Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT00451451
Status:
COMPLETED
Last Update Posted:
2015-01-26
First Post:
2007-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Italy', 'Kazakhstan', 'Lithuania', 'Russia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D012008', 'term': 'Recurrence'}, {'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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069462', 'term': 'Dimethyl Fumarate'}, {'id': 'D000068717', 'term': 'Glatiramer Acetate'}], 'ancestors': [{'id': 'D005650', 'term': 'Fumarates'}, {'id': 'D003998', 'term': 'Dicarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogenidec.com', 'title': 'Biogen Idec Study Medical Director', 'organization': 'Biogen Idec'}, 'certainAgreement': {'otherDetails': "The provisions of our agreement are subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'description': 'The safety population consisted of all subjects who received at least 1 dose of study treatment. Safety data were analyzed by actual treatment received. One patient randomly assigned to the BG00012 TID group \\& included in the group of the ITT population took GA throughout the study and was therefore counted in the GA group of the safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received two placebo capsules orally three times daily (TID)', 'otherNumAtRisk': 363, 'otherNumAffected': 332, 'seriousNumAtRisk': 363, 'seriousNumAffected': 79}, {'id': 'EG001', 'title': 'BG00012 240 mg Twice Daily (BID)', 'description': 'Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)', 'otherNumAtRisk': 359, 'otherNumAffected': 336, 'seriousNumAtRisk': 359, 'seriousNumAffected': 61}, {'id': 'EG002', 'title': 'BG00012 240 mg 3 Times Daily (TID)', 'description': 'Participants received two 120 mg BG00012 capsules orally three times daily (TID)', 'otherNumAtRisk': 344, 'otherNumAffected': 316, 'seriousNumAtRisk': 344, 'seriousNumAffected': 54}, {'id': 'EG003', 'title': 'Total BG00012', 'description': 'Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group', 'otherNumAtRisk': 703, 'otherNumAffected': 652, 'seriousNumAtRisk': 703, 'seriousNumAffected': 115}, {'id': 'EG004', 'title': 'Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)', 'description': 'Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)', 'otherNumAtRisk': 351, 'otherNumAffected': 303, 'seriousNumAtRisk': 351, 'seriousNumAffected': 60}], 'otherEvents': [{'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 63}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 125}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 51}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 91}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 83}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 36}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 36}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 28}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'MULTIPLE SCLEROSIS RELAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 147}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 104}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 81}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 185}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 115}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 46}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 98}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 46}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 42}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'HYPOAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 30}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 15}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'FLUSHING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 110}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 83}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 193}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'HOT FLUSH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 37}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 34}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'DIARRHEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 95}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 91}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 69}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 51}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 48}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 52}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'PRURITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 44}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 37}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 70}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 32}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 47}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 47}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 34}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'PROTEINURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 64}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 30}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'MICROALBUMINURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 15}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 70}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 35}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'INJECTION SITE ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'INJECTION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 29}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 38}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'ALBUMIN URINE PRESENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 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344, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'BETA 