Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-31 @ 3:41 AM
Study NCT ID:
NCT00731692
Status:
TERMINATED
Last Update Posted:
2017-06-14
First Post:
2008-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.
Sponsor:
Organization:
Raw JSON
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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 or disclosure of trial results in their entirety", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Core: FTY720 1.25 mg', 'description': 'Patients who received FTY720 1.25 mg during core', 'otherNumAtRisk': 147, 'otherNumAffected': 132, 'seriousNumAtRisk': 147, 'seriousNumAffected': 38}, {'id': 'EG001', 'title': 'Core: FTY720 0.5 mg', 'description': 'Patients who received FTY720 0.5 mg during core', 'otherNumAtRisk': 336, 'otherNumAffected': 278, 'seriousNumAtRisk': 336, 'seriousNumAffected': 84}, {'id': 'EG002', 'title': 'Core: Placebo', 'description': 'Patients who received Placebo during core', 'otherNumAtRisk': 487, 'otherNumAffected': 406, 'seriousNumAtRisk': 487, 'seriousNumAffected': 117}, {'id': 'EG003', 'title': 'Extension: FTY1.25-0.5', 'description': 'Patients who received FTY20 1.25 mg in core and received 0.5 mg of FTY during Extension', 'otherNumAtRisk': 74, 'otherNumAffected': 43, 'seriousNumAtRisk': 74, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': 'Extension: FTY0.5-0.5', 'description': 'Patients who received FTY20 0.5 mg in core and received 0.5 mg of FTY during Extension', 'otherNumAtRisk': 196, 'otherNumAffected': 70, 'seriousNumAtRisk': 196, 'seriousNumAffected': 10}, {'id': 'EG005', 'title': 'Extension: Placebo-FTY0.5', 'description': 'Patients who received Placebo in core and received 0.5 mg of FTY during Extension', 'otherNumAtRisk': 301, 'otherNumAffected': 138, 'seriousNumAtRisk': 301, 'seriousNumAffected': 37}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 135}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 57}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 75}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 91}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 75}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Seborrhoeic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 77}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 37}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 29}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 18}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Anaemia macrocytic', 'stats': [{'groupId': 'EG000', 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{'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Actinic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': "Jessner's lymphocytic infiltration", 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lentigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Activities of daily living impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Poor personal hygiene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Arterial spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': "Raynaud's phenomenon", 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 336, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 487, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 196, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 301, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '487', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '77.2', 'groupId': 'OG000', 'lowerLimit': '71.87', 'upperLimit': '82.51'}, {'value': '80.3', 'groupId': 'OG001', 'lowerLimit': '73.31', 'upperLimit': '87.25'}]}]}], 'analyses': [{'pValue': '0.544', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.12', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 36 months after the last patient was randomized', 'description': "3-month sustained increase from Baseline in EDSS (at least 1 point increase from Baseline for patients with a Baseline value of 5 or less or at least 0.5 point increase from Baseline for patients with a Baseline value of 5.5 or more) or 3-month sustained increase of at least 20% from BL in the time taken to complete the timed 25-foot walk test (25' TWT); or 3-month sustained increase of at least 20% from BL in the time taken to complete the 9-HPT. The 25' TWT is a quantitative measure of lower extremity function. The EDSS is a scale assessing neurologic impairment, including a series of scores in each of 8 functional systems: Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. The score ranges from 0 (normal) to 10 (death due to MS)). The 9-hole peg test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.'