Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT00340834
Status:
COMPLETED
Last Update Posted:
2017-09-21
First Post:
2006-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': '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': "There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.\n\nThe 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 (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'COR FTY720 1.25 mg', 'description': 'COR FTY720 1.25 mg', 'otherNumAtRisk': 420, 'otherNumAffected': 310, 'seriousNumAtRisk': 420, 'seriousNumAffected': 45}, {'id': 'EG001', 'title': 'COR FTY720 0.5 mg', 'description': 'COR FTY720 0.5 mg', 'otherNumAtRisk': 429, 'otherNumAffected': 302, 'seriousNumAtRisk': 429, 'seriousNumAffected': 30}, {'id': 'EG002', 'title': 'COR Interferon Beta-1a', 'description': 'COR Interferon beta-1a', 'otherNumAtRisk': 431, 'otherNumAffected': 359, 'seriousNumAtRisk': 431, 'seriousNumAffected': 25}, {'id': 'EG003', 'title': 'EXT FTY720 1.25 mg', 'description': 'EXT FTY720 1.25 mg', 'otherNumAtRisk': 504, 'otherNumAffected': 446, 'seriousNumAtRisk': 504, 'seriousNumAffected': 77}, {'id': 'EG004', 'title': 'EXT FTY720 0.5 mg', 'description': 'EXT FTY720 0.5 mg', 'otherNumAtRisk': 523, 'otherNumAffected': 439, 'seriousNumAtRisk': 523, 'seriousNumAffected': 76}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 108}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 77}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 48}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 37}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 158}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 76}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 49}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 44}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 52}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 88}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 158}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 162}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 36}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 34}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 75}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 59}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 49}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 44}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 34}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 32}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 72}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 42}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 32}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 38}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 39}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 60}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 53}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 39}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 53}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 51}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 99}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 88}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 86}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 107}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 40}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 44}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 32}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 30}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 54}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 53}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 38}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 37}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 29}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Autoimmune thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Adenomyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Haemorrhagic ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Infertility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Menometrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Spermatocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Testicular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 420, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 429, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 504, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 523, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '429', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'OG002', 'title': 'Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg', 'description': 'Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.203', 'groupId': 'OG000', 'lowerLimit': '0.157', 'upperLimit': '0.264'}, {'value': '0.161', 'groupId': 'OG001', 'lowerLimit': '0.122', 'upperLimit': '0.212'}, {'value': '0.331', 'groupId': 'OG002', 'lowerLimit': '0.262', 'upperLimit': '0.417'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 12', 'description': 'The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.', 'unitOfMeasure': 'Estimate relapses per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '429', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'OG002', 'title': 'Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg', 'description': 'Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '3.23', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '3.16', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '5.50', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 