Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-01-01 @ 3:40 AM
Study NCT ID:
NCT00355134
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
2006-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Lithuania']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], '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': 'D000068876', 'term': 'Fingolimod Hydrochloride'}], 'ancestors': [{'id': 'D013110', 'term': 'Sphingosine'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011409', 'term': 'Propylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Duration of treatment was up to 24 months during the Core phase, and dependent on the length of patient participation during the Extension phase (up to approximately 54 months overall duration of treatment).', 'eventGroups': [{'id': 'EG000', 'title': 'Core: Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.', 'otherNumAtRisk': 370, 'otherNumAffected': 335, 'seriousNumAtRisk': 370, 'seriousNumAffected': 53}, {'id': 'EG001', 'title': 'Core: Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase.', 'otherNumAtRisk': 358, 'otherNumAffected': 320, 'seriousNumAtRisk': 358, 'seriousNumAffected': 53}, {'id': 'EG002', 'title': 'Core: Placebo', 'description': 'Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.', 'otherNumAtRisk': 355, 'otherNumAffected': 305, 'seriousNumAtRisk': 355, 'seriousNumAffected': 45}, {'id': 'EG003', 'title': 'Extension: Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.', 'otherNumAtRisk': 308, 'otherNumAffected': 216, 'seriousNumAtRisk': 308, 'seriousNumAffected': 27}, {'id': 'EG004', 'title': 'Extension: Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day in the Extension phase.', 'otherNumAtRisk': 324, 'otherNumAffected': 223, 'seriousNumAtRisk': 324, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 54}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 85}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 50}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 52}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 87}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 86}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 49}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 40}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 54}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 16}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 21}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 83}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 76}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 53}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 23}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Idiopathic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 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'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Suicidal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chromaturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Adenomyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cervical cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhagic ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Uterovaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 324, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.203', 'groupId': 'OG000', 'lowerLimit': '0.165', 'upperLimit': '0.249'}, {'value': '0.208', 'groupId': 'OG001', 'lowerLimit': '0.170', 'upperLimit': '0.254'}, {'value': '0.403', 'groupId': 'OG002', 'lowerLimit': '0.342', 'upperLimit': '0.475'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25.\n\nA relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\\<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist).\n\nARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS).', 'unitOfMeasure': 'relapses per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set, including all patients who were randomized and took at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Aggregate Annualized Relapse Rate (ARR) Estimate up to End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.180', 'groupId': 'OG000', 'lowerLimit': '0.147', 'upperLimit': '0.222'}, {'value': '0.192', 'groupId': 'OG001', 'lowerLimit': '0.157', 'upperLimit': '0.234'}, {'value': '0.363', 'groupId': 'OG002', 'lowerLimit': '0.305', 'upperLimit': '0.431'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until end of study (up to approximately 54 months).', 'description': 'ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25.\n\nA relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\\<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist).\n\nARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS).', 'unitOfMeasure': 'relapses per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Brain Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.'