}, {'type': 'SECONDARY', 'title': 'Kaplan-Meier Estimate of the Risk of 3- Month Confirmed Disability Progression Based on Expanded Disability Status Scale (EDSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '336', 'groupId': 'OG000'}, {'value': '487', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '54.3', 'groupId': 'OG000', 'lowerLimit': '47.16', 'upperLimit': '61.45'}, {'value': '58.7', 'groupId': 'OG001', 'lowerLimit': '53.30', 'upperLimit': '64.18'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 36 months after the last patient was randomized', 'description': 'The Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in MS (Kurtzke 1983) and includes a series of scores in each of 8 functional systems and the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Fatigue is not included in the Cerebral score of the EDSS. The score ranges from 0 (normal) to 10 (death due to MS)', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Brain Volume at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '421', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.49', 'groupId': 'OG000', 'lowerLimit': '-1.64', 'upperLimit': '-1.35'}, {'value': '-1.53', 'groupId': 'OG001', 'lowerLimit': '-1.65', 'upperLimit': '-1.41'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to month 36', 'description': 'The percent change from Baseline in brain volume was analyzed using a random coefficients model. The model included: 1) fixed effects: treatment and region and 2) continuous covariates: time, number of Gd enhancing lesions at Baseline, Baseline T2 volume, and normalized brain volume at Baseline. Time as a continuous covariate allowed for the estimation of different slopes and intercepts among treatment groups.', 'unitOfMeasure': 'Percent Change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. N= Total number of patients included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 9-HPT.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '24.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 36 months after the last patient was randomized', 'description': 'The 9-HPT is a quantitative measure of upper extremity (arm and hand) function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis', 'unitOfMeasure': 'Percentge of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.'}, {'type': 'SECONDARY', 'title': "Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 25' TWT.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000'}, {'value': '56.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 36 months after the last patient was randomized', 'description': "The 25' TWT is a quantitative measure of lower extremity function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.'}, {'type': 'SECONDARY', 'title': 'Number of New/Enlarging T2 Lesions Per Year Measured From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '298', 'groupId': 'OG000'}, {'value': '421', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '0.18'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.40', 'upperLimit': '0.61'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 36 months', 'description': 'Inflammatory disease, as measured by number of new or newly-enlarging T2 lesions, was assessed by Magnetic resonance Imaging (MRI) scanning of the brain and full spinal cord. N= Total number of patients included in the analysis', 'unitOfMeasure': 'T2 Lesions per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) -The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.'}, {'type': 'SECONDARY', 'title': 'Number of Gd-enhancing Lesions at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.09'}, {'value': '0.21', 'groupId': 'OG001', 'lowerLimit': '0.15', 'upperLimit': '0.30'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 36 months', 'description': 'Inflammatory disease, as measured by number of T1 Gd-enhancing lesions, was assessed by MRI scanning of the brain and full spinal cord. N= Total number of patients included in the analysis', 'unitOfMeasure': 'Gd-enhanced lesions per patient per scan', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.'}, {'type': 'SECONDARY', 'title': 'Percent Change in Total T2 Lesion Volume From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.2', 'spread': '30.55', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '44.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to month 36', 'description': 'Inflammatory disease as measured by percent change in total T2 lesion volume (mm3) was assessed by MRI. N= Total number of patients included in the analysis', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Patient Reported Indices in Multiple Sclerosis (PRIMUS-QoL Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 1.25 mg to 0.5 mg', 'description': 'Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment'}, {'id': 'OG001', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2424', 'spread': '4.18444', 'groupId': 'OG000'}, {'value': '0.5921', 'spread': '4.77704', 'groupId': 'OG001'}, {'value': '0.9597', 'spread': '4.38578', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 months', 'description': 'The quality of life scale contains 22 items. Each item will be given a score of 1 or 0. A score of 1 (or 0) indicates the presence (or absence) of the symptom or adverse quality of life. All 22 item scores will be summed to obtain a total score ranging from 0 (good) to 22 (poor), which is the PRIMUS QoL scale score', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PRIMUS-Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 1.25 mg to 0.5 mg', 'description': 'Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment'}, {'id': 'OG001', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5504', 'spread': '7.05241', 'groupId': 'OG000'}, {'value': '2.6324', 'spread': '6.22256', 'groupId': 'OG001'}, {'value': '2.8830', 'spread': '6.76499', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 months', 'description': 'The activities subscale of PRIMUS contains 15 items and each item is given a score of 0 (able to do on own without difficulties), 1 (able to do on own with difficulties), or 2 (unable to do on own). All 15 items were summed to obtain a total score ranging from 0 (good) to 30 (poor).