Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT00221104
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Japan Statin Treatment Against Recurrent Stroke (J-STARS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017035', 'term': 'Pravastatin'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kagimura@tri-kobe.org', 'phone': '+81-78-303-9108', 'title': 'Director of Medical Statistics Division', 'organization': 'Translational Research Informatics Center, Kobe, Hyogo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Mean length of follow-up was 4.89 years.', 'description': 'In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Pravastatin Group', 'description': 'The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 780, 'seriousNumAffected': 188}, {'id': 'EG001', 'title': 'Control Group', 'description': 'The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 785, 'seriousNumAffected': 164}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Atrioventricular block second d', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hypertrophic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cataract diabetic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Retinal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Vitreous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Anal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Diverticulitis intestinal haemo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Diverticulum intestinal haemorr', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Duodenal ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Ileus paralytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Upper gastrointestinal haemorrh', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Therapy responder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Disuse syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hepatic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hepatic 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'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pneumonia mycoplasmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pyothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Encephalitis brain stem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Infected epidermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Biliary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Extradural abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Enterocolitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Carbon monoxide poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Median nerve injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Heat illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Blood creatine phosphokinase in', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Catheterisation cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Diabetes mellitus inadequate co', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Adrenal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Adrenocortical carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': "Bowen's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Chronic myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hypopharyngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Malignant ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Neoplasm skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Rectosigmoid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Thymoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Thyroid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Carcinoid tumour of the duodenu', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Small intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Large intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 7}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Gastric adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Lip and/or oral cavity cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Gingival cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Autonomic nervous system imbala', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Guillain-Barre syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hypertensive encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hypoglycaemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Normal pressure hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Reversible ischaemic neurologic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 39}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Cubital tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Spinal cord infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Mental disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Nephritis', 'stats': 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'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Urethral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Diabetic nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Breast mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Chronic obstructive pulmonary d', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Laryngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Nasal septum deviation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pulmonary alveolar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pulmonary infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Sleep apnea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Epiglottic cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Pemphigus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Social stay hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Gastrostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Coronary angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hepatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Removal of foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Laminaplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Percutaneous coronary intervent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Thrombophlebitis migrans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Subclavian artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Aortic rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}, {'term': 'Arteriosclerosis obliterans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 780, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 785, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 14.