Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2025-12-27 @ 10:36 PM
Study NCT ID:
NCT00811395
Status:
COMPLETED
Last Update Posted:
2012-12-31
First Post:
2008-12-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C527525', 'term': 'teriflunomide'}, {'id': 'D000068556', 'term': 'Interferon beta-1a'}, {'id': 'D000068576', 'term': 'Interferon beta-1b'}, {'id': 'D000068717', 'term': 'Glatiramer Acetate'}], 'ancestors': [{'id': 'D016899', 'term': 'Interferon-beta'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Contact_US@sanofi-aventis.com', 'title': 'Trial Transparency Team', 'organization': 'sanofi-aventis'}, 'certainAgreement': {'otherDetails': 'If no publication has occurred within 12 months after trial completion, the Investigator can publish the results. Prior to publication, the sponsor shall review the manuscript and can request changes, provided they do not jeopardize the accuracy and/or the scientific value of the publication. The approval is given in writing by the sponsor, not exceeding 90 days.\n\nTo protect by property right the sponsor can postpone the publication of any information, for a period not exceeding 18 months.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Events (AE) were collected regardless of seriousness or relationship to the drug, spanning from signature of the Informed Consent up to the last visit.', 'description': 'The analysis was performed on the exposed population and included all AE that developed or worsened from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured first (64 weeks max).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + IFN-β', 'description': 'Placebo (for teriflunomide) once daily concomitantly with interferon-β \\[IFN-β\\]', 'otherNumAtRisk': 41, 'otherNumAffected': 28, 'seriousNumAtRisk': 41, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Teriflunomide 7 mg + IFN-β', 'description': 'Teriflunomide 7 mg once daily concomitantly with interferon-β \\[IFN-β\\]', 'otherNumAtRisk': 37, 'otherNumAffected': 33, 'seriousNumAtRisk': 37, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Teriflunomide 14 mg + IFN-β', 'description': 'Teriflunomide 14 mg once daily concomitantly with interferon-β \\[IFN-β\\]', 'otherNumAtRisk': 38, 'otherNumAffected': 32, 'seriousNumAtRisk': 38, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo + GA', 'description': 'Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate \\[GA\\]', 'otherNumAtRisk': 40, 'otherNumAffected': 34, 'seriousNumAtRisk': 40, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'Teriflunomide 7 mg + GA', 'description': 'Teriflunomide 7 mg once daily concomitantly with glatiramer acetate \\[GA\\]', 'otherNumAtRisk': 42, 'otherNumAffected': 30, 'seriousNumAtRisk': 42, 'seriousNumAffected': 5}, {'id': 'EG005', 'title': 'Teriflunomide 14 mg + GA', 'description': 'Teriflunomide 14 mg once daily concomitantly with glatiramer acetate \\[GA\\]', 'otherNumAtRisk': 41, 'otherNumAffected': 34, 'seriousNumAtRisk': 41, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Muscle spasticity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG005', 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'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 41, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overview of Adverse Events [AE]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IFN-β', 'description': 'Placebo (for teriflunomide) once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg + IFN-β', 'description': 'Teriflunomide 7 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg + IFN-β', 'description': 'Teriflunomide 14 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG003', 'title': 'Placebo + GA', 'description': 'Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG004', 'title': 'Teriflunomide 7 mg + GA', 'description': 'Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG005', 'title': 'Teriflunomide 14 mg + GA', 'description': 'Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '38', 'groupId': 'OG005'}]}]}, {'title': '- serious AE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': '- AE leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '- AE leading to study drug discontinuation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)', 'description': 'AE 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': 'All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.'