Viewing Study NCT00170950

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Ignite Creation Date: 2025-12-24 @ 5:04 PM
Ignite Modification Date: 2026-02-24 @ 5:11 PM
Study NCT ID: NCT00170950
Status: TERMINATED
Last Update Posted: 2023-10-24
First Post: 2005-09-10
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension
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': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C044946', 'term': 'benazepril'}, {'id': 'D017311', 'term': 'Amlodipine'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862 778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study was stopped early, as recommended by the Data Monitoring Committee, due to positive efficacy results.'}}, 'adverseEventsModule': {'timeFrame': 'Double-blind period', 'description': 'Safety population includes all randomized patients who took at least one dose of study medication by actual treatment group (7 Benazepril / Amlodipine and 2 Benazepril / HCTZ patients did not take study medication; 3 patients assigned to Benazepril / HCTZ received Benazepril / Amlodipine medication instead).', 'eventGroups': [{'id': 'EG000', 'title': 'Benazepril / Amlodipine', 'description': 'Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1), 40/5 mg (Dose Level 2), and 40/10 mg (Dose Level 3) capsules for oral administration once daily', 'otherNumAtRisk': 5740, 'otherNumAffected': 3077, 'seriousNumAtRisk': 5740, 'seriousNumAffected': 1844}, {'id': 'EG001', 'title': 'Benazepril / HCTZ', 'description': 'Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1), 40/12.5 mg (Dose Level 2), and 40/25 mg (Dose Level 3) capsules for oral administration once daily', 'otherNumAtRisk': 5757, 'otherNumAffected': 2663, 'seriousNumAtRisk': 5757, 'seriousNumAffected': 2026}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1787}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 768}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1175}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1440}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1172}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1217}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Acquired haemophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 41}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhagic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoprothrombinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retroperitoneal lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'AV dissociation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 106}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 113}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 131}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aortic valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 115}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 113}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 31}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 86}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac ventricular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 124}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 18}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 21}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 126}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mesenteric artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mesenteric artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Obstruction gastric', 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'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sensation of heaviness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spondylolisthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Torticollis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Adenocarcinoma pancreas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Adenoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anal cancer stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Astrocytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Benign breast neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Benign colonic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Benign duodenal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Benign neoplasm of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Benign renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bile duct cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bone neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bone sarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 14}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchioloalveolar carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Castleman's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': 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5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colon cancer stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colon neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Endometrial cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 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'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal tract adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Glioblastoma multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Glioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gliosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Hodgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leiomyosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leiomyosarcoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Liposarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung adenocarcinoma stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 22}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung squamous cell carcinoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malignant glioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malignant lymphoid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malignant neoplasm of islets of Langerhans', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malignant pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mesothelioma malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastatic renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Multiple myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neoplasm prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-small cell lung cancer stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-small cell lung cancer stage IIIB', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oesophageal adenocarcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatic carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Paraneoplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Parathyroid tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Penile malignant neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Penis carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pituitary tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pituitary tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Polycythaemia vera', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 51}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Refractory anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory tract neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Salivary gland neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sebaceous adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Small cell lung cancer extensive stage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Small cell lung cancer stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Small intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Small intestine carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spindle cell sarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Throat cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aortic rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arterial insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arterial restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 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'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood pressure inadequately controlled', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoperfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 27}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Poor peripheral circulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post thrombotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renovascular hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subclavian steal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Takayasu's 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vascular occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vascular stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Venous occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Venous stasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5740, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5757, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5744', 'groupId': 'OG000'}, {'value': '5762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Benazepril/Amlodipine', 'description': 'Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily'}, {'id': 'OG001', 'title': 'Benazepril/Hydrochlorothiazide', 'description': 'Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])', 'description': 'CV morbidity was defined as non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure. CV mortality was defined as death due to MI, stroke, coronary intervention, congestive heart failure (CHF), sudden cardiac death, or other CV causes.', 'unitOfMeasure': 'Percentage of Patients with an event', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized patients by assigned treatment group'}, {'type': 'SECONDARY', 'title': 'Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5744', 'groupId': 'OG000'}, {'value': '5762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Benazepril/Amlodipine', 'description': 'Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily'}, {'id': 'OG001', 'title': 'Benazepril/Hydrochlorothiazide', 'description': 'Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For each patient, baseline to time of first CV morbidity event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])]', 'description': 'Cardiovascular morbidity was defined as including any of the following events: non-fatal MI, non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure (PCI or CABG).', 'unitOfMeasure': 'Percentage of Patients with an Event', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized patients by assigned treatment group'}, {'type': 'SECONDARY', 'title': 'Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5744', 'groupId': 'OG000'}, {'value': '5762', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Benazepril/Amlodipine', 'description': 'Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily'}, {'id': 'OG001', 'title': 'Benazepril/Hydrochlorothiazide', 'description': 'Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For each patient, baseline to time of first CV mortality event, MI (non-fatal), or stroke (non-fatal) (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])', 'description': 'CV mortality was defined as death due to sudden cardiac death, fatal MI, fatal stroke, coronary intervention, congestive heart failure (CHF), or other CV causes.', 'unitOfMeasure': 'Percentage of Patients with an Event', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All randomized patients by assigned treatment group'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Benazepril/Amlodipine', 'description': 'Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily'}, {'id': 'FG001', 'title': 'Benazepril/Hydrochlorothiazide', 'description': 'Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5744'}, {'groupId': 'FG001', 'numSubjects': '5762'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4859'}, {'groupId': 'FG001', 'numSubjects': '4852'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '885'}, {'groupId': 'FG001', 'numSubjects': '910'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '236'}, {'groupId': 'FG001', 'numSubjects': '274'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '496'}, {'groupId': 'FG001', 'numSubjects': '498'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '115'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Termination Data Not Recorded', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '22'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5744', 'groupId': 'BG000'}, {'value': '5761', 'groupId': 'BG001'}, {'value': '11505', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Benazepril/Amlodipine', 'description': 'Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily'}, {'id': 'BG001', 'title': 'Benazepril/Hydrochlorothiazide', 'description': 'Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.4', 'spread': '6.86', 'groupId': 'BG000'}, {'value': '68.3', 'spread': '6.86', 'groupId': 'BG001'}, {'value': '68.4', 'spread': '6.