Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT00853658
Status:
COMPLETED
Last Update Posted:
2016-11-25
First Post:
2009-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hungary', 'Iceland']}, 'interventionBrowseModule': {'meshes': [{'id': 'D004656', 'term': 'Enalapril'}, {'id': 'C446481', 'term': 'aliskiren'}], 'ancestors': [{'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, '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 or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received.\n\nTreatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Combination of Aliskiren and Enalapril', 'description': 'Aliskiren/Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg', 'otherNumAtRisk': 2347, 'otherNumAffected': 1698, 'seriousNumAtRisk': 2347, 'seriousNumAffected': 1466}, {'id': 'EG001', 'title': 'Aliskiren', 'description': 'Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.', 'otherNumAtRisk': 2348, 'otherNumAffected': 1605, 'seriousNumAtRisk': 2348, 'seriousNumAffected': 1504}, {'id': 'EG002', 'title': 'Enalapril', 'description': 'Enalapril monotherapy -10 mg film-coated tablet and administered orally.', 'otherNumAtRisk': 2345, 'otherNumAffected': 1623, 'seriousNumAtRisk': 2345, 'seriousNumAffected': 1501}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 115}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 111}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 86}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 71}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 199}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 238}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 184}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 241}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 254}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 238}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 55}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 79}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 82}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 145}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 117}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 116}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 107}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 101}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 182}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 183}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 176}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 151}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 138}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 147}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 86}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 185}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 187}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 186}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 95}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 78}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 79}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 84}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 57}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 79}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 96}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 84}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 113}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 91}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 469}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 283}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 350}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 108}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 93}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 149}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 116}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 86}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 71}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 98}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 179}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 140}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 144}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 67}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 91}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 92}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 98}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 414}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 298}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 328}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 285}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 223}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 286}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 204}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 216}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 213}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 188}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 180}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 137}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 409}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 308}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 332}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Acquired haemophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 28}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia vitamin B12 deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aplastic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bicytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bone marrow infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhagic diathesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypochromic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypocoagulable state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Jaundice acholuric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphadenopathy mediastinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Normochromic normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Retroperitoneal lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Splenic embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Splenic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Splenic vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 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3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer female', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 7}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Carcinoma in situ of penis', 'stats': [{'groupId': 'EG000', 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{'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 12}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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{'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastatic malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastatic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 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'sourceVocabulary': 