}, {'type': 'SECONDARY', 'title': 'Annualized Relapse Rate [ARR]: Poisson Regression Estimates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IFN-β', 'description': 'Placebo (for teriflunomide) once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg + IFN-β', 'description': 'Teriflunomide 7 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg + IFN-β', 'description': 'Teriflunomide 14 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG003', 'title': 'Placebo + GA', 'description': 'Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate \\[GA\\]'}, {'id': 'OG004', 'title': 'Teriflunomide 7 mg + GA', 'description': 'Teriflunomide 7 mg once daily concomitantly with glatiramer acetate \\[GA\\]'}, {'id': 'OG005', 'title': 'Teriflunomide 14 mg + GA', 'description': 'Teriflunomide 14 mg once daily concomitantly with glatiramer acetate \\[GA\\]'}], 'classes': [{'categories': [{'measurements': [{'value': '0.343', 'groupId': 'OG000', 'lowerLimit': '0.162', 'upperLimit': '0.727'}, {'value': '0.231', 'groupId': 'OG001', 'lowerLimit': '0.101', 'upperLimit': '0.529'}, {'value': '0.144', 'groupId': 'OG002', 'lowerLimit': '0.065', 'upperLimit': '0.318'}, {'value': '0.420', 'groupId': 'OG003', 'lowerLimit': '0.270', 'upperLimit': '0.654'}, {'value': '0.262', 'groupId': 'OG004', 'lowerLimit': '0.140', 'upperLimit': '0.489'}, {'value': '0.497', 'groupId': 'OG005', 'lowerLimit': '0.316', 'upperLimit': '0.783'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.\n\nEach 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 Expanded Disability Status Scale \\[EDSS\\] score or Functional System scores.\n\nTo account for the different treatment durations among participants, two Poisson regression models with robust error variance were used (total number of confirmed relapses as response variable, log-transformed treatment duration as "offset" variable and:\n\n* Model 1 (IFN-β groups): treatment group, region of enrollment and IFN-β dose level as covariates\n* Model 2 (GA groups): treatment group and region of enrollment as covariates)', 'unitOfMeasure': 'relapses per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.'}, {'type': 'PRIMARY', 'title': 'Overview of AE With Potential Risk of Occurence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IFN-β', 'description': 'Placebo (for teriflunomide) once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg + IFN-β', 'description': 'Teriflunomide 7 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg + IFN-β', 'description': 'Teriflunomide 14 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG003', 'title': 'Placebo + GA', 'description': 'Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG004', 'title': 'Teriflunomide 7 mg + GA', 'description': 'Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG005', 'title': 'Teriflunomide 14 mg + GA', 'description': 'Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}], 'classes': [{'title': 'Any AE with potential risk of occurence', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}]}, {'title': '- Hepatic disorder AE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': '- Immune effects related AE', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}]}]}, {'title': '- Pancreatic disorder AE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}]}, {'title': '- Malignancy AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '- Hair loss / hair thinning AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}, {'title': '- Pulmonary disorder AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '- Hypertension-related AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': '- Peripheral neuropathy AE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}]}, {'title': '- Psychiatric disorder AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': '- Hypersensitivity AE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)', 'description': 'AE with potential risk of occurrence were defined as follows:\n\n* Hepatic disorders;\n* Immune effects, mainly effects on bone marrow and infection;\n* Pancreatic disorders;\n* Malignancy;\n* Skin disorders, mainly hair loss and hair thinning;\n* Pulmonary disorders;\n* Hypertension;\n* Peripheral neuropathy;\n* Psychiatric disorders;\n* Hypersensitivity.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.'