Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-11 @ 12:29 AM
Study NCT ID:
NCT01633112
Status:
TERMINATED
Last Update Posted:
2019-05-28
First Post:
2012-06-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'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'}, {'id': 'D000068717', 'term': 'Glatiramer Acetate'}, {'id': 'D020755', 'term': 'Coat Protein Complex I'}], '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'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D033921', 'term': 'Vesicular Transport Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Terminated due to slow recruitment.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) and Serious AEs (SAEs) were collected during treatment exposure and follow up where: AE summaries on the follow-up set were conducted for time periods defined by days relative to study drug discontinuation: days 1 - 45 after discontinuation, or day 46 or later after drug discontinuation. For SAEs (death and non-fatal ), all SAEs starting after the first dose date, including those starting > 45 days after study drug discontinuation, were included in the safety set summaries.', 'eventGroups': [{'id': 'EG000', 'title': 'Fingolimod 0.5 mg', 'description': 'Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months', 'otherNumAtRisk': 345, 'deathsNumAtRisk': 345, 'otherNumAffected': 214, 'seriousNumAtRisk': 345, 'deathsNumAffected': 0, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': 'FTY 0.25 mg', 'description': 'Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months', 'otherNumAtRisk': 366, 'deathsNumAtRisk': 366, 'otherNumAffected': 245, 'seriousNumAtRisk': 366, 'deathsNumAffected': 0, 'seriousNumAffected': 32}, {'id': 'EG002', 'title': 'GA 20 mg', 'description': 'Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months', 'otherNumAtRisk': 324, 'deathsNumAtRisk': 324, 'otherNumAffected': 190, 'seriousNumAtRisk': 324, 'deathsNumAffected': 0, 'seriousNumAffected': 20}, {'id': 'EG003', 'title': 'All@Patients', 'description': 'All patients in the trial', 'otherNumAtRisk': 1035, 'deathsNumAtRisk': 1035, 'otherNumAffected': 649, 'seriousNumAtRisk': 1035, 'deathsNumAffected': 0, 'seriousNumAffected': 77}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 42}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 69}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 114}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 60}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 85}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 122}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 39}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 48}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 54}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 65}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 53}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 128}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 43}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 60}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 48}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 72}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': "Pituitary-dependent Cushing's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 2}], 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'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 345, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 366, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1035, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Confirmed Annualized Relapse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg', 'description': 'Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months'}, {'id': 'OG001', 'title': 'FTY720 0.25 mg', 'description': 'Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months'}, {'id': 'OG002', 'title': 'GA 20 mg', 'description': 'Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.153', 'groupId': 'OG000', 'lowerLimit': '0.111', 'upperLimit': '0.212'}, {'value': '0.221', 'groupId': 'OG001', 'lowerLimit': '0.168', 'upperLimit': '0.290'}, {'value': '0.258', 'groupId': 'OG002', 'lowerLimit': '0.196', 'upperLimit': '0.341'}]}]}], 'analyses': [{'pValue': '0.0138', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'H01: µ FTY 0.5 mg = µ GA versus HA1: µ FTY 0.5 mg ≠µ GA H02: µ FTY 0.25 mg = µ GA versus HA2: µ FTY 0.25 mg ≠µ GA', 'statisticalMethod': 'negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for treatment, geographical region, number of relapses in the previous year, baseline EDSS, and baseline Gd-enhancing T1 lesion count.', 'nonInferiorityComment': 'For each of the 2 FTY720 doses, the null hypothesis was that there was no difference in the ARRs between subjects treated with FTY720 and those treated with GA versus the alternative hypothesis that there was a difference between the 2 treatment arms. In order to preserve the Type I experiment-wise error rate, the null hypothesis was rejected if the observed p-value for the between-treatment comparison was less than the significance level as specified in the multiplicity adjustment procedure.'