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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 11:33 PM

Ignite Modification Date: 2025-12-25 @ 9:21 PM

Study NCT ID: NCT01201356

Status: COMPLETED

Last Update Posted: 2021-04-21

First Post: 2010-09-10

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Costa Rica']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068876', 'term': 'Fingolimod Hydrochloride'}], 'ancestors': [{'id': 'D013110', 'term': 'Sphingosine'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011409', 'term': 'Propylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from first dose of study treatment in Study Part I until end of study treatment in Study Part II plus 6 weeks post treatment, up to a maximum duration of 8 years.', 'eventGroups': [{'id': 'EG000', 'title': 'Fingolimod 0.5 mg/Day', 'description': 'Open-label fingolimod 0.5 mg, taken orally once daily', 'otherNumAtRisk': 4083, 'deathsNumAtRisk': 4083, 'otherNumAffected': 2125, 'seriousNumAtRisk': 4083, 'deathsNumAffected': 16, 'seriousNumAffected': 515}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 219}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 232}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 214}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 275}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 706}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 346}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 335}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 212}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 208}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 279}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 348}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 205}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 243}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Immune thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Bicuspid aortic valve', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Congenital cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Congenital knee dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hyperprolactinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Thyroid mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Retinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Retinal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abdominal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': "Barrett's oesophagus", 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Duodenal ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gastric disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Rectal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Death neonatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Fat tissue increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Vascular stent stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Biliary cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Biliary dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cholangitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Muscle injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Near drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pubis fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Splenic rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Traumatic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Traumatic spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Ulnar nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Vaginal laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hyperamylasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Amyotrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Chondromalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Chondropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Compartment syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Jaw disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Joint instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Lateral patellar compression syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Mobility decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Torticollis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 30}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Benign hydatidiform mole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Benign neoplasm of thyroid gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Benign ovarian tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Bone giant cell tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': "Bowen's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Brain neoplasm benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 11}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Colon cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Desmoid tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Extranodal marginal zone B-cell lymphoma (MALT type)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Fibroadenoma of breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gastrointestinal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Invasive lobular breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Laryngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Metastases to spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Ovarian adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Ovarian cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Phyllodes tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Seminoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Thyroid adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 10}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Brain hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cauda equina syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Central nervous system lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cerebral venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Demyelination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Facial spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Fine motor skill dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Focal dyscognitive seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hemianopia homonymous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hyperaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Muscle spasticity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Myelitis transverse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Optic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Secondary progressive multiple sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Ulnar nerve palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': "Wernicke's encephalopathy", 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 10}], 'organSystem': 'Pregnancy, puerperium and perinatal 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'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Drug dependence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Eating disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Persecutory delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Personality change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Personality change due to a general medical condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Psychogenic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Somatic symptom disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Renal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Adnexa uteri cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Breast calcifications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 7}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dysfunctional uterine bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Endometriosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gynaecomastia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Postmenopausal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Uterine cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Uterine haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Uterine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Nasal polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Erythema annulare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Skin erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypoperfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Venous stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4083, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4083', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 0.5 mg/Day', 'description': 'Open-label fingolimod 0.5 mg, taken orally once daily'}], 'classes': [{'title': 'Adverse Event (AEs)', 'categories': [{'measurements': [{'value': '2125', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Events (SAEs)', 'categories': [{'measurements': [{'value': '515', 'groupId': 'OG000'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years', 'description': 'Analysis of absolute and relative frequencies for Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Fingolimod 0.5 mg/day is safe in patients with relapsing forms of Multiple Sclerosis (MS) through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4046', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 0.5 mg/Day', 'description': 'Open-label fingolimod 0.5 mg, taken orally once daily'}], 'classes': [{'title': 'Month 0 to Month 6', 'categories': [{'measurements': [{'value': '0.325', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 12', 'categories': [{'measurements': [{'value': '0.273', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 24', 'categories': [{'measurements': [{'value': '0.237', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 36', 'categories': [{'measurements': [{'value': '0.217', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 48', 'categories': [{'measurements': [{'value': '0.208', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 60', 'categories': [{'measurements': [{'value': '0.197', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 72', 'categories': [{'measurements': [{'value': '0.190', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 84', 'categories': [{'measurements': [{'value': '0.182', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 96', 'categories': [{'measurements': [{'value': '0.177', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 108', 'categories': [{'measurements': [{'value': '0.172', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 120', 'categories': [{'measurements': [{'value': '0.170', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 132', 'categories': [{'measurements': [{'value': '0.170', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 144', 'categories': [{'measurements': [{'value': '0.169', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 156', 'categories': [{'measurements': [{'value': '0.169', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to end of Study', 'categories': [{'measurements': [{'value': '0.166', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to end of Follow-up', 'categories': [{'measurements': [{'value': '0.169', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)', 'description': 'Annualized relapse rate (ARR) is defined as the number of all relapses (including both confirmed and unconfirmed relapses) experienced during a specific period of time adjusted to a one-year period. ARR is calculated as follows: (total number of all relapses) / (total number of days in the study for all patients for that specific period of time) x 365.25. Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.', 'unitOfMeasure': 'Annual number of relapses per patient', 'reportingStatus': 'POSTED', 'populationDescription': 'Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.'}, {'type': 'SECONDARY', 'title': 'Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4046', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 0.5 mg/Day', 'description': 'Open-label fingolimod 0.5 mg, taken orally once daily'}], 'classes': [{'title': 'Month 0 to Month 6', 'categories': [{'measurements': [{'value': '655', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 12', 'categories': [{'measurements': [{'value': '992', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 24', 'categories': [{'measurements': [{'value': '1461', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 36', 'categories': [{'measurements': [{'value': '1794', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 48', 'categories': [{'measurements': [{'value': '2127', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 60', 'categories': [{'measurements': [{'value': '2383', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 72', 'categories': [{'measurements': [{'value': '2616', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 84', 'categories': [{'measurements': [{'value': '2793', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 96', 'categories': [{'measurements': [{'value': '2944', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 108', 'categories': [{'measurements': [{'value': '3036', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 120', 'categories': [{'measurements': [{'value': '3063', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 132', 'categories': [{'measurements': [{'value': '3072', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 144', 'categories': [{'measurements': [{'value': '3075', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 156', 'categories': [{'measurements': [{'value': '3079', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to end of Study', 'categories': [{'measurements': [{'value': '2970', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to end of Follow-up', 'categories': [{'measurements': [{'value': '3079', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)', 'description': 'A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\\<37.5°C) or infection.\n\nIn Study Part One, a relapse must be confirmed by an Expanded Disability Status Scale (EDSS) certified Physician within 7 days of the onset of symptoms. A relapse is confirmed when it is accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.'}, {'type': 'SECONDARY', 'title': 'Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4046', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 0.5 mg/Day', 'description': 'Open-label fingolimod 0.5 mg, taken orally once daily'}], 'classes': [{'title': 'Month 0 to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.324', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '785', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.073', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1771', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.360', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1730', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.042', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1514', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.011', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1453', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.008', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1231', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.957', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1270', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.963', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.906', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '578', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.813', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '651', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.713', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.702', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.659', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.681', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to Month 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.637', 'groupId': 'OG000'}]}]}, {'title': 'Month 0 to end of study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1320', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.751', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 0 (Core Baseline) to End of Study (an average of Month 156)', 'description': 'Annualized rate of new/newly enlarging T2 lesions (ARneT2) is defined as the number of new or newly enlarging T2 lesions experienced during a specific period of time adjusted to a one-year period. ARneT2 was calculated as follows: (total number of new/newly enlarging T2 lesions) / (total number of days in the study for all patients for that specific period of time) x 365.25.Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.', 'unitOfMeasure': 'Annual number of T2 lesions per patient', 'reportingStatus': 'POSTED', 'populationDescription': 'Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.'}, {'type': 'SECONDARY', 'title': 'Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4046', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 0.5 mg/Day', 'description': 'Open-label fingolimod 0.5 mg, taken orally once daily'}], 'classes': [{'title': 'T2 volume change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-749.5', 'spread': '5269.04', 'groupId': 'OG000'}]}]}, {'title': 'T2 volume change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-207.0', 'spread': '1385.64', 'groupId': 'OG000'}]}]}, {'title': 'T2 volume change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1747', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-55.0', 'spread': '1700.16', 'groupId': 'OG000'}]}]}, {'title': 'T2 volume change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1591', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.2', 'spread': '2009.87', 'groupId': 'OG000'}]}]}, {'title': 'T2 volume change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1463', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '235.8', 'spread': '2519.39', 'groupId': 'OG000'}]}]}, {'title': 'T2 volume change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '875.1', 'spread': '4145.99', 'groupId': 'OG000'}]}]}, {'title': 'T2 volume change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1181', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1546.3', 'spread': '4556.51', 'groupId': 'OG000'}]}]}, {'title': 'T2 volume change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1273', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1719.2', 'spread': '5184.27', 'groupId': 'OG000'}]}]}, {'title': 'T2 volume change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1053', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1635.8', 'spread': '5075.13', 'groupId': 'OG000'}]}]}, {'title': 'T2 volume change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1303.9', 'spread': '4712.78', 'groupId': 'OG000'}]}]}, {'title': 'T2 volume change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '648', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1562.0', 'spread': '4654.67', 'groupId': 'OG000'}]}]}, {'title': 'T2 volume change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1393.1', 'spread': '4908.76', 'groupId': 'OG000'}]}]}, {'title': 'T2 volume change at Month 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '905.9', 'spread': '3960.94', 'groupId': 'OG000'}]}]}, {'title': 'T2 volume change at Month 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '702.7', 'spread': '3765.80', 'groupId': 'OG000'}]}]}, {'title': 'T2 volume change at Month 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '274.0', 'spread': '5784.85', 'groupId': 'OG000'}]}]}, {'title': 'T2 volume change at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1314', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1588.5', 'spread': '5157.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3 to End of Study (Study Completion Visit)', 'description': 'Total volume of T2 lesions was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.'}, {'type': 'SECONDARY', 'title': 'Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4046', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 0.5 mg/Day', 'description': 'Open-label fingolimod 0.5 mg, taken orally once daily'}], 'classes': [{'title': 'T1 volume change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-519.8', 'spread': '1339.62', 'groupId': 'OG000'}]}]}, {'title': 'T1 volume change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '988', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.1', 'spread': '718.77', 'groupId': 'OG000'}]}]}, {'title': 'T1 volume change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1490', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.1', 'spread': '786.02', 'groupId': 'OG000'}]}]}, {'title': 'T1 volume change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1348', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '151.08', 'spread': '1001.28', 'groupId': 'OG000'}]}]}, {'title': 'T1 volume change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1023', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '524.8', 'spread': '1706.26', 'groupId': 'OG000'}]}]}, {'title': 'T1 volume change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1068', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '853.6', 'spread': '1957.74', 'groupId': 'OG000'}]}]}, {'title': 'T1 volume change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1175', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '975.7', 'spread': '2637.67', 'groupId': 'OG000'}]}]}, {'title': 'T1 volume change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1012', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '930.1', 'spread': '2471.70', 'groupId': 'OG000'}]}]}, {'title': 'T1 volume change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '753.4', 'spread': '1845.63', 'groupId': 'OG000'}]}]}, {'title': 'T1 volume change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '554', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '628.7', 'spread': '1922.45', 'groupId': 'OG000'}]}]}, {'title': 'T1 volume change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '817.3', 'spread': '2198.58', 'groupId': 'OG000'}]}]}, {'title': 'T1 volume change at Month 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '726.7', 'spread': 'NA', 'comment': 'NA: Not estimable due to insufficient number of participants with events', 'groupId': 'OG000'}]}]}, {'title': 'T1 volume change at End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1236', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '800.6', 'spread': '2247.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3 to End of Study (Study Completion Visit)', 'description': 'T1 hypointense lesion (black hole) volume was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.'}, {'type': 'SECONDARY', 'title': 'Part I: Percent Brain Volume Change (PBVC) Relative to First Dose of Fingolimod', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4046', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 0.5 mg/Day', 'description': 'Open-label fingolimod 0.5 mg, taken orally once daily'}], 'classes': [{'title': 'Percent volume change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.660', 'groupId': 'OG000'}]}]}, {'title': 'Percent volume change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '758', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.801', 'groupId': 'OG000'}]}]}, {'title': 'Percent volume change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1720', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.901', 'groupId': 'OG000'}]}]}, {'title': 'Percent volume change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1699', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.74', 'spread': '1.209', 'groupId': 'OG000'}]}]}, {'title': 'Percent volume change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1480', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.03', 'spread': '1.541', 'groupId': 'OG000'}]}]}, {'title': 'Percent volume change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1414', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.44', 'spread': '1.851', 