}, {'type': 'SECONDARY', 'title': 'Overview of 12-week Sustained Disability Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IFN-β', 'description': 'Placebo (for teriflunomide) once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg + IFN-β', 'description': 'Teriflunomide 7 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg + IFN-β', 'description': 'Teriflunomide 14 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG003', 'title': 'Placebo + GA', 'description': 'Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG004', 'title': 'Teriflunomide 7 mg + GA', 'description': 'Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG005', 'title': 'Teriflunomide 14 mg + GA', 'description': 'Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}], 'classes': [{'title': 'Disability progression', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.9'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.3'}, {'value': '1', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '4', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '13.2'}]}]}, {'title': 'Free of disability progression', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '23.1'}, {'value': '36', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '15.2'}, {'value': '37', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '20.4'}, {'value': '41', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '9.8'}, {'value': '36', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '24.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': '12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score \\>5.5) that persisted for at least 12 weeks.\n\nIf no disability progression was observed on or before last EDSS evaluation before study drug discontinuation, then the participant was considered as free of disability progression.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.'}, {'type': 'SECONDARY', 'title': 'Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IFN-β', 'description': 'Placebo (for teriflunomide) once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg + IFN-β', 'description': 'Teriflunomide 7 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg + IFN-β', 'description': 'Teriflunomide 14 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG003', 'title': 'Placebo + GA', 'description': 'Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG004', 'title': 'Teriflunomide 7 mg + GA', 'description': 'Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG005', 'title': 'Teriflunomide 14 mg + GA', 'description': 'Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}], 'classes': [{'title': 'Probability of disability progression at 24 weeks', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.9'}, {'value': '2.7', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.9'}, {'value': '2.5', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.3'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '5.6', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '13.2'}]}]}, {'title': 'Probability of disability progression at 48 weeks', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '23.1'}, {'value': '6.4', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '15.2'}, {'value': '10.6', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '20.4'}, {'value': '3.3', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '9.8'}, {'value': '12.8', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '24.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Probability of disability progression at 24 and 48 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase. Participants free of disability progression were censored at the date of the last on-treatment EDSS evaluation.\n\nKaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t.', 'unitOfMeasure': 'percent probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.'}, {'type': 'SECONDARY', 'title': 'Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IFN-β', 'description': 'Placebo (for teriflunomide) once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg + IFN-β', 'description': 'Teriflunomide 7 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg + IFN-β', 'description': 'Teriflunomide 14 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG003', 'title': 'Placebo + GA', 'description': 'Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG004', 'title': 'Teriflunomide 7 mg + GA', 'description': 'Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG005', 'title': 'Teriflunomide 14 mg + GA', 'description': 'Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.017', 'spread': '0.028', 'groupId': 'OG000', 'lowerLimit': '-11.29', 'upperLimit': '7.26'}, {'value': '-0.011', 'spread': '0.030', 'groupId': 'OG001', 'lowerLimit': '-9.63', 'upperLimit': '3.35'}, {'value': '-0.012', 'spread': '0.029', 'groupId': 'OG002', 'lowerLimit': '-8.97', 'upperLimit': '7.29'}, {'value': '0.016', 'spread': '0.036', 'groupId': 'OG003', 'lowerLimit': '-15.62', 'upperLimit': '19.44'}, {'value': '-0.010', 'spread': '0.037', 'groupId': 'OG004', 'lowerLimit': '-15.91', 'upperLimit': '7.04'}, {'value': '-0.063', 'spread': '0.039', 'groupId': 'OG005', 'lowerLimit': '-10.69', 'upperLimit': '7.02'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline (before randomization in PDY6045 or PDY6046) and 48 weeks', 'description': 'Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.