Ignite Creation Date:
2025-12-25 @ 5:10 AM
Ignite Modification Date:
2025-12-26 @ 4:15 AM
Study NCT ID:
NCT01000727
Status:
COMPLETED
Last Update Posted:
2017-08-10
First Post:
2009-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529040', 'term': 'darapladib'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'SAEs and non-serious AEs were collected from start of the study treatment up to 42 days after last dose of study treatment/FU visit.', 'description': 'SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all randomized participants who received at least one dose of investigational product. Post-randomization AEs have an onset date that is on or after the randomization date. The safety population excluded 57 participants in the placebo group and 52 participants in the darapladib group who were randomized but did not receive study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.', 'otherNumAtRisk': 6465, 'deathsNumAtRisk': 6465, 'otherNumAffected': 3416, 'seriousNumAtRisk': 6465, 'deathsNumAffected': 403, 'seriousNumAffected': 3011}, {'id': 'EG001', 'title': 'Darapladib 160 mg', 'description': 'Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.', 'otherNumAtRisk': 6452, 'deathsNumAtRisk': 6452, 'otherNumAffected': 3698, 'seriousNumAtRisk': 6452, 'deathsNumAffected': 376, 'seriousNumAffected': 2933}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 409}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 370}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 132}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 154}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 398}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 363}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 185}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 154}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 355}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 324}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 310}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 286}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 187}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 184}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 357}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 354}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 202}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 175}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 134}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 334}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 302}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 431}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 414}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 245}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 239}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 140}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 135}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abnormal faeces', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 525}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 174}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 165}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 351}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 675}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 116}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 130}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 127}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 176}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 198}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urine odour abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 344}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Skin odour abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 241}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 207}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 158}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 262}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 224}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 98}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 186}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 215}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 221}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 181}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 358}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 325}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 178}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 192}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 143}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 141}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 279}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 273}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 144}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 162}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 205}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 157}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Angiodysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Aortic occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Aortic thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arterial disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arterial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arterial insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Coeliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diabetic microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Femoral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Femoral artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Femoral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haemodynamic instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 18}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Iliac artery rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ischaemic limb pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Leriche syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lymphatic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 36}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Peripheral artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 25}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Polyarteritis nodosa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Coronary angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Coronary artery bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Percutaneous coronary intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 252}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 