32.7'}, {'value': '29.4', 'groupId': 'OG001', 'lowerLimit': '21.7', 'upperLimit': '37.1'}, {'value': '33.9', 'groupId': 'OG002', 'lowerLimit': '22.3', 'upperLimit': '45.4'}, {'value': '22.0', 'groupId': 'OG003', 'lowerLimit': '15.3', 'upperLimit': '28.8'}]}]}, {'title': 'Percent Probability of Conversion at 168 Weeks', 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '32.7'}, {'value': '32.2', 'groupId': 'OG001', 'lowerLimit': '24.2', 'upperLimit': '40.3'}, {'value': '33.9', 'groupId': 'OG002', 'lowerLimit': '22.3', 'upperLimit': '45.4'}, {'value': '22.8', 'groupId': 'OG003', 'lowerLimit': '16.0', 'upperLimit': '29.7'}]}]}, {'title': 'Percent Probability of Conversion at 192 Weeks', 'categories': [{'measurements': [{'value': '22.3', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '32.7'}, {'value': '37.5', 'groupId': 'OG001', 'lowerLimit': '28.6', 'upperLimit': '46.4'}, {'value': '35.9', 'groupId': 'OG002', 'lowerLimit': '24.0', 'upperLimit': '47.8'}, {'value': '24.8', 'groupId': 'OG003', 'lowerLimit': '17.6', 'upperLimit': '32.0'}]}]}, {'title': 'Percent Probability of Conversion at 216 Weeks', 'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '37.3'}, {'value': '38.9', 'groupId': 'OG001', 'lowerLimit': '29.8', 'upperLimit': '48.1'}, {'value': '39.3', 'groupId': 'OG002', 'lowerLimit': '26.3', 'upperLimit': '52.3'}, {'value': '24.8', 'groupId': 'OG003', 'lowerLimit': '17.6', 'upperLimit': '32.0'}]}]}, {'title': 'Percent Probability of Conversion at 240 Weeks', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '42.9'}, {'value': '40.8', 'groupId': 'OG001', 'lowerLimit': '31.3', 'upperLimit': '50.4'}, {'value': '39.3', 'groupId': 'OG002', 'lowerLimit': '26.3', 'upperLimit': '52.3'}, {'value': '26.3', 'groupId': 'OG003', 'lowerLimit': '18.7', 'upperLimit': '34.0'}]}]}, {'title': 'Percent Probability of Conversion at 264 Weeks', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '42.9'}, {'value': '43.0', 'groupId': 'OG001', 'lowerLimit': '32.9', 'upperLimit': '53.2'}, {'value': '39.3', 'groupId': 'OG002', 'lowerLimit': '26.3', 'upperLimit': '52.3'}, {'value': '26.3', 'groupId': 'OG003', 'lowerLimit': '18.7', 'upperLimit': '34.0'}]}]}, {'title': 'Percent Probability of Conversion at 288 Weeks', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '42.9'}, {'value': '43.0', 'groupId': 'OG001', 'lowerLimit': '32.9', 'upperLimit': '53.2'}, {'value': '39.3', 'groupId': 'OG002', 'lowerLimit': '26.3', 'upperLimit': '52.3'}, {'value': '26.3', 'groupId': 'OG003', 'lowerLimit': '18.7', 'upperLimit': '34.0'}]}]}, {'title': 'Percent Probability of Conversion at 312 Weeks', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '42.9'}, {'value': '43.0', 'groupId': 'OG001', 'lowerLimit': '32.9', 'upperLimit': '53.2'}, {'value': '49.4', 'groupId': 'OG002', 'lowerLimit': '28.3', 'upperLimit': '70.5'}, {'value': '26.3', 'groupId': 'OG003', 'lowerLimit': '18.7', 'upperLimit': '34.0'}]}]}, {'title': 'Percent Probability of Conversion at 336 Weeks', 'categories': [{'measurements': [{'value': '29.5', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '42.9'}, {'value': '48.7', 'groupId': 'OG001', 'lowerLimit': '34.7', 'upperLimit': '62.7'}, {'value': '49.4', 'groupId': 'OG002', 'lowerLimit': '28.3', 'upperLimit': '70.5'}, {'value': '26.3', 'groupId': 'OG003', 'lowerLimit': '18.7', 'upperLimit': '34.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization in the core period up to 390 Weeks (Extension treatment period [maximum exposure: 283 Weeks])', 'description': 'Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion was estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population: all randomized participants in the extension who had at least 1 day IMP exposure. Participants were analyzed according to the treatment group allocated by the randomization in the core study followed by the re-randomized treatment group during the extension period.'}, {'type': 'SECONDARY', 'title': 'Extension Treatment Period: Overview of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '150', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Teriflunomide 7 mg', 'description': 'Core treatment period: Placebo matched to teriflunomide tablet once daily orally.\n\nExtension treatment period: Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg/ 7mg', 'description': 'Core treatment period: Teriflunomide 7 mg tablet once daily orally.\n\nExtension treatment period: Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Placebo/ Teriflunomide 14 mg', 'description': 'Core treatment period: Placebo matched to teriflunomide tablet once daily orally.\n\nExtension treatment period: Teriflunomide 14 mg tablet once daily orally.'}, {'id': 'OG003', 'title': 'Teriflunomide 14 mg/14 mg', 'description': 'Core treatment period: Teriflunomide 14 mg tablet once daily orally.