\n\nLeast-square means were estimated using two Mixed-effect models with repeated measures \\[MMRM\\] on cubic root transformed volume data:\n\n* Model 1 (IFN-β groups): treatment group, region of enrollment, IFN-β dose level, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors;\n* Model 2 (GA groups): treatment group, region of enrollment, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors.', 'unitOfMeasure': 'mililiters (mL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.'}, {'type': 'SECONDARY', 'title': 'Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IFN-β', 'description': 'Placebo (for teriflunomide) once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg + IFN-β', 'description': 'Teriflunomide 7 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg + IFN-β', 'description': 'Teriflunomide 14 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG003', 'title': 'Placebo + GA', 'description': 'Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG004', 'title': 'Teriflunomide 7 mg + GA', 'description': 'Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG005', 'title': 'Teriflunomide 14 mg + GA', 'description': 'Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}], 'classes': [{'categories': [{'measurements': [{'value': '0.521', 'groupId': 'OG000', 'lowerLimit': '0.318', 'upperLimit': '0.854'}, {'value': '0.080', 'groupId': 'OG001', 'lowerLimit': '0.032', 'upperLimit': '0.204'}, {'value': '0.090', 'groupId': 'OG002', 'lowerLimit': '0.052', 'upperLimit': '0.154'}, {'value': '0.333', 'groupId': 'OG003', 'lowerLimit': '0.171', 'upperLimit': '0.649'}, {'value': '0.120', 'groupId': 'OG004', 'lowerLimit': '0.059', 'upperLimit': '0.243'}, {'value': '0.178', 'groupId': 'OG005', 'lowerLimit': '0.098', 'upperLimit': '0.324'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.\n\nTo account for the different number of scans among participants, two Poisson regression models with robust error variance were used (total number of Gd-enhancing T1-lesions as response variable, log-transformed number of scans as "offset" variable and:\n\n* Model 1 (IFN-β groups): Treatment group, region of enrollment, IFN-β dose level and baseline number of Gd-enhancing T1-lesions as covariates\n* Model 2 (GA groups): Treatment group, region of enrollment and baseline number of Gd-enhancing T1-lesions as covariates)', 'unitOfMeasure': 'lesions per scan', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.'}, {'type': 'PRIMARY', 'title': 'Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '41', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IFN-β', 'description': 'Placebo (for teriflunomide) once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg + IFN-β', 'description': 'Teriflunomide 7 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg + IFN-β', 'description': 'Teriflunomide 14 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG003', 'title': 'Placebo + GA', 'description': 'Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG004', 'title': 'Teriflunomide 7 mg + GA', 'description': 'Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG005', 'title': 'Teriflunomide 14 mg + GA', 'description': 'Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}], 'classes': [{'title': 'ALT >3 ULN', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': '- ALT >5 ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': '- ALT >10 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'AST >3 ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': '- AST >5 ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Alkaline Phosphatase >1.5 ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'TB >1.5 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'ALT >3 ULN and TB >2 ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)', '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 Normal Limit \\[ULN\\];\n* Aspartate aminotransferase \\[AST\\] \\>3, 5, 10 or 20 ULN;\n* Alkaline Phosphatase \\>1.5 ULN;\n* Total Bilirubin \\[TB\\] \\>1.5 or 2 ULN;\n* ALT \\>3 ULN and TB \\>2 ULN;', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.'