262}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Acute leukaemia', 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'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Benign laryngeal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Benign lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Benign neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Benign neoplasm of adrenal gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Benign neoplasm of bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Benign neoplasm of prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 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{'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bladder cancer stage 0, with cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bladder papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bone giant cell tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Borderline ovarian tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Brain neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 10}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Central nervous system neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cerebellar tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Choroid melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 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'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Colorectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cystadenocarcinoma ovary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Desmoplastic melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 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'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastrointestinal stromal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastrointestinal stromal tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastrointestinal tract adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Glioblastoma multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Glottis carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haemangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms 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'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Melanoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 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and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Metastases to spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Metastatic bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Metastatic gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and 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'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Renal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Renal cell carcinoma stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Renal oncocytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sarcoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Signet-ring cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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16.1'}, {'term': 'Small intestine adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Testis cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Thymoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Thyroid cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tongue cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tongue carcinoma stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tongue neoplasm malignant stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tonsil cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tracheal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Transitional cell carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Uterine cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vaginal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Allergy to arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Allergy to arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hernia obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Patient-device incompatibility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pelvic mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Polyserositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pseudopolyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, 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{'term': 'Stent-graft endoleak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Surgical failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Thrombosis in device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vessel puncture site thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abnormal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Affective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Alcohol withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Alcoholism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Emotional distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Osteomyelitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Osteomyelitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 113}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 130}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia influenzal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia pseudomonas aeruginosa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Post procedural pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Post procedural sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Postoperative abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pseudomembranous colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyoderma streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Renal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Salmonellosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Scrotal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Skin bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Staphylococcal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Staphylococcal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Streptococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Streptococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Superinfection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Testicular abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tracheitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary tract infection enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary tract infection pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vestibular neuronitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Wound