}], 'classes': [{'title': 'Month 24 [N=247; 266; 249]', 'categories': [{'measurements': [{'value': '-0.595', 'spread': '1.3897', 'groupId': 'OG000'}, {'value': '-0.858', 'spread': '1.2215', 'groupId': 'OG001'}, {'value': '-1.279', 'spread': '1.5028', 'groupId': 'OG002'}]}]}, {'title': 'End of study [N=178; 187; 182]', 'categories': [{'measurements': [{'value': '-1.130', 'spread': '1.6380', 'groupId': 'OG000'}, {'value': '-1.266', 'spread': '1.6941', 'groupId': 'OG001'}, {'value': '-1.694', 'spread': '1.9567', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 24 and end of study (up to approximately 54 months)', 'description': 'Brain volume was measured using magnetic resonance imaging (MRI). Change from Baseline in brain volume is expressed as a percentage of the Baseline brain volume.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. Patients were grouped according to the assigned treatment. "N" indicates the number of participants with data available for the specified time period.'}, {'type': 'SECONDARY', 'title': 'Number of New or Newly Enlarged T2 Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.'}], 'classes': [{'title': 'Core Phase (Month 0 to 24) [N=245; 264; 251]', 'categories': [{'measurements': [{'value': '1.6', 'spread': '5.41', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '7.26', 'groupId': 'OG001'}, {'value': '8.9', 'spread': '13.86', 'groupId': 'OG002'}]}]}, {'title': 'Month 24 to 36 [N=103; 111; 102]', 'categories': [{'measurements': [{'value': '0.63', 'spread': '2.856', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '1.360', 'groupId': 'OG001'}, {'value': '0.63', 'spread': '1.455', 'groupId': 'OG002'}]}]}, {'title': 'Month 36 to 48 [N=24; 15; 15]', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.448', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.258', 'groupId': 'OG001'}, {'value': '2.53', 'spread': '8.741', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline until Month 48', 'description': 'Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions, by year.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. Patients were grouped according to the assigned treatment. "N" indicates the number of participants with MRI data available for the specified time period.'}, {'type': 'SECONDARY', 'title': 'Number of Gadolinium-enhanced T1 Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.'}], 'classes': [{'title': 'Core Phase (Month 24) [N=251; 269; 256]', 'categories': [{'measurements': [{'value': '0.24', 'spread': '2.395', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '1.841', 'groupId': 'OG001'}, {'value': '1.22', 'spread': '2.967', 'groupId': 'OG002'}]}]}, {'title': 'End of Extension study [N=184; 194; 184]', 'categories': [{'measurements': [{'value': '0.46', 'spread': '2.381', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.308', 'groupId': 'OG001'}, {'value': '0.45', 'spread': '3.618', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 24 and end of study (up to approximately 54 months)', 'description': 'Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. "N" indicates the number of participants with evaluable MRI data for the specified time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lesion Volume at Month 24 (Core Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.'}], 'classes': [{'title': 'T2 lesions [N=248, 266, 251]', 'categories': [{'measurements': [{'value': '-436.92', 'spread': '1557.820', 'groupId': 'OG000'}, {'value': '-223.27', 'spread': '1405.459', 'groupId': 'OG001'}, {'value': '541.83', 'spread': '2830.868', 'groupId': 'OG002'}]}]}, {'title': 'T1 hypointense lesions [N=247, 266, 248]', 'categories': [{'measurements': [{'value': '-99.13', 'spread': '391.210', 'groupId': 'OG000'}, {'value': '-111.28', 'spread': '530.961', 'groupId': 'OG001'}, {'value': '-37.68', 'spread': '671.708', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 24', 'description': 'Change from Baseline in lesion volume was measured by MRI for T2 lesions and for T1 hypointense lesions.', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set for whom data were available. N=the number of patients with non-missing baseline and post-baseline values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Free of 3-month Confirmed Disability Progression at Month 24 and End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.'}], 'classes': [{'title': 'At month 24', 'categories': [{'measurements': [{'value': '78.3', 'groupId': 'OG000', 'lowerLimit': '73.74', 'upperLimit': '82.87'}, {'value': '74.7', 'groupId': 'OG001', 'lowerLimit': '69.86', 'upperLimit': '79.52'}, {'value': '71.0', 'groupId': 'OG002', 'lowerLimit': '65.94', 'upperLimit': '76.13'}]}]}, {'title': 'At end of study', 'categories': [{'measurements': [{'value': '66.64', 'groupId': 'OG000', 'lowerLimit': '59.81', 'upperLimit': '73.47'}, {'value': '58.89', 'groupId': 'OG001', 'lowerLimit': '48.98', 'upperLimit': '68.80'}, {'value': '63.51', 'groupId': 'OG002', 'lowerLimit': '57.15', 'upperLimit': '69.87'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months and end of study (up to approximately 54 months)', 'description': 'Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression was defined as a 3-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan-Meier method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Free of 6-month Confirmed Disability Progression at Month 24 and End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.'