}, {'type': 'SECONDARY', 'title': 'Cerebral MRI Assessment: Total Volume of Gd-enhancing T1-lesions Per Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + IFN-β', 'description': 'Placebo (for teriflunomide) once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG001', 'title': 'Teriflunomide 7 mg + IFN-β', 'description': 'Teriflunomide 7 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG002', 'title': 'Teriflunomide 14 mg + IFN-β', 'description': 'Teriflunomide 14 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'OG003', 'title': 'Placebo + GA', 'description': 'Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG004', 'title': 'Teriflunomide 7 mg + GA', 'description': 'Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'OG005', 'title': 'Teriflunomide 14 mg + GA', 'description': 'Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}], 'classes': [{'categories': [{'measurements': [{'value': '0.068', 'groupId': 'OG000'}, {'value': '0.019', 'groupId': 'OG001'}, {'value': '0.020', 'groupId': 'OG002'}, {'value': '0.052', 'groupId': 'OG003'}, {'value': '0.031', 'groupId': 'OG004'}, {'value': '0.014', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 weeks', 'description': 'Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.', 'unitOfMeasure': 'mililiters per scan', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized and treated participants; Participants were included in the treatment group according to the drug actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + IFN-β', 'description': 'Placebo (for teriflunomide) once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'FG001', 'title': 'Teriflunomide 7 mg + IFN-β', 'description': 'Teriflunomide 7 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'FG002', 'title': 'Teriflunomide 14 mg + IFN-β', 'description': 'Teriflunomide 14 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'FG003', 'title': 'Placebo + GA', 'description': 'Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'FG004', 'title': 'Teriflunomide 7 mg + GA', 'description': 'Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'FG005', 'title': 'Teriflunomide 14 mg + GA', 'description': 'Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}], 'periods': [{'title': 'Initial Treatment (PDY6045 or PDY6046)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'comment': 'One participant received 7 mg instead of 14 mg as per randomization', 'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '40'}, {'groupId': 'FG004', 'numSubjects': '42'}, {'groupId': 'FG005', 'numSubjects': '41'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'completed 24-week treatment (for more information see PDY6045/NCT00489489 record)', 'groupId': 'FG000', 'numSubjects': '38'}, {'comment': 'completed 24-week treatment (for more information see PDY6045/NCT00489489 record)', 'groupId': 'FG001', 'numSubjects': '33'}, {'comment': 'completed 24-week treatment (for more information see PDY6045/NCT00489489 record)', 'groupId': 'FG002', 'numSubjects': '36'}, {'comment': 'completed 24-week treatment (for more information see PDY6046/NCT00475865 record)', 'groupId': 'FG003', 'numSubjects': '38'}, {'comment': 'completed 24-week treatment (for more information see PDY6046/NCT00475865 record)', 'groupId': 'FG004', 'numSubjects': '37'}, {'comment': 'completed 24-week treatment (for more information see PDY6046/NCT00475865 record)', 'groupId': 'FG005', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '6'}]}]}, {'title': 'Extension Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'continued initial treatment', 'groupId': 'FG000', 'numSubjects': '31'}, {'comment': 'continued initial treatment', 'groupId': 'FG001', 'numSubjects': '28'}, {'comment': 'continued initial treatment', 'groupId': 'FG002', 'numSubjects': '27'}, {'comment': 'continued initial treatment', 'groupId': 'FG003', 'numSubjects': '37'}, {'comment': 'continued initial treatment', 'groupId': 'FG004', 'numSubjects': '30'}, {'comment': 'continued initial treatment', 'groupId': 'FG005', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'completed 48-week treatment', 'groupId': 'FG000', 'numSubjects': '29'}, {'comment': 'completed 48-week treatment', 'groupId': 'FG001', 'numSubjects': '22'}, {'comment': 'completed 48-week treatment', 'groupId': 'FG002', 'numSubjects': '24'}, {'comment': 'completed 48-week treatment', 'groupId': 'FG003', 'numSubjects': '34'}, {'comment': 'completed 48-week treatment', 'groupId': 'FG004', 'numSubjects': '30'}, {'comment': 'completed 48-week treatment', 'groupId': 'FG005', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Participant did not wish to continue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other than above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '107 and 110 participants who successfully completed 24-week visit in, respectively, PDY6045 and PDY6046 studies, were offered to continue their treatment in this extension study.