infection pseudomonas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Wound infection staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Wound sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia legionella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cerebellar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6465, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6452, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events During the Time Period for Follow-up (FU) of Cardiovascular (CV) Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6522', 'groupId': 'OG000'}, {'value': '6504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib 160 mg', 'description': 'Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '910', 'groupId': 'OG000'}, {'value': '903', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.929', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.02', 'paramValue': '1.00', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.09', 'pValueComment': 'Statistical significance of this p-value is based on the alpha-spending function of this study.', 'statisticalMethod': 'Cox Proportional Hazard Regression Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'Coronary heart disease (CHD) death=occurrence of a fatal myocardial infarction (MI), death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a nonischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent coronary revascularization (CR) for MI=ischemic discomfort at rest that prompted CR during the same hospitalization or resulted in hospital transfer for the purpose of CR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Randomized intent-to-treat (ITT) Population consisted of all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal MI or Non-fatal Stroke) During the Time Period for Follow-up of CV Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6522', 'groupId': 'OG000'}, {'value': '6504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib 160 mg', 'description': 'Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '838', 'groupId': 'OG000'}, {'value': '824', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.777', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.02', 'paramValue': '0.99', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.09', 'pValueComment': 'Statistical significance of this p-value is based on the alpha-spending function of this study.', 'statisticalMethod': 'Cox Proportional Hazard Regression Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting \\>24 hours or results in death (in \\<24 hours).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Randomized ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiovascular Death During the Time Period for Follow-up of Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6522', 'groupId': 'OG000'}, {'value': '6504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Darapladib 160 mg', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '268', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.274', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.08', 'pValueComment': 'Statistical significance of this p-value is based on the alpha-spending function of this study.', 'statisticalMethod': 'Cox Proportional Hazard Regression Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'CV death is defined as a death due to a CV cause, which includes but is not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Randomized ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of MI (Fatal/Nonfatal) During the Time Period for Follow-up of Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6522', 'groupId': 'OG000'}, {'value': '6504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib 160 mg', 'description': 'Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '564', 'groupId': 'OG000'}, {'value': '547', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.631', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.09', 'estimateComment': 'A hazard ratio \\<1 indicates a lower risk with this treatment compared to Placebo', 'statisticalMethod': 'Cox Proportional Hazard Regression Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Randomized ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6522', 'groupId': 'OG000'}, {'value': '6504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib 160 mg', 'description': 'Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.354', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.42', 'estimateComment': 'A hazard ratio \\< 1 indicates a lower risk with this treatment compared to Placebo', 'statisticalMethod': 'Cox Proportional Hazard Regression Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting \\>24 hours or results in death (in \\<24 hours).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Randomized ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CHD Death During the Time Period for Follow-up of Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6522', 'groupId': 'OG000'}, {'value': '6504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib 160 mg', 'description': 'Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.161', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.05', 'statisticalMethod': 'Cox Proportional Hazard Regression Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Randomized ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Urgent Coronary Revascularization for Myocardial Ischemia During the Time Period for Follow-up of Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6522', 'groupId': 'OG000'}, {'value': '6504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib 160 mg', 'description': 'Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '218', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.360', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.31', 'statisticalMethod': 'Cox Proportional Hazard Regression Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'Urgent coronary revascularization for myocardial ischemia is defined as ischemic discomfort at rest that prompts coronary revascularization (PCI or coronary artery bypass graft \\[CABG\\]) during the same hospitalization or resulting in hospital transfer for the purpose of coronary revascularization. PCI is defined as any attempt at revascularization even if not successful (e.g., angioplasty, atherectomy or stenting).