Viewing Study NCT00799903

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Ignite Creation Date: 2025-12-24 @ 7:46 PM
Ignite Modification Date: 2025-12-29 @ 11:19 AM
Study NCT ID: NCT00799903
Status: COMPLETED
Last Update Posted: 2017-08-10
First Post: 2008-11-26
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529040', 'term': 'darapladib'}]}}, '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': 'Start=Randomization; Stop=Longer of 35 days after last dose of IP or follow-up (FU) visit. "SAEs assessed as related to IP, study participation, or a GSK concomitant medication" and cancer/GI polyps/neoplasms were recorded up to/including any FU contact.', '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.', 'otherNumAtRisk': 7890, 'deathsNumAtRisk': 7904, 'otherNumAffected': 4885, 'seriousNumAtRisk': 7890, 'deathsNumAffected': 577, 'seriousNumAffected': 3448}, {'id': 'EG001', 'title': 'Darapladib', 'description': 'Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.', 'otherNumAtRisk': 7912, 'deathsNumAtRisk': 7924, 'otherNumAffected': 5171, 'seriousNumAtRisk': 7912, 'deathsNumAffected': 582, 'seriousNumAffected': 3369}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 208}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 191}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 528}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 457}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 245}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 257}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 198}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 203}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 188}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 163}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 152}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 180}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abnormal faeces', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 728}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 255}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 247}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 479}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 949}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 182}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 177}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 189}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 192}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 159}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 160}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 144}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Large intestine polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 265}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 259}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 222}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 228}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 357}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 354}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 376}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 366}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 419}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 431}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 416}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 389}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 253}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 223}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 588}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 548}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 189}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 157}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 425}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 367}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 296}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 260}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 181}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 171}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 197}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 173}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 608}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 566}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 401}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 385}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 466}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 421}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 168}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 164}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 219}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 180}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 244}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 207}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 176}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 167}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 354}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 315}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 491}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 456}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 357}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 296}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 164}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 126}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urine odour abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 473}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 404}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 401}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 346}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 324}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skin odour abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 383}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 660}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 643}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 181}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 184}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 489}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 472}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 359}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 303}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 271}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 248}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 177}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 168}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 178}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 155}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 125}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 135}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 123}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 