'groupId': 'OG000'}]}]}, {'title': 'Percent volume change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.65', 'spread': '2.196', 'groupId': 'OG000'}]}]}, {'title': 'Percent volume change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.02', 'spread': '2.514', 'groupId': 'OG000'}]}]}, {'title': 'Percent volume change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '950', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.38', 'spread': '2.638', 'groupId': 'OG000'}]}]}, {'title': 'Percent volume change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.41', 'spread': '2.607', 'groupId': 'OG000'}]}]}, {'title': 'Percent volume change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '593', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.91', 'spread': '2.863', 'groupId': 'OG000'}]}]}, {'title': 'Percent volume change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.42', 'spread': '2.911', 'groupId': 'OG000'}]}]}, {'title': 'Percent volume change at Month 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.61', 'spread': '2.511', 'groupId': 'OG000'}]}]}, {'title': 'Percent volume change at Month 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.21', 'spread': '2.778', 'groupId': 'OG000'}]}]}, {'title': 'Percent volume change at Month 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.33', 'spread': '3.146', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3 to Month 156', 'description': 'Descriptive statistics on percent brain volume change from first dose of fingolimod baseline were presented by visit. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.'}, {'type': 'SECONDARY', 'title': 'Part I: Annualized Rate of Brain Atrophy (ARBA) Relative to First Dose of Fingolimod', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4046', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 0.5 mg/Day', 'description': 'Open-label fingolimod 0.5 mg, taken orally once daily'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.73', 'spread': '2.834', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '758', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.39', 'spread': '1.590', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1720', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.891', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1699', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.37', 'spread': '0.615', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1480', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.522', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1414', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.37', 'spread': '0.480', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.451', 'groupId': 'OG000'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1151', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.433', 'groupId': 'OG000'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '950', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.395', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '511', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.31', 'spread': '0.340', 'groupId': 'OG000'}]}]}, {'title': 'Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '593', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.326', 'groupId': 'OG000'}]}]}, {'title': 'Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.308', 'groupId': 'OG000'}]}]}, {'title': 'Month 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.43', 'spread': '0.240', 'groupId': 'OG000'}]}]}, {'title': 'Month 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.244', 'groupId': 'OG000'}]}]}, {'title': 'Month 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.256', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3 to Month 156', 'description': 'The annualized rate of brain volume change is an "averaged annual percentage change" in brain volume. ARBA was calculated as: ARBA = \\[(SIENA/100+1) \\^ (365.25/#days)-1\\]\\*100 where SIENA=(Vk/V0-1)\\*100 and Vk is the brain volume at time k, V0 is the brain volume at time 0 and k is the total number of days in the study for all patients for that specific period of time) × 365.25. Only descriptive analysis performed.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.'}, {'type': 'SECONDARY', 'title': 'Part I: Number of Participants With Confirmed 6-month Disability Progression After First Dose of Fingolimod', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4046', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 0.5 mg/Day', 'description': 'Open-label fingolimod 0.5 mg, taken orally once daily'}], 'classes': [{'title': 'Month 12', 'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '336', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'categories': [{'measurements': [{'value': '434', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'categories': [{'measurements': [{'value': '519', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'categories': [{'measurements': [{'value': '590', 'groupId': 'OG000'}]}]}, {'title': 'Month 72', 'categories': [{'measurements': [{'value': '659', 'groupId': 'OG000'}]}]}, {'title': 'Month 84', 'categories': [{'measurements': [{'value': '714', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'categories': [{'measurements': [{'value': '753', 'groupId': 'OG000'}]}]}, {'title': 'Month 108', 'categories': [{'measurements': [{'value': '767', 'groupId': 'OG000'}]}]}, {'title': 'Month 120', 'categories': [{'measurements': [{'value': '772', 'groupId': 'OG000'}]}]}, {'title': 'Month 132', 'categories': [{'measurements': [{'value': '775', 'groupId': 'OG000'}]}]}, {'title': 'Month 144', 'categories': [{'measurements': [{'value': '776', 'groupId': 'OG000'}]}]}, {'title': 'Month 156', 'categories': [{'measurements': [{'value': '777', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12 to Month 156', 'description': 'Disability progression was defined based on an increase in the EDSS score by 1.5 point for patients with a first dose of fingolimod (FDF) baseline EDSS score of 0, 1 point for patients with FDF baseline EDSS of \\>=1 and \\<=5.5, and by 0.5 points for patients with an FDF baseline EDSS\\>5.5, confirmed after 6 months and all intermediate EDSS assessments. A 6-month confirmed disability progression was defined as a 6-month sustained increase from the reference (potential onset of progression) value in the EDSS scores. i.e., every EDSS score (scheduled or unscheduled) within a 6-month duration after the first progression should meet the progression criteria as specified above. The confirmation could only happen at a scheduled visit and in the absence of a relapse. Only descriptive analysis performed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Fingolimod full analysis set'}, {'type': 'SECONDARY', 'title': 'Part I: Number of Participants With Categorized Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) Overall Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4046', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 0.5 mg/Day', 'description': 'Open-label fingolimod 0.5 mg, taken orally once daily'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3769', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '374', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '3126', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '269', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3748', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '508', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '2900', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '340', 'groupId': 'OG000'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3211', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '482', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '2425', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '304', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2674', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '422', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '1930', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '322', 