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Randomized ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During the Time Period for FU of CV Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6522', 'groupId': 'OG000'}, {'value': '6504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib 160 mg', 'description': 'Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '1352', 'groupId': 'OG000'}, {'value': '1290', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.202', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.03', 'estimateComment': 'A hazard ratio \\<1 indicates a lower risk with this treatment compared to Placebo', 'statisticalMethod': 'Cox Proportional Hazard Regression Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'CHD death, acute MI, and prior MI diagnosed post-randomization are defined in the primary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort was found not to be caused by myocardial ischemia. Coronary revascularization procedures exclude PCI planned prior to randomization but performed after randomization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Randomized ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of Any Coronary Revascularization Procedures (Excluding Coronary Revascularization Planned Prior to Randomization, But Performed After Randomization) During the Time Period for Follow-up of Cardiovascular Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6522', 'groupId': 'OG000'}, {'value': '6504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib 160 mg', 'description': 'Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '967', 'groupId': 'OG000'}, {'value': '926', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.329', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.05', 'statisticalMethod': 'Cox Proportional Hazard Regression Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'All coronary revascularization procedures (except for PCI planned prior to randomization but performed after randomization) are included. Examples include coronary artery bypass graft, balloon angioplasty and stenting. The number of participants, with first occurrence of any coronary revascularization procedures, were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Randomized ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Nonfatal Stroke During the Time Period for Follow-up of Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6522', 'groupId': 'OG000'}, {'value': '6504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib 160 mg', 'description': 'Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '928', 'groupId': 'OG000'}, {'value': '914', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.797', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.08', 'statisticalMethod': 'Cox Proportional Hazard Regression Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting \\>24 hours or results in death (in \\<24 hours).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Randomized ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of Any Event in the Composite of CHD Death and Non-fatal MI During the Time Period for Follow-up of Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6522', 'groupId': 'OG000'}, {'value': '6504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib 160 mg', 'description': 'Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '725', 'groupId': 'OG000'}, {'value': '701', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.546', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.07', 'estimateComment': 'A hazard ratio \\<1 indicates a lower risk with this treatment compared to Placebo', 'statisticalMethod': 'Cox Proportional Hazard Regression Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Randomized ITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Mortality During the Time Period for Vital Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6522', 'groupId': 'OG000'}, {'value': '6504', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib 160 mg', 'description': 'Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '403', 'groupId': 'OG000'}, {'value': '376', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.362', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.08', 'statisticalMethod': 'Cox Proportional Hazard Regression Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'Number of participants who died, during the vital status time-period were reported. The participants who were known to have died, date of death was used; for participants who completed the study the study completion date was used; for participants who withdrew from the study where vital status was ascertained , and are known to have not died , the last known date to be alive was used and for participants whom vital status was not ascertained, following study withdrawal the study withdrawal date was used.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All-Randomized ITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'FG001', 'title': 'Darapladib 160 mg', 'description': 'Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6522'}, {'groupId': 'FG001', 'numSubjects': '6504'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6347'}, {'groupId': 'FG001', 'numSubjects': '6328'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '176'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '109'}]}, {'type': 'Study closed/terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}]}], 'recruitmentDetails': 'The study was conducted at 868 centers in 36 countries: North America (282), Western Europe (210), Eastern Europe (166), Asia/Pacific (127), South America (83) during 07 December 2009 to 24 April 2014. A total of 13026 participants were randomized to the study.', 'preAssignmentDetails': 'During the screening phase of the study, participants presenting with acute coronary syndrome (ACS) were randomized within 30 days. Approximately 77% of participants underwent percutaneous coronary intervention (PCI) for the qualifying event.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6522', 'groupId': 'BG000'}, {'value': '6504', 'groupId': 'BG001'}, {'value': '13026', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'BG001', 'title': 'Darapladib 160 mg', 'description': 'Participants were randomized to receive darapladib 160 mg enteric-coated tablets once daily.