}, {'pValue': '0.4153', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'H01: µ FTY 0.5 mg = µ GA versus HA1: µ FTY 0.5 mg ≠µ GA H02: µ FTY 0.25 mg = µ GA versus HA2: µ FTY 0.25 mg ≠µ GA', 'statisticalMethod': 'negative binomial regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for treatment, geographical region, number of relapses in the previous year, baseline EDSS, and baseline Gd-enhancing T1 lesion count.', 'nonInferiorityComment': 'For each of the 2 FTY720 doses, the null hypothesis was that there was no difference in the ARRs between subjects treated with FTY720 and those treated with GA versus the alternative hypothesis that there was a difference between the 2 treatment arms. In order to preserve the Type I experiment-wise error rate, the null hypothesis was rejected if the observed p-value for the between-treatment comparison was less than the significance level as specified in the multiplicity adjustment procedure.'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 months', 'description': 'Annualized relapse rate (ARR) was defined as the average number of confirmed relapses per year (i.e., the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses included all the confirmed relapses experienced during the study from first dose to end of study.', 'unitOfMeasure': 'relapses/year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.'}, {'type': 'SECONDARY', 'title': 'New or Newly Enlarging T2 Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg', 'description': 'Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months'}, {'id': 'OG001', 'title': 'FTY720 0.25 mg', 'description': 'Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months'}, {'id': 'OG002', 'title': 'GA 20 mg', 'description': 'Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '5.42', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '6.94', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '10.71', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'negative binomial regression model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Adjusted for treatment, geog. region, age, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'negative binomial regression model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Adjusted for treatment, geog. region, age, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.'}], 'paramType': 'MEAN', 'timeFrame': 'At 12 months/end of study', 'description': 'Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.', 'unitOfMeasure': 'Lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Free of New/Newly Enlarged T2 Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg', 'description': 'Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months'}, {'id': 'OG001', 'title': 'FTY720 0.25 mg', 'description': 'Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months'}, {'id': 'OG002', 'title': 'GA 20 mg', 'description': 'Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 12 months/end of study', 'description': 'Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in T2 Lesion Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg', 'description': 'Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months'}, {'id': 'OG001', 'title': 'FTY720 0.25 mg', 'description': 'Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months'}, {'id': 'OG002', 'title': 'GA 20 mg', 'description': 'Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.14', 'spread': '1.583', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '2.340', 'groupId': 'OG001'}, {'value': '0.42', 'spread': '2.305', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'rank ANCOVA with covariates: adjusted for treatment, age, region, number of relapses experienced in the previous year, and baseline T2 lesion volume.'}, {'pValue': '0.0060', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'rank ANCOVA with covariates: adjusted for treatment, age, region, number of relapses experienced in the previous year, and baseline T2 lesion volume.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 months/end of study', 'description': 'Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion volume', 'unitOfMeasure': 'cubic centimeters (cc)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.'}, {'type': 'SECONDARY', 'title': 'Gd Enhancing T1 Lesion Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg', 'description': 'Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months'}, {'id': 'OG001', 'title': 'FTY720 0.25 mg', 'description': 'Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months'}, {'id': 'OG002', 'title': 'GA 20 mg', 'description': 'Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '1.57', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.56', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '3.67', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0167', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'negative binomial regression model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'adjusted for treatment, age, geog. region, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses .'}, {'pValue': '0.0011', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'negative binomial regression model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'adjusted for treatment, age, geog. region, baseline T2 lesion count, baseline Gd-enhancing T1 lesion count, and the number of previous year relapses.'}], 'paramType': 'MEAN', 'timeFrame': 'At 12 months/end of study', 'description': 'Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.'