'groupId': 'OG000'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2454', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '405', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '1764', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '285', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1977', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '345', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '1361', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '271', 'groupId': 'OG000'}]}]}, {'title': 'Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2187', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '376', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '1524', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '287', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1913', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '320', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '1299', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '294', 'groupId': 'OG000'}]}]}, {'title': 'Month 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1854', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '313', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '1271', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '270', 'groupId': 'OG000'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1796', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '305', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '1204', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '287', 'groupId': 'OG000'}]}]}, {'title': 'Month 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1790', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '326', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '1172', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '292', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1662', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '309', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '1065', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '288', 'groupId': 'OG000'}]}]}, {'title': 'Month 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1575', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '284', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '1015', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '276', 'groupId': 'OG000'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1517', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '282', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '948', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '287', 'groupId': 'OG000'}]}]}, {'title': 'Month 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1382', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '244', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '875', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '263', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1352', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '250', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '838', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '264', 'groupId': 'OG000'}]}]}, {'title': 'Month 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1275', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '244', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '784', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '247', 'groupId': 'OG000'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1295', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '256', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '788', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '251', 'groupId': 'OG000'}]}]}, {'title': 'Month 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1140', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '201', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '694', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '245', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '986', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '175', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '577', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '234', 'groupId': 'OG000'}]}]}, {'title': 'Month 63', 'denoms': [{'units': 'Participants', 'counts': [{'value': '913', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '182', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '540', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '191', 'groupId': 'OG000'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '880', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '165', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '499', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '216', 'groupId': 'OG000'}]}]}, {'title': 'Month 69', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '156', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '503', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '193', 'groupId': 'OG000'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '789', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '143', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '440', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '206', 'groupId': 'OG000'}]}]}, {'title': 'Month 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '794', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '156', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '437', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '201', 'groupId': 'OG000'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '760', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '136', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '398', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '226', 'groupId': 'OG000'}]}]}, {'title': 'Month 81', 'denoms': [{'units': 'Participants', 'counts': [{'value': '823', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '150', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '456', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '217', 'groupId': 'OG000'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '132', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '407', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '207', 'groupId': 'OG000'}]}]}, {'title': 'Month 87', 'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '147', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '450', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '227', 'groupId': 'OG000'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '737', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '120', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '413', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '204', 'groupId': 'OG000'}]}]}, {'title': 'Month 93', 'denoms': [{'units': 'Participants', 'counts': [{'value': '716', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '143', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '386', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '187', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '678', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '117', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '375', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '186', 'groupId': 'OG000'}]}]}, {'title': 'Month 99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '110', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '325', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '159', 'groupId': 'OG000'}]}]}, {'title': 'Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '531', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '94', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '283', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '154', 'groupId': 'OG000'}]}]}, {'title': 'Month 105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '103', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '261', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '131', 'groupId': 'OG000'}]}]}, {'title': 'Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '87', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '287', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '138', 