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'spread': '9.50', 'groupId': 'BG000'}, {'value': '64.1', 'spread': '9.52', 'groupId': 'BG001'}, {'value': '64.2', 'spread': '9.51', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1669', 'groupId': 'BG000'}, {'value': '1657', 'groupId': 'BG001'}, {'value': '3326', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4853', 'groupId': 'BG000'}, {'value': '4847', 'groupId': 'BG001'}, {'value': '9700', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White - White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '5329', 'groupId': 'BG000'}, {'value': '5331', 'groupId': 'BG001'}, {'value': '10660', 'groupId': 'BG002'}]}]}, {'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '351', 'groupId': 'BG000'}, {'value': '349', 'groupId': 'BG001'}, {'value': '700', 'groupId': 'BG002'}]}]}, {'title': 'Asian - Central/South Asian Heritage', 'categories': [{'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '411', 'groupId': 'BG002'}]}]}, {'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}]}, {'title': 'White - Arabic/North African Heritage', 'categories': [{'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}]}, {'title': 'Asian - South East Asian Heritage', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}]}]}, {'title': 'Asian - Japanese Heritage', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '218', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}]}, {'title': 'Mixed Race', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Asian - Mixed Race', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'White - Mixed Race', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13026}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'dispFirstSubmitDate': '2014-09-11', 'completionDateStruct': {'date': '2014-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-12', 'studyFirstSubmitDate': '2009-10-22', 'dispFirstSubmitQcDate': '2014-09-11', 'resultsFirstSubmitDate': '2017-06-09', 'studyFirstSubmitQcDate': '2009-10-22', 'dispFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-12', 'studyFirstPostDateStruct': {'date': '2009-10-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events During the Time Period for Follow-up (FU) of Cardiovascular (CV) Event', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'Coronary heart disease (CHD) death=occurrence of a fatal myocardial infarction (MI), death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a nonischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent coronary revascularization (CR) for MI=ischemic discomfort at rest that prompted CR during the same hospitalization or resulted in hospital transfer for the purpose of CR.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal MI or Non-fatal Stroke) During the Time Period for Follow-up of CV Events', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting \\>24 hours or results in death (in \\<24 hours).'}, {'measure': 'Number of Participants With Cardiovascular Death During the Time Period for Follow-up of Cardiovascular Events', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'CV death is defined as a death due to a CV cause, which includes but is not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.'}, {'measure': 'Number of Participants With First Occurrence of MI (Fatal/Nonfatal) During the Time Period for Follow-up of Cardiovascular Events', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.'}, {'measure': 'Number of Participants With First Occurrence of Stroke (Fatal/Non-fatal) During the Time Period for Follow-up of Cardiovascular Events', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting \\>24 hours or results in death (in \\<24 hours).'}, {'measure': 'Number of Participants With CHD Death During the Time Period for Follow-up of Cardiovascular Events', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.'}, {'measure': 'Number of Participants With Urgent Coronary Revascularization for Myocardial Ischemia During the Time Period for Follow-up of Cardiovascular Events', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'Urgent coronary revascularization for myocardial ischemia is defined as ischemic discomfort at rest that prompts coronary revascularization (PCI or coronary artery bypass graft \\[CABG\\]) during the same hospitalization or resulting in hospital transfer for the purpose of coronary revascularization. PCI is defined as any attempt at revascularization even if not successful (e.g., angioplasty, atherectomy or stenting).'}, {'measure': 'Number of Participants With First Occurrence of Any Event in the Composite of Total Coronary Events (CHD Death, Non-fatal MI, Hospitalization for Unstable Angina, or Any Coronary Revascularization Procedure) During the Time Period for FU of CV Events', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'CHD death, acute MI, and prior MI diagnosed post-randomization are defined in the primary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort was found not to be caused by myocardial ischemia. Coronary revascularization procedures exclude PCI planned prior to randomization but performed after randomization.'}, {'measure': 'Number of Participants With First Occurrence of Any Coronary Revascularization Procedures (Excluding Coronary Revascularization Planned Prior to Randomization, But Performed After Randomization) During the Time Period for Follow-up of Cardiovascular Event', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'All coronary revascularization procedures (except for PCI planned prior to randomization but performed after randomization) are included. Examples include coronary artery bypass graft, balloon angioplasty and stenting. The number of participants, with first occurrence of any coronary revascularization procedures, were reported.'}, {'measure': 'Number of Participants With First Occurrence of Any Component of the Composite of All-cause Mortality, Non-fatal MI, or Nonfatal Stroke During the Time Period for Follow-up of Cardiovascular Events', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting \\>24 hours or results in death (in \\<24 hours).'}, {'measure': 'Number of Participants With First Occurrence of Any Event in the Composite of CHD Death and Non-fatal MI During the Time Period for Follow-up of Cardiovascular Events', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.'}, {'measure': 'Number of Participants With All-cause Mortality During the Time Period for Vital Status', 'timeFrame': 'From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years)', 'description': 'Number of participants who died, during the vital status time-period were reported. The participants who were known to have died, date of death was used; for participants who completed the study the study completion date was used; for participants who withdrew from the study where vital status was ascertained , and are known to have not died , the last known date to be alive was used and for participants whom vital status was not ascertained, following study withdrawal the study withdrawal date was used.