56}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 56}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 47}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 37}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 27}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 28}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 17}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 19}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 17}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 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'numAtRisk': 7890, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Basal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastases to lymph node', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Small Cell Lung Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 8}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Non-Small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oesophageal Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Adenocarcinoma gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Meningioma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastatic lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Benign neoplasm of bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Benign salivary gland neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bile duct cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bladder cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastases to spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastatic malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Adenoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chronic myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Malignant neoplasm of unknown primary site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastases to adrenals', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Non-small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Penile cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Benign breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Benign neoplasm of thyroid gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bile duct adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bone cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bone cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Brain neoplasm benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Carcinoid tumour of the duodenum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cholesteatoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gallbladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastric adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Glioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypopharyngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Laryngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lymphocytic lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Malignant peritoneal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastases to abdominal cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Metastatic carcinoma of the bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neoplasm prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 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1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Angiosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Benign anorectal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Benign hepatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 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'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Carcinoid tumour of the gastrointestinal tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac myxoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chondrosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chronic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Chronic lymphocytic leukaemia stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 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'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Colorectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Endometrial cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 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'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Haemangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hepatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypopharyngeal cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Intraductal papillary-mucinous carcinoma of pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Invasive lobular breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Large intestine benign neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Laryngeal cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Leiomyosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lentigo maligna', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lip and/or oral cavity cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 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'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Transitional cell cancer of the renal pelvis and ureter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tumour invasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 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{'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Eczema asteatotic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Erythema nodosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Keloid scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Leukocytoclastic vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Neuropathic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pemphigoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyoderma gangrenosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skin necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Stasis dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 14}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vertigo labyrinthine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Otosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ototoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Adrenal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hyperparathyroidism primary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thyroid cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Thyroid disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Toxic nodular goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 6}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertrophic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Congenital coronary artery malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Spinal vessel congenital anomaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Syringomyelia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Allergy to arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Allergy to arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Allergic oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Disability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Coronary revascularisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7890, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 7912, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [MI] or Non-fatal Stroke) During the Time Period for Follow-up of CV Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7904', 'groupId': 'OG000'}, {'value': '7924', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib', 'description': 'Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '819', 'groupId': 'OG000'}, {'value': '769', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.199', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.1', 'paramValue': '0.94', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.03', 'pValueComment': 'Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \\< 1 indicates a lower risk with this treatment compared to Placebo.', 'statisticalMethod': 'Regression, Cox', '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 4.25 years/average of 3.51 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 Intent-to-treat (ITT) population comprised of all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (FU) of CV Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7904', 'groupId': 'OG000'}, {'value': '7924', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib', 'description': 'Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '814', 'groupId': 'OG000'}, {'value': '737', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.045', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.00', 'pValueComment': 'Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \\< 1 indicates a lower risk with this treatment compared to Placebo.', 'statisticalMethod': 'Regression, Cox', '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 4.25 years/average of 3.51 years)', 'description': 'CHD death=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. 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. Urgent CR for MI=ischemic discomfort at rest that prompted CR (percutaneous coronary intervention \\[PCI: any attempt at CR even if not successful\\] or coronary artery bypass graft) during the same hospitalization or resulted in hospital transfer for the purpose of CR.', '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 Time Period for FU of CV Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7904', 'groupId': 'OG000'}, {'value': '7924', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib', 'description': 'Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '1269', 'groupId': 'OG000'}, {'value': '1159', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.84', 'ciUpperLimit': '0.98', 'pValueComment': 'Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \\< 1 indicates a lower risk with this treatment compared to Placebo.', 'statisticalMethod': 'Regression, Cox', '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 4.25 years/average of 3.51 years)', 'description': 'CHD death, acute MI, and prior MI are defined in the previous secondary 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 is found not to be caused by myocardial ischemia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CV Death During the Time Period for Follow-up of CV Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7904', 'groupId': 'OG000'}, {'value': '7924', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib', 'description': 'Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '373', 'groupId': 'OG000'}, {'value': '359', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.594', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.11', 'pValueComment': 'Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. A hazard ratio \\< 1 indicates a lower risk with this treatment compared to Placebo.', 'statisticalMethod': 'Regression, Cox', '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 4.25 years/average of 3.51 years)', 'description': 'CV death is defined as a 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With First Occurrence of MI (Fatal/Non-fatal) During the Time Period for Follow-up of CV Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7904', 'groupId': 'OG000'}, {'value': '7924', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'OG001', 'title': 'Darapladib', 'description': 'Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '405', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.108', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.03', 'pValueComment': 'Hazard ratio and p-value are estimated using a Cox proportional hazard regression model with treatment as the only covariate. 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The median treatment duration was anticipated to be 2.75 years.', 'preAssignmentDetails': 'During the Screening Phase of the study, participants presenting with chronic Coronary Heart Disease (CHD) were randomized within 8 weeks. In addition to chronic CHD, participants were required to have at least one additional predictor of cardiovascular risk specified in the protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7904', 'groupId': 'BG000'}, {'value': '7924', 'groupId': 'BG001'}, {'value': '15828', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo once daily.'}, {'id': 'BG001', 'title': 'Darapladib', 'description': 'Participants were randomized to receive darapladib 160 milligram (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': '9.39', 'groupId': 'BG000'}, {'value': '64.5', 'spread': '9.31', 'groupId': 'BG001'}, {'value': '64.4', 'spread': '9.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1506', 'groupId': 'BG000'}, {'value': '1461', 'groupId': 'BG001'}, {'value': '2967', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6398', 'groupId': 'BG000'}, {'value': '6463', 'groupId': 'BG001'}, {'value': '12861', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1366', 'groupId': 'BG000'}, {'value': '1351', 'groupId': 'BG001'}, {'value': '2717', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '191', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '366', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6177', 'groupId': 'BG000'}, {'value': '6233', 'groupId': 'BG001'}, {'value': '12410', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, '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': 15828}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'dispFirstSubmitDate': '2014-03-27', 'completionDateStruct': {'date': '2013-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-12', 'studyFirstSubmitDate': '2008-11-26', 'dispFirstSubmitQcDate': '2014-03-27', 'resultsFirstSubmitDate': '2017-07-12', 'studyFirstSubmitQcDate': '2008-11-28', 'dispFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-12', 'studyFirstPostDateStruct': {'date': '2008-12-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With First Occurrence of Any Component of the Composite of Major Adverse Cardiovascular Events (Cardiovascular [CV] Death, Non-fatal Myocardial Infarction [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 4.25 years/average of 3.51 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).