Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-02-12 @ 8:41 AM
Study NCT ID:
NCT01707992
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2012-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Kazakhstan', 'Mexico', 'Portugal']}, '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': 'C476223', 'term': 'laquinimod'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info.era-clinical@teva.de', 'phone': '215-591-3000', 'title': 'Director, Clinical Research', 'organization': 'Teva Branded Pharmaceutical Products, R&D Inc.'}, 'certainAgreement': {'otherDetails': "Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'description': 'Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.', 'otherNumAtRisk': 727, 'deathsNumAtRisk': 727, 'otherNumAffected': 262, 'seriousNumAtRisk': 727, 'deathsNumAffected': 1, 'seriousNumAffected': 57}, {'id': 'EG001', 'title': 'Placebo-Controlled Phase: Laquinimod 1.2 mg', 'description': 'Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.', 'otherNumAtRisk': 732, 'deathsNumAtRisk': 732, 'otherNumAffected': 286, 'seriousNumAtRisk': 732, 'deathsNumAffected': 1, 'seriousNumAffected': 49}, {'id': 'EG002', 'title': 'Placebo-Controlled Phase: Placebo', 'description': 'Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.', 'otherNumAtRisk': 740, 'deathsNumAtRisk': 740, 'otherNumAffected': 243, 'seriousNumAtRisk': 740, 'deathsNumAffected': 2, 'seriousNumAffected': 43}, {'id': 'EG003', 'title': 'Active Treatment Phase: Early Laquinimod 0.6 mg', 'description': 'Participants who completed the placebo-controlled phase on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.', 'otherNumAtRisk': 580, 'deathsNumAtRisk': 580, 'otherNumAffected': 102, 'seriousNumAtRisk': 580, 'deathsNumAffected': 2, 'seriousNumAffected': 24}, {'id': 'EG004', 'title': 'Active Treatment Phase: Early Laquinimod 1.2 mg', 'description': 'Participants who completed the placebo-controlled phase on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.', 'otherNumAtRisk': 268, 'deathsNumAtRisk': 268, 'otherNumAffected': 46, 'seriousNumAtRisk': 268, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG005', 'title': 'Active Treatment Phase: Off Drug', 'description': 'Participants who were discontinued from treatment with laquinimod 1.2 mg during the placebo-controlled phase due to sponsor decision after 01 January 2016, continued to the active-treatment phase off drug for 24 months.', 'otherNumAtRisk': 215, 'deathsNumAtRisk': 215, 'otherNumAffected': 35, 'seriousNumAtRisk': 215, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Active Treatment Phase: From Placebo to Laquinimod 0.6 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.', 'otherNumAtRisk': 311, 'deathsNumAtRisk': 311, 'otherNumAffected': 43, 'seriousNumAtRisk': 311, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG007', 'title': 'Active Treatment Phase: From Placebo to Laquinimod 1.2 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.', 'otherNumAtRisk': 236, 'deathsNumAtRisk': 236, 'otherNumAffected': 43, 'seriousNumAtRisk': 236, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 32, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 50, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 35, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 90, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 86, 'numAffected': 60}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 91, 'numAffected': 63}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 52, 'numAffected': 40}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 20, 'numAffected': 14}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 54, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 37, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 56, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 43, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 74, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 110, 'numAffected': 85}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 47, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 238, 'numAffected': 122}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 227, 'numAffected': 131}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 222, 'numAffected': 116}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 38, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 25, 'numAffected': 14}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 15, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Hypochromic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Immune thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 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'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 727, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 732, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 740, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 580, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 311, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 236, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'OG000'}, {'value': '727', 'groupId': 'OG001'}, {'value': '732', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo-Controlled Phase: Placebo', 'description': 'Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.'}, {'id': 'OG001', 'title': 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'description': 'Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.'