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Unidimensional Fatigue Impact (U-FIS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '241', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 1.25 mg to 0.5 mg', 'description': 'Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment'}, {'id': 'OG001', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3197', 'spread': '12.44042', 'groupId': 'OG000'}, {'value': '2.8451', 'spread': '14.04769', 'groupId': 'OG001'}, {'value': '3.1394', 'spread': '12.20929', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 months', 'description': 'Unidimensional Fatigue Impact Scale (U-FIS), contains 22 patient-reported items that assess the impact of fatigue on cognitive, physical, and psychosocial functioning. Responses formed a single unidimensional scale measuring fatigue impact. The U-FIS was calculated and analyzed according to the U-FIS scoring manual. The U-FIS scale contains 22 items with 5 possible outcomes for each item. Two response categories (about half the time and a lot of the time) were combined into 1 category to obtain 4 possible outcomes: 0 (never), 1 (a little of the time), 2 (about half the time/a lot of the time), and 3 (all the time). The 22 condensed item scores were summed to obtain a total score ranging from 0 (no fatigue) to 66 (severe fatigue impact).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}, {'value': '320', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 1.25 mg to 0.5 mg', 'description': 'Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment'}, {'id': 'OG001', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0332', 'spread': '0.19420', 'groupId': 'OG000'}, {'value': '-0.0475', 'spread': '0.26099', 'groupId': 'OG001'}, {'value': '-0.0539', 'spread': '0.22383', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 months', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Multiple Sclerosis Walking Scale (MSWS-12 Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '261', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 1.25 mg to 0.5 mg', 'description': 'Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment'}, {'id': 'OG001', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4444', 'spread': '23.81568', 'groupId': 'OG000'}, {'value': '5.5616', 'spread': '24.59030', 'groupId': 'OG001'}, {'value': '9.5899', 'spread': '23.98316', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 36 months', 'description': 'The Multiple Sclerosis Walking Scaleis a patient reported measure of walking quality (Hobart et al 2003), consisting of 12 items asking patients to rate the impact of MS upon their walking ability. Responses were captured on a 3-point scale ranging from 1 (Not at all) to 3 (A lot) for items 1 to 3 and on a 5-point scale ranging from 1 (not limited) to 5 (extremely) for items 4 to 12. All 12 item scores were summed to obtain a total score ranging from 12 (good) to 54 (poor) which is the MSWS-12 scale score. The total score was transformed to a 0 to 100 scale score. The MSWS-12 scale score will be transformed to a 0-100 scale score before any summaries or statistical analyses are performed. The transformed score is obtained by subtracting 12 and divided by 42 and multiplying by 100 (i.e., transformed scale score = (raw scale score- 12)/42\\*100).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. Only subjects with a value at both baseline and at month 36 are included.'}, {'type': 'SECONDARY', 'title': 'Blood Concentrations of Fingolimod and Fingolimod-phosphate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 1.25 mg to 0.5 mg', 'description': 'Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment'}, {'id': 'OG001', 'title': 'FTY720 1.25mg to 0.5 mg', 'description': 'fingolimod 1.25mg/0.5 mg group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg'}, {'id': 'OG002', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}], 'classes': [{'title': 'Month 3 Fingolimod (n=64, 179)', 'categories': [{'measurements': [{'value': '6.04', 'spread': '3.11', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No evaluable blood concentration available', 'groupId': 'OG001'}, {'value': '2.58', 'spread': '1.34', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 Fingolimod (n=23, 161)', 'categories': [{'measurements': [{'value': '6.24', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '2.87', 'spread': '1.70', 'groupId': 'OG001'}, {'value': '2.55', 'spread': '1.37', 'groupId': 'OG002'}]}]}, {'title': 'Month 18 Fingolimod (n=71,155)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Patients switched to 0.5mg. No evaluable blood concentration available', 'groupId': 'OG000'}, {'value': '2.44', 'spread': '1.15', 'groupId': 'OG001'}, {'value': '2.59', 'spread': '1.44', 'groupId': 'OG002'}]}]}, {'title': 'Month 24 Fingolimod (n=67, 160)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Patients switched to 0.5mg. No