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence Rate of Stroke and TIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '793', 'groupId': 'OG000'}, {'value': '785', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pravastatin', 'description': 'The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.56', 'groupId': 'OG000', 'lowerLimit': '2.04', 'upperLimit': '3.08'}, {'value': '2.65', 'groupId': 'OG001', 'lowerLimit': '2.12', 'upperLimit': '3.18'}]}]}], 'analyses': [{'pValue': '0.8234', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.29', 'estimateComment': 'the adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus', 'groupDescription': 'the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 5 years', 'description': 'Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)', 'unitOfMeasure': 'events /100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Atherothrombotic Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '785', 'groupId': 'OG000'}, {'value': '793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.'}, {'id': 'OG001', 'title': 'Pravastatin', 'description': 'The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000', 'lowerLimit': '0.40', 'upperLimit': '0.91'}, {'value': '0.21', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '0.35'}]}]}], 'analyses': [{'pValue': '0.0047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '0.15', 'ciUpperLimit': '0.74', 'estimateComment': 'The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus', 'groupDescription': 'the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 5 years', 'description': 'Incidence rate of patients with atherothrombotic infarction', 'unitOfMeasure': 'events /100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Lacunar Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '793', 'groupId': 'OG000'}, {'value': '785', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pravastatin', 'description': 'The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.26', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '1.63'}, {'value': '1.01', 'groupId': 'OG001', 'lowerLimit': '0.69', 'upperLimit': '1.33'}]}]}], 'analyses': [{'pValue': '0.3075', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.25', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.91', 'estimateComment': 'The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus', 'groupDescription': 'the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 5 years', 'description': 'Incidence rate of patients with lacunar infarction', 'unitOfMeasure': 'events /100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Cardioembolic Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '793', 'groupId': 'OG000'}, {'value': '785', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pravastatin', 'description': 'The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.18', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.32'}, {'value': '0.08', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.16'}]}]}], 'analyses': [{'pValue': '0.1986', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.36', 'ciLowerLimit': '0.61', 'ciUpperLimit': '9.14', 'estimateComment': 'The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus', 'groupDescription': 'the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 5 years', 'description': 'Incidence rate of patients with cardioembolic infarction', 'unitOfMeasure': 'events /100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Intracranial Hemorrhage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '793', 'groupId': 'OG000'}, {'value': '785', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pravastatin', 'description': 'The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.29', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.46'}, {'value': '0.31', 'groupId': 'OG001', 'lowerLimit': '0.14', 'upperLimit': '0.49'}]}]}], 'analyses': [{'pValue': '0.9953', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.45', 'ciUpperLimit': '2.22', 'estimateComment': 'The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus', 'groupDescription': 'the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)', 'statisticalMethod': 'Stratified log-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 5 years', 'description': 'Incidence rate of patients with intracranial hemorrhage', 'unitOfMeasure': 'events /100 person-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pravastatin Group', 'description': 'The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '793'}, {'groupId': 'FG001', 'numSubjects': '785'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '710'}, {'groupId': 'FG001', 'numSubjects': '709'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '76'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Others', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '47'}]}]}], 'recruitmentDetails': 'Participants were enrolled from March 2004 and February 2009 recruited at 123 clinical sites in Japan', 'preAssignmentDetails': 'Participants were randomly assigned to the pravastatin group or the control with 1:1 allocation rate. The patient allocation was dynamically balanced with the stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence) between the two groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '793', 'groupId': 'BG000'}, {'value': '785', 'groupId': 'BG001'}, {'value': '1578', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pravastatin', 'description': 'The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '335', 'groupId': 'BG000'}, {'value': '329', 'groupId': 'BG001'}, {'value': '664', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '458', 'groupId': 'BG000'}, {'value': '456', 'groupId': 'BG001'}, {'value': '914', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '248', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '491', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '545', 'groupId': 'BG000'}, {'value': '542', 'groupId': 'BG001'}, {'value': '1087', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '793', 'groupId': 'BG000'}, {'value': '785', 'groupId': 'BG001'}, {'value': '1578', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '793', 'groupId': 