}, {'id': 'OG002', 'title': 'Placebo-Controlled Phase: Laquinimod 1.2 mg', 'description': 'Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '= 0.7057', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.937', 'ciLowerLimit': '0.668', 'ciUpperLimit': '1.313', 'pValueComment': 'Threshold for significance at 0.05 level.', 'groupDescription': 'The primary analysis for the comparison between laquinimod 0.6 mg versus placebo was conducted using the baseline adjusted Cox proportional hazards model. Categorical EDSS at baseline (less than or equal to \\[\\<=\\] 4 or greater than \\[\\>\\] 4), country/geographical region (CGR), categorical age at baseline (\\<=38 or \\>38), and T2 volume at baseline were included as covariates in the model.', 'statisticalMethod': 'Cox proportional hazards model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Month 24', 'description': "Time to CDP was defined as the time to a sustained increase in Kurtzke's Expanded Disability Status Scale (EDSS) score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least three months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis \\[MS\\]). Data is presented as distribution of CDP (number of participants with CDP) sustained for 3 months.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'OG000'}, {'value': '636', 'groupId': 'OG001'}, {'value': '616', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo-Controlled Phase: Placebo', 'description': 'Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.'}, {'id': 'OG001', 'title': 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'description': 'Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.'}, {'id': 'OG002', 'title': 'Placebo-Controlled Phase: Laquinimod 1.2 mg', 'description': 'Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.02', 'groupId': 'OG000', 'lowerLimit': '1.02'}, {'value': '-0.4', 'spread': '1.01', 'groupId': 'OG001', 'lowerLimit': '1.01'}, {'value': '-0.4', 'spread': '1.05', 'groupId': 'OG002', 'lowerLimit': '1.05'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 15', 'description': 'Brain atrophy was defined by the percent change in brain volume from baseline to Month 15. For participants who prematurely discontinued treatment or completed the placebo-controlled phase before Month 15, the last available measurement was used, provided it was performed at least 9 months following the initiation of study drug.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The modified intent-to-treat 1 (mITT1) analysis set included data from all randomized participants at the Month 15 visit. Here, 'Overall number of participants analyzed' = Participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'OG000'}, {'value': '727', 'groupId': 'OG001'}, {'value': '732', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo-Controlled Phase: Placebo', 'description': 'Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.'}, {'id': 'OG001', 'title': 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'description': 'Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.'}, {'id': 'OG002', 'title': 'Placebo-Controlled Phase: Laquinimod 1.2 mg', 'description': 'Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '332', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Month 24', 'description': "Relapse was defined as appearance of one or more new neurological abnormalities or reappearance or worsening of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in EDSS; or one grade in score of 2 or more of 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in score of one of the FS as compared to previous evaluation. EDSS assesses disability in 8 FS with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of relapsing participants (number of participants with confirmed relapse).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'OG000'}, {'value': '727', 'groupId': 'OG001'}, {'value': '732', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo-Controlled Phase: Placebo', 'description': 'Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.'}, {'id': 'OG001', 'title': 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'description': 'Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.'}, {'id': 'OG002', 'title': 'Placebo-Controlled Phase: Laquinimod 1.2 mg', 'description': 'Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Month 24', 'description': "Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 6 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 6 months.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'OG000'}, {'value': '727', 'groupId': 'OG001'}, {'value': '732', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo-Controlled Phase: Placebo', 'description': 'Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.'}, {'id': 'OG001', 'title': 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'description': 'Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.'}, {'id': 'OG002', 'title': 'Placebo-Controlled Phase: Laquinimod 1.2 mg', 'description': 'Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Month 24', 'description': "Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 9 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 9 months.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all randomized participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'OG000'}, {'value': '727', 'groupId': 'OG001'}, {'value': '732', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo-Controlled Phase: Placebo', 'description': 'Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.'