evaluable blood concentration available', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '1.30', 'groupId': 'OG001'}, {'value': '2.64', 'spread': '1.50', 'groupId': 'OG002'}]}]}, {'title': 'Month 30 Fingolimod (n=62, 158)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Patients switched to 0.5mg. No evaluable blood concentration available', 'groupId': 'OG000'}, {'value': '2.52', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '2.60', 'spread': '1.33', 'groupId': 'OG002'}]}]}, {'title': 'Month 36 Fingolimod (n=55, 118)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Patients switched to 0.5mg. No evaluable blood concentration available', 'groupId': 'OG000'}, {'value': '2.44', 'spread': '1.08', 'groupId': 'OG001'}, {'value': '2.63', 'spread': '1.38', 'groupId': 'OG002'}]}]}, {'title': 'End of treatment Fingolimod (n=32, 115)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Patients switched to 0.5mg. No evaluable blood concentration available', 'groupId': 'OG000'}, {'value': '2.02', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '2.57', 'spread': '1.51', 'groupId': 'OG002'}]}]}, {'title': 'Month 3 Fingolimod-Phosphate (n=64, 179)', 'categories': [{'measurements': [{'value': '3.20', 'spread': '1.73', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No evaluable blood concentration available', 'groupId': 'OG001'}, {'value': '1.40', 'spread': '0.747', 'groupId': 'OG002'}]}]}, {'title': 'Month 12 Fingolimod-Phosphate (n=23, 161)', 'categories': [{'measurements': [{'value': '3.21', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '0.871', 'groupId': 'OG001'}, {'value': '1.43', 'spread': '0.805', 'groupId': 'OG002'}]}]}, {'title': 'Month 18 Fingolimod-Phosphate (n=71,155)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Patients switched to 0.5mg. No evaluable blood concentration available', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '0.630', 'groupId': 'OG001'}, {'value': '1.41', 'spread': '0.758', 'groupId': 'OG002'}]}]}, {'title': 'Month 24 Fingolimod-Phosphate (n=67, 160)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Patients switched to 0.5mg. No evaluable blood concentration available', 'groupId': 'OG000'}, {'value': '1.35', 'spread': '0.765', 'groupId': 'OG001'}, {'value': '1.44', 'spread': '0.790', 'groupId': 'OG002'}]}]}, {'title': 'Month 30 Fingolimod-Phosphate (n=62, 158)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Patients switched to 0.5mg. No evaluable blood concentration available', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0.676', 'groupId': 'OG001'}, {'value': '1.48', 'spread': '0.759', 'groupId': 'OG002'}]}]}, {'title': 'Month 36 Fingolimod-Phosphate (n=55, 118)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Patients switched to 0.5mg. No evaluable blood concentration available', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0.591', 'groupId': 'OG001'}, {'value': '1.51', 'spread': '0.765', 'groupId': 'OG002'}]}]}, {'title': 'End of treatment Fingolimod-Phosphate (n=32, 115', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Patients switched to 0.5mg. No evaluable blood concentration available', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '0.618', 'groupId': 'OG001'}, {'value': '1.50', 'spread': '0.900', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3 up to 36 months', 'description': 'Concentrations of fingolimod and fingolimod-phosphate in whole blood were determined by validated liquid chromatography methods with tandem mass spectrometry. The lower limits of quantification were 0.08 ng/ml for fingolimod and 0.1 ng/ml for fingolimod-phosphate.\n\nVenous blood samples were collected for the analysis.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) -The main efficacy analyses were performed using the FAS, in patients who were initially randomized to either FTY 0.5mg or to Placebo. (N). Only participants (n) who provided one or more evaluable blood concentration were included in the pharmacokinetic analysis population. Analysis include 147 patients (cohort 1)'}, {'type': 'SECONDARY', 'title': 'Change in MSFC Z-score and Subscale Scores From Baseline to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.189', 'spread': '0.6980', 'groupId': 'OG000'}, {'value': '-0.212', 'spread': '0.8468', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 36', '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': 'Z-scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) - The main efficacy analyses were performed using the FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FTY720 1.25 mg to 0.5 mg', 'description': 'Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment'}, {'id': 'FG001', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'FG002', 'title': 'Placebo to -FTY 0.5 mg', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}], 'periods': [{'title': 'Core Study (36 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '336'}, {'groupId': 'FG002', 'numSubjects': '487'}]}, {'type': 'Safety Set (SAF)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '336'}, {'groupId': 'FG002', 'numSubjects': '487'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '336'}, {'groupId': 'FG002', 'numSubjects': '487'}]}, {'type': 