'BG000'}, {'value': '785', 'groupId': 'BG001'}, {'value': '1578', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ischemic stroke subtype', 'classes': [{'title': 'Atherothrombotic infarction', 'categories': [{'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}]}, {'title': 'Lacunar infarction', 'categories': [{'measurements': [{'value': '502', 'groupId': 'BG000'}, {'value': '504', 'groupId': 'BG001'}, {'value': '1006', 'groupId': 'BG002'}]}]}, {'title': 'Infarction of undetermined etiology', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'High blood pressure', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '308', 'groupId': 'BG000'}, {'value': '309', 'groupId': 'BG001'}, {'value': '617', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '485', 'groupId': 'BG000'}, {'value': '476', 'groupId': 'BG001'}, {'value': '961', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The high blood pressure was defined ≥150/90 mmHg at baseline.', 'unitOfMeasure': 'participants'}, {'title': 'Diabetes mellitus', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '608', 'groupId': 'BG000'}, {'value': '601', 'groupId': 'BG001'}, {'value': '1209', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'intention to treat'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1578}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2005-09-13', 'resultsFirstSubmitDate': '2016-07-06', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-19', 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Rate of Stroke and TIA', 'timeFrame': 'up to 5 years', 'description': 'Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)'}], 'secondaryOutcomes': [{'measure': 'Incidence Rate of Atherothrombotic Infarction', 'timeFrame': 'up to 5 years', 'description': 'Incidence rate of patients with atherothrombotic infarction'}, {'measure': 'Incidence Rate of Lacunar Infarction', 'timeFrame': 'up to 5 years', 'description': 'Incidence rate of patients with lacunar infarction'}, {'measure': 'Incidence Rate of Cardioembolic Infarction', 'timeFrame': 'up to 5 years', 'description': 'Incidence rate of patients with cardioembolic infarction'}, {'measure': 'Incidence Rate of Intracranial Hemorrhage', 'timeFrame': 'up to 5 years', 'description': 'Incidence rate of patients with intracranial hemorrhage'}]}, 'conditionsModule': {'keywords': ['stroke', 'brain ischemia', 'cerebrovascular accident', 'statin', 'hydroxymethylglutaryl-CoA reductase inhibitors', 'cholesterol', 'hypercholesterolemia', 'hyperlipidemia', 'multicenter studies', 'prospective studies', 'endpoint determination', 'randomized controlled trials', 'recurrence', 'pravastatin'], 'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '29511130', 'type': 'DERIVED', 'citation': 'Hosomi N, Kitagawa K, Nagai Y, Nakagawa Y, Aoki S, Nezu T, Kagimura T, Maruyama H, Origasa H, Minematsu K, Uchiyama S, Matsumoto M; J-STARS Collaborators. Desirable Low-Density Lipoprotein Cholesterol Levels for Preventing Stroke Recurrence: A Post Hoc Analysis of the J-STARS Study (Japan Statin Treatment Against Recurrent Stroke). Stroke. 2018 Apr;49(4):865-871. doi: 10.1161/STROKEAHA.117.018870. Epub 2018 Mar 6.'}, {'pmid': '28924103', 'type': 'DERIVED', 'citation': 'Hosomi N, Nagai Y, Kitagawa K, Nakagawa Y, Aoki S, Nezu T, Kagimura T, Maruyama H, Origasa H, Minematsu K, Uchiyama S, Matsumoto M; J-STARS collaborators. Pravastatin Reduces the Risk of Atherothrombotic Stroke when Administered within Six Months of an Initial Stroke Event. J Atheroscler Thromb. 2018 Mar 1;25(3):262-268. doi: 10.5551/jat.40196. Epub 2017 Sep 16.'}, {'pmid': '28135841', 'type': 'DERIVED', 'citation': 'Nakamura M, Fukukawa T, Kitagawa K, Nagai Y, Hosomi N, Minematsu K, Uchiyama S, Matsumoto M, Miyamoto Y; for J-STARS collaborators. Ten-year standardization of lipids and high-sensitivity C-reactive protein in a randomized controlled trial to assess the effects of statins on secondary stroke prevention: Japan Statin Treatment Against Recurrent Stroke. Ann Clin Biochem. 2018 Jan;55(1):128-135. doi: 10.1177/0004563217693651. Epub 2017 Jul 10.'}], 'seeAlsoLinks': [{'url': 'http://jstars.umin.ne.jp', 'label': 'Japan Statin Treatment Against Recurrent Stroke (J-STARS) only in Japanese'}]}, 'descriptionModule': {'briefSummary': 'Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset\n* Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days\n* Able to visit outpatient department\n* Informed consent on the form.\n\nExclusion Criteria:\n\n* Ischemic stroke of other determined cause according to the TOAST classification\n* Ischemic heart disease and necessary to use statin\n* Hemorrhagic disorders\n* Platelet count \\<=100,000/ul within 3 months prior to study start\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\\>= 100IU/L within 3 months prior to study start\n* Serum creatinine \\>=2.0mg/dl within 3 months prior to study start\n* A scheduled operation\n* The presence of malignant disorder'}, 'identificationModule': {'nctId': 'NCT00221104', 'briefTitle': 'Japan Statin Treatment Against Recurrent Stroke (J-STARS)', 'organization': {'class': 'OTHER', 'fullName': 'Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan'}, 'officialTitle': 'Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke', 'orgStudyIdInfo': {'id': 'J-STARS'}, 'secondaryIdInfos': [{'id': 'C000000207', 'type': 'OTHER', 'domain': 'UMIN CTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pravastatin', 'description': 'Patient has 10mg oral administration of Pravastatin per day. It starts within one month from their entry and continues every day until the end of the study or its endpoints.', 'interventionNames': ['Drug: Pravastatin']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Patient has no intervention.'}], 'interventions': [{'name': 'Pravastatin', 'type': 'DRUG', 'armGroupLabels': ['Pravastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '734-8551', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima University', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}], 'overallOfficials': [{'name': 'Masayasu Matsumoto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hiroshima University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Labour and Welfare, Japan', 'class': 'OTHER_GOV'}, {'name': 'Hiroshima University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}