2 MICROGLOBULIN URINE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'HEPATIC ENZYME INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'FEMUR FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'MUSCLE STRAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'ALCOHOL POISONING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'FACIAL BONES FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'FOOT FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'LIGAMENT RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'ROAD TRAFFIC ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'TRAUMATIC HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'WRIST FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'EYE INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'HAND FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'LIGAMENT INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'MENISCUS LESION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'RADIUS FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'TENDON RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'THERAPEUTIC AGENT TOXICITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'WHIPLASH INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'BREAST LUMP REMOVAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'INTERVERTEBRAL DISC OPERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'MEDICAL DIET', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'CERVICAL CONISATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'STERILISATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'TURBINECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'SOCIAL PROBLEM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 363, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 344, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 703, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 351, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annualized Relapse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}, {'value': '350', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo capsules orally three times daily (TID)'}, {'id': 'OG001', 'title': 'BG00012 240 mg Twice Daily (BID)', 'description': 'Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)'}, {'id': 'OG002', 'title': 'BG00012 240 mg 3 Times Daily (TID)', 'description': 'Participants received two 120 mg BG00012 capsules orally three times daily (TID)'}, {'id': 'OG003', 'title': 'Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)', 'description': 'Participants received Glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.401', 'groupId': 'OG000', 'lowerLimit': '0.329', 'upperLimit': '0.488'}, {'value': '0.224', 'groupId': 'OG001', 'lowerLimit': '0.179', 'upperLimit': '0.282'}, {'value': '0.198', 'groupId': 'OG002', 'lowerLimit': '0.156', 'upperLimit': '0.252'}, {'value': '0.286', 'groupId': 'OG003', 'lowerLimit': '0.232', 'upperLimit': '0.353'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee.\n\nThe adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(≤2.0 versus\\>2.0), age (\\<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.', 'unitOfMeasure': 'Relapses Per Year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population was defined as all subjects who were randomized and received at least 1 dose of study treatment. Among subjects who switched to an alternative therapy for multiple sclerosis, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of New or Newly Enlarging T2 Hyperintense Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo capsules orally three times daily (TID)'}, {'id': 'OG001', 'title': 'BG00012 240 mg Twice Daily (BID)', 'description': 'Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)'}, {'id': 'OG002', 'title': 'BG00012 240 mg 3 Times Daily (TID)', 'description': 'Participants received two 120 mg BG00012 capsules orally three times daily (TID)'}, {'id': 'OG003', 'title': 'Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)', 'description': 'Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '13.5', 'upperLimit': '22.4'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '6.6'}, {'value': '4.7', 'groupId': 'OG002', 'lowerLimit': '3.6', 'upperLimit': '6.2'}, {'value': '8.0', 'groupId': 'OG003', 'lowerLimit': '6.3', 'upperLimit': '10.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume.', 'unitOfMeasure': 'Number of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 681 subjects in the MRI cohort, 572 (139 placebo, 140 BG00012 BID, 140 BG00012 TID, 153 GA) had post-baseline T2 hyperintense data \\& were included in the analysis. Missing data before the use of alternative MS medications \\& visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption.'}, {'type': 'SECONDARY', 'title': 'Number of New T1 Hypointense Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}, {'value': '153', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo capsules orally three times daily (TID)'}, {'id': 'OG001', 'title': 'BG00012 240 mg Twice Daily (BID)', 'description': 'Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)'}, {'id': 'OG002', 'title': 'BG00012 240 mg 3 Times Daily (TID)', 'description': 'Participants received two 120 mg BG00012 capsules orally three times daily (TID)'}, {'id': 'OG003', 'title': 'Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)', 'description': 'Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '9.2'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '4.0'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '3.2'}, {'value': '4.1', 'groupId': 'OG003', 'lowerLimit': '3.2', 'upperLimit': '5.