'Pharmacokinetic Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '249'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Post Protocol Amendment 5 Switch', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'post protocol amendment 121 patients switch to 0.5 mg dose from 125mg dose', 'groupId': 'FG001', 'numSubjects': '121'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '220'}, {'groupId': 'FG002', 'numSubjects': '317'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '116'}, {'groupId': 'FG002', 'numSubjects': '170'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '64'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Abnormal Test Procedure Result', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Abnormal Lab values', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '46'}]}]}, {'title': 'Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '196'}, {'groupId': 'FG002', 'numSubjects': '301'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '196'}, {'groupId': 'FG002', 'numSubjects': '301'}]}], 'dropWithdraws': [{'type': 'Admin Problems: Terminated # patients', 'reasons': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '189'}, {'groupId': 'FG002', 'numSubjects': '277'}]}, {'type': 'Abnormal test procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Abnormal lab values', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'Patients were randomized equally to receive either fingolimod or placebo. Patients initially randomized to fingolimod 1.25 mg/day or matching placebo groups switched in a blinded manner to fingolimod 0.5 mg/day or continued on placebo after amendment in Nov. 2009. Patients were randomized to receive either fingolimod 0.5 mg/day or placebo..', 'preAssignmentDetails': 'Prior to protocol amendment 147 patients received 1.25mg of FTY720; post protocol amendment 5 not all 147 patients switched to 0.5mg FTY720, only 121 switched and their data is presented under the 0.5mg dose.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '336', 'groupId': 'BG001'}, {'value': '487', 'groupId': 'BG002'}, {'value': '970', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'FTY720 1.25 mg to 0.5 mg', 'description': 'Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment'}, {'id': 'BG001', 'title': 'FTY720 0.5 mg to 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment)'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Cohort 1 and 2: Patients who started on placebo continued on placebo after re-randomization'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.8', 'spread': '8.47', 'groupId': 'BG000'}, {'value': '48.5', 'spread': '8.59', 'groupId': 'BG001'}, {'value': '48.5', 'spread': '8.31', 'groupId': 'BG002'}, {'value': '48.5', 'spread': '8.42', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<=30', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': '31 to 40', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '172', 'groupId': 'BG003'}]}]}, {'title': '41 to 50', 'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}, {'value': '389', 'groupId': 'BG003'}]}]}, {'title': '>50', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}, {'value': '396', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Particpants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}, {'value': '469', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}, {'value': '501', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 970}}, 'statusModule': {'whyStopped': 'The extension study was terminated early after the results of the core study showed the study did not meet primary endpoint; confirmed disability progression', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-06-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-09', 'studyFirstSubmitDate': '2008-08-07', 'resultsFirstSubmitDate': '2015-12-16', 'studyFirstSubmitQcDate': '2008-08-07', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-09', 'studyFirstPostDateStruct': {'date': '2008-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kaplan-Meier Estimate of the Risk of 3-month Confirmed Disability Progression Based on Composite Endpoint', 'timeFrame': 'up to 36 months after the last patient was randomized', 'description': "3-month sustained increase from Baseline in EDSS (at least 1 point increase from Baseline for patients with a Baseline value of 5 or less or at least 0.5 point increase from Baseline for patients with a Baseline value of 5.5 or more) or 3-month sustained increase of at least 20% from BL in the time taken to complete the timed 25-foot walk test (25' TWT); or 3-month sustained increase of at least 20% from BL in the time taken to complete the 9-HPT. The 25' TWT is a quantitative measure of lower extremity function. The EDSS is a scale assessing neurologic impairment, including a series of scores in each of 8 functional systems: Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. The score ranges from 0 (normal) to 10 (death due to MS)). The 9-hole peg test (9-HPT) is a quantitative measure of upper extremity (arm and hand) function."