}], 'classes': [{'title': 'At Month 24', 'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000', 'lowerLimit': '83.16', 'upperLimit': '90.61'}, {'value': '86.2', 'groupId': 'OG001', 'lowerLimit': '82.34', 'upperLimit': '89.97'}, {'value': '82.2', 'groupId': 'OG002', 'lowerLimit': '77.90', 'upperLimit': '86.44'}]}]}, {'title': 'At end of study', 'categories': [{'measurements': [{'value': '79.92', 'groupId': 'OG000', 'lowerLimit': '74.43', 'upperLimit': '85.41'}, {'value': '74.89', 'groupId': 'OG001', 'lowerLimit': '68.36', 'upperLimit': '81.43'}, {'value': '75.03', 'groupId': 'OG002', 'lowerLimit': '69.59', 'upperLimit': '80.47'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months and end of study (up to approximately 54 months)', 'description': 'Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined as a 6-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan-Meier method.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Relapse-free up to Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '73.2', 'groupId': 'OG000', 'lowerLimit': '68.38', 'upperLimit': '78.01'}, {'value': '71.5', 'groupId': 'OG001', 'lowerLimit': '66.55', 'upperLimit': '76.44'}, {'value': '52.7', 'groupId': 'OG002', 'lowerLimit': '47.20', 'upperLimit': '58.24'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 months', 'description': 'Estimates of the percentage of participants relapse-free at 24 months were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\\<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Relapse-free up to End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.88', 'groupId': 'OG000', 'lowerLimit': '56.19', 'upperLimit': '71.57'}, {'value': '66.57', 'groupId': 'OG001', 'lowerLimit': '60.86', 'upperLimit': '72.28'}, {'value': '49.12', 'groupId': 'OG002', 'lowerLimit': '43.35', 'upperLimit': '54.89'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until the end of study (up to approximately 54 months)', 'description': 'Estimates of the percentage of participants relapse-free at end of study were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\\<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}, {'value': '355', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.'}], 'classes': [{'title': 'Month 24 [N=250; 271; 258]', 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.916', 'groupId': 'OG000', 'lowerLimit': '-6.9', 'upperLimit': '1.3'}, {'value': '0.00', 'spread': '0.600', 'groupId': 'OG001', 'lowerLimit': '-5.4', 'upperLimit': '1.5'}, {'value': '-0.07', 'spread': '0.540', 'groupId': 'OG002', 'lowerLimit': '-3.6', 'upperLimit': '1.3'}]}]}, {'title': 'End of Study [N=174; 187; 184]', 'categories': [{'measurements': [{'value': '0.011', 'spread': '0.3499', 'groupId': 'OG000'}, {'value': '-0.091', 'spread': '0.8770', 'groupId': 'OG001'}, {'value': '0.019', 'spread': '0.6304', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 24 and end of study (up to approximately 54 months)', 'description': 'The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Core intent-to-treat (ITT) population: All patients who were randomized in the Core phase and received at least one dose of Core phase drug. "N" indicates the number of participants with non-missing data at each time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'FG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.'}, {'id': 'FG002', 'title': 'Placebo (Core)', 'description': 'Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'FG003', 'title': 'Extension: Fingolimod 1.25 mg', 'description': 'Participants who had received placebo in the Core phase and then received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'FG004', 'title': 'Extension: Fingolimod 0.5 mg', 'description': 'Participants who had received placebo in the Core phase and then received 0.5 mg fingolimod orally once a day in the Extension phase.'}], 'periods': [{'title': 'Core Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '370'}, {'groupId': 'FG001', 'numSubjects': '358'}, {'groupId': 'FG002', 'numSubjects': '355'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '272'}, {'groupId': 'FG002', 'numSubjects': '255'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '86'}, {'groupId': 'FG002', 'numSubjects': '100'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Abnormal test procedure result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Condition no longer requires study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '217'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '105'}, {'groupId': 'FG004', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '180'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '89'}, {'groupId': 'FG004', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Abnormal test procedure result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Patients were randomized to receive fingolimod 0.5 mg, 1.25 mg or placebo for up to 24 months. Upon entry into the Extension phase, patients treated with fingolimod 0.5 mg or 1.25 mg during the Core phase continued treatment at the same dose, those previously treated with placebo were re-randomized in to receive one of the two doses of fingolimod.