'groupId': 'OG000'}]}]}, {'title': 'Month 111', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '74', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '198', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '101', 'groupId': 'OG000'}]}]}, {'title': 'Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '45', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '181', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Month 117', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '31', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '94', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '88', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Month 123', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '45', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Month 129', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Month 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '36', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Month 135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Month 138', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Month 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Month 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Month 147', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Month 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Month 153', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Month 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Month 159', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Month 162', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'End of study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3814', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '610', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '2419', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '785', 'groupId': 'OG000'}]}]}, {'title': 'Month 3 follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1491', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '203', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '907', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '381', 'groupId': 'OG000'}]}]}, {'title': 'Month 6 follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Improvement', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Stable', 'measurements': [{'value': '111', 'groupId': 'OG000'}]}, {'title': 'Deterioration', 'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 3 to Month 6 Follow-up', 'description': "The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) 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. Based on the assessment of each FS, the participant's overall score is categorized as Improvement, Stable or Deterioration.\n\nIf baseline EDSS score is \\<=5, improvement is indicated by an EDSS score change of \\<= -1, stable is indicated by an EDSS score change of \\> -1 and \\<= 0.5, deterioration is indicated by an EDSS score change of \\> 0.5; if baseline EDSS score is \\> 5, improvement is indicated by an EDSS score change of \\<= -0.5, stable is indicated by an EDSS score change of \\> -0.5 and \\<= 0, deterioration is indicated by an EDSS score change of \\> 0. Only descriptive analysis performed.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.'}, {'type': 'SECONDARY', 'title': 'Part I: Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4046', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Fingolimod 0.5 mg/Day', 'description': 'Open-label fingolimod 0.5 mg, taken orally once daily'}], 'classes': [{'title': 'Baseline (BL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4042', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.39', 'spread': '1.452', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3769', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.638', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3748', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.716', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.750', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2674', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.815', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2454', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.814', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1977', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.890', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2187', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.876', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1913', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.916', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1854', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.932', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1796', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.935', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1790', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.951', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1662', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.997', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1575', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.963', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1517', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '1.015', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1382', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '1.006', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1352', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '1.063', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1275', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '1.071', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1295', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '1.120', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1140', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '1.077', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '986', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '1.144', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 63', 'denoms': [{'units': 'Participants', 'counts': [{'value': '913', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '1.123', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '880', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '1.220', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 69', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '1.116', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '789', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.22', 'spread': '1.205', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '794', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '1.159', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '760', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '1.259', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 81', 'denoms': [{'units': 'Participants', 'counts': [{'value': '823', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '1.158', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '746', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.25', 'spread': '1.236', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 87', 'denoms': [{'units': 'Participants', 'counts': [{'value': '824', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '1.206', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '737', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.29', 'spread': '1.282', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 93', 'denoms': [{'units': 'Participants', 'counts': [{'value': '716', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '1.219', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '678', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.31', 'spread': '1.355', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '594', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '1.220', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '531', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '1.332', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '1.320', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '1.270', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 