}], 'secondaryOutcomes': [{'measure': 'Kaplan-Meier Estimate of the Risk of 3- Month Confirmed Disability Progression Based on Expanded Disability Status Scale (EDSS)', 'timeFrame': 'up to 36 months after the last patient was randomized', 'description': 'The Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in MS (Kurtzke 1983) and includes a series of scores in each of 8 functional systems and the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Fatigue is not included in the Cerebral score of the EDSS. The score ranges from 0 (normal) to 10 (death due to MS)'}, {'measure': 'Percent Change From Baseline in Brain Volume at Month 36', 'timeFrame': 'Baseline to month 36', 'description': 'The percent change from Baseline in brain volume was analyzed using a random coefficients model. The model included: 1) fixed effects: treatment and region and 2) continuous covariates: time, number of Gd enhancing lesions at Baseline, Baseline T2 volume, and normalized brain volume at Baseline. Time as a continuous covariate allowed for the estimation of different slopes and intercepts among treatment groups.'}, {'measure': 'Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 9-HPT.', 'timeFrame': 'up to 36 months after the last patient was randomized', 'description': 'The 9-HPT is a quantitative measure of upper extremity (arm and hand) function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis'}, {'measure': "Kaplan Meier Estimate -Percentage of Participants With 3- Month Confirmed Disability Progression Based on 25' TWT.", 'timeFrame': 'up to 36 months after the last patient was randomized', 'description': "The 25' TWT is a quantitative measure of lower extremity function designed and validated for evaluation of MS patients. N= Total number of patients included in the analysis"}, {'measure': 'Number of New/Enlarging T2 Lesions Per Year Measured From Baseline to Month 36', 'timeFrame': 'Baseline to 36 months', 'description': 'Inflammatory disease, as measured by number of new or newly-enlarging T2 lesions, was assessed by Magnetic resonance Imaging (MRI) scanning of the brain and full spinal cord. N= Total number of patients included in the analysis'}, {'measure': 'Number of Gd-enhancing Lesions at Month 36', 'timeFrame': 'Baseline to 36 months', 'description': 'Inflammatory disease, as measured by number of T1 Gd-enhancing lesions, was assessed by MRI scanning of the brain and full spinal cord. N= Total number of patients included in the analysis'}, {'measure': 'Percent Change in Total T2 Lesion Volume From Baseline to Month 36', 'timeFrame': 'Baseline to month 36', 'description': 'Inflammatory disease as measured by percent change in total T2 lesion volume (mm3) was assessed by MRI. N= Total number of patients included in the analysis'}, {'measure': 'Change From Baseline in the Patient Reported Indices in Multiple Sclerosis (PRIMUS-QoL Score)', 'timeFrame': 'Baseline, 36 months', 'description': 'The quality of life scale contains 22 items. Each item will be given a score of 1 or 0. A score of 1 (or 0) indicates the presence (or absence) of the symptom or adverse quality of life. All 22 item scores will be summed to obtain a total score ranging from 0 (good) to 22 (poor), which is the PRIMUS QoL scale score'}, {'measure': 'Change From Baseline in PRIMUS-Activities', 'timeFrame': 'Baseline, 36 months', 'description': 'The activities subscale of PRIMUS contains 15 items and each item is given a score of 0 (able to do on own without difficulties), 1 (able to do on own with difficulties), or 2 (unable to do on own). All 15 items were summed to obtain a total score ranging from 0 (good) to 30 (poor).'}, {'measure': 'Change From Baseline in Unidimensional Fatigue Impact (U-FIS) Score', 'timeFrame': 'Baseline, 36 months', 'description': 'Unidimensional Fatigue Impact Scale (U-FIS), contains 22 patient-reported items that assess the impact of fatigue on cognitive, physical, and psychosocial functioning. Responses formed a single unidimensional scale measuring fatigue impact. The U-FIS was calculated and analyzed according to the U-FIS scoring manual. The U-FIS scale contains 22 items with 5 possible outcomes for each item. Two response categories (about half the time and a lot of the time) were combined into 1 category to obtain 4 possible outcomes: 0 (never), 1 (a little of the time), 2 (about half the time/a lot of the time), and 3 (all the time). The 22 condensed item scores were summed to obtain a total score ranging from 0 (no fatigue) to 66 (severe fatigue impact).'}, {'measure': 'Change From Baseline in European Quality of Life - 5 Dimensions (EQ-5D Score)', 'timeFrame': 'Baseline, 36 months', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.'}, {'measure': 'Change From Baseline in Multiple Sclerosis Walking Scale (MSWS-12 Score)', 'timeFrame': 'Baseline, 36 months', 'description': 'The Multiple Sclerosis Walking Scaleis a patient reported measure of walking quality (Hobart et al 2003), consisting of 12 items asking patients to rate the impact of MS upon their walking ability. Responses were captured on a 3-point scale ranging from 1 (Not at all) to 3 (A lot) for items 1 to 3 and on a 5-point scale ranging from 1 (not limited) to 5 (extremely) for items 4 to 12. All 12 item scores were summed to obtain a total score ranging from 12 (good) to 54 (poor) which is the MSWS-12 scale score. The total score was transformed to a 0 to 100 scale score. The MSWS-12 scale score will be transformed to a 0-100 scale score before any summaries or statistical analyses are performed. The transformed score is obtained by subtracting 12 and divided by 42 and multiplying by 100 (i.e., transformed scale score = (raw scale score- 12)/42\\*100).'