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'BG000'}, {'value': '358', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}, {'value': '107', 'groupId': 'BG004'}, {'value': '1295', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'BG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.'}, {'id': 'BG002', 'title': 'Placebo (Core)', 'description': 'Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'BG003', 'title': 'Extension: Fingolimod 1.25 mg', 'description': 'Participants who had received placebo in the Core phase and then received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.'}, {'id': 'BG004', 'title': 'Extension: Fingolimod 0.5 mg', 'description': 'Participants who had received placebo in the Core phase and then received 0.5 mg fingolimod orally once a day in the Extension phase.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.9', 'spread': '8.90', 'groupId': 'BG000'}, {'value': '40.6', 'spread': '8.39', 'groupId': 'BG001'}, {'value': '40.1', 'spread': '8.42', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Age demographic data presented for Core phase population only.', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Age demographic data presented for Core phase population only.', 'groupId': 'BG004'}, {'value': '40.5', 'spread': '8.58', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Demographic data for the Core phase participant population.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'spread': '8.71', 'groupId': 'BG000'}, {'value': '40.8', 'spread': '7.96', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Age demographic data presented for the Extension phase population only.', 'groupId': 'BG002'}, {'value': '39.8', 'spread': '8.32', 'groupId': 'BG003'}, {'value': '41.1', 'spread': '8.11', 'groupId': 'BG004'}, {'value': '40.6', 'spread': '8.28', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Demographic data for the Extension phase population. The number of participants in each treatment group in the Extension phase was 203, 217, 0, 105 and 107; Total participants 632.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '281', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '844', 'groupId': 'BG005'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '239', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'description': 'Demographic data for the Core phase participant population.', 'unitOfMeasure': 'participants'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}, {'value': '85', 'groupId': 'BG004'}, {'value': '481', 'groupId': 'BG005'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '151', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'description': 'Demographic data for the Extension phase population. The number of participants in each treatment group in the Extension phase was 203, 217, 0, 105 and 107; Total participants 632.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1083}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-02', 'studyFirstSubmitDate': '2006-07-19', 'resultsFirstSubmitDate': '2012-05-23', 'studyFirstSubmitQcDate': '2006-07-19', 'lastUpdatePostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-23', 'studyFirstPostDateStruct': {'date': '2006-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aggregate Annualized Relapse Rate (ARR) Estimate up to Month 24', 'timeFrame': '24 months', 'description': 'ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25.\n\nA relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\\<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist).\n\nARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS).'}], 'secondaryOutcomes': [{'measure': 'Aggregate Annualized Relapse Rate (ARR) Estimate up to End of Study', 'timeFrame': 'From Baseline until end of study (up to approximately 54 months).', 'description': 'ARR is the average number of relapses in a year calculated by negative binomial regression as the sum of confirmed relapses of all patients in the group divided by the sum of the number of days on study of all patients in the group and multiplied by 365.25.\n\nA relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\\<37.5C) or known infection. A relapse must be confirmed by the Independent Evaluating Physician (examining neurologist).