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Demographic data for 1 patient in the benazepril/hydrochlorothiazide was not available.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2296', 'groupId': 'BG000'}, {'value': '2246', 'groupId': 'BG001'}, {'value': '4542', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3448', 'groupId': 'BG000'}, {'value': '3515', 'groupId': 'BG001'}, {'value': '6963', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Demographic data for 1 patient in the benazepril/hydrochlorothiazide was not available.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11506}}, 'statusModule': {'whyStopped': 'The study was terminated early because of significant efficacy results for the primary endpoint in favor of benazepril/amlodipine treatment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-11', 'studyFirstSubmitDate': '2005-09-10', 'resultsFirstSubmitDate': '2011-01-13', 'studyFirstSubmitQcDate': '2005-09-10', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-04-19', 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event', 'timeFrame': 'For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])', 'description': 'CV morbidity was defined as non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure. CV mortality was defined as death due to MI, stroke, coronary intervention, congestive heart failure (CHF), sudden cardiac death, or other CV causes.'}], 'secondaryOutcomes': [{'measure': 'Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event', 'timeFrame': 'For each patient, baseline to time of first CV morbidity event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])]', 'description': 'Cardiovascular morbidity was defined as including any of the following events: non-fatal MI, non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure (PCI or CABG).'}, {'measure': 'Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke', 'timeFrame': 'For each patient, baseline to time of first CV mortality event, MI (non-fatal), or stroke (non-fatal) (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])', 'description': 'CV mortality was defined as death due to sudden cardiac death, fatal MI, fatal stroke, coronary intervention, congestive heart failure (CHF), or other CV causes.'}]}, 'conditionsModule': {'keywords': ['cardiovascular morbidity', 'cardiovascular mortality', 'benazepril', 'amlodipine', 'high risk population'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '19052124', 'type': 'RESULT', 'citation': 'Jamerson K, Weber MA, Bakris GL, Dahlof B, Pitt B, Shi V, Hester A, Gupte J, Gatlin M, Velazquez EJ; ACCOMPLISH Trial Investigators. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med. 2008 Dec 4;359(23):2417-28. doi: 10.1056/NEJMoa0806182.'}, {'pmid': '33216879', 'type': 'DERIVED', 'citation': 'Brook RD, Kaciroti N, Bakris G, Dahlof B, Pitt B, Velazquez E, Weber MA, Jamerson KA. Cardiovascular Benefits of Angiotensin-Converting Enzyme Inhibition Plus Calcium Channel Blockade in Patients Achieving Tight Blood Pressure Control and With Resistant Hypertension. Am J Hypertens. 2021 May 22;34(5):531-539. doi: 10.1093/ajh/hpaa192.'}, {'pmid': '23219284', 'type': 'DERIVED', 'citation': 'Weber MA, Jamerson K, Bakris GL, Weir MR, Zappe D, Zhang Y, Dahlof B, Velazquez EJ, Pitt B. Effects of body size and hypertension treatments on cardiovascular event rates: subanalysis of the ACCOMPLISH randomised controlled trial. Lancet. 2013 Feb 16;381(9866):537-45. doi: 10.1016/S0140-6736(12)61343-9. Epub 2012 Dec 6.'}, {'pmid': '20620720', 'type': 'DERIVED', 'citation': 'Weber MA, Bakris GL, Jamerson K, Weir M, Kjeldsen SE, Devereux RB, Velazquez EJ, Dahlof B, Kelly RY, Hua TA, Hester A, Pitt B; ACCOMPLISH Investigators. Cardiovascular events during differing hypertension therapies in patients with diabetes. J Am Coll Cardiol. 2010 Jun 29;56(1):77-85. doi: 10.1016/j.jacc.2010.02.046.'}, {'pmid': '20170948', 'type': 'DERIVED', 'citation': 'Bakris GL, Sarafidis PA, Weir MR, Dahlof B, Pitt B, Jamerson K, Velazquez EJ, Staikos-Byrne L, Kelly RY, Shi V, Chiang YT, Weber MA; ACCOMPLISH Trial investigators. Renal outcomes with different fixed-dose combination therapies in patients with hypertension at high risk for cardiovascular events (ACCOMPLISH): a prespecified secondary analysis of a randomised controlled trial. Lancet. 2010 Apr 3;375(9721):1173-81. doi: 10.1016/S0140-6736(09)62100-0. Epub 2010 Feb 18.'}]}, 'descriptionModule': {'briefSummary': 'A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 55 years of age.\n* Previously untreated or treated hypertension.\n* For patients \\>= 60 years, evidence of at least one CV disease or target organ damage, or for patients 55-59 years evidence of at least two CV diseases or target organ damage from two different organ systems as defined in the protocol.\n\nExclusion Criteria:\n\n* Allergy to any of the drugs administered in this trial.\n* Current angina pectoris (ie, no anginal event requiring NTG within 1 month prior to Visit 1).\n* Secondary hypertension.\n* Refractory hypertension defined as SBP \\>= 180 mmHg and/or DBP \\>= 110 mmHg unresponsive to triple-drug regimens of sympatholytics, diuretics and vasodilators.\n* History of symptomatic heart failure (NYHA classes II-IV) or ejection fraction \\< 40%.