}, {'measure': 'Blood Concentrations of Fingolimod and Fingolimod-phosphate', 'timeFrame': 'Month 3 up to 36 months', 'description': 'Concentrations of fingolimod and fingolimod-phosphate in whole blood were determined by validated liquid chromatography methods with tandem mass spectrometry. The lower limits of quantification were 0.08 ng/ml for fingolimod and 0.1 ng/ml for fingolimod-phosphate.\n\nVenous blood samples were collected for the analysis.'}, {'measure': 'Change in MSFC Z-score and Subscale Scores From Baseline to Month 36', 'timeFrame': 'Baseline to Month 36', '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': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FTY720, primary progressive multiple sclerosis,PPMS'], 'conditions': ['Primary Progressive Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '37823722', 'type': 'DERIVED', 'citation': 'Calvi A, Mendelsohn Z, Hamed W, Chard D, Tur C, Stutters J, MacManus D, Kanber B, Wheeler-Kingshott CAMG, Barkhof F, Prados F. Treatment reduces the incidence of newly appearing multiple sclerosis lesions evolving into chronic active, slowly expanding lesions: A retrospective analysis. Eur J Neurol. 2024 Jan;31(1):e16092. doi: 10.1111/ene.16092. Epub 2023 Oct 12.'}, {'pmid': '35379762', 'type': 'DERIVED', 'citation': 'Leppert D, Kropshofer H, Haring DA, Dahlke F, Patil A, Meinert R, Tomic D, Kappos L, Kuhle J. Blood Neurofilament Light in Progressive Multiple Sclerosis: Post Hoc Analysis of 2 Randomized Controlled Trials. Neurology. 2022 May 24;98(21):e2120-e2131. doi: 10.1212/WNL.0000000000200258. Epub 2022 Apr 4.'}, {'pmid': '34392376', 'type': 'DERIVED', 'citation': 'Koch MW, Mostert J, Repovic P, Bowen JD, Strijbis E, Uitdehaag B, Cutter G. Smoking, obesity, and disability worsening in PPMS: an analysis of the INFORMS original trial dataset. J Neurol. 2022 Mar;269(3):1663-1669. doi: 10.1007/s00415-021-10750-z. Epub 2021 Aug 15.'}, {'pmid': '34376508', 'type': 'DERIVED', 'citation': 'Koch MW, Mostert J, Zhang Y, Wolinsky JS, Lublin FD, Strijbis E, Cutter G. Association of Age With Contrast-Enhancing Lesions Across the Multiple Sclerosis Disease Spectrum. Neurology. 2021 Sep 28;97(13):e1334-e1342. doi: 10.1212/WNL.0000000000012603. Epub 2021 Aug 10.'}, {'pmid': '29560379', 'type': 'DERIVED', 'citation': 'Miller DH, Lublin FD, Sormani MP, Kappos L, Yaldizli O, Freedman MS, Cree BAC, Weiner HL, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, MacManus DG, Yousry TA, Gandini Wheeler-Kingshott CAM, Li B, Putzki N, Merschhemke M, Haring DA, Wolinsky JS. Brain atrophy and disability worsening in primary progressive multiple sclerosis: insights from the INFORMS study. Ann Clin Transl Neurol. 2018 Jan 30;5(3):346-356. doi: 10.1002/acn3.534. eCollection 2018 Mar.'}, {'pmid': '26827074', 'type': 'DERIVED', 'citation': 'Lublin F, Miller DH, Freedman MS, Cree BAC, Wolinsky JS, Weiner H, Lubetzki C, Hartung HP, Montalban X, Uitdehaag BMJ, Merschhemke M, Li B, Putzki N, Liu FC, Haring DA, Kappos L; INFORMS study investigators. Oral fingolimod in primary progressive multiple sclerosis (INFORMS): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2016 Mar 12;387(10023):1075-1084. doi: 10.1016/S0140-6736(15)01314-8. Epub 2016 Jan 28.'}, {'pmid': '19847907', 'type': 'DERIVED', 'citation': 'Hartung HP, Aktas O. Bleak prospects for primary progressive multiple sclerosis therapy: downs and downs, but a glimmer of hope. Ann Neurol. 2009 Oct;66(4):429-32. doi: 10.1002/ana.21880. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS. This was an open-label, single-arm extension study to a double-blind, randomized multicenter, placebo-controlled, parallel-group core study. The core study completed and eligible patients enrolled into the extension study at the next scheduled or unscheduled core study visit. All patients, regardless of their treatment in the core study, received fingolimod 0.5 mg in the extension study. The extension study was terminated early after the results of the core study became available showing that the study did not meet its primary endpoint which was defined as confirmed disability progression in this population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nGeneral\n\n1. sign written informed consent prior to participating in the study\n2. 25 through 65 years of age inclusive\n3. females of childbearing potential must:\n\n * have a negative pregnancy test at Baseline (prior to randomization) and\n * use simultaneously two forms of effective contraception during the treatment and 3-months after discontinuation of study medication\n\nPrimary Progressive Multiple sclerosis.\n\n1. diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria):\n2. time since first reported symptoms between 2 and 10 years\n3. evidence of clinical disability progression in the 2 years prior to Screening\n4. disability status at Screening\n\n * EDSS score of 3.5-6.0 inclusive\n * pyramidal functional system score of 2 or more\n * 25'TWT less than 30 seconds\n\nExtension study Inclusion criteria\n\n* Patients initially randomized to fingolimod 1.25 mg or placebo as part of the first study cohort, were to have completed at least 3 years on study drug treatment at the time of extension study initiation.