\n\nExtension treatment period: Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '120', 'groupId': 'OG003'}]}]}, {'title': 'Any Serious AE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}, {'title': 'Any AE Leading to Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any AE leading to Permanent Discontinuation', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From re-randomization up to 283 Weeks', 'description': 'AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. Safety population included all randomized population who actually received at least 1 dose of the IMP in extension and analyzed according to the treatment actually received in core study followed by treatment actually received in the extension treatment period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Safety population. In Placebo/teriflunomide 7mg arm, 2 received 7mg in the core period; In Placebo/teriflunomide 14mg, 1 received 7mg in the core period, hence, they were included in the 7mg/7mg arm in extension period as treatment received in the core period for consistency.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg', 'description': 'Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg', 'description': 'Teriflunomide 14 mg tablet once daily orally.'}], 'classes': [{'title': 'ALT >3 ULN (n=190, 207, 216)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'ALT >5 ULN (n=190, 207, 216)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'ALT >10 ULN (n=190, 207, 216)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'ALT >20 ULN (n=190, 207, 216)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'AST >3 ULN (n=190, 207, 216)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'AST >5 ULN (n=190, 207, 216)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'AST >10 ULN (n=190, 207, 216)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'AST >20 ULN (n=190, 207, 216)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Alkaline Phosphatase >1.5 ULN (n=190, 207, 216)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'TB >1.5 ULN (n=190, 207, 216)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'TB >2 ULN (n=190, 207, 216)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'TB >3 ULN (n=190, 207, 216)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'ALT >3 ULN and TB >2 ULN (n=190, 207, 216)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first', 'description': 'PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.\n\nHepatic parameters thresholds were defined as follows:\n\n* Alanine Aminotransferase (ALT) \\>3, 5, 10 or 20 upper limit of normal(ULN);\n* Aspartate aminotransferase (AST) \\>3, 5, 10 or 20 ULN;\n* Alkaline Phosphatase \\>1.5 ULN;\n* Total Bilirubin (TB) \\>1.5, 2, or 3 ULN;\n* ALT \\>3 ULN and TB \\>2 ULN.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population as described in Outcome Measure 13. Here 'n' signifies the number of participants for the treatment group who had that parameter assessed at post-baseline."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Core treatment period: Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'FG001', 'title': 'Teriflunomide 7 mg', 'description': 'Core treatment period: Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'FG002', 'title': 'Teriflunomide 14 mg', 'description': 'Core treatment period: Teriflunomide 14 mg tablet once daily orally.'}, {'id': 'FG003', 'title': 'Placebo/ Teriflunomide 7 mg', 'description': 'Core treatment period: Placebo matched to teriflunomide tablet once daily orally.\n\nExtension treatment period: Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'FG004', 'title': 'Teriflunomide 7 mg/7 mg', 'description': 'Core treatment period: Teriflunomide 7 mg tablet once daily orally.\n\nExtension treatment period: Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'FG005', 'title': 'Placebo/Teriflunomide 14 mg', 'description': 'Core treatment period: Placebo matched to teriflunomide tablet once daily orally.\n\nExtension treatment period: Teriflunomide 14 mg tablet once daily orally.'}, {'id': 'FG006', 'title': 'Teriflunomide 14 mg/14 mg', 'description': 'Core treatment period: Teriflunomide 14 mg tablet once daily orally.\n\nExtension treatment period: Teriflunomide 14 mg tablet once daily orally.'}], 'periods': [{'title': 'Core Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '205'}, {'groupId': 'FG002', 'numSubjects': '216'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '197'}, {'groupId': 'FG001', 'numSubjects': '203'}, {'groupId': 'FG002', 'numSubjects': '214'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '150'}, {'groupId': 'FG002', 'numSubjects': '163'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '53'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Randomized but Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Death', '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': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'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': '12'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other than specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Extension Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants were re-randomized in a 1:1 ratio to either teriflunomide 7 mg or 14 mg treatment arm.', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'comment': '10 participants completed core treatment period but did not enter in extension treatment period.', 'groupId': 'FG003', 'numSubjects': '64'}, {'comment': '8 participants completed core treatment period but did not enter