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With First Occurrence of Any Event in the Composite of Major Coronary Events (Coronary Heart Disease [CHD] Death, Non-fatal MI, or Urgent Coronary Revascularization [CR] for MI) During the Time Period for Follow-up (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 4.25 years/average of 3.51 years)', 'description': 'CHD death=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. 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. Urgent CR for MI=ischemic discomfort at rest that prompted CR (percutaneous coronary intervention \\[PCI: any attempt at CR even if not successful\\] or coronary artery bypass graft) during the same hospitalization or resulted in hospital transfer for the purpose of CR.'}, {'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 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 4.25 years/average of 3.51 years)', 'description': 'CHD death, acute MI, and prior MI are defined in the previous secondary endpoint (major coronary events). 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Deaths not clearly attributable to non-CV causes are considered to be CV deaths.'}, {'measure': 'Number of Participants With First Occurrence of MI (Fatal/Non-fatal) 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 4.25 years/average of 3.51 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 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 4.25 years/average of 3.51 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 First Occurrence of Any Component of the Composite of All-cause Mortality, 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 4.25 years/average of 3.51 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 All-cause Mortality During the Time Period for Vital Status', 'timeFrame': 'From randomization until death or study completion (up to 4.49 years/average of 3.65 years)', 'description': 'The number of participants with all-cause mortality was assessed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['heart disease', 'Lp-PLA2 inhibitor', 'cardiovascular disease', 'coronary heart disease', 'CV risk', 'Atherosclerosis'], 'conditions': ['Atherosclerosis']}, 'referencesModule': {'availIpds': [{'id': '100601', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '100601', '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': '100601', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '100601', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '100601', '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': '100601', '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': '100601', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '39390990', 'type': 'DERIVED', 'citation': 'Jiang W, Huang G, Du J, Yang H, Zhou S, Dai D, Tang K, Fang L, Wang X, Deng X. White blood cell counts can predict 4-year cardiovascular disease risk in patients with stable coronary heart disease: a prospective cohort study. Front Cardiovasc Med. 2024 Sep 26;11:1358378. doi: 10.3389/fcvm.2024.1358378. eCollection 2024.'}, {'pmid': '35861814', 'type': 'DERIVED', 'citation': 'Sjolin K, Aulin J, Wallentin L, Eriksson N, Held C, Kultima K, Oldgren J, Burman J. Serum Neurofilament Light Chain in Patients With Atrial Fibrillation. J Am Heart Assoc. 2022 Jul 19;11(14):e025910. doi: 10.1161/JAHA.122.025910. Epub 2022 Jul 15.'}, {'pmid': '35060389', 'type': 'DERIVED', 'citation': 'Held C, Hadziosmanovic N, Aylward PE, Hagstrom E, Hochman JS, Stewart RAH, White HD, Wallentin L. Body Mass Index and Association With Cardiovascular Outcomes in Patients With Stable Coronary Heart Disease - A STABILITY Substudy. J Am Heart Assoc. 2022 Feb;11(3):e023667. doi: 10.1161/JAHA.121.023667. 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PLoS Med. 2021 Jan 13;18(1):e1003513. doi: 10.1371/journal.pmed.1003513. eCollection 2021 Jan.'}, {'pmid': '32480059', 'type': 'DERIVED', 'citation': 'White HD, Stewart RAH, Dalby AJ, Stebbins A, Cannon CP, Budaj A, Linhart A, Pais P, Diaz R, Steg PG, Krug-Gourley S, Granger CB, Hochman JS, Koenig W, Harrington RA, Held C, Wallentin L; STABILITY Investigators. In patients with stable coronary heart disease, low-density lipoprotein-cholesterol levels < 70 mg/dL and glycosylated hemoglobin A1c < 7% are associated with lower major cardiovascular events. Am Heart J. 2020 Jul;225:97-107. doi: 10.1016/j.ahj.2020.04.004. Epub 2020 Apr 18.'}, {'pmid': '32375553', 'type': 'DERIVED', 'citation': 'Hilvo M, Wallentin L, Ghukasyan Lakic T, Held C, Kauhanen D, Jylha A, Lindback J, Siegbahn A, Granger CB, Koenig W, Stewart RAH, White H, Laaksonen R; STABILITY Investigators. 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Inflammatory Biomarkers Interleukin-6 and C-Reactive Protein and Outcomes in Stable Coronary Heart Disease: Experiences From the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Oct 24;6(10):e005077. doi: 10.1161/JAHA.116.005077.'}, {'pmid': '28960596', 'type': 'DERIVED', 'citation': 'Hagstrom E, Norlund F, Stebbins A, Armstrong PW, Chiswell K, Granger CB, Lopez-Sendon J, Pella D, Soffer J, Sy R, Wallentin L, White HD, Stewart RAH, Held C. Psychosocial stress and major cardiovascular events in patients with stable coronary heart disease. J Intern Med. 2018 Jan;283(1):83-92. doi: 10.1111/joim.12692. Epub 2017 Oct 23.'}, {'pmid': '28912210', 'type': 'DERIVED', 'citation': 'Guimaraes PO, Granger CB, Stebbins A, Chiswell K, Held C, Hochman JS, Krug-Gourley S, Lonn E, Lopes RD, Stewart RAH, Vinereanu D, Wallentin L, White HD, Hagstrom E, Danchin N. Sex Differences in Clinical Characteristics, Psychosocial Factors, and Outcomes Among Patients With Stable Coronary Heart Disease: Insights from the STABILITY (Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy) Trial. J Am Heart Assoc. 2017 Sep 14;6(9):e006695. doi: 10.1161/JAHA.117.006695.'}, {'pmid': '28862971', 'type': 'DERIVED', 'citation': 'Stewart RAH, Hagstrom E, Held C, Wang TKM, Armstrong PW, Aylward PE, Cannon CP, Koenig W, Lopez-Sendon JL, Mohler ER 3rd, Hadziosmanovic N, Krug-Gourley S, Ramos Corrales MA, Siddique S, Steg PG, White HD, Wallentin L; STABILITY Investigators. Self-Reported Health and Outcomes in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2017 Aug 22;6(8):e006096. doi: 10.1161/JAHA.117.006096.'}, {'pmid': '28797349', 'type': 'DERIVED', 'citation': 'Lindholm D, Lindback J, Armstrong PW, Budaj A, Cannon CP, Granger CB, Hagstrom E, Held C, Koenig W, Ostlund O, Stewart RAH, Soffer J, White HD, de Winter RJ, Steg PG, Siegbahn A, Kleber ME, Dressel A, Grammer TB, Marz W, Wallentin L. Biomarker-Based Risk Model to Predict Cardiovascular Mortality in Patients With Stable Coronary Disease. J Am Coll Cardiol. 