\n* Patients initially randomized to fingolimod 0.5 mg or placebo as part of the second study cohort, were to have continued on study drug treatment until such time as the last ongoing patient enrolled in the study had reached 3 years in study\n\nExclusion Criteria:\n\nPPMS specific:\n\n* History of relapses/attacks\n* Progressive neurological disorder other than PPMS\n* Pure cerebellar syndrome or pure visual progressive syndrome or pure\n* cognitive progressive syndrome\n* Presence of spinal cord compression at screening MRI\n* Relevant history of vitamin B12 deficit\n* Evidence of syphilis or borreliosis at Screening\n\nCardiovascular conditions:\n\n* Myocardial infarction within the past 6 months or current unstable ischemic heart disease\n* History of angina pectoris due to coronary spasm or history of Raynaud's phenomenon\n* Severe cardiac failure or cardiac arrest\n* History of symptomatic bradycardia\n* Resting pulse \\<55 bpm pre-dose\n* History of sick sinus syndrome or sino-atrial heart block\n* History or presence of second and third degree AV block or an increase QT interval (QTc\\>440 ms)\n* Arrythmia requiring treatment with class III antiarrythmic drugs\n* History of positive tilt test from workout of vasovagal syncope\n* Hypertension, not controlled with medication\n\nPulmonary:\n\n* Severe respiratory disease or pulmonary fibrosis\n* TB\n* Abnormal X-ray, suggestive of active pulmonary disease\n* Abnormal PFT: \\<70% of predicted for FEV1 and FVC; \\<60% for DLCO\n* Patients receiving chronic (daily) therapies for asthma\n\nHepatic:\n\n* Known history of alcohol abuse, chronic liver or biliary disease\n* Total or conjugated Brb \\>ULN, unless in context of Gilbert's syndrome\n* AP \\>1.5xULN; ALT/AST \\>2xULN; GGT\\>3xULN\n\nOther:\n\n* History of chronic disease of the immune system other than MS\n* Malignancy (other than successfully treated SCC or BCC)\n* Diabetes Mellitus\n* Macular Edema present at screening\n* HIV, Hepatitis C or B, other active infection\n* History of total lymphoid irradiation or bone marrow transplantation\n* Serum creatinine \\>1.7 mg/dl\n* WBC \\<3500 cells/mm3\n* Lymphocyte count \\<800 cells/mm3\n* History of substance abuse or any other factor that may interfere with subject ability to cooperate and comply with the study procedures\n* Unable to undergo MRI scans\n* Participation in any therapeutical clinical research study in the 6 months prior to randomization\n* Pregnant or lactating women\n* Drugs requiring wash-out period:\n\n 3 months:\n * Systemic corticosteroids or ACTH\n * INF-beta\n\n 6 months:\n * Immunosuppressive medication\n * Immunoglobulins\n * Monoclonal antibodies\n* Drugs that exclude participation in the study:\n* Cladribine\n* Cyclophosphamide\n* Mitoxantrone (except: patients who received a cumulative dose of no more than 60mg/m2 more than 5 years ago could enter the study)\n\nExtension study Exclusion criteria\n\n-Patients were not eligible for enrollment in the extension study if they had any of the following key exclusion criteria at the extension study Baseline visit: active chronic immune system disease other than MS (or stable disease treated with immune therapy); known immunodeficiency syndrome; active infection; uncontrolled diabetes mellitus; macularedema; treatment with Class Ia or III antiarrhythmic drugs; any of the specified cardiac, pulmonary, or hepatic conditions; or any medically unstable condition"}, 'identificationModule': {'nctId': 'NCT00731692', 'acronym': 'INFORMS', 'briefTitle': 'This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.', 'nctIdAliases': ['NCT01779934'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5mg Fingolimod Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis and An Open-label, Single-arm Extension Study to the Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of0.5 mg FTY720 Administered Orally Once Daily Versus Placebo in Patients With Primary Progressive Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'CFTY720D2306'}, 'secondaryIdInfos': [{'id': '2007-002627-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FTY720D 0.5 mg', 'description': 'Cohort 2: The 0.5 mg group consists of patients who were directly randomized to fingolimod 0.5 mg (i.e. AFTER the amendment', 'interventionNames': ['Drug: FTY720']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Cohort 1 and 2: Patients randomized to placebo continued on placebo after re-randomization', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'FTY720D 1.25 mg switch to 0.5 mg', 'description': 'Cohort 1: fingolimod 1.25 group consists of patients who were initially randomized to fingolimod 1.25 mg and switched to fingolimod 0.5 mg after amendment on Nov 2009', 'interventionNames': ['Drug: FTY720']}], 'interventions': [{'name': 'FTY720', 'type': 'DRUG', 'description': 'Fingolimod capsules at doses of 1.25 mg (prior to implementation of Amendment 5) and 0.5 mg (after Amendment 5) were administered orally once daily', 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