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atherosclerosis', 'Heart disease', 'Cardiovascular disease', 'Lp-PLA2 inhibitor', 'The TIMI Study Group', 'Coronary Heart Disease (CHD)', 'Acute Coronary Syndrome (ACS)'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'availIpds': [{'id': '480848/033', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '480848/033', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '480848/033', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '480848/033', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '480848/033', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '480848/033', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '30371283', 'type': 'DERIVED', 'citation': "Correa S, Morrow DA, Braunwald E, Davies RY, Goodrich EL, Murphy SA, Cannon CP, O'Donoghue ML. Cystatin C for Risk Stratification in Patients After an Acute Coronary Syndrome. J Am Heart Assoc. 2018 Oct 16;7(20):e009077. doi: 10.1161/JAHA.118.009077."}, {'pmid': '29018021', 'type': 'DERIVED', 'citation': "Barger LK, Rajaratnam SMW, Cannon CP, Lukas MA, Im K, Goodrich EL, Czeisler CA, O'Donoghue ML. Short Sleep Duration, Obstructive Sleep Apnea, Shiftwork, and the Risk of Adverse Cardiovascular Events in Patients After an Acute Coronary Syndrome. J Am Heart Assoc. 2017 Oct 10;6(10):e006959. doi: 10.1161/JAHA.117.006959."}, {'pmid': '28077384', 'type': 'DERIVED', 'citation': "Eisen A, Cannon CP, Braunwald E, Steen DL, Zhou J, Goodrich EL, Im K, Dalby AJ, Spinar J, Daga S, Lukas MA, O'Donoghue ML. Predictors of Nonuse of a High-Potency Statin After an Acute Coronary Syndrome: Insights From the Stabilization of Plaques Using Darapladib-Thrombolysis in Myocardial Infarction 52 (SOLID-TIMI 52) Trial. J Am Heart Assoc. 2017 Jan 11;6(1):e004332. doi: 10.1161/JAHA.116.004332."}, {'pmid': '25173516', 'type': 'DERIVED', 'citation': "O'Donoghue ML, Braunwald E, White HD, Lukas MA, Tarka E, Steg PG, Hochman JS, Bode C, Maggioni AP, Im K, Shannon JB, Davies RY, Murphy SA, Crugnale SE, Wiviott SD, Bonaca MP, Watson DF, Weaver WD, Serruys PW, Cannon CP; SOLID-TIMI 52 Investigators; Steen DL. Effect of darapladib on major coronary events after an acute coronary syndrome: the SOLID-TIMI 52 randomized clinical trial. JAMA. 2014 Sep 10;312(10):1006-15. doi: 10.1001/jama.2014.11061."}, {'pmid': '21982651', 'type': 'DERIVED', 'citation': "O'Donoghue ML, Braunwald E, White HD, Serruys P, Steg PG, Hochman J, Maggioni AP, Bode C, Weaver D, Johnson JL, Cicconetti G, Lukas MA, Tarka E, Cannon CP. Study design and rationale for the Stabilization of pLaques usIng Darapladib-Thrombolysis in Myocardial Infarction (SOLID-TIMI 52) trial in patients after an acute coronary syndrome. Am Heart J. 2011 Oct;162(4):613-619.e1. doi: 10.1016/j.ahj.2011.07.018. Epub 2011 Sep 15."}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g. medical procedures performed to restore the normal blood flow in patients with atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome (also called ACS).', 'detailedDescription': 'Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo administered in addition to standard therapy. Following the baseline visit, subjects will be expected to return for clinic visits at 1 month, 3 months, 6 months and every 6 months until the end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent.\n* Men or women at least 18 years old (in Taiwan, at least 20 years old). Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.\n* Hospitalization for acute coronary syndrome (ACS) within 30 days prior to study entry.\n* Clinically stable for 24 hours prior to study entry.\n* A planned percutaneous coronary intervention (PCI) should be performed prior to study entry, whenever possible.\n* At least one of the following:\n* At least 60 years old.\n* Myocardial infarction prior to the qualifying ACS event.\n* Diabetes mellitus requiring treatment with medication.\n* Diagnosed mild or moderate reduction in kidney function.\n* Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months prior to study entry) OR peripheral artery disease.\n\nExclusion Criteria:\n\n* ACS symptoms or lab results not believed to be caused by a narrowing or blocked coronary artery.\n* No major coronary artery with a blockage of more than 50% (unless all stenoses are successfully treated by PCI).\n* Planned coronary artery bypass graft (CABG) surgery, or CABG surgery performed after the qualifying ACS event and prior to study entry.\n* Certain types of liver disease.\n* Severe reduction in kidney function OR removal of a kidney OR kidney transplant.\n* Severe heart failure.\n* Blood pressure higher than normal despite lifestyle changes and treatment with medications.\n* Any life-threatening disease with a life expectancy of less than 2 years (other than heart disease) that may prevent the subject from completing the study.\n* Severe asthma that is poorly controlled with medication.\n* Pregnancy (Note: A pregnancy test will be performed on all non-sterile women prior to study entry).\n* Previous severe allergic reaction to food, medications, drink, insect stings, etc.\n* Drug or alcohol abuse within the past 6 months. Mental/psychological impairment that may prevent the subject from complying with study procedures or understanding the goal and potential risks of participating in the study.\n* Certain medications that may interfere with the study medication (these will be identified by the study doctor).\n* If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less than or equal to 20.0 nmol/min/mL are excluded.\n* Previously took darapladib (SB-480848).\n* Participation in a study of an investigational medication within the past 30 days.\n* Current participation in a study of an investigational device.\n* Any other reason the investigator deems the subject should not participate in the study.'}, 'identificationModule': {'nctId': 'NCT01000727', 'acronym': 'SOLID-TIMI 52', 'briefTitle': 'The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).', 'orgStudyIdInfo': {'id': '480848/033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Darapladib 160 mg', 'description': 'Single daily oral tablet', 'interventionNames': ['Drug: Darapladib 160 mg', 'Other: Standard Therapy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single daily oral tablet', 'interventionNames': ['Drug: Placebo', 'Other: Standard Therapy']}], 'interventions': [{'name': 'Darapladib 160 mg', 'type': 'DRUG', 'otherNames': ['SB-480848'], 'description': 'Lp-PLA2 inhibitor', 'armGroupLabels': ['Darapladib 160 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered', 'armGroupLabels': ['Placebo']}, {'name': 'Standard Therapy', 'type': 'OTHER', 'description': "Guideline mandated therapy for individual's condition", 'armGroupLabels': ['Darapladib 160 mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United 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