}, {'type': 'SECONDARY', 'title': 'Gd Enhancing T1 Lesion Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg', 'description': 'Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months'}, {'id': 'OG001', 'title': 'FTY720 0.25 mg', 'description': 'Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months'}, {'id': 'OG002', 'title': 'GA 20 mg', 'description': 'Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '364', 'groupId': 'OG001'}, {'value': '322', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.31', 'spread': '1.067', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '1.421', 'groupId': 'OG001'}, {'value': '0.22', 'spread': '0.841', 'groupId': 'OG002'}]}]}, {'title': 'Month 12/end of study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.215', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.181', 'groupId': 'OG001'}, {'value': '0.12', 'spread': '0.450', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0052', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ranked ANCOVA with covariates: treatment, region, age, baseline Gd-enhancing T1 lesion volume, and number ofrelapses experienced in the previous year.'}, {'pValue': '0.0636', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ranked ANCOVA with covariates: treatment, region, age, baseline Gd-enhancing T1 lesion volume, and number ofrelapses experienced in the previous year.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 months/end of study', 'description': 'Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count', 'unitOfMeasure': 'cubic centimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Free of New T1 Hypointense Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg', 'description': 'Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months'}, {'id': 'OG001', 'title': 'FTY720 0.25 mg', 'description': 'Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months'}, {'id': 'OG002', 'title': 'GA 20 mg', 'description': 'Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '55.3', 'groupId': 'OG000'}, {'value': '52.1', 'groupId': 'OG001'}, {'value': '44.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0011', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'adjusted for treatment, region, age, proper baseline T1 lesion variable, baseline Gd-enhancing T1 lesion count and number of previous year relapses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'pair-wise comparisons between treatment groups using a logistic regression model.'}, {'pValue': '0.0146', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'adjusted for treatment, region, age, proper baseline T1 lesion variable, baseline Gd-enhancing T1 lesion count and number of previous year relapses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'pair-wise comparisons between treatment groups using a logistic regression model.'}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Based on MRI measures of new T1 hypointense lesions', 'unitOfMeasure': 'Percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in TSQM Scales', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg', 'description': 'Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months'}, {'id': 'OG001', 'title': 'FTY720 0.25 mg', 'description': 'Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months'}, {'id': 'OG002', 'title': 'GA 20 mg', 'description': 'Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months'}], 'classes': [{'title': 'Global Satisfaction (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '153', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.8', 'spread': '28.15', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '27.04', 'groupId': 'OG001'}, {'value': '14.4', 'spread': '25.42', 'groupId': 'OG002'}]}]}, {'title': 'Global Satisfaction (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.2', 'spread': '31.87', 'groupId': 'OG000'}, {'value': '20.5', 'spread': '32.21', 'groupId': 'OG001'}, {'value': '9.4', 'spread': '30.43', 'groupId': 'OG002'}]}]}, {'title': 'Effectiveness (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.2', 'spread': '25.96', 'groupId': 'OG000'}, {'value': '18.2', 'spread': '25.05', 'groupId': 'OG001'}, {'value': '12.9', 'spread': '23.43', 'groupId': 'OG002'}]}]}, {'title': 'Effectiveness (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.8', 'spread': '26.85', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '28.29', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '27.38', 'groupId': 'OG002'}]}]}, {'title': 'Side Effects (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.9', 'spread': '31.58', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '30.63', 'groupId': 'OG001'}, {'value': '9.3', 'spread': '31.94', 'groupId': 'OG002'}]}]}, {'title': 'Side Effects (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.2', 'spread': '31.52', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '32.52', 'groupId': 'OG001'}, {'value': '7.6', 'spread': '32.76', 'groupId': 'OG002'}]}]}, {'title': 'Convenience (Month 6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '176', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '151', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.7', 'spread': '25.76', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '25.93', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '20.73', 'groupId': 'OG002'}]}]}, {'title': 'Convenience (Month 12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '29.5', 'spread': '24.42', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '26.36', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '25.72', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Global Satisfaction (Month 6): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Global Satisfaction (Month 6): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Global Satisfaction (Month 6): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Global Satisfaction (Month 12): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Global Satisfaction (Month 12): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Global Satisfaction (Month 12): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Effectiveness (Month 6): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Effectiveness (Month 6): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Effectiveness (Month 6): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Effectiveness (Month 12): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Effectiveness (Month 12): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG002'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Effectiveness (Month 12): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Side Effects (Month 6): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Side Effects (Month 6): p-values for within treatment comparison from baseline'}, {'pValue': '0.0005', 'groupIds': ['OG002'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Side Effects (Month 6): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0051', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Side Effects (Month 12): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Side Effects (Month 12): p-values for within treatment comparison from baseline'}, {'pValue': '0.0051', 'groupIds': ['OG002'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Side Effects (Month 12): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Convenience (Month 6): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Convenience (Month 6): p-values for within treatment comparison from baseline'}, {'pValue': '0.0068', 'groupIds': ['OG002'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Convenience (Month 6): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Convenience (Month 12): p-values for within treatment comparison from baseline'}, {'pValue': '<0.0001', 'groupIds': ['OG001'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Convenience (Month 12): p-values for within treatment comparison from baseline'}, {'pValue': '0.4595', 'groupIds': ['OG002'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Convenience (Month 12): p-values for within treatment comparison from baseline'}], 'paramType': 'MEAN', 'timeFrame': '6 months, 12 months/end of study', 'description': 'Treatment Satisfaction Questionnaire for Medication (TSQM) was developed and validated as a general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with study drug.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.'}, {'type': 'SECONDARY', 'title': 'Percent Brain Volume Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '366', 'groupId': 'OG001'}, {'value': '324', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FTY720 0.5 mg', 'description': 'Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months'}, {'id': 'OG001', 'title': 'FTY720 0.25 mg', 'description': 'Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months'}, {'id': 'OG002', 'title': 'GA 20 mg', 'description': 'Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.652', 'spread': '0.7810', 'groupId': 'OG000'}, {'value': '-0.636', 'spread': '0.8097', 'groupId': 'OG001'}, {'value': '-0.561', 'spread': '0.7819', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1045', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'rank ANCOVA model adjusted for treatment, region, age, the number of relapses experienced in the previous year, and baseline normalized brain volume'}, {'pValue': '0.1358', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'rank ANCOVA model adjusted for treatment, region, age, the number of relapses experienced in the previous year, and baseline normalized brain volume'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 months, end of study', 'description': 'Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans were performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.', 'unitOfMeasure': 'Percentages of volume change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full-analysis set: All subjects who were randomly assigned and took at least 1 dose of study drug. Following the intent-to-treat principle, subjects were grouped according to the assigned treatment at randomization. Efficacy analyses were performed using the full analysis set unless otherwise notified.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FTY720 0.5 mg', 'description': 'Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months'}, {'id': 'FG001', 'title': 'FTY720 0.25 mg', 'description': 'Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months'}, {'id': 'FG002', 'title': 'GA 20 mg', 'description': 'Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '352'}, {'groupId': 'FG001', 'numSubjects': '370'}, {'groupId': 'FG002', 'numSubjects': '342'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '310'}, {'groupId': 'FG002', 'numSubjects': '250'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '92'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Abnormal test procedure result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Subject no longer requires study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '41'}]}, {'type': 'missing Study Completion CRF', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'A total of 1461 subjects were screened