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 years', 'description': 'The number of new T1 hypointense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T1 hypointense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T1 hypointense lesion volume.', 'unitOfMeasure': 'Number of lesions', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 681 subjects in the MRI cohort, 573 (139 placebo,140 BG00012 BID,140 BG00012 TID,154 GA) had post-baseline new T1 hypointense data \\& were included in the analysis. Missing data before the use of alternative MS medications \\& visits after subjects switched to alternative MS medications were imputed with the use of a constant rate assumption'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Relapsed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}, {'value': '350', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo capsules orally three times daily (TID)'}, {'id': 'OG001', 'title': 'BG00012 240 mg Twice Daily (BID)', 'description': 'Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)'}, {'id': 'OG002', 'title': 'BG00012 240 mg 3 Times Daily (TID)', 'description': 'Participants received two 120 mg BG00012 capsules orally three times daily (TID)'}, {'id': 'OG003', 'title': 'Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)', 'description': 'Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.410', 'groupId': 'OG000'}, {'value': '0.291', 'groupId': 'OG001'}, {'value': '0.241', 'groupId': 'OG002'}, {'value': '0.321', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.', 'unitOfMeasure': 'Proportion of subjects,confirmed relapse', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was based on the ITT population, defined as all subjects who were randomized and received at least 1 dose of study treatment. Among subjects who switched to an alternative therapy for MS, all the data before the switch were used for the analysis. In all other subjects, all relapses were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}, {'value': '350', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received two placebo capsules orally three times daily (TID)'}, {'id': 'OG001', 'title': 'BG00012 240 mg Twice Daily (BID)', 'description': 'Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)'}, {'id': 'OG002', 'title': 'BG00012 240 mg 3 Times Daily (TID)', 'description': 'Participants received two 120 mg BG00012 capsules orally three times daily (TID)'}, {'id': 'OG003', 'title': 'Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)', 'description': 'Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.169', 'groupId': 'OG000'}, {'value': '0.128', 'groupId': 'OG001'}, {'value': '0.130', 'groupId': 'OG002'}, {'value': '0.156', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or ≥1.5 point increase in subjects with a baseline EDSS=0, and required that the increase from baseline was confirmed ≥ 12weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution', 'unitOfMeasure': 'Proportion of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of the intent-to-treat (ITT) population (all subjects who were randomized and received at least 1 dose of study treatment) who had a baseline EDSS assessment. Analyses were based on all observed data. Onset of disability progression must begin before a subject switched to alternative MS medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received two placebo capsules orally three times daily (TID)'}, {'id': 'FG001', 'title': 'BG00012 240 mg Twice Daily (BID)', 'description': 'Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)'}, {'id': 'FG002', 'title': 'BG00012 240 mg 3 Times Daily (TID)', 'description': 'Participants received two 120 mg BG00012 capsules orally three times daily (TID)'}, {'id': 'FG003', 'title': 'Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)', 'description': 'Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '363 participants were dosed; 363 participants were randomized', 'groupId': 'FG000', 'numSubjects': '363'}, {'comment': '359 participants were dosed; 362 participants were randomized', 'groupId': 'FG001', 'numSubjects': '359'}, {'comment': '345 participants were dosed; 345 participants were randomized', 'groupId': 'FG002', 'numSubjects': '345'}, {'comment': '350 participants were dosed; 360 participants were randomized', 'groupId': 'FG003', 'numSubjects': '350'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '278'}, {'groupId': 'FG001', 'numSubjects': '284'}, {'groupId': 'FG002', 'numSubjects': '273'}, {'groupId': 'FG003', 'numSubjects': '292'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '72'}, {'groupId': 'FG003', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Consent Withdrawn', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Subject Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other Reasons for Not Completing Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '14'}]}]}], 'recruitmentDetails': 'Subjects were randomized at 205 investigational sites in 28 countries.', 'preAssignmentDetails': 'From screening, 1430 eligible subjects were equally randomized. Of these, 1417 subjects received at least one dose of study treatment and comprised the intent-to-treat (ITT) and safety populations.