12', 'description': 'The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.', 'unitOfMeasure': 'T2 lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '429', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'OG002', 'title': 'Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg', 'description': 'Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '90.92', 'upperLimit': '95.77'}, {'value': '94.1', 'groupId': 'OG001', 'lowerLimit': '91.82', 'upperLimit': '96.33'}, {'value': '92.1', 'groupId': 'OG002', 'lowerLimit': '89.45', 'upperLimit': '94.66'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 12', 'description': 'The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \\& bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '429', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'OG002', 'title': 'Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg', 'description': 'Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.'}], 'classes': [{'title': 'Month 12 to Month 24, n=330, 356, 341', 'categories': [{'measurements': [{'value': '0.156', 'groupId': 'OG000', 'lowerLimit': '0.114', 'upperLimit': '0.214'}, {'value': '0.182', 'groupId': 'OG001', 'lowerLimit': '0.138', 'upperLimit': '0.242'}, {'value': '0.266', 'groupId': 'OG002', 'lowerLimit': '0.207', 'upperLimit': '0.341'}]}]}, {'title': 'Month 24 to Month 36, n=287, 321, 293', 'categories': [{'measurements': [{'value': '0.116', 'groupId': 'OG000', 'lowerLimit': '0.079', 'upperLimit': '0.169'}, {'value': '0.110', 'groupId': 'OG001', 'lowerLimit': '0.076', 'upperLimit': '0.160'}, {'value': '0.121', 'groupId': 'OG002', 'lowerLimit': '0.084', 'upperLimit': '0.176'}]}]}, {'title': 'Month 36 to Month 48, n=267, 303, 271', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to sparse data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to sparse data.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to sparse data.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 48 to end of study, n=36, 38, 29', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable due to sparse data.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to sparse data.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not estimable due to sparse data.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Month 0 to end of study, n=420, 429, 431', 'categories': [{'measurements': [{'value': '0.192', 'groupId': 'OG000', 'lowerLimit': '0.160', 'upperLimit': '0.229'}, {'value': '0.166', 'groupId': 'OG001', 'lowerLimit': '0.139', 'upperLimit': '0.199'}, {'value': '0.271', 'groupId': 'OG002', 'lowerLimit': '0.230', 'upperLimit': '0.318'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 0 to end of study (up to approximately 4.5 years)', 'description': 'The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.', 'unitOfMeasure': 'Estimated relapses per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population (ITT): All patients who were randomized and received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}, {'value': '288', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'OG002', 'title': 'Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg', 'description': 'Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.'}], 'classes': [{'title': 'Month 12 to Month 24', 'categories': [{'measurements': [{'value': '1.08', 'spread': '2.644', 'groupId': 'OG000'}, {'value': '0.87', 'spread': '1.624', 'groupId': 'OG001'}, {'value': '0.97', 'spread': '1.923', 'groupId': 'OG002'}]}]}, {'title': 'Month 24 to Month 36, n=255, 289, 258', 'categories': [{'measurements': [{'value': '1.40', 'spread': '3.418', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '4.408', 'groupId': 'OG001'}, {'value': '0.72', 'spread': '1.733', 'groupId': 'OG002'}]}]}, {'title': 'Month 36 to Month 48, n=36, 34, 35', 'categories': [{'measurements': [{'value': '0.97', 'spread': '1.682', 'groupId': 'OG000'}, {'value': '0.59', 'spread': '1.438', 'groupId': 'OG001'}, {'value': '0.49', 'spread': '1.483', 'groupId': 'OG002'}]}]}, {'title': 'Last MRI scan to end of study, n=275, 309, 290', 'categories': [{'measurements': [{'value': '1.75', 'spread': '7.248', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '2.674', 'groupId': 'OG001'}, {'value': '1.03', 'spread': '4.350', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12 to end of study (up to approximately 3.5 years)', 'description': 'The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.', 'unitOfMeasure': 'T2 lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '429', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'OG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'OG002', 'title': 'Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg', 'description': 'Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.'