for participation in this study; of those, 1064 subjects were randomly assigned to study treatment'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'BG000'}, {'value': '370', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}, {'value': '1064', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'FTY720 0.5 mg', 'description': 'Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months'}, {'id': 'BG001', 'title': 'FTY720 0.25 mg', 'description': 'Fingolimod (FTY720) 0.25 mg orally once a day for up to 12 months'}, {'id': 'BG002', 'title': 'GA 20 mg', 'description': 'Glatiramer acetate (GA) 20 mg s.c. once a day for up to 12 months'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.3', 'spread': '11.12', 'groupId': 'BG000'}, {'value': '38.9', 'spread': '11.01', 'groupId': 'BG001'}, {'value': '39.6', 'spread': '10.80', 'groupId': 'BG002'}, {'value': '39.6', 'spread': '10.98', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}, {'value': '792', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '272', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Caucasian', 'measurements': [{'value': '268', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '243', 'groupId': 'BG002'}, {'value': '790', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Ramdomized set: All subjects who were assigned randomization numbers. The subjects in this set were called randomized subjects. This set was used to summarize subject disposition, demographic and baseline characteristics, and protocol deviation information. Subjects were grouped according to randomized treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-20', 'size': 767924, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-04-29T09:34', 'hasProtocol': True}, {'date': '2018-11-02', 'size': 1008926, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-04-29T09:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Fingolimod patients were dose blind.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1064}}, 'statusModule': {'whyStopped': 'slow recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-29', 'studyFirstSubmitDate': '2012-06-29', 'resultsFirstSubmitDate': '2019-04-29', 'studyFirstSubmitQcDate': '2012-07-03', 'lastUpdatePostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-29', 'studyFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmed Annualized Relapse Rate', 'timeFrame': 'up to 12 months', 'description': 'Annualized relapse rate (ARR) was defined as the average number of confirmed relapses per year (i.e., the total number of confirmed relapses divided by the total days in the study multiplied by 365.25). The number of relapses included all the confirmed relapses experienced during the study from first dose to end of study.'}], 'secondaryOutcomes': [{'measure': 'New or Newly Enlarging T2 Lesions', 'timeFrame': 'At 12 months/end of study', 'description': 'Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.'}, {'measure': 'Number of Participants Free of New/Newly Enlarged T2 Lesions', 'timeFrame': 'At 12 months/end of study', 'description': 'Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion count.'}, {'measure': 'Change From Baseline in T2 Lesion Volume', 'timeFrame': 'Baseline, 12 months/end of study', 'description': 'Inflammatory activity based on MRI measurement of new/newly enlarged T2 lesion volume'}, {'measure': 'Gd Enhancing T1 Lesion Count', 'timeFrame': 'At 12 months/end of study', 'description': 'Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count'}, {'measure': 'Gd Enhancing T1 Lesion Volume', 'timeFrame': 'Baseline, 12 months/end of study', 'description': 'Inflammatory activity based on MRI measurement of Gd enhancing T1 lesion count'}, {'measure': 'Percentage of Patients Free of New T1 Hypointense Lesions', 'timeFrame': '12 months', 'description': 'Based on MRI measures of new T1 hypointense lesions'}, {'measure': 'Change From Baseline in TSQM Scales', 'timeFrame': '6 months, 12 months/end of study', 'description': 'Treatment Satisfaction Questionnaire for Medication (TSQM) was developed and validated as a general measure for treatment satisfaction. Each scale score was calculated by summing individual items and then transformed to a 0-100 scale. Higher summary scores indicate better satisfaction with study drug.'}, {'measure': 'Percent Brain Volume Change From Baseline', 'timeFrame': 'Baseline, 12 months, end of study', 'description': 'Using a Central MRI vendor to ensure calibrated MRI scanning equipment across all sites, MRI scans were performed on subjects following the established parameters and transferred to the central vendor for review of quality and assessment/evaluation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Relapsing-remitting Multiple Sclerosis (RRMS)']}, 'referencesModule': {'references': [{'pmid': '32852530', 'type': 'DERIVED', 'citation': 'Cree BAC, Goldman MD, Corboy JR, Singer BA, Fox EJ, Arnold DL, Ford C, Weinstock-Guttman B, Bar-Or A, Mientus S, Sienkiewicz D, Zhang Y, Karan R, Tenenbaum N; ASSESS Trial Investigators. Efficacy and Safety of 2 Fingolimod Doses vs Glatiramer Acetate for the Treatment of Patients With Relapsing-Remitting Multiple Sclerosis: A Randomized Clinical Trial. JAMA Neurol. 2020 Aug 24;78(1):1-13. doi: 10.1001/jamaneurol.2020.2950. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25 mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12 months in patients with relapsing-remitting MS', 'detailedDescription': 'This was a multicenter, randomized, rater- and dose-blinded, study to compare the efficacy and safety of 0.25 mg and 0.5 mg of fingolimod with glatimer acetate 20 mg s.c. in patients with RRMS.\n\nThis study consisted of 3 periods:\n\n* Screening Period: up to 45 days for all patients\n* Treatment Period: 12 months of glatiramer acetate 20 mg, fingolimod 0.25 mg, or fingolimod 0.5 mg\n* Follow-up occurred 3 months (12 weeks) after the last dose of study drug for all patients The informed consent form was signed prior to any study related activities at the screening visit. Randomization to either treatment group was preformed at visit 1 after a diligent check of applicable in- and exclusion criteria in a 1:1:1 ratio (changed to 5:3:2 after implementation of Amendment 2 in 2015).\n\nTreatment groups:\n\n* fingolimod 0.5 mg/day orally for up to 12 months\n* fingolimod 0.25 mg/day orally for up to 12 months\n* glatiramer acetate 20 mg/day subcutaneously for up to 12 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Written informed consent must be obtained before any assessment is performed\n* Male and female patients 18 to 65 years of age, inclusive.\n* Patients with RRMS, as defined by 2010 revised McDonald criteria.\n* Patients must be neurologically stable with no onset of relapse within 30 days of randomization\n* Patients with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years before randomization.\n* Patients with an EDSS score of 0 to 6, inclusive, at Screening. A score of 6.0 indicates unilateral assistance (cane or crutch) required to walk at least 100 meters with or without resting.\n\nExclusion criteria:\n\n* Patients with a history of malignancy of any organ system (other than cutaneous basal cell carcinoma) in the last 5 years that do not have confirmation of absence of a malignancy prior to randomization\n* Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, ulcerative colitis) or with a known immunodeficiency syndrome (HIV-antibody positive, AIDS, hereditary immune deficiency, drug-induced immune deficiency).\n* Patients who have been treated with:\n* High-dose intravenous (IV) immunoglobulin (Ig) within 4 weeks before randomization\n* Immunosuppressive/chemotherapeutic medications (e.g., azathioprine, cyclophosphamide, methotrexate) within 6 months before randomization\n* Natalizumab within 2 months before randomization\n* Previous treatment with lymphocyte-depleting therapies (e.g., rituximab, alemtuzumab, ofatumumab, ocrelizumab, or cladribine) within 1 year before randomization Previous treatment with mitoxantrone within 6 months before randomization\n* Use of teriflunomide within 3.5 months prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done. In that case, plasma levels are required to be measured and be below 0.02 mg/L before randomization.\n\nNo washout period is necessary for patients treated with dimethyl fumarate, interferon (IFN) beta, or glatiramer acetate.\n\nPatients being treated with dimethyl fumarate, glatiramer acetate, or IFN beta at the Screening visit can continue drug intake up to the day before Day 1 of this study (i.e., there is no need for a washout period).\n\n* Patients who have been treated with systemic corticosteroids or adrenocorticotropic hormones in the past 30 days prior to the screening magnetic resonance imaging (MRI) procedure.\n* Patients with uncontrolled diabetes mellitus (glycosylated hemoglobin \\>9%) or with diabetic neuropathy.\n* Patients with a diagnosis of macular edema during Screening (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at Screening).\n* Patients with severe active bacterial, viral, or fungal infections.\n* Patients without acceptable evidence of immunity to varicella zoster virus (VZV) at randomization.\n* Patients who have received any live or live-attenuated vaccines (including VZV, herpes simplex, or measles) within 1 month before randomization.\n* Patients who have received total lymphoid irradiation or bone marrow transplantation.\n* Patients with any unstable medical/psychiatric condition, as assessed by the primary treating physician at each site.\n* Patients who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): myocardial infarction, unstable angina, stroke, transient ischemic attack or decompensated heart failure requiring hospitalization or Class III/IV heart failure."}, 'identificationModule': {'nctId': 'NCT01633112', 'acronym': 'ASSESS', 'briefTitle': 'MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12-month, Randomized, Rater- and Dose-blinded Study to Compare the Efficacy and Safety of Fingolimod 0.25 mg and 0.5 mg Administered Orally Once Daily With Glatiramer Acetate 20 mg Administered Subcutaneously Once Daily in Patients With Relapsing-remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'CFTY720D2312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fingolimod 0.5 mg', 'description': 'orally once daily', 'interventionNames': ['Drug: fingolimod']}, {'type': 'EXPERIMENTAL', 'label': 'fingolimod 0.25mg', 'description': 'orally once daily', 'interventionNames': ['Drug: fingolimod']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'glatiramer acetate 20 mg', 'description': 'subcutaneous once daily', 'interventionNames': ['Drug: glatiramer acetate']}], 'interventions': [{'name': 'fingolimod', 'type': 'DRUG', 'otherNames': ['FTY720, fingolimod hydrochloride,', 'Gilenya'], 'description': 'capsule', 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