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '363', 'groupId': 'BG000'}, {'value': '359', 'groupId': 'BG001'}, {'value': '345', 'groupId': 'BG002'}, {'value': '350', 'groupId': 'BG003'}, {'value': '1417', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received two placebo capsules orally three times daily (TID)'}, {'id': 'BG001', 'title': 'BG00012 240 mg Twice Daily (BID)', 'description': 'Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)'}, {'id': 'BG002', 'title': 'BG00012 240 mg 3 Times Daily (TID)', 'description': 'Participants received two 120 mg BG00012 capsules orally three times daily (TID)'}, {'id': 'BG003', 'title': 'Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)', 'description': 'Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'spread': '9.24', 'groupId': 'BG000'}, {'value': '37.8', 'spread': '9.35', 'groupId': 'BG001'}, {'value': '37.8', 'spread': '9.39', 'groupId': 'BG002'}, {'value': '36.7', 'spread': '9.06', 'groupId': 'BG003'}, {'value': '37.3', 'spread': '9.26', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}, {'value': '247', 'groupId': 'BG003'}, {'value': '993', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '424', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mean Expanded Disability Status Scale (EDSS) score', 'classes': [{'categories': [{'measurements': [{'value': '2.59', 'spread': '1.170', 'groupId': 'BG000'}, {'value': '2.56', 'spread': '1.202', 'groupId': 'BG001'}, {'value': '2.52', 'spread': '1.185', 'groupId': 'BG002'}, {'value': '2.57', 'spread': '1.223', 'groupId': 'BG003'}, {'value': '2.56', 'spread': '1.194', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'The EDSS scores range from 0.0 (normal exam) to 10.0 (death due to MS).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean number of relapses within the previous 3 years', 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '1.46', 'groupId': 'BG000'}, {'value': '2.4', 'spread': '1.27', 'groupId': 'BG001'}, {'value': '2.6', 'spread': '1.50', 'groupId': 'BG002'}, {'value': '2.4', 'spread': '1.32', 'groupId': 'BG003'}, {'value': '2.5', 'spread': '1.39', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Number of relapses', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean number of relapses within the past 12 months', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.80', 'groupId': 'BG000'}, {'value': '1.3', 'spread': '0.63', 'groupId': 'BG001'}, {'value': '1.4', 'spread': '0.72', 'groupId': 'BG002'}, {'value': '1.4', 'spread': '0.64', 'groupId': 'BG003'}, {'value': '1.4', 'spread': '0.70', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Number of relapses', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Time since first multiple sclerosis (MS) diagnosis', 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '5.01', 'groupId': 'BG000'}, {'value': '4.9', 'spread': '5.11', 'groupId': 'BG001'}, {'value': '4.6', 'spread': '5.23', 'groupId': 'BG002'}, {'value': '4.4', 'spread': '4.70', 'groupId': 'BG003'}, {'value': '4.7', 'spread': '5.01', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean number of Gadolinium(Gd)-enhancing T1-weighted lesions', 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '7.71', 'groupId': 'BG000'}, {'value': '2.7', 'spread': '6.22', 'groupId': 'BG001'}, {'value': '1.9', 'spread': '5.02', 'groupId': 'BG002'}, {'value': '2.4', 'spread': '6.81', 'groupId': 'BG003'}, {'value': '2.4', 'spread': '6.51', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'This baseline measure could only be assessed in the magnetic resonance imaging (MRI) cohort. The MRI cohort included 681 intent-to-treat (ITT) subjects who were enrolled at sites that participated in the MRI portion of the study and who had MRI data (167 placebo, 169 BG00012 BID, 170 BG00012 TID, and 175 GA). Sites could participate only if their MRI capability was validated by the independent MRI reading center. Approximately 95% of all subjects enrolled at MRI sites participated in the MRI portion of the study.', 'unitOfMeasure': 'Number of Gd enhancing lesions', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1417}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'dispFirstSubmitDate': '2012-11-01', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-13', 'studyFirstSubmitDate': '2007-03-21', 'dispFirstSubmitQcDate': '2012-11-01', 'resultsFirstSubmitDate': '2014-05-05', 'studyFirstSubmitQcDate': '2007-03-22', 'dispFirstPostDateStruct': {'date': '2012-11-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-05', 'studyFirstPostDateStruct': {'date': '2007-03-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Relapse Rate', 'timeFrame': '2 years', 'description': 'A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee.\n\nThe adjusted annualized relapse rate was calculated from a negative binomial regression model , adjusted for baseline Expanded Disability Status Scale (EDSS ) score(≤2.0 versus\\>2.0), age (\\<40 versus ≥40 years), region, and the number of relapses in the 1 year prior to enrollment.'}], 'secondaryOutcomes': [{'measure': 'Number of New or Newly Enlarging T2 Hyperintense Lesions', 'timeFrame': '2 years', 'description': 'The number of new or newly enlarging T2 hyperintense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T2 hyperintense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T2 hyperintense lesion volume.'}, {'measure': 'Number of New T1 Hypointense Lesions', 'timeFrame': '2 years', 'description': 'The number of new T1 hypointense lesions at 2 years that developed in each subject compared to baseline assessed on brain magnetic resonance imaging (MRI) scans. The estimates of mean T1 hypointense lesion count were calculated from a negative binomial regression model adjusted for region and baseline T1 hypointense lesion volume.'}, {'measure': 'Proportion of Subjects Relapsed', 'timeFrame': '2 years', 'description': 'A protocol-defined relapse was defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted at least 24 hours, and were separated by at least 30 days from onset of a preceding relapse. All protocol-defined relapses were evaluated by an independent neurologic evaluation committee. The proportion of subjects with a relapse was estimated using the Kaplan-Meier method, which was based on the time-to-first-relapse survival distribution.'