\n\nARR estimates were calculated from a negative binomial regression model adjusted for treatment, pooled center, number of relapses in the previous 2 years prior to enrollment, and Baseline expanded disability status scale (EDSS).'}, {'measure': 'Percent Change From Baseline in Brain Volume', 'timeFrame': 'Baseline, Month 24 and end of study (up to approximately 54 months)', 'description': 'Brain volume was measured using magnetic resonance imaging (MRI). Change from Baseline in brain volume is expressed as a percentage of the Baseline brain volume.'}, {'measure': 'Number of New or Newly Enlarged T2 Lesions', 'timeFrame': 'From Baseline until Month 48', 'description': 'Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of new or newly enlarged T2 lesions, by year.'}, {'measure': 'Number of Gadolinium-enhanced T1 Lesions', 'timeFrame': 'Month 24 and end of study (up to approximately 54 months)', 'description': 'Inflammatory disease activity was assessed by magnetic resonance imaging (MRI) measurement of the number of gadolinium-enhanced T1 lesions.'}, {'measure': 'Change From Baseline in Lesion Volume at Month 24 (Core Phase)', 'timeFrame': 'Baseline and Month 24', 'description': 'Change from Baseline in lesion volume was measured by MRI for T2 lesions and for T1 hypointense lesions.'}, {'measure': 'Percentage of Participants Free of 3-month Confirmed Disability Progression at Month 24 and End of Study', 'timeFrame': '24 months and end of study (up to approximately 54 months)', 'description': 'Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 3-month confirmed disability progression was defined as a 3-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan-Meier method.'}, {'measure': 'Percentage of Participants Free of 6-month Confirmed Disability Progression at Month 24 and End of Study', 'timeFrame': '24 months and end of study (up to approximately 54 months)', 'description': 'Disability progression was defined using the following criteria: One point increase from baseline in patients with Baseline Expanded Disability Status Scale (EDSS) score from 0 to 5.0; or half a point increase from Baseline in patients with Baseline EDSS score of 5.5 or above. A 6-month confirmed disability progression was defined as a 6-month sustained increase from Baseline in EDSS score. The EDSS quantifies disability in multiple sclerosis in 8 functional systems; the score ranges from 0 (normal) to 10 (death due to MS). Progression curves were generated by the Kaplan-Meier method.'}, {'measure': 'Percentage of Participants Relapse-free up to Month 24', 'timeFrame': '24 months', 'description': 'Estimates of the percentage of participants relapse-free at 24 months were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\\<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.'}, {'measure': 'Percentage of Participants Relapse-free up to End of Study', 'timeFrame': 'From Baseline until the end of study (up to approximately 54 months)', 'description': 'Estimates of the percentage of participants relapse-free at end of study were generated from Kaplan-Meier curves of the time to first relapse. A relapse was defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\\<37.5C) or infection. A relapse was confirmed by an Independent Evaluating Physician.'}, {'measure': 'Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z-score', 'timeFrame': 'Baseline, Month 24 and end of study (up to approximately 54 months)', 'description': 'The Multiple Sclerosis Functional Composite (MSFC) is a multidimensional clinical outcome measure that includes quantitative tests of leg function/ambulation (Timed 25-Foot Walk), arm function (9-Hole Peg Test), and cognitive function (Paced Auditory Serial Addition Test). The overall MSFC z-score as an average of the three standardized scores derived using baseline data pooled over each treatment arm as reference population. Higher scores reflect better neurological function and a positive change from Baseline indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fingolimod', 'FTY720', 'relapsing-remitting multiple sclerosis', 'MS', 'RRMS'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '36286605', 'type': 'DERIVED', 'citation': 'Wang L, Tan H, Yu J, ZhangBao J, Huang W, Chang X, Zhou L, Lu C, Xiao Y, Lu J, Zhao C, Wang M, Wu X, Wu M, Dong Q, Ngew KY, Quan C. Baseline retinal nerve fiber layer thickness as a predictor of multiple sclerosis progression: New insights from the FREEDOMS II study. Eur J Neurol. 2023 Feb;30(2):443-452. doi: 10.1111/ene.15612. Epub 2022 Nov 15.'}, {'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': '26121423', 'type': 'DERIVED', 'citation': 'Derfuss T, Bergvall NK, Sfikas N, Tomic DL. Efficacy of fingolimod in patients with highly active relapsing-remitting multiple sclerosis. Curr Med Res Opin. 2015;31(9):1687-91. doi: 10.1185/03007995.2015.1067191. Epub 2015 Aug 20.'