}, {'id': 'OG001', 'title': 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'description': 'Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.'}, {'id': 'OG002', 'title': 'Placebo-Controlled Phase: Laquinimod 1.2 mg', 'description': 'Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '546', 'groupId': 'OG000'}, {'value': '565', 'groupId': 'OG001'}, {'value': '575', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Month 24', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were randomized and received at least one dose of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Active-Treatment Phase: Number of Participants With AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '891', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment Phase: Laquinimod 0.6 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.'}, {'id': 'OG001', 'title': 'Active Treatment Phase: Laquinimod 1.2 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '442', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'OG000'}, {'value': '727', 'groupId': 'OG001'}, {'value': '732', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo-Controlled Phase: Placebo', 'description': 'Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.'}, {'id': 'OG001', 'title': 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'description': 'Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.'}, {'id': 'OG002', 'title': 'Placebo-Controlled Phase: Laquinimod 1.2 mg', 'description': 'Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 24', 'description': 'Clinically significant vital signs abnormalities included: Pulse rate: greater than or equal to (\\>=) 120 beats per minute (bpm) and increase from baseline of \\>=30 bpm, \\<=45 bpm and decrease from baseline of \\>=30 bpm; Systolic blood pressure: \\>=180 millimeters of mercury (mmHg) and increase from baseline of \\>=30 mmHg, \\<=90 and decrease from baseline of \\>=30 mmHg; Diastolic blood pressure: \\>=100 mmHg and increase from baseline of \\>=20 mmHg, \\<=50 mmHg and decrease from baseline of \\>=20 mmHg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were randomized and received at least one dose of study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '891', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment Phase: Laquinimod 0.6 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.'}, {'id': 'OG001', 'title': 'Active Treatment Phase: Laquinimod 1.2 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase', 'description': 'Clinically significant vital signs abnormalities included: Pulse rate: \\>=120 bpm and increase from baseline of \\>=30 bpm, \\<=45 bpm and decrease from baseline of \\>=30 bpm; Systolic blood pressure: \\>=180 mmHg and increase from baseline of \\>=30 mmHg, \\<=90 and decrease from baseline of \\>=30 mmHg; Diastolic blood pressure: \\>=100 mmHg and increase from baseline of \\>=20 mmHg, \\<=50 mmHg and decrease from baseline of \\>=20 mmHg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Placebo-Controlled Phase: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '734', 'groupId': 'OG000'}, {'value': '723', 'groupId': 'OG001'}, {'value': '724', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo-Controlled Phase: Placebo', 'description': 'Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.'}, {'id': 'OG001', 'title': 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'description': 'Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.'}, {'id': 'OG002', 'title': 'Placebo-Controlled Phase: Laquinimod 1.2 mg', 'description': 'Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.'}], 'classes': [{'categories': [{'title': 'Normal - Normal', 'measurements': [{'value': '463', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}, {'value': '470', 'groupId': 'OG002'}]}, {'title': 'Normal - Abnormal NCS', 'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}, {'title': 'Normal - Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}, {'title': 'Abnormal NCS - Normal', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}, {'title': 'Abnormal NCS - Abnormal NCS', 'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}]}, {'title': 'Abnormal NCS - Abnormal CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'Abnormal CS - Normal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Abnormal CS - Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Abnormal CS - Abnormal CS', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Endpoint (Month 24)', 'description': "ECG parameters included: PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed=participants evaluable for this outcome measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Active Treatment Phase: Number of Participants With Shift From Baseline to Endpoint in ECG Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '888', 'groupId': 'OG000'}, {'value': '501', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment Phase: Laquinimod 0.6 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.'}, {'id': 'OG001', 'title': 'Active Treatment Phase: Laquinimod 1.2 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.'