\n\nAfter signature of the informed consent and confirmation of selection criteria, 86 and 96 participants entered the extension study.', 'preAssignmentDetails': 'An Interactive Voice Response System was used to allocate kits containing the same treatment as in the initial study.\n\nAnalysis included all participants randomized in the initial studies and all data collected from randomization according to intent-to-treat principal.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}, {'value': '239', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + IFN-β', 'description': 'Placebo (for teriflunomide) once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'BG001', 'title': 'Teriflunomide 7 mg + IFN-β', 'description': 'Teriflunomide 7 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'BG002', 'title': 'Teriflunomide 14 mg + IFN-β', 'description': 'Teriflunomide 14 mg once daily concomitantly with interferon-β \\[IFN-β\\]'}, {'id': 'BG003', 'title': 'Placebo + GA', 'description': 'Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'BG004', 'title': 'Teriflunomide 7 mg + GA', 'description': 'Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'BG005', 'title': 'Teriflunomide 14 mg + GA', 'description': 'Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate \\[GA\\]'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<38 years', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '77', 'groupId': 'BG006'}]}]}, {'title': '>=38 years', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '162', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'Baseline characteristics before randomization in the initial study (PDY6045 or PDY6046)', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}, {'value': '178', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '61', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Europe', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}, {'value': '143', 'groupId': 'BG006'}]}]}, {'title': 'North America', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}, {'value': '96', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'description': 'Europe: Austria, Germany, Italy, Spain and United Kingdom\n\nNorth America: Canada and United States', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'dispFirstSubmitDate': '2011-05-24', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-18', 'studyFirstSubmitDate': '2008-12-18', 'dispFirstSubmitQcDate': '2011-06-08', 'resultsFirstSubmitDate': '2012-10-03', 'studyFirstSubmitQcDate': '2008-12-18', 'dispFirstPostDateStruct': {'date': '2011-06-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-12-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-18', 'studyFirstPostDateStruct': {'date': '2008-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overview of Adverse Events [AE]', 'timeFrame': 'from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)', 'description': 'AE are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.'}, {'measure': 'Overview of AE With Potential Risk of Occurence', 'timeFrame': 'from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)', 'description': 'AE with potential risk of occurrence were defined as follows:\n\n* Hepatic disorders;\n* Immune effects, mainly effects on bone marrow and infection;\n* Pancreatic disorders;\n* Malignancy;\n* Skin disorders, mainly hair loss and hair thinning;\n* Pulmonary disorders;\n* Hypertension;\n* Peripheral neuropathy;\n* Psychiatric disorders;\n* Hypersensitivity.'}, {'measure': 'Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA]', 'timeFrame': 'from first study drug intake in PDY6045/PDY6046 study up to 112 days after last intake in initial study or in the extension study, whichever occured last (64 weeks max)', '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 Normal Limit \\[ULN\\];\n* Aspartate aminotransferase \\[AST\\] \\>3, 5, 10 or 20 ULN;\n* Alkaline Phosphatase \\>1.5 ULN;\n* Total Bilirubin \\[TB\\] \\>1.5 or 2 ULN;\n* ALT \\>3 ULN and TB \\>2 ULN;'}], 'secondaryOutcomes': [{'measure': 'Annualized Relapse Rate [ARR]: Poisson Regression Estimates', 'timeFrame': '48 weeks', 'description': 'ARR is obtained from the total number of confirmed relapses that occured during the treatment period divided by the sum of the treatment durations.\n\nEach 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 Expanded Disability Status Scale \\[EDSS\\] score or Functional System scores.