in extension treatment period.', 'groupId': 'FG004', 'numSubjects': '142'}, {'comment': '10 participants completed core treatment period but did not enter in extension treatment period.', 'groupId': 'FG005', 'numSubjects': '67'}, {'comment': '13 participants completed core treatment period but did not enter in extension treatment period.', 'groupId': 'FG006', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '43'}, {'groupId': 'FG004', 'numSubjects': '103'}, {'groupId': 'FG005', 'numSubjects': '50'}, {'groupId': 'FG006', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '39'}, {'groupId': 'FG005', 'numSubjects': '17'}, {'groupId': 'FG006', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '10'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other than specified above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 846 participants were screened, of which 618 randomized in core treatment period. Out of 618, 423 entered in extension treatment period. End date of core treatment period was 17 December 2012 (maximum treatment duration: 120 weeks). End date of extension treatment period was 05 February 2016 (maximum treatment duration: 283 weeks).', 'preAssignmentDetails': 'Participants were randomized in 1:1:1 ratio to teriflunomide 7 mg,14 mg or placebo in core treatment period. Those completing core period, given opportunity to enter long-term extension period (participants originally given placebo re-randomized \\[1:1\\]to teriflunomide 7 mg/14 mg; those originally given 7 mg,14 mg continued with the same fixed dose).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'BG000'}, {'value': '205', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}, {'value': '618', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matched to teriflunomide tablet once daily orally.'}, {'id': 'BG001', 'title': 'Teriflunomide 7 mg', 'description': 'Teriflunomide 7 mg tablet once daily orally.'}, {'id': 'BG002', 'title': 'Teriflunomide 14 mg', 'description': 'Teriflunomide 14 mg tablet once daily orally.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.0', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '31.6', 'spread': '9.0', 'groupId': 'BG001'}, {'value': '32.8', 'spread': '8.1', 'groupId': 'BG002'}, {'value': '32.7', 'spread': '8.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '419', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '199', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region', 'classes': [{'title': 'Eastern Europe', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '291', 'groupId': 'BG003'}]}]}, {'title': 'Western Europe', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '224', 'groupId': 'BG003'}]}]}, {'title': 'Americas and Australia', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Expanded Disability Status Scale (EDSS) Score', 'classes': [{'categories': [{'measurements': [{'value': '1.71', 'spread': '1.00', 'groupId': 'BG000'}, {'value': '1.50', 'spread': '1.02', 'groupId': 'BG001'}, {'value': '1.80', 'spread': '0.97', 'groupId': 'BG002'}, {'value': '1.67', 'spread': '1.00', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Randomized population: all randomized participants according to the treatment group to which they were assigned in the core treatment period.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 618}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'dispFirstSubmitDate': '2013-12-16', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-20', 'studyFirstSubmitDate': '2008-02-14', 'dispFirstSubmitQcDate': '2013-12-16', 'resultsFirstSubmitDate': '2014-11-07', 'studyFirstSubmitQcDate': '2008-02-22', 'dispFirstPostDateStruct': {'date': '2014-01-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-17', 'studyFirstPostDateStruct': {'date': '2008-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA)', 'timeFrame': 'From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first', 'description': 'PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.\n\nHepatic parameters thresholds were defined as follows:\n\n* Alanine Aminotransferase (ALT) \\>3, 5, 10 or 20 upper limit of normal(ULN);\n* Aspartate aminotransferase (AST) \\>3, 5, 10 or 20 ULN;\n* Alkaline Phosphatase \\>1.5 ULN;\n* Total Bilirubin (TB) \\>1.5, 2, or 3 ULN;\n* ALT \\>3 ULN and TB \\>2 ULN.'}], 'primaryOutcomes': [{'measure': 'Core Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS)', 'timeFrame': 'Up to a maximum of 108 weeks depending on time of enrollment', 'description': 'Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.'}], 'secondaryOutcomes': [{'measure': 'Core Treatment Period: Time to Conversion to Definite Multiple Sclerosis (DMS)', 'timeFrame': 'Up to a maximum of 108 weeks depending on time of enrollment', 'description': "Conversion to DMS was demonstrated by dissemination of MRI lesions in time (as per McDonald criteria) or a relapse, whichever occurs first. MRI Imaging criteria were detection of Gadolinium (Gd) enhancement at least 3 months after onset of initial clinical event, if not at site corresponding to initial event; detection of new T2 lesion if it appears at any time compared with reference scan (done at time of screening) done at least 30 days after onset of the initial clinical event. Occurrence of relapse was defined as new neurological abnormality separated by at least 30 days from onset of preceding clinical event, present for at least 24 hours and occurring in absence of fever or known infection. New clinical abnormality (neurological sign) that is consistent with participant's symptoms with increase in at least one Functional System (FS) or EDSS score compared to last EDSS assessment. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method."}, {'measure': 'Core Treatment Period: Annualized Relapse Rate (ARR)', 'timeFrame': 'Up to a maximum of 108 weeks depending on time of enrollment', 'description': 'ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. Each episode of relapse (appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever) was to be confirmed by an increase in EDSS score or Functional System scores. ARR was assessed using Poisson regression model with robust error variance. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses onset between randomization date and last dose date as the response variable, treatment, region and baseline monofocal/multifocal status as covariates, and log-transformed treatment duration as an offset variable).'}, {'measure': 'Core Treatment Period: Brain Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Lesion Volume at Week 108', 'timeFrame': 'Baseline, Week 108', 'description': 'The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.'}, {'measure': 'Core Treatment Period: Brain MRI Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan (Poisson Regression Estimates)', 'timeFrame': 'Up to a maximum of 108 weeks depending on time of enrollment', 'description': 'Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).'}, {'measure': 'Core Treatment Period: Brain MRI Assessment: Volume of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan', 'timeFrame': 'Up to a maximum of 108 weeks depending on time of enrollment', 'description': 'Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).'}, {'measure': 'Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of Hypointense Post-Gadolinium T1 Lesion Component', 'timeFrame': 'Baseline, Week 108', 'description': 'Volume of hypointense post-gadolinium T1 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction'}, {'measure': 'Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of T2 Lesion Component', 'timeFrame': 'Baseline, Week 108', 'description': 'Volume of T2 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction.'}, {'measure': 'Core Treatment Period: Brain MRI Assessment: Percent Change From Baseline in Atrophy', 'timeFrame': 'Baseline, Week 108', 'description': 'Atrophy was measured by MRI scan.'}, {'measure': 'Core Treatment Period: Time to 12-Week Sustained Disability Progression', 'timeFrame': 'Up to a maximum of 108 weeks depending on time of enrollment', 'description': 'The 12-week sustained disability progression was defined as increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score of greater than \\[\\>\\] 5.5) that persisted for at least 12 weeks. Percent probability of participants free of 12-week sustained disability progression at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.'}, {'measure': 'Core Treatment Period: Change From Baseline in EDSS at Week 108', 'timeFrame': 'Baseline, Week 108', 'description': 'EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction'}, {'measure': 'Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 108', 'timeFrame': 'Baseline, Week 108', 'description': 'FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social. FIS total score ranges from 0 (no problem) to 160 (extreme problem). Least-square means were estimated using a Mixed-effect model with repeated measures \\[MMRM\\] on FIS total score data adjusted for or baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction.'}, {'measure': 'Core Treatment Period: Overview of Adverse Events (AEs)', 'timeFrame': 'From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first', 'description': 'AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.'}, {'measure': 'Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS)', 'timeFrame': 'From randomization in the core period up to 390 Weeks (Extension treatment period [maximum exposure: 283 Weeks])', 'description': 'Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion was estimated using Kaplan-Meier method.'}, {'measure': 'Extension Treatment Period: Overview of Adverse Events (AEs)', 'timeFrame': 'From re-randomization up to 283 Weeks', 'description': 'AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. Safety population included all randomized population who actually received at least 1 dose of the IMP in extension and analyzed according to the treatment actually received in core study followed by treatment actually received in the extension treatment period.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['MS', 'Clinically Isolated Syndrome', 'CIS', 'CDMS', 'relapses'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '25192851', 'type': 'BACKGROUND', 'citation': "Miller AE, Wolinsky JS, Kappos L, Comi G, Freedman MS, Olsson TP, Bauer D, Benamor M, Truffinet P, O'Connor PW; TOPIC Study Group. Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Oct;13(10):977-86. doi: 10.1016/S1474-4422(14)70191-7. Epub 2014 Sep 2."}]}, 'descriptionModule': {'briefSummary': 'The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day \\[mg/day\\] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS).\n\nThe secondary objectives were:\n\n* To demonstrate the effect of teriflunomide, in comparison to placebo, on:\n\n * Reducing conversion to definite multiple sclerosis (DMS)\n * Reducing annualized relapse rate (ARR)\n * Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI)\n * Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS)\n * Proportion of disability-free participants as assessed by the EDSS\n * Reducing participant-reported fatigue\n* To evaluate the safety and tolerability of teriflunomide\n* To evaluate the pharmacokinetics (PK) of teriflunomide\n* Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes', 'detailedDescription': "The study consisted of 4 periods:\n\n* Screening period: up to 4 weeks,\n* Placebo-controlled treatment period: up to 108 weeks (at least 24 weeks for participants who experienced conversion to CDMS),\n* Extension treatment period (without placebo-control): the extension period continued until teriflunomide was commercially available in participant's country of residence.\n* Post-treatment washout period: 4 weeks after last treatment intake.\n\nThe maximal duration of the study period per participant was expected to be 116 weeks if he/she did not continue in the extension treatment period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* First acute or subacute, well-defined neurological event consistent with demyelination (that is, optic neuritis confirmed by an ophthalmologist, spinal cord syndrome, brainstem/cerebellar syndromes)\n* Onset of MS symptoms occurring within 90 days of randomization\n* A screening MRI scan with 2 or more T2 lesions at least 3 millimeter (mm) in diameter that are characteristic of MS\n\nExclusion Criteria:\n\n* Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease\n* Significantly impaired bone marrow function\n* Pregnancy or nursing\n* Alcohol or drug abuse\n* Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment\n* Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00622700', 'acronym': 'TOPIC', 'briefTitle': 'Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period', 'orgStudyIdInfo': {'id': 'EFC6260'}, 'secondaryIdInfos': [{'id': 'HMR1726D-3005', 'type': 'OTHER', 'domain': 'HMR'}, {'id': '2006-001152-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/Teriflunomide 7 mg or Teriflunomide 14 mg', 'description': 'Core treatment period: Placebo matched to teriflunomide tablet once daily orally.\n\nExtension treatment period: Re-randomized in 1:1 ratio to either teriflunomide 7 mg or 14 mg once daily orally.', 'interventionNames': ['Drug: Teriflunomide', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Teriflunomide 7 mg/7 mg', 'description': 'Core treatment period: Teriflunomide 7 mg tablet once daily orally.\n\nExtension treatment period: Teriflunomide 7 mg tablet once daily orally.', 'interventionNames': ['Drug: Teriflunomide']}, {'type': 'EXPERIMENTAL', 'label': 'Teriflunomide 14 mg/14 mg', 'description': 'Core treatment period: Teriflunomide 14 mg tablet once daily orally.\n\nExtension treatment period: Teriflunomide 14 mg tablet once daily orally.', 'interventionNames': ['Drug: Teriflunomide']}], 'interventions': [{'name': 'Teriflunomide', 'type': 'DRUG', 'otherNames': ['HMR1726', 'Aubagio'], 'description': 'Film-coated tablet Oral administration', 'armGroupLabels': ['Placebo/Teriflunomide 7 mg or Teriflunomide 14 mg', 'Teriflunomide 14 mg/14 mg', 'Teriflunomide 7 mg/7 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Film-coated tablet Oral administration', 'armGroupLabels': ['Placebo/Teriflunomide 7 mg or Teriflunomide 14 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35058', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigational Site Number 8965', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '85013-4496', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 8954', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85060', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigational Site Number 8946', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Investigational Site Number 8962', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '32761', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8920', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigational Site Number 8953', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '63104', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 8914', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Investigational Site Number 8940', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigational Site Number 8922', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 8955', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49684', 'city': 'Traverse City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigational Site Number 8949', 'geoPoint': {'lat': 44.76306, 'lon': -85.62063}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigational Site Number 8937', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Investigational Site Number 8951', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10029-6574', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Investigational Site Number 8925', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Site Number 8941', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '45409', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigational Site Number 8924', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigational Site Number 8905', 'geoPoint': {'lat': 36.26508, 'lon': -84.26354}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Investigational Site Number 8930', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Investigational Site Number 8963', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '3220', 'city': 'Geelong', 'country': 'Australia', 'facility': 'Investigational Site Number 1405', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}, {'zip': '3081', 'city': 'Heidelberg', 'country': 'Australia', 'facility': 'Investigational Site Number 1404', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '7001', 'city': 'Hobart', 'country': 'Australia', 'facility': 'Investigational Site Number 1407', 'geoPoint': {'lat': -42.87936, 'lon': 147.32941}}, {'zip': '3050', 'city': 'Parkville', 'country': 'Australia', 'facility': 'Investigational Site Number 1401', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Investigational Site Number 4004', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Investigational Site Number 4005', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1010', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Investigational Site Number 4001', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Investigational Site Number 5312', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '1000', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Investigational Site Number 5307', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1407', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Investigational Site Number 5304', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Investigational Site Number 5309', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1527', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Investigational Site Number 5303', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1606', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Investigational Site Number 5306', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': 'J4V 2J2', 'city': 'Greenfield Park', 'country': 'Canada', 'facility': 'Investigational Site Number 5402', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'N6A 5A5', 'city': 'London', 'country': 'Canada', 'facility': 'Investigational Site Number 5403', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'country': 'Canada', 'facility': 'Investigational Site Number 5409', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'country': 'Canada', 'facility': 'Investigational Site Number 5401', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'G1J 1Z4', 'city': 'Québec', 'country': 'Canada', 'facility': 'Investigational Site Number 5406', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'country': 'Canada', 'facility': 'Investigational Site Number 5408', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Investigational Site Number 5410', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'country': 'Canada', 'facility': 'Investigational Site Number 5404', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '760-0746', 'city': 'Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number 5602', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number 5601', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Investigational Site Number 5606', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '2520997', 'city': 'Viña del Mar', 'country': 'Chile', 'facility': 'Investigational Site Number 5605', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}, {'zip': '65691', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Investigational Site Number 5801', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '50005', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Investigational Site Number 5803', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '77520', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Investigational Site Number 5804', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '70852', 'city': 'Ostrava - Poruba', 'country': 'Czechia', 'facility': 'Investigational Site Number 5805'}, {'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Investigational Site Number 6002', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}, {'zip': '6700', 'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'Investigational Site Number 6004', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'zip': '10617', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'Investigational Site Number 6201', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '50406', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'Investigational Site 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