}], 'classes': [{'categories': [{'title': 'Normal - Normal', 'measurements': [{'value': '641', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}, {'title': 'Normal - Abnormal NCS', 'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}, {'title': 'Normal - Abnormal CS', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS - Normal', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS - Abnormal NCS', 'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Abnormal NCS - Abnormal CS', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS - Normal', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS - Abnormal NCS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Abnormal CS - Abnormal CS', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase), endpoint (Month 24 of active-treatment phase)', 'description': 'ECG parameters included: PR interval, QRS interval, QTcF and QTcB. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase and had ECG shift from baseline data available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '736', 'groupId': 'OG000'}, {'value': '723', 'groupId': 'OG001'}, {'value': '724', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo-Controlled Phase: Placebo', 'description': 'Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.'}, {'id': 'OG001', 'title': 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'description': 'Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.'}, {'id': 'OG002', 'title': 'Placebo-Controlled Phase: Laquinimod 1.2 mg', 'description': 'Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '165', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Month 24', 'description': 'Potentially clinically significant serum chemistry abnormalities included: Glucose \\<=3 and \\>=13.88 millimoles per liter (mmol/L); Alanine aminotransferase (ALT) (in units per liter \\[U/L\\]), aspartate aminotransferase (AST) (in U/L), alkaline phosphatase (in U/L), gamma-glutamyltransferase (GGT) (in U/L), creatine phosphokinase (CPK) (in U/L), C-reactive protein (CRP) (in milligrams per liter \\[mg/L\\]), pancreatic amylase (in U/L)\\>=3 \\* upper limit of normal (ULN); Fibrinogen \\>=6 grams per liter (gm/L); Sodium \\<=130 and \\>=150 mmol/L; Potassium \\<=3.2 and \\>=5.5 mmol/L; Calcium \\<=1.87 and \\>=2.75 mmol/L; Phosphate \\<=0.65 and \\>=1.61 mmol/L.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '891', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment Phase: Laquinimod 0.6 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.'}, {'id': 'OG001', 'title': 'Active Treatment Phase: Laquinimod 1.2 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '887', 'groupId': 'OG000'}, {'value': '501', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase', 'description': 'Potentially clinically significant serum chemistry abnormalities included: Glucose \\<=3 and \\>=13.88 mmol/L; ALT (in U/L), AST (in U/L), alkaline phosphatase (in U/L), GGT (in U/L), CPK (in U/L), CRP (in mg/L), pancreatic amylase (in U/L)\\>=3 \\* ULN; Fibrinogen \\>=6 gm/L; Sodium \\<=130 and \\>=150 mmol/L; Potassium \\<=3.2 and \\>=5.5 mmol/L; Calcium \\<=1.87 and \\>=2.75 mmol/L; Phosphate \\<=0.65 and \\>=1.61 mmol/L; Blood urea nitrogen (in mmol/L); Total bilirubin \\>=28 micromols per liter (micromols/L); Creatinine \\>=117 micromols/L; Albumin \\<=25 gm/L.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '735', 'groupId': 'OG000'}, {'value': '723', 'groupId': 'OG001'}, {'value': '723', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo-Controlled Phase: Placebo', 'description': 'Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.'}, {'id': 'OG001', 'title': 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'description': 'Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.'}, {'id': 'OG002', 'title': 'Placebo-Controlled Phase: Laquinimod 1.2 mg', 'description': 'Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Month 24', 'description': 'Potentially clinically significant hematological abnormalities included: Hemoglobin \\<=11.5 grams per deciliter (gm/dL) in males and \\<=10 gm/dL in females; White blood cells (WBCs) count \\<=2.5 and \\>=21\\*10\\^9 per liter (L); Absolute neutrophil count (ANC) \\<=1.49\\*10\\^9 per L; Platelet count \\<=100 and \\>=600\\*10\\^9 per L.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis set included all participants who were randomized and received at least one dose of study drug. Here, 'Overall number of participants analyzed'=participants evaluable for this outcome measure."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '891', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Treatment Phase: Laquinimod 0.6 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.'}, {'id': 'OG001', 'title': 'Active Treatment Phase: Laquinimod 1.2 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '886', 'groupId': 'OG000'}, {'value': '499', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase', 'description': 'Potentially clinically significant hematological abnormalities included: Hemoglobin \\<=11.5, \\>=20 gm/dL in males, and \\<=10, \\>=18.5 gm/dL in females; WBCs count \\<=2.5 and \\>=21\\*10\\^9 per L; ANC \\<=1.49\\*10\\^9 per L; Platelet count \\<=100 and \\>=600\\*10\\^9 per L.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set in active-treatment phase included all participants who completed placebo-controlled phase on treatment and continued to either of the 2 laquinimod treatments during active-treatment phase.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo-Controlled Phase: Placebo', 'description': 'Participants received 2 capsules of placebo (matched to laquinimod 0.6 milligrams \\[mg\\]) once daily orally for up to 24 months.'