}, {'pmid': '25245812', 'type': 'DERIVED', 'citation': 'Chinea Martinez AR, Correale J, Coyle PK, Meng X, Tenenbaum N. Efficacy and safety of fingolimod in Hispanic patients with multiple sclerosis: pooled clinical trial analyses. Adv Ther. 2014 Oct;31(10):1072-81. doi: 10.1007/s12325-014-0154-4. Epub 2014 Sep 23.'}, {'pmid': '24685276', 'type': 'DERIVED', 'citation': 'Calabresi PA, Radue EW, Goodin D, Jeffery D, Rammohan KW, Reder AT, Vollmer T, Agius MA, Kappos L, Stites T, Li B, Cappiello L, von Rosenstiel P, Lublin FD. Safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis (FREEDOMS II): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Jun;13(6):545-56. doi: 10.1016/S1474-4422(14)70049-3. Epub 2014 Mar 28.'}, {'pmid': '24051419', 'type': 'DERIVED', 'citation': 'Winges KM, Werner JS, Harvey DJ, Cello KE, Durbin MK, Balcer LJ, Calabresi PA, Keltner JL. Baseline retinal nerve fiber layer thickness and macular volume quantified by OCT in the North American phase 3 fingolimod trial for relapsing-remitting multiple sclerosis. J Neuroophthalmol. 2013 Dec;33(4):322-9. doi: 10.1097/WNO.0b013e31829c51f7.'}], 'seeAlsoLinks': [{'url': 'http://www.msclinicaltrials.com', 'label': 'Fingolimod clinical trials information website'}]}, 'descriptionModule': {'briefSummary': 'This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).', 'detailedDescription': 'This randomized, multicenter, parallel-group study consisted of 2 phases: a 24-month double-blind, randomized, multicenter, placebo-controlled, parallel-group study and an Extension phase which consisted of a dose-blinded period and an open-label period.\n\nIn the Core phase, patients were randomized to receive a fixed dose of fingolimod (0.5 mg/day), fingolimod (1.25 mg/day) or placebo for up to 24 months.\n\nFor the Extension phase, patients who were treated with fingolimod during the Core phase continued treatment at the assigned dose level, while those previously treated with placebo during the Core phase were re-randomized in a 1:1 ratio to receive one of the two doses of fingolimod (1.25 mg or 0.5 mg). All patients in the extension received blinded investigational drug: fingolimod 1.25 mg and 0.5 mg in capsules for oral administration once daily until the decision to discontinue the fingolimod 1.25 mg dose became effective and subsequently all patients were switched to open-label fingolimod 0.5 mg.\n\nWith the implementation of Amendment 11, the 1.25 mg dose was discontinued and all patients were switched to fingolimod 0.5 mg dose. With the implementation of Amendment 12, all patients treated with Placebo in the fingolimod Core phase were switched to treatment with 0.5 mg fingolimod per day. The Extension phase continued until all patients either discontinued or transferred to Study CFTY720D2399 (NCT01201356; initiated in September 2010).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis\n* Patients with a relapsing-remitting disease course\n* Patients with expanded disability status scale (EDSS) score of 0-5.5\n\nExclusion Criteria:\n\n* Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.\n* Pregnant or nursing women\n\nFor inclusion in the extension phase patients should complete the 24 month core study with or without 24 months on study drug. If a patient discontinued study drug during the core study due to an adverse event, serious adverse event, laboratory abnormality etc. they would be excluded from the Extension Phase.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00355134', 'acronym': 'FREEDOMS II', 'briefTitle': 'Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis', 'nctIdAliases': ['NCT00774670'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': '24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase', 'orgStudyIdInfo': {'id': 'CFTY720D2309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fingolimod 1.25 mg', 'description': 'Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally once a day.\n\nNote: Upon implementation of a protocol amendment all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.', 'interventionNames': ['Drug: Fingolimod']}, {'type': 'EXPERIMENTAL', 'label': 'Fingolimod 0.5 mg', 'description': 'Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.', 'interventionNames': ['Drug: Fingolimod']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day.\n\nNote: Upon implementation of a protocol amendment all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Fingolimod', 'type': 'DRUG', 'otherNames': ['FTY720', 'Gilenya®'], 'description': 'Fingolimod capsules for oral administration', 'armGroupLabels': ['Fingolimod 0.5 mg', 'Fingolimod 1.25 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo capsules for oral administration.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35058', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'North Central Neurology Associates, PC', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '36693', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama - 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