2017 Aug 15;70(7):813-826. doi: 10.1016/j.jacc.2017.06.030.'}, {'pmid': '28735759', 'type': 'DERIVED', 'citation': 'Vedin O, Hagstrom E, Ostlund O, Avezum A, Budaj A, Flather MD, Harrington RA, Koenig W, Soffer J, Siegbahn A, Steg PG, Stewart RAH, Wallentin L, White HD, Held C; STABILITY Investigators. Associations between tooth loss and prognostic biomarkers and the risk for cardiovascular events in patients with stable coronary heart disease. Int J Cardiol. 2017 Oct 15;245:271-276. doi: 10.1016/j.ijcard.2017.07.036. Epub 2017 Jul 17.'}, {'pmid': '27811204', 'type': 'DERIVED', 'citation': 'Hagstrom E, Held C, Stewart RA, Aylward PE, Budaj A, Cannon CP, Koenig W, Krug-Gourley S, Mohler ER 3rd, Steg PG, Tarka E, Ostlund O, White HD, Siegbahn A, Wallentin L; STABILITY Investigators. Growth Differentiation Factor 15 Predicts All-Cause Morbidity and Mortality in Stable Coronary Heart Disease. Clin Chem. 2017 Jan;63(1):325-333. doi: 10.1373/clinchem.2016.260570. Epub 2016 Nov 3.'}, {'pmid': '27329448', 'type': 'DERIVED', 'citation': 'Wallentin L, Held C, Armstrong PW, Cannon CP, Davies RY, Granger CB, Hagstrom E, Harrington RA, Hochman JS, Koenig W, Krug-Gourley S, Mohler ER 3rd, Siegbahn A, Tarka E, Steg PG, Stewart RA, Weiss R, Ostlund O, White HD; STABILITY Investigators. Lipoprotein-Associated Phospholipase A2 Activity Is a Marker of Risk But Not a Useful Target for Treatment in Patients With Stable Coronary Heart Disease. J Am Heart Assoc. 2016 Jun 21;5(6):e003407. doi: 10.1161/JAHA.116.003407.'}, {'pmid': '26920728', 'type': 'DERIVED', 'citation': 'Hijazi Z, Lindback J, Alexander JH, Hanna M, Held C, Hylek EM, Lopes RD, Oldgren J, Siegbahn A, Stewart RA, White HD, Granger CB, Wallentin L; ARISTOTLE and STABILITY Investigators. The ABC (age, biomarkers, clinical history) stroke risk score: a biomarker-based risk score for predicting stroke in atrial fibrillation. Eur Heart J. 2016 May 21;37(20):1582-90. doi: 10.1093/eurheartj/ehw054. Epub 2016 Feb 25.'}, {'pmid': '26672609', 'type': 'DERIVED', 'citation': 'Vedin O, Hagstrom E, Budaj A, Denchev S, Harrington RA, Koenig W, Soffer J, Sritara P, Stebbins A, Stewart RH, Swart HP, Viigimaa M, Vinereanu D, Wallentin L, White HD, Held C; STABILITY Investigators. Tooth loss is independently associated with poor outcomes in stable coronary heart disease. Eur J Prev Cardiol. 2016 May;23(8):839-46. doi: 10.1177/2047487315621978. Epub 2015 Dec 16.'}, {'pmid': '24721691', 'type': 'DERIVED', 'citation': 'Vedin O, Hagstrom E, Gallup D, Neely ML, Stewart R, Koenig W, Budaj A, Sritara P, Wallentin L, White HD, Held C. Periodontal disease in patients with chronic coronary heart disease: Prevalence and association with cardiovascular risk factors. Eur J Prev Cardiol. 2015 Jun;22(6):771-8. doi: 10.1177/2047487314530660. Epub 2014 Apr 10.'}, {'pmid': '24678955', 'type': 'DERIVED', 'citation': 'STABILITY Investigators; White HD, Held C, Stewart R, Tarka E, Brown R, Davies RY, Budaj A, Harrington RA, Steg PG, Ardissino D, Armstrong PW, Avezum A, Aylward PE, Bryce A, Chen H, Chen MF, Corbalan R, Dalby AJ, Danchin N, De Winter RJ, Denchev S, Diaz R, Elisaf M, Flather MD, Goudev AR, Granger CB, Grinfeld L, Hochman JS, Husted S, Kim HS, Koenig W, Linhart A, Lonn E, Lopez-Sendon J, Manolis AJ, Mohler ER 3rd, Nicolau JC, Pais P, Parkhomenko A, Pedersen TR, Pella D, Ramos-Corrales MA, Ruda M, Sereg M, Siddique S, Sinnaeve P, Smith P, Sritara P, Swart HP, Sy RG, Teramoto T, Tse HF, Watson D, Weaver WD, Weiss R, Viigimaa M, Vinereanu D, Zhu J, Cannon CP, Wallentin L. Darapladib for preventing ischemic events in stable coronary heart disease. N Engl J Med. 2014 May 1;370(18):1702-11. doi: 10.1056/NEJMoa1315878. Epub 2014 Mar 30.'}, {'pmid': '22496275', 'type': 'DERIVED', 'citation': 'Vedin O, Hagstrom E, Stewart R, Brown R, Krug-Gourley S, Davies R, Wallentin L, White H, Held C. Secondary prevention and risk factor target achievement in a global, high-risk population with established coronary heart disease: baseline results from the STABILITY study. Eur J Prev Cardiol. 2013 Aug;20(4):678-85. doi: 10.1177/2047487312444995. Epub 2012 Apr 10.'}], '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 stroke) in people with coronary heart disease.', '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, and every 6 months until the end of the study. Average time in the study for an individual subject is expected to be about 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women at least 18 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy.\n* Current treatment with statin therapy unless the study doctor determines statins are not appropriate for the subject.\n* Chronic coronary heart disease\n* At least one of the following:\n* At least 60 years old\n* Diabetes requiring treatment with medication\n* Low HDL cholesterol ("good cholesterol")\n* Currently smoke cigarettes or stopped smoking within the past 3 months\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 arterial disease.\n\nExclusion Criteria:\n\n* Planned coronary revascularization (such as stent placement or heart bypass) or any other major surgical procedure.\n* 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 expected to result in death within the next 2 years (other than heart disease)\n* Severe asthma that is poorly controlled with medication\n* Pregnant (Note: A pregnancy test will be performed on all non-sterile women prior to study entry)\n* Previous severe allergic response to food, drink, insect stings, etc.\n* Drug or alcohol abuse within the past 6 months OR 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* Participation in a study of an investigational medication within the past 30 days\n* Current participation in a study of an investigational device'}, 'identificationModule': {'nctId': 'NCT00799903', 'acronym': 'STABILITY', 'briefTitle': 'The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'LPL100601, A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects With Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE)', 'orgStudyIdInfo': {'id': '100601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Darapladib', 'description': 'Single daily oral tablet', 'interventionNames': ['Drug: Darapladib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single daily oral tablet', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Darapladib', 'type': 'DRUG', 'description': 'Lp-PLA2 inhibitor administered in addition to standard therapy', 'armGroupLabels': ['Darapladib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered in addition to standard therapy', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294-0007', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '72204', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94520', 'city': 'Concord', 'state': 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