}, {'id': 'FG001', 'title': 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'description': 'Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.'}, {'id': 'FG002', 'title': 'Placebo-Controlled Phase: Laquinimod 1.2 mg', 'description': 'Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.'}, {'id': 'FG003', 'title': 'Active Treatment Phase: Laquinimod 0.6 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.'}, {'id': 'FG004', 'title': 'Active Treatment Phase: Laquinimod 1.2 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.'}, {'id': 'FG005', 'title': 'Active Treatment Phase: Off Drug', 'description': 'Participants who were discontinued from treatment with laquinimod 1.2 mg during the placebo-controlled phase due to sponsor decision after 01 January 2016 continued to the active-treatment phase off drug for 24 months.'}], 'periods': [{'title': 'Placebo-Controlled Phase (24 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '740'}, {'groupId': 'FG001', 'numSubjects': '727'}, {'groupId': 'FG002', 'numSubjects': '732'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '596'}, {'groupId': 'FG001', 'numSubjects': '623'}, {'groupId': 'FG002', 'numSubjects': '532'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '104'}, {'groupId': 'FG002', 'numSubjects': '200'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '68'}, {'groupId': 'FG002', 'numSubjects': '154'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Noncompliance with drug administration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Active Treatment Phase (24 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '891'}, {'groupId': 'FG004', 'numSubjects': '504'}, {'groupId': 'FG005', 'numSubjects': '215'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '884'}, {'groupId': 'FG004', 'numSubjects': '494'}, {'groupId': 'FG005', 'numSubjects': '215'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '58'}, {'groupId': 'FG004', 'numSubjects': '220'}, {'groupId': 'FG005', 'numSubjects': '32'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '809'}, {'groupId': 'FG004', 'numSubjects': '243'}, {'groupId': 'FG005', 'numSubjects': '174'}]}, {'type': 'Participant withdrew per Sponsor request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The study was conducted at 215 sites in 29 countries.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'BG000'}, {'value': '727', 'groupId': 'BG001'}, {'value': '732', 'groupId': 'BG002'}, {'value': '2199', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo-Controlled Phase: Placebo', 'description': 'Participants received 2 capsules of placebo (matched to laquinimod 0.6 mg) once daily orally for up to 24 months.'}, {'id': 'BG001', 'title': 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'description': 'Participants received 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.'}, {'id': 'BG002', 'title': 'Placebo-Controlled Phase: Laquinimod 1.2 mg', 'description': 'Participants received laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'BG000'}, {'value': '727', 'groupId': 'BG001'}, {'value': '732', 'groupId': 'BG002'}, {'value': '2199', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '35.9', 'spread': '8.95', 'groupId': 'BG000'}, {'value': '36.8', 'spread': '9.25', 'groupId': 'BG001'}, {'value': '36.1', 'spread': '9.22', 'groupId': 'BG002'}, {'value': '36.3', 'spread': '9.14', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'BG000'}, {'value': '727', 'groupId': 'BG001'}, {'value': '732', 'groupId': 'BG002'}, {'value': '2199', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Adults (18-64 years)', 'measurements': [{'value': '740', 'groupId': 'BG000'}, {'value': '727', 'groupId': 'BG001'}, {'value': '732', 'groupId': 'BG002'}, {'value': '2199', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'BG000'}, {'value': '727', 'groupId': 'BG001'}, {'value': '732', 'groupId': 'BG002'}, {'value': '2199', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '488', 'groupId': 'BG000'}, {'value': '510', 'groupId': 'BG001'}, {'value': '475', 'groupId': 'BG002'}, {'value': '1473', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}, {'value': '726', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'BG000'}, {'value': '727', 'groupId': 'BG001'}, {'value': '732', 'groupId': 'BG002'}, {'value': '2199', 'groupId': 'BG003'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '724', 'groupId': 'BG000'}, {'value': '712', 'groupId': 'BG001'}, {'value': '717', 'groupId': 'BG002'}, {'value': '2153', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Kurtzke's Expanded Disability Status Scale (EDSS) Score", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'BG000'}, {'value': '727', 'groupId': 'BG001'}, {'value': '732', 'groupId': 'BG002'}, {'value': '2199', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Less than or equal to (<=) 4.0', 'measurements': [{'value': '653', 'groupId': 'BG000'}, {'value': '635', 'groupId': 'BG001'}, {'value': '644', 'groupId': 'BG002'}, {'value': '1932', 'groupId': 'BG003'}]}, {'title': 'Greater than (>) 4.0', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '265', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis \\[MS\\]).', 'unitOfMeasure': 'Participants'}, {'title': 'Normalized Brain Volume', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '737', 'groupId': 'BG000'}, {'value': '722', 'groupId': 'BG001'}, {'value': '728', 'groupId': 'BG002'}, {'value': '2187', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1437.2', 