\n\nTo account for the different treatment durations among participants, two Poisson regression models with robust error variance were used (total number of confirmed relapses as response variable, log-transformed treatment duration as "offset" variable and:\n\n* Model 1 (IFN-β groups): treatment group, region of enrollment and IFN-β dose level as covariates\n* Model 2 (GA groups): treatment group and region of enrollment as covariates)'}, {'measure': 'Overview of 12-week Sustained Disability Progression', 'timeFrame': '48 weeks', 'description': '12-week sustained disability progression was defined as an increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score \\>5.5) that persisted for at least 12 weeks.\n\nIf no disability progression was observed on or before last EDSS evaluation before study drug discontinuation, then the participant was considered as free of disability progression.'}, {'measure': 'Time to 12-week Sustained Disability Progression: Kaplan-Meier Estimates of the Rate of Disability Progression at Timepoints', 'timeFrame': '48 weeks', 'description': 'Probability of disability progression at 24 and 48 weeks was estimated using Kaplan-Meier method on the time to disability progression defined as the time from randomization to first EDSS increase. Participants free of disability progression were censored at the date of the last on-treatment EDSS evaluation.\n\nKaplan-Meier method consists in computing probabilities of non occurrence of event at any observed time of event and multiplying successive probabilities for time ≤t by any earlier computed probabilities to estimate the probability of being event-free for the amount of time t. Probability of event at time t is 1 minus the probability of being event-free for the amount of time t.'}, {'measure': 'Cerebral Magnetic Resonance Imaging [MRI] Assessment: Change From Baseline in Total Lesion Volume (Burden of Disease)', 'timeFrame': 'baseline (before randomization in PDY6045 or PDY6046) and 48 weeks', 'description': 'Total lesion volume is the sum of the total volume of all T2-lesions and the total volume all T1-hypointense post-gadolinium lesions measured through T2/proton density scan analysis and gadolinium-enhanced T1 scan analysis.\n\nLeast-square means were estimated using two Mixed-effect models with repeated measures \\[MMRM\\] on cubic root transformed volume data:\n\n* Model 1 (IFN-β groups): treatment group, region of enrollment, IFN-β dose level, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors;\n* Model 2 (GA groups): treatment group, region of enrollment, visit, treatment-by-visit interaction, baseline value (cubic root transformed), and baseline-by-visit interaction as factors.'}, {'measure': 'Cerebral MRI Assessment: Number of Gd-enhancing T1-lesions Per Scan (Poisson Regression Estimates)', 'timeFrame': '48 weeks', 'description': 'Number of Gd-enhancing T1-lesions per scan is obtained from the total number of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.\n\nTo account for the different number of scans among participants, two Poisson regression models with robust error variance were used (total number of Gd-enhancing T1-lesions as response variable, log-transformed number of scans as "offset" variable and:\n\n* Model 1 (IFN-β groups): Treatment group, region of enrollment, IFN-β dose level and baseline number of Gd-enhancing T1-lesions as covariates\n* Model 2 (GA groups): Treatment group, region of enrollment and baseline number of Gd-enhancing T1-lesions as covariates)'}, {'measure': 'Cerebral MRI Assessment: Total Volume of Gd-enhancing T1-lesions Per Scan', 'timeFrame': '48 weeks', 'description': 'Total volume of Gd-enhancing T1-lesions per scan is obtained from the sum of the volumes of Gd-enhancing T1-lesions observed during the study divided by the total number of scans performed during the study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '22622860', 'type': 'RESULT', 'citation': "Freedman MS, Wolinsky JS, Wamil B, Confavreux C, Comi G, Kappos L, Olsson TP, Miller A, Benzerdjeb H, Li H, Simonson C, O'Connor PW; Teriflunomide Multiple Sclerosis Trial Group and the MRI Analysis Center. Teriflunomide added to interferon-beta in relapsing multiple sclerosis: a randomized phase II trial. Neurology. 2012 Jun 5;78(23):1877-85. doi: 10.1212/WNL.0b013e318258f7d4. Epub 2012 May 23."}, {'pmid': '28607708', 'type': 'DERIVED', 'citation': "Freedman MS, Wolinsky JS, Truffinet P, Comi G, Kappos L, Miller AE, Olsson TP, Benamor M, Chambers S, O'Connor PW. A randomized trial of teriflunomide added to glatiramer acetate in relapsing multiple sclerosis. Mult Scler J Exp Transl Clin. 2015 Dec 7;1:2055217315618687. doi: 10.1177/2055217315618687. eCollection 2015 Jan-Dec."}]}, 'descriptionModule': {'briefSummary': 'The primary objective was to evaluate the long-term safety and tolerability of teriflunomide when added to treatment with interferon-β \\[IFN-β\\] or glatiramer Acetate \\[GA\\] in patients with multiple sclerosis \\[MS\\] with relapses.