}], 'classes': [{'title': 'Free of 3-month progression', 'categories': [{'measurements': [{'value': '67.01', 'groupId': 'OG000', 'lowerLimit': '57.26', 'upperLimit': '95.77'}, {'value': '71.28', 'groupId': 'OG001', 'lowerLimit': '63.69', 'upperLimit': '78.87'}, {'value': '73.40', 'groupId': 'OG002', 'lowerLimit': '68.56', 'upperLimit': '78.23'}]}]}, {'title': 'Free of 6-month progression', 'categories': [{'measurements': [{'value': '79.54', 'groupId': 'OG000', 'lowerLimit': '75.07', 'upperLimit': '84.00'}, {'value': '79.76', 'groupId': 'OG001', 'lowerLimit': '75.53', 'upperLimit': '83.98'}, {'value': '81.61', 'groupId': 'OG002', 'lowerLimit': '77.39', 'upperLimit': '85.83'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of study (up to approximately 4.5 years)', 'description': 'The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \\& bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population (ITT): All randomized patients who received at least 1 dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'FG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'FG002', 'title': 'Interferon β-1a 30 µg', 'description': 'Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.'}, {'id': 'FG003', 'title': 'Interferon β-1a/Fingolimod 1.25 mg', 'description': 'Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily.'}, {'id': 'FG004', 'title': 'Interferon β-1a/Fingolimod 0.5 mg', 'description': 'Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily.'}], 'periods': [{'title': 'Core Phase of Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '426'}, {'groupId': 'FG001', 'numSubjects': '431'}, {'groupId': 'FG002', 'numSubjects': '435'}, {'comment': 'This group was formed at the beginning of the extension phase of the study.', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'This group was formed at the beginning of the extension phase of the study.', 'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'On study drug: 358, Off study drug: 11', 'groupId': 'FG000', 'numSubjects': '369'}, {'comment': 'On study drug: 385, Off study drug: 13', 'groupId': 'FG001', 'numSubjects': '398'}, {'comment': 'On study drug: 380, Off study drug: 6', 'groupId': 'FG002', 'numSubjects': '386'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Administrative Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Abnormal test procedure result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Extension Phase of Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Entry into the extension phase of the study was optional.', 'groupId': 'FG000', 'numSubjects': '330'}, {'comment': 'Entry into the extension phase of the study was optional.', 'groupId': 'FG001', 'numSubjects': '357'}, {'comment': 'This group did not exist in the extension phase of the study.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'Entry into the extension phase of the study was optional.', 'groupId': 'FG003', 'numSubjects': '176'}, {'comment': 'Entry into the extension phase of the study was optional.', 'groupId': 'FG004', 'numSubjects': '167'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '330'}, {'groupId': 'FG001', 'numSubjects': '356'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '174'}, {'groupId': 'FG004', 'numSubjects': '167'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '245'}, {'groupId': 'FG001', 'numSubjects': '281'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '123'}, {'groupId': 'FG004', 'numSubjects': '123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '53'}, {'groupId': 'FG004', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Subject did not receive study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Subject withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '15'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Subject no longer requires study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'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': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients randomized in the Core Phase (CP) to receive 0.5 mg or 1.25 mg fingolimod received the same dose in the Extension Phase (EP). Patients randomized to receive interferon-β-1a in the CP were re-randomized to receive either 0.5 mg or 1.25 mg fingolimod in a 1:1 ratio in the EP. Upon protocol amendment, all patients received 0.5 mg fingolimod.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'BG000'}, {'value': '431', 'groupId': 'BG001'}, {'value': '435', 'groupId': 'BG002'}, {'value': '174', 'groupId': 'BG003'}, {'value': '167', 'groupId': 'BG004'}, {'value': '1633', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Fingolimod 1.25 mg', 'description': 'Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'BG001', 'title': 'Fingolimod 0.5 mg', 'description': 'Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.'}, {'id': 'BG002', 'title': 'Interferon β-1a 30 µg', 'description': 'Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.'}, {'id': 'BG003', 'title': 'Interferon β-1a/Fingolimod 1.25 mg', 'description': 'Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily.'}, {'id': 'BG004', 'title': 'Interferon β-1a/Fingolimod 0.5 mg', 'description': 'Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.8', 'spread': '8.39', 'groupId': 'BG000'}, {'value': '36.7', 'spread': '8.81', 'groupId': 'BG001'}, {'value': '36.0', 'spread': '8.29', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG004'}, {'value': '36.2', 'spread': '8.50', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Core phase of study. Total number of patients is 1292. Demographics are based on the randomized population.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'spread': '8.42', 'groupId': 'BG000'}, {'value': '36.5', 'spread': '8.67', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This group did not exist in the extension phase of the study.', 'groupId': 'BG002'}, {'value': '36.1', 'spread': '8.11', 'groupId': 'BG003'}, {'value': '36.1', 'spread': '8.59', 'groupId': 'BG004'}, {'value': '36.0', 'spread': '8.48', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Extension phase of study. The number of patients in the optional extension phase was less than the overall number of baseline participants who started the study. Total number of patients is 1027. Demographics are based on the intent-to-treat population.