'spread': '93.37', 'groupId': 'BG000'}, {'value': '1433.0', 'spread': '92.49', 'groupId': 'BG001'}, {'value': '1434.4', 'spread': '93.41', 'groupId': 'BG002'}, {'value': '1434.9', 'spread': '93.07', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'milliliters (mL)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'This characteristic was analyzed for a total of 2187 participants (Placebo \\[737\\], Laquinimod 0.6 mg \\[722\\], and Laquinimod 1.2 mg \\[728\\])'}], 'populationDescription': 'Intent-to-treat (ITT) analysis set included all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'dispFirstSubmitDate': '2018-05-02', 'completionDateStruct': {'date': '2017-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2012-09-28', 'dispFirstSubmitQcDate': '2018-05-02', 'resultsFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2012-10-15', 'dispFirstPostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-20', 'studyFirstPostDateStruct': {'date': '2012-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Placebo-Controlled Phase: Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Baseline up to Month 24', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.'}, {'measure': 'Active-Treatment Phase: Number of Participants With AEs', 'timeFrame': 'Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs.'}, {'measure': 'Placebo-Controlled Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities', 'timeFrame': 'Baseline up to Week 24', 'description': 'Clinically significant vital signs abnormalities included: Pulse rate: greater than or equal to (\\>=) 120 beats per minute (bpm) and increase from baseline of \\>=30 bpm, \\<=45 bpm and decrease from baseline of \\>=30 bpm; Systolic blood pressure: \\>=180 millimeters of mercury (mmHg) and increase from baseline of \\>=30 mmHg, \\<=90 and decrease from baseline of \\>=30 mmHg; Diastolic blood pressure: \\>=100 mmHg and increase from baseline of \\>=20 mmHg, \\<=50 mmHg and decrease from baseline of \\>=20 mmHg.'}, {'measure': 'Active-Treatment Phase: Number of Participants With Clinically Significant Vital Signs Abnormalities', 'timeFrame': 'Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase', 'description': 'Clinically significant vital signs abnormalities included: Pulse rate: \\>=120 bpm and increase from baseline of \\>=30 bpm, \\<=45 bpm and decrease from baseline of \\>=30 bpm; Systolic blood pressure: \\>=180 mmHg and increase from baseline of \\>=30 mmHg, \\<=90 and decrease from baseline of \\>=30 mmHg; Diastolic blood pressure: \\>=100 mmHg and increase from baseline of \\>=20 mmHg, \\<=50 mmHg and decrease from baseline of \\>=20 mmHg.'}, {'measure': 'Placebo-Controlled Phase: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters', 'timeFrame': 'Baseline, Endpoint (Month 24)', 'description': "ECG parameters included: PR interval, QRS interval, QT interval corrected using the Fridericia formula (QTcF) and QT interval corrected using the Bazett's formula (QTcB). Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding."}, {'measure': 'Active Treatment Phase: Number of Participants With Shift From Baseline to Endpoint in ECG Parameters', 'timeFrame': 'Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase), endpoint (Month 24 of active-treatment phase)', 'description': 'ECG parameters included: PR interval, QRS interval, QTcF and QTcB. Shifts represented as Baseline - endpoint value (last observed post-baseline value). Abnormal NCS indicated an abnormal but not clinically significant finding. Abnormal CS indicated an abnormal and clinically significant finding.'}, {'measure': 'Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry', 'timeFrame': 'Baseline up to Month 24', 'description': 'Potentially clinically significant serum chemistry abnormalities included: Glucose \\<=3 and \\>=13.88 millimoles per liter (mmol/L); Alanine aminotransferase (ALT) (in units per liter \\[U/L\\]), aspartate aminotransferase (AST) (in U/L), alkaline phosphatase (in U/L), gamma-glutamyltransferase (GGT) (in U/L), creatine phosphokinase (CPK) (in U/L), C-reactive protein (CRP) (in milligrams per liter \\[mg/L\\]), pancreatic amylase (in U/L)\\>=3 \\* upper limit of normal (ULN); Fibrinogen \\>=6 grams per liter (gm/L); Sodium \\<=130 and \\>=150 mmol/L; Potassium \\<=3.2 and \\>=5.5 mmol/L; Calcium \\<=1.87 and \\>=2.75 mmol/L; Phosphate \\<=0.65 and \\>=1.61 mmol/L.'}, {'measure': 'Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Serum Chemistry', 'timeFrame': 'Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase', 'description': 'Potentially clinically significant serum chemistry abnormalities included: Glucose \\<=3 and \\>=13.88 mmol/L; ALT (in U/L), AST (in U/L), alkaline phosphatase (in U/L), GGT (in U/L), CPK (in U/L), CRP (in mg/L), pancreatic amylase (in U/L)\\>=3 \\* ULN; Fibrinogen \\>=6 gm/L; Sodium \\<=130 and \\>=150 mmol/L; Potassium \\<=3.2 and \\>=5.5 mmol/L; Calcium \\<=1.87 and \\>=2.75 mmol/L; Phosphate \\<=0.65 and \\>=1.61 mmol/L; Blood urea nitrogen (in mmol/L); Total bilirubin \\>=28 micromols per liter (micromols/L); Creatinine \\>=117 micromols/L; Albumin \\<=25 gm/L.'}, {'measure': 'Placebo-Controlled Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values', 'timeFrame': 'Baseline up to Month 24', 'description': 'Potentially clinically significant hematological abnormalities included: Hemoglobin \\<=11.5 grams per deciliter (gm/dL) in males and \\<=10 gm/dL in females; White blood cells (WBCs) count \\<=2.5 and \\>=21\\*10\\^9 per liter (L); Absolute neutrophil count (ANC) \\<=1.49\\*10\\^9 per L; Platelet count \\<=100 and \\>=600\\*10\\^9 per L.'