'MedDRA'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 26}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iliac artery embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemic limb pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post thrombotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Secondary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subclavian artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Varicophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Varicose ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vascular rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Venous haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2347, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2348, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2345, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2340', 'groupId': 'OG000'}, {'value': '2340', 'groupId': 'OG001'}, {'value': '2336', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Aliskiren / Enalapril', 'description': 'Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.'}, {'id': 'OG001', 'title': 'Aliskiren', 'description': 'Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.'}, {'id': 'OG002', 'title': 'Enalapril', 'description': 'Enalapril monotherapy -10 mg film-coated tablet and administered orally.'}], 'classes': [{'title': 'Primary Composite', 'categories': [{'measurements': [{'value': '770', 'groupId': 'OG000'}, {'value': '791', 'groupId': 'OG001'}, {'value': '808', 'groupId': 'OG002'}]}]}, {'title': 'CV death', 'categories': [{'measurements': [{'value': '512', 'groupId': 'OG000'}, {'value': '562', 'groupId': 'OG001'}, {'value': '547', 'groupId': 'OG002'}]}]}, {'title': '1st HF Hospitalization', 'categories': [{'measurements': [{'value': '430', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}, {'value': '452', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1724', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.03', 'groupDescription': '(superiority)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4579', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.07', 'groupDescription': '(superiority) Non-Diabetic patients', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0368', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.10', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Pre-specified Non-inferiority margin 1.104 is used.'}, {'pValue': '0.9118', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.90', 'ciUpperLimit': '1.10', 'groupDescription': '(superiority)', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'up to End of Study (78 months)', 'description': 'Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2340', 'groupId': 'OG000'}, {'value': '2340', 'groupId': 'OG001'}, {'value': '2336', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Aliskiren / Enalapril', 'description': 'Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.'}, {'id': 'OG001', 'title': 'Aliskiren', 'description': 'Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.'}, {'id': 'OG002', 'title': 'Enalapril', 'description': 'Enalapril monotherapy -10 mg film-coated tablet and administered orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.04', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-6.03', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '-5.01', 'spread': '0.55', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Month 12', 'description': 'Change from baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.', 'unitOfMeasure': 'KCCQ Score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations.'}, {'type': 'SECONDARY', 'title': 'All Cause Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2340', 'groupId': 'OG000'}, {'value': '2340', 'groupId': 'OG001'}, {'value': '2336', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Aliskiren / Enalapril', 'description': 'Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.'}, {'id': 'OG001', 'title': 'Aliskiren', 'description': 'Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.'}, {'id': 'OG002', 'title': 'Enalapril', 'description': 'Enalapril monotherapy -10 mg film-coated tablet and administered orally.'}], 'classes': [{'categories': [{'measurements': [{'value': '595', 'groupId': 'OG000'}, {'value': '654', 'groupId': 'OG001'}, {'value': '646', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to end of study (78 months)', 'description': 'Number of patients - All-cause death. All-cause death is common in Heart Failure HF patients this measures how many patients had this event.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Combination Aliskiren / Enalapril', 'description': 'Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.'}, {'id': 'FG001', 'title': 'Aliskiren', 'description': 'Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.'}, {'id': 'FG002', 'title': 'Enalapril', 'description': 'Enalapril monotherapy -10 mg film-coated tablet and administered orally.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2354'}, {'groupId': 'FG001', 'numSubjects': '2356'}, {'groupId': 'FG002', 'numSubjects': '2354'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2340'}, {'groupId': 'FG001', 'numSubjects': '2340'}, {'groupId': 'FG002', 'numSubjects': '2336'}]}, {'type': 'Safety Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2347'}, {'groupId': 'FG001', 'numSubjects': '2348'}, {'groupId': 'FG002', 'numSubjects': '2345'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1567'}, {'groupId': 'FG001', 'numSubjects': '1524'}, {'groupId': 'FG002', 'numSubjects': '1539'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '787'}, {'groupId': 'FG001', 'numSubjects': '832'}, {'groupId': 'FG002', 'numSubjects': '815'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '713'}, {'groupId': 'FG001', 'numSubjects': '768'}, {'groupId': 'FG002', 'numSubjects': '753'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'H.A. Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'IRB request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Vital Status known (alive) at study end', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Vital Status unknown at study end', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Vital Status at study end N/A', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': "Patient's request", 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Missing study completion information', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'During Active Run-in period, patients received enalapril for step 1 \\& 2 and then aliskiren on top of the max tolerated dose of enalapril for step 3. Patients who completed the run in were randomized in a 1:1:1 ratio to one of the 3 treatment arms (aliskiren/enalapril combination therapy, aliskiren monotherapy, or enalapril monotherapy).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2340', 'groupId': 'BG000'}, {'value': '2340', 'groupId': 'BG001'}, {'value': '2336', 'groupId': 'BG002'}, {'value': '7016', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Combination Aliskiren / Enalapril', 'description': 'Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.'