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 18', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}, {'title': '18-30', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG004'}, {'value': '355', 'groupId': 'BG005'}]}]}, {'title': '31-40', 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG004'}, {'value': '495', 'groupId': 'BG005'}]}]}, {'title': '41-55', 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG004'}, {'value': '442', 'groupId': 'BG005'}]}]}, {'title': '> 55', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'description': 'Core phase of study. Total number of patients is 1292. Demographics are based on the randomized population.', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Customized', 'classes': [{'title': '< 18', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'This group did not exist in the extension phase of the study.', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}, {'title': '18-30', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'This group did not exist in the extension phase of the study.', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}, {'value': '285', 'groupId': 'BG005'}]}]}, {'title': '31-40', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'This group did not exist in the extension phase of the study.', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '394', 'groupId': 'BG005'}]}]}, {'title': '41-55', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'This group did not exist in the extension phase of the study.', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}, {'value': '348', 'groupId': 'BG005'}]}]}, {'title': '>55', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'This group did not exist in the extension phase of the study.', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'description': 'Extension phase of study. The number of patients in the optional extension phase was less than the overall number of baseline participants who started the study. Total number of patients is 1027. Demographics are based on the intent-to-treat population.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '293', 'groupId': 'BG000'}, {'value': '282', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'This group did not exist in the core phase of the study.', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Core phase of study. Total number of patients is 1292. Demographics are based on the randomized population.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'This group did not exist in the extension phase of the study.', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}, {'value': '109', 'groupId': 'BG004'}, {'value': '685', 'groupId': 'BG005'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'This group did not exist in the extension phase of the study.', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}, {'value': '342', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'description': 'Extension phase of study. The number of patients in the optional extension phase was less than the overall number of baseline participants who started the study. Total number of patients is 1027. Demographics are based on the intent-to-treat population.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1292}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-18', 'studyFirstSubmitDate': '2006-06-19', 'resultsFirstSubmitDate': '2011-01-04', 'studyFirstSubmitQcDate': '2006-06-20', 'lastUpdatePostDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-04-20', 'studyFirstPostDateStruct': {'date': '2006-06-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated Annualized Aggregate Relapse Rate (ARR) in the Core Phase of the Study', 'timeFrame': 'Baseline to Month 12', 'description': 'The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.'}], 'secondaryOutcomes': [{'measure': 'Number of New or Newly Enlarged T2 Lesions in Comparison With Baseline in the Core Phase of the Study', 'timeFrame': 'Baseline to Month 12', 'description': 'The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.'}, {'measure': 'Percentage of Participants Free of 3-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Core Phase of the Study', 'timeFrame': 'Baseline to Month 12', 'description': 'The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \\& bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.'}, {'measure': 'Estimated Annualized Aggregate Relapse Rate (ARR) in the Core and Extension Phases of the Study', 'timeFrame': 'Month 0 to end of study (up to approximately 4.5 years)', 'description': 'The ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was calculated using negative binomial regression adjusted by treatment, country, number of relapses in the previous 2 years, and the baseline Expanded Disability Status Scale score.'}, {'measure': 'Number of New or Newly Enlarged T2 Lesions in the Extension Phase of the Study', 'timeFrame': 'Month 12 to end of study (up to approximately 3.5 years)', 'description': 'The number of new or newly enlarged T2 lesions in comparison to baseline was assessed with T2-weighted magnetic resonance image (MRI) scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2-weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.'