}, {'measure': 'Active Treatment Phase: Number of Participants With Potentially Clinically Significant Abnormal Hematology Values', 'timeFrame': 'Baseline (Month 0 of active-treatment phase/Month 24 of placebo-controlled phase) up to Month 24 of active-treatment phase', 'description': 'Potentially clinically significant hematological abnormalities included: Hemoglobin \\<=11.5, \\>=20 gm/dL in males, and \\<=10, \\>=18.5 gm/dL in females; WBCs count \\<=2.5 and \\>=21\\*10\\^9 per L; ANC \\<=1.49\\*10\\^9 per L; Platelet count \\<=100 and \\>=600\\*10\\^9 per L.'}], 'primaryOutcomes': [{'measure': 'Placebo-Controlled Phase: Time to Confirmed Disease Progression (CDP) Confirmed After At Least 3 Months (Number of Participants With CDP After At Least 3 Months)', 'timeFrame': 'Baseline to Month 24', 'description': "Time to CDP was defined as the time to a sustained increase in Kurtzke's Expanded Disability Status Scale (EDSS) score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least three months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to multiple sclerosis \\[MS\\]). Data is presented as distribution of CDP (number of participants with CDP) sustained for 3 months."}], 'secondaryOutcomes': [{'measure': 'Placebo-Controlled Phase: Percent Change From Baseline in Brain Volume at Month 15', 'timeFrame': 'Baseline, Month 15', 'description': 'Brain atrophy was defined by the percent change in brain volume from baseline to Month 15. For participants who prematurely discontinued treatment or completed the placebo-controlled phase before Month 15, the last available measurement was used, provided it was performed at least 9 months following the initiation of study drug.'}, {'measure': 'Placebo-Controlled Phase: Time to First Confirmed Relapse (Number of Participants With Confirmed Relapse)', 'timeFrame': 'Baseline to Month 24', 'description': "Relapse was defined as appearance of one or more new neurological abnormalities or reappearance or worsening of one or more previously observed neurological abnormalities, lasting for at least 48 hours (in absence of fever or any infection) and immediately preceded by an improving neurological state of at least 30 days from onset of previous relapse. An event was counted as a relapse only when the participant's symptoms were accompanied by observed objective neurological changes, consistent with an increase of at least 0.5 in EDSS; or one grade in score of 2 or more of 7 Functional Systems (FS) (excluding changes in bowel or bladder function or cognition); or 2 grades in score of one of the FS as compared to previous evaluation. EDSS assesses disability in 8 FS with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of relapsing participants (number of participants with confirmed relapse)."}, {'measure': 'Placebo-Controlled Phase: Time to CDP Confirmed After At Least 6 Months (Number of Participants With CDP After At Least 6 Months)', 'timeFrame': 'Baseline to Month 24', 'description': "Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 6 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 6 months."}, {'measure': 'Placebo-Controlled Phase: Time to CDP Confirmed After At Least 9 Months (Number of Participants With Confirmed Relapse After At Least 9 Months)', 'timeFrame': 'Baseline to Month 24', 'description': "Time to CDP was defined as the time to a sustained increase in Kurtzke's EDSS score of at least 1 point if baseline EDSS score was less than or equal to 5.0, or at least 0.5 point if the baseline EDSS score was 5.5, over a period of at least 9 months. EDSS assesses disability in 8 functional systems with an overall score ranging from 0 (normal) to 10 (death due to MS). Data is presented as distribution of CDP (number of participants with CDP) sustained for 9 months."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '34378456', 'type': 'DERIVED', 'citation': 'Comi G, Dadon Y, Sasson N, Steinerman JR, Knappertz V, Vollmer TL, Boyko A, Vermersch P, Ziemssen T, Montalban X, Lublin FD, Rocca MA, Volkinshtein R, Rubinchick S, Halevy N, Filippi M. CONCERTO: A randomized, placebo-controlled trial of oral laquinimod in relapsing-remitting multiple sclerosis. Mult Scler. 2022 Apr;28(4):608-619. doi: 10.1177/13524585211032803. Epub 2021 Aug 11.'}]}, 'descriptionModule': {'briefSummary': 'This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod in participants with RRMS. The study has 2 periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must have a confirmed and documented multiple sclerosis (MS) diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course.\n* Participants must be ambulatory with Kurtzke's expanded disability status scale (EDSS) score of 0 to 5.5 in both screening and randomization visits.\n* Participants must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment \\[intravenous (IV), intramuscular (IM) and/or per os (PO)/oral\\] or adrenocorticotrophic hormone, 60 days prior to randomization.\n* Participants must have experienced at least one documented relapse in the 12 months prior to randomization.\n* Participants must have disease duration of not more than 15 years.\n* Women of child-bearing potential (for example, women who are not postmenopausal or surgically sterilized) must practice an acceptable method of birth control for 30 days before taking the study drug and two acceptable methods of birth control during the duration of the study and until 30 days after the last dose of study medication.