\n* Myocardial infarction, coronary revascularization (CABG or PCI), unstable angina within one month of Visit 1.\n* Stroke or transient ischemic event (TIA) within 3 months of Visit 1.\n* Significant obstructive valvular cardiovascular disease or any valvular disease expected to lead to surgery during the course of the study.\n* Evidence of hepatic disease (AST or ALT values \\>= 2 X upper limit of normal).\n* Impaired renal function (serum creatinine \\>= 2.5 mg/dL (221 µmol/L)).\n* Baseline serum potassium of \\> 5.2 meq/L not on potassium supplements.\n* History of malignancy including leukemia and lymphoma (but not basal cell skin cancer) within the last 5 years.\n* History of clinically significant auto immune disorders such as Systemic Lupus Erythematosus.\n* Significant non-cardiovascular illness or condition likely to result in death prior to trial completion, e.g., major organ transplant (life expectancy \\<5 years).\n* Significant cardiovascular disease such as an aortic aneurysm ≥ 6 cm, likely requiring surgical intervention during the course of the study.\n\nOther protocol-defined exclusion criteria applied to the study.'}, 'identificationModule': {'nctId': 'NCT00170950', 'acronym': 'ACCOMPLISH', 'briefTitle': 'Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension', 'nctIdAliases': ['NCT00097864'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Prospective, Multinational, Multicenter Trial to Compare the Effects of Amlodipine/Benazepril to Benazepril and Hydrochlorothiazide Combined on the Reduction of Cardiovascular Morbidity and Mortality in Patients With High Risk Hypertension', 'orgStudyIdInfo': {'id': 'CCIB002I2301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Benazepril/amlodipine', 'description': 'Patients were instructed to take one capsule with water in the morning, except on the morning of their next office visit. On office visit days, study medication was taken after completion of the visit evaluations. Following randomization, all patients were treated at Dose Level 1 for 4 weeks, followed by a forced titration to Dose Level 2 for a subsequent 4 week period. Thereafter, patients were titrated as needed to Dose Level 3 to achieve a target blood pressure of \\< 140/\\< 90 mm Hg. For patients with diabetes or chronic kidney disease, investigators were encouraged to use a target blood pressure of 130/80 mm Hg.', 'interventionNames': ['Drug: Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1', 'Drug: Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2', 'Drug: Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Benazepril/hydrochlorothiazide', 'description': 'Patients were instructed to take one capsule with water in the morning, except on the morning of their next office visit. On office visit days, study medication was taken after completion of the visit evaluations. Following randomization, all patients were treated at Dose Level 1 for 4 weeks, followed by a forced titration to Dose Level 2 for a subsequent 4 week period. Thereafter, patients were titrated as needed to Dose Level 3 to achieve a target blood pressure of \\< 140/\\< 90 mm Hg. For patients with diabetes or chronic kidney disease, investigators were encouraged to use a target blood pressure of 130/80 mm Hg.', 'interventionNames': ['Drug: Benazepril/hydrochlorothiazide 20/12.5 mg - Dose Level 1 from Day 1 to Month 1', 'Drug: Benazepril/hydrochlorothiazide 40/12.5 mg - Dose Level 2 from Month 1 to Month 2', 'Drug: Benazepril/hydrochlorothiazide 40/25 mg - Dose Level 3 from Month 2 to Month 3 and thereafter']}], 'interventions': [{'name': 'Benazepril/amlodipine 20/5 mg - Dose Level 1 from Day 1 to Month 1', 'type': 'DRUG', 'description': 'Benazepril hydrochloride (HCl)/amlodipine besylate 10/5 mg capsules for oral administration once daily.', 'armGroupLabels': ['Benazepril/amlodipine']}, {'name': 'Benazepril/amlodipine 40/5 mg - Dose Level 2 from Month 1 to Month 2', 'type': 'DRUG', 'description': 'Benazepril hydrochloride (HCl)/amlodipine besylate 20/5 mg capsules for oral administration once daily.', 'armGroupLabels': ['Benazepril/amlodipine']}, {'name': 'Benazepril/amlodipine 40/10 mg - Dose Level 3 from Month 2 to Month 3 and thereafter', 'type': 'DRUG', 'description': 'Benazepril hydrochloride (HCl)/amlodipine besylate: 40/10 mg capsules for oral administration once daily. Patients titrated to this dose level had the possibility of subsequent free add-on antihypertensive agents after month 3 based on target blood pressure.', 'armGroupLabels': ['Benazepril/amlodipine']}, {'name': 'Benazepril/hydrochlorothiazide 20/12.5 mg - Dose Level 1 from Day 1 to Month 1', 'type': 'DRUG', 'description': 'Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 20/12.5 mg capsules for oral administration once daily.', 'armGroupLabels': ['Benazepril/hydrochlorothiazide']}, {'name': 'Benazepril/hydrochlorothiazide 40/12.5 mg - Dose Level 2 from Month 1 to Month 2', 'type': 'DRUG', 'description': 'Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 40/12.5 mg capsules for oral administration once daily.', 'armGroupLabels': ['Benazepril/hydrochlorothiazide']}, {'name': 'Benazepril/hydrochlorothiazide 40/25 mg - Dose Level 3 from Month 2 to Month 3 and thereafter', 'type': 'DRUG', 'description': 'Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ) 40/25 mg capsules for oral administration once daily. Patients titrated to this dose level had the possibility of subsequent free add-on antihypertensive agents after month 3 based on target blood pressure.', 'armGroupLabels': ['Benazepril/hydrochlorothiazide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Pharmaceuticals', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}, {'city': 'Denmark', 'country': 'Denmark', 'facility': 'sites in Denmark'}, {'city': 'Finland', 'country': 'Finland', 'facility': 'sites in Finland'}, {'city': 'Norway', 'country': 'Norway', 'facility': 'sites in Norway'}, {'city': 'Sweden', 'country': 'Sweden', 'facility': 'sites in Sweden'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Diorector', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}