}, {'measure': 'Percentage of Participants Free of 3-month and 6-month Disability Progression Assessed With the Expanded Disability Status Scale (EDSS) at the End of the Extension Phase of the Study', 'timeFrame': 'Baseline to end of study (up to approximately 4.5 years)', 'description': 'The EDSS is a scale for assessing disability in 8 functional systems (visual, brain stem, pyramidal, cerebellar, sensory, bowel \\& bladder, cerebral, other functions). An overall score ranging from 0 (normal) to 10 (death due to MS) is calculated. Disability progression was determined by the EDSS score based on the following criteria: One point increase from baseline in patients with baseline EDSS score from 0 to 5.0; or half a point increase in patients with baseline EDSS score of 5.5 or above. Percent of patients free of disability progression was calculated using the Kaplan-Meier method.'}]}, 'conditionsModule': {'keywords': ['FTY720', 'Interferon', 'RRMS', 'Multiple Sclerosis', 'Efficacy'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '26111826', 'type': 'DERIVED', 'citation': 'Cohen JA, Khatri B, Barkhof F, Comi G, Hartung HP, Montalban X, Pelletier J, Stites T, Ritter S, von Rosenstiel P, Tomic D, Kappos L; TRANSFORMS (TRial Assessing injectable interferoN vS. FTY720 Oral in RRMS) Study Group. Long-term (up to 4.5 years) treatment with fingolimod in multiple sclerosis: results from the extension of the randomised TRANSFORMS study. J Neurol Neurosurg Psychiatry. 2016 May;87(5):468-75. doi: 10.1136/jnnp-2015-310597. Epub 2015 Jun 25.'}, {'pmid': '25876473', 'type': 'DERIVED', 'citation': 'Khatri BO, Pelletier J, Kappos L, Hartung HP, Comi G, Barkhof F, von Rosenstiel P, Meng X, Grinspan A, Hashmonay R, Cohen JA; TRANSFORMS Study Group. Effect of prior treatment status and reasons for discontinuation on the efficacy and safety of fingolimod vs. interferon beta-1a intramuscular: Subgroup analyses of the Trial Assessing Injectable Interferon vs. Fingolimod Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS). Mult Scler Relat Disord. 2014 May;3(3):355-63. doi: 10.1016/j.msard.2013.11.006. Epub 2013 Dec 12.'}, {'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': '23531349', 'type': 'DERIVED', 'citation': 'Zarbin MA, Jampol LM, Jager RD, Reder AT, Francis G, Collins W, Tang D, Zhang X. Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis. Ophthalmology. 2013 Jul;120(7):1432-9. doi: 10.1016/j.ophtha.2012.12.040. Epub 2013 Mar 24.'}, {'pmid': '21571593', 'type': 'DERIVED', 'citation': 'Khatri B, Barkhof F, Comi G, Hartung HP, Kappos L, Montalban X, Pelletier J, Stites T, Wu S, Holdbrook F, Zhang-Auberson L, Francis G, Cohen JA; TRANSFORMS Study Group. Comparison of fingolimod with interferon beta-1a in relapsing-remitting multiple sclerosis: a randomised extension of the TRANSFORMS study. Lancet Neurol. 2011 Jun;10(6):520-9. doi: 10.1016/S1474-4422(11)70099-0. Epub 2011 May 13.'}, {'pmid': '20937112', 'type': 'DERIVED', 'citation': 'Twiss J, Doward LC, McKenna SP, Eckert B. Interpreting scores on multiple sclerosis-specific patient reported outcome measures (the PRIMUS and U-FIS). Health Qual Life Outcomes. 2010 Oct 11;8:117. doi: 10.1186/1477-7525-8-117.'}, {'pmid': '20089954', 'type': 'DERIVED', 'citation': 'Cohen JA, Barkhof F, Comi G, Hartung HP, Khatri BO, Montalban X, Pelletier J, Capra R, Gallo P, Izquierdo G, Tiel-Wilck K, de Vera A, Jin J, Stites T, Wu S, Aradhye S, Kappos L; TRANSFORMS Study Group. Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. N Engl J Med. 2010 Feb 4;362(5):402-15. doi: 10.1056/NEJMoa0907839. Epub 2010 Jan 20.'}], 'seeAlsoLinks': [{'url': 'http://www.msclinicaltrials.com', 'label': 'Fingolimod clinical trials information website'}]}, 'descriptionModule': {'briefSummary': 'This study assessed the safety, tolerability, and efficacy of 2 doses of oral fingolimod versus interferon β-1a to reduce the frequency of relapses in patients with relapsing-remitting multiple sclerosis.'}, '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 (MS)\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* Patients who cannot tolerate treatment with an interferon\n\nOther protocol-defined inclusion/exclusion criteria applied to the study.'}, 'identificationModule': {'nctId': 'NCT00340834', 'acronym': 'TRANSFORMS', 'briefTitle': 'Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12-month Double-blind, Randomized, Multicenter, Active-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Interferon ß-1a (Avonex) Administered im Once Weekly in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase', 'orgStudyIdInfo': {'id': 'CFTY720D2302'}, 'secondaryIdInfos': [{'id': 'CFTY720D2302E1', 'type': 'OTHER', 'domain': 'Novartis'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fingolimod 1.25 mg', 'interventionNames': ['Drug: Fingolimod 1.25 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Fingolimod 0.5 mg', 'interventionNames': ['Drug: Fingolimod 0.5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interferon β-1a 30 µg', 'interventionNames': ['Drug: Interferon β-1a 30 µg']}], 'interventions': [{'name': 'Fingolimod 1.25 mg', 'type': 'DRUG', 'otherNames': ['FTY720'], 'description': 'Core: Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.