111', 'denoms': [{'units': 'Participants', 'counts': [{'value': '373', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.24', 'spread': '1.343', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '305', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '1.258', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 117', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '1.389', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '1.271', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 123', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.60', 'spread': '1.302', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '1.441', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 129', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '1.448', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '1.450', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.51', 'spread': '1.519', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 138', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.42', 'spread': '1.527', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.54', 'spread': '1.509', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.60', 'spread': '1.553', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 147', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.67', 'spread': '1.640', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '1.483', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 153', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '1.534', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.26', 'spread': '1.427', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 159', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.17', 'spread': '1.369', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 162', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '1.061', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at End of study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3814', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '1.108', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 3 follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1491', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.29', 'spread': '1.248', 'groupId': 'OG000'}]}]}, {'title': 'Change from BL at Month 6 follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.56', 'spread': '1.487', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)', 'description': "The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) 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. Based on the assessment of each FS, the participant's overall score is determined between 0 to 10. A negative change from baseline indicates improvement. Only descriptive analysis performed.", 'unitOfMeasure': 'EDDS Overall Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Fingolimod full analysis set. Only participants with an observed value were considered for the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fingolimod 0.5 mg/Day', 'description': 'Open-label fingolimod 0.5 mg, taken orally once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'All enrolled patients', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4125'}]}, {'type': 'Safety Set', 'comment': 'At least one dose of fingolimod in any study and a post-baseline safety assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4083'}]}, {'type': 'Fingolimod Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4046'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3481'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '644'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '170'}]}, {'type': 'Abnormal laboratory value(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'Abnormal test procedure result(s)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '112'}]}, {'type': 'Condition no longer requires study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '144'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '74'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'This was an open-label, multi-center, single treatment arm design allowing patients participating in the fingolimod MS clinical development program to enroll in order to collect additional long-term safety, tolerability, efficacy, and health outcomes data.', 'preAssignmentDetails': 'This study had two parts: Part 1, collecting long-term safety, tolerability, efficacy and health outcomes data until all Part 1 end of study (EOS) visits and last follow-up visit; Part 2, collecting limited safety and tolerability data, in a subset of patients who participated in Part 1, and other eligible patients from ongoing fingolimod trials.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4125', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fingolimod 0.5 mg/Day', 'description': 'Open-label fingolimod 0.5 mg, taken orally once daily'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'spread': '9.05', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 18 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '18 - 30 years', 'categories': [{'measurements': [{'value': '951', 'groupId': 'BG000'}]}]}, {'title': '31 - 40 years', 'categories': [{'measurements': [{'value': '1497', 'groupId': 'BG000'}]}]}, {'title': '41 - 55 years', 'categories': [{'measurements': [{'value': '1605', 'groupId': 'BG000'}]}]}, {'title': '> 55 years', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2933', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1192', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '3927', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participant Flow and Baseline Characteristics were based on the Enrolled set. Efficacy analyses were based on the Fingolimod Full Analysis Set..'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-01', 'size': 651725, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-15T10:22', 'hasProtocol': True}, {'date': '2018-11-26', 'size': 992414, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-15T10:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4125}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-26', 'studyFirstSubmitDate': '2010-09-10', 'resultsFirstSubmitDate': '2019-10-15', 'studyFirstSubmitQcDate': '2010-09-13', 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-15', 'studyFirstPostDateStruct': {'date': '2010-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death', 'timeFrame': 'Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years', 'description': 'Analysis of absolute and relative frequencies for Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Fingolimod 0.5 mg/day is safe in patients with relapsing forms of Multiple Sclerosis (MS) through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.'}], 'secondaryOutcomes': [{'measure': 'Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod', 'timeFrame': 'Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)', 'description': 'Annualized relapse rate (ARR) is defined as the number of all relapses (including both confirmed and unconfirmed relapses) experienced during a specific period of time adjusted to a one-year period. ARR is calculated as follows: (total number of all relapses) / (total number of days in the study for all patients for that specific period of time) x 365.25. Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.'}, {'measure': 'Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod', 'timeFrame': 'Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)', 'description': 'A relapse is defined as the appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event. The abnormality must be present for at least 24 hours and occur in the absence of fever (\\<37.5°C) or infection.