\n\nSecondary objectives were to evaluate the long-term effect on relapse rate, disability progression and Magnetic Resonance Imaging \\[MRI\\] parameters.\n\nThis study is the extension study of the PDY6045 (NCT00489489) and PDY6046 (NCT00475865) studies. Participants who successfully completed the initial study were offered to continue their treatment (same compound, same dose) for 24 additional weeks.', 'detailedDescription': 'The duration of the extension study per participants was 40 weeks broken down as follows:\n\n* 24-week double-blind treatment period,\n* 16-week post-treatment elimination follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* PDY6045 or PDY6046 participant who:\n\n * completed the week 24 visit of either study PDY6045 or PDY6046,\n * was still meeting eligibility criteria for receiving treatment,\n * had agreed to continue stable dose of Interferon-β \\[IFN-β\\] or Glatiramer Acetate \\[GA\\] and consented to continue on treatment.\n\nExclusion Criteria:\n\n* Any known condition or circumstance that would have prevented in the investigator's opinion, compliance or completion of the study\n\nThe above information is not intended to contain all considerations relevant to patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00811395', 'briefTitle': 'Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Long-term Extension of the Multinational, Double-blind, Placebo Controlled Studies PDY6045 and PDY6046 to Document the Safety of Teriflunomide When Added to Treatment With Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis With Relapses', 'orgStudyIdInfo': {'id': 'LTS6047'}, 'secondaryIdInfos': [{'id': 'HMR1726D/2005', 'type': 'OTHER', 'domain': 'HMR'}, {'id': '2007-003997-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + IFN-β', 'description': 'Placebo (for teriflunomide) once daily concomitantly with interferon-β \\[IFN-β\\] for 24 additional weeks', 'interventionNames': ['Drug: Placebo (for teriflunomide)', 'Drug: Interferon-β [IFN-β]']}, {'type': 'EXPERIMENTAL', 'label': 'Teriflunomide 7 mg + IFN-β', 'description': 'Teriflunomide 7 mg once daily concomitantly with interferon-β \\[IFN-β\\] for 24 additional weeks', 'interventionNames': ['Drug: Teriflunomide', 'Drug: Interferon-β [IFN-β]']}, {'type': 'EXPERIMENTAL', 'label': 'Teriflunomide 14 mg + IFN-β', 'description': 'Teriflunomide 14 mg once daily concomitantly with interferon-β \\[IFN-β\\] for 24 additional weeks', 'interventionNames': ['Drug: Teriflunomide', 'Drug: Interferon-β [IFN-β]']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + GA', 'description': 'Placebo (for teriflunomide) once daily concomitantly with glatiramer acetate \\[GA\\] for 24 additional weeks', 'interventionNames': ['Drug: Placebo (for teriflunomide)', 'Drug: Glatiramer Acetate [GA]']}, {'type': 'EXPERIMENTAL', 'label': 'Teriflunomide 7 mg + GA', 'description': 'Teriflunomide 7 mg once daily concomitantly with glatiramer acetate \\[GA\\] for 24 additional weeks', 'interventionNames': ['Drug: Teriflunomide', 'Drug: Glatiramer Acetate [GA]']}, {'type': 'EXPERIMENTAL', 'label': 'Teriflunomide 14 mg + GA', 'description': 'Teriflunomide 14 mg once daily concomitantly with glatiramer acetate \\[GA\\] for 24 additional weeks', 'interventionNames': ['Drug: Teriflunomide', 'Drug: Glatiramer Acetate [GA]']}], 'interventions': [{'name': 'Teriflunomide', 'type': 'DRUG', 'otherNames': ['HMR1726'], 'description': 'Film-coated tablet\n\nOral administration', 'armGroupLabels': ['Teriflunomide 14 mg + GA', 'Teriflunomide 14 mg + IFN-β', 'Teriflunomide 7 mg + GA', 'Teriflunomide 7 mg + IFN-β']}, {'name': 'Placebo (for teriflunomide)', 'type': 'DRUG', 'description': 'Film-coated tablet\n\nOral administration', 'armGroupLabels': ['Placebo + GA', 'Placebo + IFN-β']}, {'name': 'Interferon-β [IFN-β]', 'type': 'DRUG', 'otherNames': ['Avonex®', 'Rebif®', 'Betaseron®'], 'description': 'Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection', 'armGroupLabels': ['Placebo + IFN-β', 'Teriflunomide 14 mg + IFN-β', 'Teriflunomide 7 mg + IFN-β']}, {'name': 'Glatiramer Acetate [GA]', 'type': 'DRUG', 'otherNames': ['Copaxone®'], 'description': 'Solution in prefilled syringe for subcutaneous injection', 'armGroupLabels': ['Placebo + GA', 'Teriflunomide 14 mg + GA', 'Teriflunomide 7 mg + GA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08807', 'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Laval', 'country': 'Canada', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Guildford', 'country': 'United Kingdom', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}