\n\n * Additional criteria apply, please contact the investigator for more information.\n\nExclusion Criteria:\n\n* Participants with progressive forms of MS.\n* Participants with neuromyelitis optica.\n* Use of experimental or investigational drugs and/or participation in drug clinical studies within the 6 months prior to randomization.\n* Use of immunosuppressive agents or cytotoxic agents, including cyclophosphamide, within 6 months prior to randomization.\n* Use of either of the following within 2 years prior to randomization visit: natalizumab (Tysabri®), rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab.\n* Use of teriflunomide (Aubagio®) within 2 years prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done 2 months or more prior to randomization.\n* Previous treatment with glatiramer acetate (Copaxone®) Interferon β (either 1a or 1b), fingolimod (Gilenya®), dimethyl fumarate (Tecfidera®) or intravenous immunoglobulins within 2 months prior to randomization.\n* Chronic (more than 30 consecutive days) systemic (IV, IM or PO) corticosteroid treatment within 2 months prior to randomization.\n* Previous use of mitoxantrone (Novantrone®), cladribine, or alemtuzumab (Lemtrada®).\n* Previous use of laquinimod.\n* Previous total body irradiation or total lymphoid irradiation.\n* Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.\n* Use of moderate/strong inhibitors of cytochrome P450 (CYP) 3A4 within 2 weeks prior to randomization.\n* Use of inducers of CYP3A4 within 2 weeks prior to randomization visit.\n* Pregnancy or breastfeeding.\n* A known history of sensitivity to gadolinium (Gd).\n* Inability to successfully undergo magnetic resonance imaging (MRI) scanning.\n* Participants who underwent endovascular treatment for chronic cerebrospinal venous insufficiency within 3 months prior to randomization.\n\n * Additional criteria apply, please contact the investigator for more information."}, 'identificationModule': {'nctId': 'NCT01707992', 'acronym': 'CONCERTO', 'briefTitle': 'The Efficacy, Safety, and Tolerability of Laquinimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)', 'orgStudyIdInfo': {'id': 'LAQ-MS-305'}, 'secondaryIdInfos': [{'id': '2012-003647-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo-Controlled Phase: Placebo', 'description': 'Participants will receive 2 capsules of placebo (matching to laquinimod 0.6 milligrams \\[mg\\]) once daily orally for up to 24 months.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'description': 'Participants will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for up to 24 months.', 'interventionNames': ['Drug: Laquinimod', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo-Controlled Phase: Laquinimod 1.2 mg', 'description': 'Participants will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for up to 24 months.', 'interventionNames': ['Drug: Laquinimod']}, {'type': 'EXPERIMENTAL', 'label': 'Active Treatment Phase: Laquinimod 0.6 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo and on laquinimod 0.6 mg treatment group after 01 January 2016, will receive 1 capsule of laquinimod 0.6 mg and 1 capsule of matching placebo once daily orally for 24 months.', 'interventionNames': ['Drug: Laquinimod', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Active Treatment Phase: Laquinimod 1.2 mg', 'description': 'Participants who completed the placebo-controlled phase on placebo and on laquinimod 1.2 mg treatment group prior to 01 January 2016, will receive laquinimod 1.2 mg (2 capsules of laquinimod 0.6 mg each) once daily orally for 24 months.', 'interventionNames': ['Drug: Laquinimod']}, {'type': 'NO_INTERVENTION', 'label': 'Active Treatment Phase: Off Drug', 'description': 'Participants who were discontinued from treatment with laquinimod 1.2 mg during the placebo-controlled phase due to sponsor decision after 01 January 2016 will continue the active-treatment phase off drug for 24 months.'}], 'interventions': [{'name': 'Laquinimod', 'type': 'DRUG', 'description': 'Laquinimod will be administered as per the dose and schedule specified in the respective arms.', 'armGroupLabels': ['Active Treatment Phase: Laquinimod 0.6 mg', 'Active Treatment Phase: Laquinimod 1.2 mg', 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'Placebo-Controlled Phase: Laquinimod 1.2 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matching to laquinimod will be administered as per the schedule specified in the respective arms.', 'armGroupLabels': ['Active Treatment Phase: Laquinimod 0.6 mg', 'Placebo-Controlled Phase: Laquinimod 0.6 mg', 'Placebo-Controlled Phase: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35058', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'Teva Investigational Site 10329', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Teva Investigational Site 10349', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '85741-3537', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Teva Investigational Site 10342', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 10310', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 10307', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80112', 'city': 'Centennial', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva 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