\n\nExtension: Patients self-administered fingolimod 1.25 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.', 'armGroupLabels': ['Fingolimod 1.25 mg']}, {'name': 'Fingolimod 0.5 mg', 'type': 'DRUG', 'otherNames': ['FTY720'], 'description': 'Core: Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.\n\nExtension: Patients self-administered fingolimod 0.5 mg capsules orally once daily.', 'armGroupLabels': ['Fingolimod 0.5 mg']}, {'name': 'Interferon β-1a 30 µg', 'type': 'DRUG', 'description': 'Core: Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.\n\nExtension: Patients self-administered either fingolimod 1.25 mg or 0.5 mg capsules orally once daily until switched to 0.5 mg capsules upon study protocol amendment.', 'armGroupLabels': ['Interferon β-1a 30 µg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35058', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'North Central Neurology Associates, PC, 1809 Kress Street', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barrow Neurological Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'The Neurology Center, 3907 Waring Road, Suite 3', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Associated Neurologists, PC, 69 Sand Pit Road, Suite 300', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '06824', 'city': 'Fairfield', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Associated Neurologists of Southern CT, PC, 75 Kings Highway Cutoff', 'geoPoint': {'lat': 41.14121, 'lon': -73.26373}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University Multiple Sclerosis Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health Science Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurology Associates, PA, 301 N. Maitland Avenue, Suite A1', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami, Department of Neurology', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33060', 'city': 'Pompano Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurological Associates', 'geoPoint': {'lat': 26.23786, 'lon': -80.12477}}, {'zip': '34243', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Roskamp Institute, 2040 Whitfield Ave.', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '32308', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'AMO Corporation', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Axiom Clinical Research of Florida, 2919 Swann Avenue, Suite 401', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida, Department of Neurology', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'The MS Center of Vero Beach', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66214', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Mid America Neuroscience Institute, 8550 Marshall Drive, Suite 100', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'University Physician Group, #1 Barnes-Jewish Hospital Plaza, Suite 16304', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Neuroscience and Spine Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Raleigh Neurology Associates, 1540 Sunday Drive', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44302', 'city': 'Akron', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neurology & Neuroscience Associates, Inc', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '44811', 'city': 'Bellevue', 'state': 'Ohio', 'country': 'United States', 'facility': 'Northern Ohio Neuroscience, LLC', 'geoPoint': {'lat': 41.27366, 'lon': -82.84158}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97062', 'city': 'Tualatin', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Neurology', 'geoPoint': {'lat': 45.38401, 'lon': -122.76399}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh, Department of Neurology', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Absher Neurology, 274-A Commonwealth Drive', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37620', 'city': 'Bristol', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Mountain Empire Neurological Associates, PC, 3183 West State Street, Suite 1201', 'geoPoint': {'lat': 36.59511, 'lon': -82.18874}}, {'zip': '37064', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Advanced Neurosciences Institute', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '79410', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Private Practice, 3815 23rd Street', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Integra Clinical Research, 4242 Medical Drive, Suite 6100', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Neuroscience Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Rockwood Clinic, P.S.', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University Health Associates', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Center for Neurological Disorders - Aurora St. Luke's Med Center", 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '1428', 'city': 'Guarda Vieja 4435, Capital Federal', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Ineba'}, {'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Fundacion Rosarina de Neurorehabilitacion', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '2000', 'city': 'Rosario', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'Instituto de Neurociencias de Rosario', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'C118ACK', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Italiano de Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 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