\n\nIn Study Part One, a relapse must be confirmed by an Expanded Disability Status Scale (EDSS) certified Physician within 7 days of the onset of symptoms. A relapse is confirmed when it is accompanied by an increase of at least half a step (0.5) on the EDSS or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.'}, {'measure': 'Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod', 'timeFrame': 'Month 0 (Core Baseline) to End of Study (an average of Month 156)', 'description': 'Annualized rate of new/newly enlarging T2 lesions (ARneT2) is defined as the number of new or newly enlarging T2 lesions experienced during a specific period of time adjusted to a one-year period. ARneT2 was calculated as follows: (total number of new/newly enlarging T2 lesions) / (total number of days in the study for all patients for that specific period of time) x 365.25.Month 0 is the first dose of fingolimod study drug among all studies in which patient participated. Only descriptive analysis performed.'}, {'measure': 'Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume', 'timeFrame': 'Month 3 to End of Study (Study Completion Visit)', 'description': 'Total volume of T2 lesions was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.'}, {'measure': 'Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume', 'timeFrame': 'Month 3 to End of Study (Study Completion Visit)', 'description': 'T1 hypointense lesion (black hole) volume was summarized by presenting descriptive statistics for change from first dose of fingolimod baseline values by visit.'}, {'measure': 'Part I: Percent Brain Volume Change (PBVC) Relative to First Dose of Fingolimod', 'timeFrame': 'Month 3 to Month 156', 'description': 'Descriptive statistics on percent brain volume change from first dose of fingolimod baseline were presented by visit. A negative change from baseline indicates improvement.'}, {'measure': 'Part I: Annualized Rate of Brain Atrophy (ARBA) Relative to First Dose of Fingolimod', 'timeFrame': 'Month 3 to Month 156', 'description': 'The annualized rate of brain volume change is an "averaged annual percentage change" in brain volume. ARBA was calculated as: ARBA = \\[(SIENA/100+1) \\^ (365.25/#days)-1\\]\\*100 where SIENA=(Vk/V0-1)\\*100 and Vk is the brain volume at time k, V0 is the brain volume at time 0 and k is the total number of days in the study for all patients for that specific period of time) × 365.25. Only descriptive analysis performed.'}, {'measure': 'Part I: Number of Participants With Confirmed 6-month Disability Progression After First Dose of Fingolimod', 'timeFrame': 'Month 12 to Month 156', 'description': 'Disability progression was defined based on an increase in the EDSS score by 1.5 point for patients with a first dose of fingolimod (FDF) baseline EDSS score of 0, 1 point for patients with FDF baseline EDSS of \\>=1 and \\<=5.5, and by 0.5 points for patients with an FDF baseline EDSS\\>5.5, confirmed after 6 months and all intermediate EDSS assessments. A 6-month confirmed disability progression was defined as a 6-month sustained increase from the reference (potential onset of progression) value in the EDSS scores. i.e., every EDSS score (scheduled or unscheduled) within a 6-month duration after the first progression should meet the progression criteria as specified above. The confirmation could only happen at a scheduled visit and in the absence of a relapse. Only descriptive analysis performed.'}, {'measure': 'Part I: Number of Participants With Categorized Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) Overall Score', 'timeFrame': 'Month 3 to Month 6 Follow-up', 'description': "The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) 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. Based on the assessment of each FS, the participant's overall score is categorized as Improvement, Stable or Deterioration.\n\nIf baseline EDSS score is \\<=5, improvement is indicated by an EDSS score change of \\<= -1, stable is indicated by an EDSS score change of \\> -1 and \\<= 0.5, deterioration is indicated by an EDSS score change of \\> 0.5; if baseline EDSS score is \\> 5, improvement is indicated by an EDSS score change of \\<= -0.5, stable is indicated by an EDSS score change of \\> -0.5 and \\<= 0, deterioration is indicated by an EDSS score change of \\> 0. Only descriptive analysis performed."}, {'measure': 'Part I: Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS)', 'timeFrame': 'Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)', 'description': "The EDSS is a scale for assessing neurological impairment in MS (Kurtzke 1983) including (1) a series of scores in each of eight functional systems, and (2) 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. Based on the assessment of each FS, the participant's overall score is determined between 0 to 10. A negative change from baseline indicates improvement. Only descriptive analysis performed."}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fingolimod', 'FTY720', 'Relapsing forms of MS', 'Multiple Sclerosis', 'Efficacy'], 'conditions': ['Relapsing Forms of Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '31598139', 'type': 'DERIVED', 'citation': 'Cohen JA, Tenenbaum N, Bhatt A, Zhang Y, Kappos L. Extended treatment with fingolimod for relapsing multiple sclerosis: the 14-year LONGTERMS study results. Ther Adv Neurol Disord. 2019 Sep 25;12:1756286419878324. doi: 10.1177/1756286419878324. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.', 'detailedDescription': 'This study had two parts:\n\n* Part 1, collecting long-term safety, tolerability, efficacy and health outcomes data through approximately 30-Jun-2016 until all end of study (EOS) visits of Part 1 and last follow-up visit through Jan-2017 and\n* Part 2, collecting limited safety and tolerability data until approximately 30 Jun 2018, in a subset of patients who participated in Part 1, and other eligible patients from ongoing fingolimod trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n\\- Patients who have completed selected ongoing or planned trials with FTY720.\n\nKey Exclusion Criteria:\n\n* Premature permanent discontinuation of a previous fingolimod study.\n* Pregnant or nursing (lactating) women.\n* Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partner's vasectomy or intrauterine device.\n* Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment.\n* Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c \\> 8%.\n* Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.\n* Previous treatment with cladribine, cyclophosphamide or mitoxantrone.\n* Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study:\n* Any of the following cardiovascular conditions that have developed during the previous fingolimod study:\n\n * Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;\n * Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;\n * Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide)\n * History or presence of a third degree AV block\n * Proven history of sick sinus syndrome or sino-atrial heart block\n * Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon\n* Any of the following pulmonary conditions during the previous fingolimod study:\n\n * Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous fingolimod study)\n * Active tuberculosis\n* Alcohol abuse, chronic liver disease during the previous fingolimod study.\n\nThe patient must have participated in a previous fingolimod trial to be eligible to participate in this trial."}, 'identificationModule': {'nctId': 'NCT01201356', 'briefTitle': 'Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'CFTY720D2399'}, 'secondaryIdInfos': [{'id': '2010-020515-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fingolimod 0.5 mg/day', 'description': 'Open-label fingolimod 0.5 mg, taken orally once daily', 'interventionNames': ['Drug: Fingolimod']}], 'interventions': [{'name': 'Fingolimod', 'type': 'DRUG', 'otherNames': ['FTY720'], 'description': '0.5 mg/day', 'armGroupLabels': ['Fingolimod 0.5 mg/day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35058', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': 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