}, {'measure': 'Proportion of Subjects Experiencing Progression of Disability Assessed Using the Expanded Disability Status Scale (EDSS)', 'timeFrame': '2 years', 'description': 'EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as ≥ 1.0 point increase in subjects with a baseline EDSS of ≥1.0, or ≥1.5 point increase in subjects with a baseline EDSS=0, and required that the increase from baseline was confirmed ≥ 12weeks later. The proportion of subjects with confirmed (12-week) disability progression was estimated using the Kaplan-Meier method, which was based on the time-to-first-progression survival distribution'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['relapsing', 'multiple sclerosis', 'oral', 'remitting'], 'conditions': ['Relapsing-Remitting Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '37061656', 'type': 'DERIVED', 'citation': 'Amezcua L, Mao-Draayer Y, Vargas WS, Farber R, Schaefer S, Branco F, England SM, Belviso N, Lewin JB, Mendoza JP, Shankar SL; ENDORSE Study Investigators. Efficacy of Dimethyl Fumarate in Young Adults with Relapsing-Remitting Multiple Sclerosis: Analysis of the DEFINE, CONFIRM, and ENDORSE Studies. Neurol Ther. 2023 Jun;12(3):883-897. doi: 10.1007/s40120-023-00475-8. Epub 2023 Apr 15.'}, {'pmid': '32426039', 'type': 'DERIVED', 'citation': "Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020."}, {'pmid': '30918100', 'type': 'DERIVED', 'citation': 'Mehta D, Miller C, Arnold DL, Bame E, Bar-Or A, Gold R, Hanna J, Kappos L, Liu S, Matta A, Phillips JT, Robertson D, von Hehn CA, Campbell J, Spach K, Yang L, Fox RJ. Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice. Neurology. 2019 Apr 9;92(15):e1724-e1738. doi: 10.1212/WNL.0000000000007262. Epub 2019 Mar 27.'}, {'pmid': '28770420', 'type': 'DERIVED', 'citation': 'Fox RJ, Gold R, Phillips JT, Okwuokenye M, Zhang A, Marantz JL. Efficacy and Tolerability of Delayed-release Dimethyl Fumarate in Black, Hispanic, and Asian Patients with Relapsing-Remitting Multiple Sclerosis: Post Hoc Integrated Analysis of DEFINE and CONFIRM. Neurol Ther. 2017 Dec;6(2):175-187. doi: 10.1007/s40120-017-0077-5. Epub 2017 Aug 2.'}, {'pmid': '28751099', 'type': 'DERIVED', 'citation': 'Fernandez O, Giovannoni G, Fox RJ, Gold R, Phillips JT, Potts J, Okwuokenye M, Marantz JL. Efficacy and Safety of Delayed-release Dimethyl Fumarate for Relapsing-remitting Multiple Sclerosis in Prior Interferon Users: An Integrated Analysis of DEFINE and CONFIRM. Clin Ther. 2017 Aug;39(8):1671-1679. doi: 10.1016/j.clinthera.2017.06.012. Epub 2017 Jul 25.'}, {'pmid': '27733070', 'type': 'DERIVED', 'citation': 'Fox RJ, Chan A, Zhang A, Xiao J, Levison D, Lewin JB, Edwards MR, Marantz JL. Comparative effectiveness using a matching-adjusted indirect comparison between delayed-release dimethyl fumarate and fingolimod for the treatment of multiple sclerosis. Curr Med Res Opin. 2017 Feb;33(2):175-183. doi: 10.1080/03007995.2016.1248380. Epub 2016 Nov 10.'}, {'pmid': '26932146', 'type': 'DERIVED', 'citation': 'Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.'}, {'pmid': '26526385', 'type': 'DERIVED', 'citation': 'Giovannoni G, Gold R, Fox RJ, Kappos L, Kita M, Yang M, Sarda SP, Zhang R, Viglietta V, Havrdova E. Relapses Requiring Intravenous Steroid Use and Multiple-Sclerosis-related Hospitalizations: Integrated Analysis of the Delayed-release Dimethyl Fumarate Phase III Studies. Clin Ther. 2015 Nov 1;37(11):2543-51. doi: 10.1016/j.clinthera.2015.09.011. Epub 2015 Oct 31.'}, {'pmid': '24131282', 'type': 'DERIVED', 'citation': "Fox RJ, Kita M, Cohan SL, Henson LJ, Zambrano J, Scannevin RH, O'Gorman J, Novas M, Dawson KT, Phillips JT. BG-12 (dimethyl fumarate): a review of mechanism of action, efficacy, and safety. Curr Med Res Opin. 2014 Feb;30(2):251-62. doi: 10.1185/03007995.2013.849236. Epub 2013 Oct 22."}, {'pmid': '22992072', 'type': 'DERIVED', 'citation': 'Fox RJ, Miller DH, Phillips JT, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, Viglietta V, Dawson KT; CONFIRM Study Investigators. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1087-97. doi: 10.1056/NEJMoa1206328.'}]}, 'descriptionModule': {'briefSummary': 'To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse.\n\nOther objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.', 'detailedDescription': 'Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. It is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:\n\nKey Inclusion Criteria:\n\n* Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4\n* Must have a baseline EDSS between 0.0 and 5.0, inclusive.\n* Must have relapsing-remitting disease course.\n\nKey Exclusion Criteria:\n\n* Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease\n* Pregnant or nursing women\n\nNote: Other protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00451451', 'acronym': 'CONFIRM', 'briefTitle': 'Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': '109MS302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BG00012 240 mg Twice Daily (BID)', 'description': 'Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)', 'interventionNames': ['Drug: BG00012', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BG00012 240 mg 3 Times Daily (TID)', 'description': 'Participants received two 120 mg BG00012 capsules orally three times daily (TID)', 'interventionNames': ['Drug: BG00012']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received two placebo capsules orally three times daily (TID)', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)', 'description': 'Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)', 'interventionNames': ['Drug: Glatiramer Acetate']}], 'interventions': [{'name': 'BG00012', 'type': 'DRUG', 'otherNames': ['dimethyl fumarate', 'Tecfidera®'], 'armGroupLabels': ['BG00012 240 mg 3 Times Daily (TID)', 'BG00012 240 mg Twice Daily (BID)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['BG00012 240 mg Twice Daily (BID)', 'Placebo']}, {'name': 'Glatiramer Acetate', 'type': 'DRUG', 'armGroupLabels': ['Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United 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