}, {'id': 'BG001', 'title': 'Aliskiren', 'description': 'Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.'}, {'id': 'BG002', 'title': 'Enalapril', 'description': 'Enalapril monotherapy -10 mg film-coated tablet and administered orally.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '11.65', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '12.06', 'groupId': 'BG001'}, {'value': '63.3', 'spread': '11.71', 'groupId': 'BG002'}, {'value': '63.2', 'spread': '11.81', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '494', 'groupId': 'BG000'}, {'value': '532', 'groupId': 'BG001'}, {'value': '499', 'groupId': 'BG002'}, {'value': '1525', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1846', 'groupId': 'BG000'}, {'value': '1808', 'groupId': 'BG001'}, {'value': '1837', 'groupId': 'BG002'}, {'value': '5491', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) - included all randomized patients but excluded 48 patients (22 mis-randomized but took no double blind and 26 patients due to GCP violations)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7064}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-03', 'studyFirstSubmitDate': '2009-02-26', 'resultsFirstSubmitDate': '2016-10-03', 'studyFirstSubmitQcDate': '2009-02-27', 'lastUpdatePostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-03', 'studyFirstPostDateStruct': {'date': '2009-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization', 'timeFrame': 'up to End of Study (78 months)', 'description': 'Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score', 'timeFrame': 'Baseline, Month 12', 'description': 'Change from baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.'}, {'measure': 'All Cause Death', 'timeFrame': 'up to end of study (78 months)', 'description': 'Number of patients - All-cause death. All-cause death is common in Heart Failure HF patients this measures how many patients had this event.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Heart Failure', 'Cardiovascular death', 'CHF hospitalization', 'morbi-mortality trial', 'outcome study', 'endpoint driven', 'plasma renin activity', 'renin angiotensin aldosterone system', 'direct renin inhibitors', 'BNP', 'KCCQ', 'eGFR', '(NYHA class II to IV) with elevated', 'BNP and reduced LVEF'], 'conditions': ['Chronic Heart Failure']}, 'referencesModule': {'references': [{'pmid': '38904251', 'type': 'DERIVED', 'citation': "Patel-Murray NL, Zhang L, Claggett BL, Xu D, Serrano-Fernandez P, Healey M, Wandel S, Chen CW, Jacob J, Xu H, Turner GM, Chutkow W, Yates DP, O'Donnell CJ, Prescott MF, Lefkowitz M, Gimpelewicz CR, Beste MT, Zhao F, Gou L, Desai AS, Jhund PS, Packer M, Pfeffer MA, Redfield MM, Rouleau JL, Zannad F, Zile MR, McMurray JJV, Mendelson MM, Solomon SD, Cunningham JW. Aptamer Proteomics for Biomarker Discovery in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Proteomic Substudy. J Am Heart Assoc. 2024 Jul 2;13(13):e033544. doi: 10.1161/JAHA.123.033544. Epub 2024 Jun 21."}, {'pmid': '37366061', 'type': 'DERIVED', 'citation': 'Kondo T, Dewan P, Anand IS, Desai AS, Packer M, Zile MR, Pfeffer MA, Solomon SD, Abraham WT, Shah SJ, Lam CSP, Jhund PS, McMurray JJV. Clinical Characteristics and Outcomes in Patients With Heart Failure: Are There Thresholds and Inflection Points in Left Ventricular Ejection Fraction and Thresholds Justifying a Clinical Classification? Circulation. 2023 Aug 29;148(9):732-749. doi: 10.1161/CIRCULATIONAHA.122.063642. Epub 2023 Jun 27.'}, {'pmid': '34101002', 'type': 'DERIVED', 'citation': 'Shen L, Claggett BL, Jhund PS, Abraham WT, Desai AS, Dickstein K, Gong J, Kober LV, Lefkowitz MP, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, McMurray JJV. Development and external validation of prognostic models to predict sudden and pump-failure death in patients with HFrEF from PARADIGM-HF and ATMOSPHERE. Clin Res Cardiol. 2021 Aug;110(8):1334-1349. doi: 10.1007/s00392-021-01888-x. Epub 2021 Jun 8.'}, {'pmid': '33089502', 'type': 'DERIVED', 'citation': 'Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.'}, {'pmid': '32720404', 'type': 'DERIVED', 'citation': 'Kristensen SL, Castagno D, Shen L, Jhund PS, Docherty KF, Rorth R, Abraham WT, Desai AS, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Kober L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators.. Prevalence and incidence of intra-ventricular conduction delays and outcomes in patients with heart failure and reduced ejection fraction: insights from PARADIGM-HF and ATMOSPHERE. Eur J Heart Fail. 2020 Dec;22(12):2370-2379. doi: 10.1002/ejhf.1972. Epub 2020 Sep 14.'}, {'pmid': '31849164', 'type': 'DERIVED', 'citation': 'Docherty KF, Shen L, Castagno D, Petrie MC, Abraham WT, Bohm M, Desai AS, Dickstein K, Kober LV, Packer M, Rouleau JL, Solomon SD, Swedberg K, Vazir A, Zile MR, Jhund PS, McMurray JJV. Relationship between heart rate and outcomes in patients in sinus rhythm or atrial fibrillation with heart failure and reduced ejection fraction. Eur J Heart Fail. 2020 Mar;22(3):528-538. doi: 10.1002/ejhf.1682. Epub 2019 Dec 17.'}, {'pmid': '31813280', 'type': 'DERIVED', 'citation': "Dewan P, Rorth R, Raparelli V, Campbell RT, Shen L, Jhund PS, Petrie MC, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, O'Meara E, Pfeffer MA, Pitt B, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Sex-Related Differences in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2019 Dec;12(12):e006539. doi: 10.1161/CIRCHEARTFAILURE.119.006539. Epub 2019 Dec 9."}, {'pmid': '29141857', 'type': 'DERIVED', 'citation': 'Shen L, Ramires F, Martinez F, Bodanese LC, Echeverria LE, Gomez EA, Abraham WT, Dickstein K, Kober L, Packer M, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Jhund PS, Gimpelewicz CR, McMurray JJV; PARADIGM-HF and ATMOSPHERE Investigators and Committees. Contemporary Characteristics and Outcomes in Chagasic Heart Failure Compared With Other Nonischemic and Ischemic Cardiomyopathy. Circ Heart Fail. 2017 Nov;10(11):e004361. doi: 10.1161/CIRCHEARTFAILURE.117.004361.'}, {'pmid': '29018174', 'type': 'DERIVED', 'citation': 'Kristensen SL, Jhund PS, Mogensen UM, Rorth R, Abraham WT, Desai A, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Kober L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators. Prognostic Value of N-Terminal Pro-B-Type Natriuretic Peptide Levels in Heart Failure Patients With and Without Atrial Fibrillation. Circ Heart Fail. 2017 Oct;10(10):e004409. doi: 10.1161/CIRCHEARTFAILURE.117.004409.'}, {'pmid': '28948656', 'type': 'DERIVED', 'citation': 'Kristensen SL, Mogensen UM, Tarnesby G, Gimpelewicz CR, Ali MA, Shao Q, Chiang Y, Jhund PS, Abraham WT, Dickstein K, McMurray JJV, Kober L. Aliskiren alone or in combination with enalapril vs. enalapril among patients with chronic heart failure with and without diabetes: a subgroup analysis from the ATMOSPHERE trial. Eur J Heart Fail. 2018 Jan;20(1):136-147. doi: 10.1002/ejhf.896. Epub 2017 Sep 25.'}, {'pmid': '27043774', 'type': 'DERIVED', 'citation': 'McMurray JJ, Krum H, Abraham WT, Dickstein K, Kober LV, Desai AS, Solomon SD, Greenlaw N, Ali MA, Chiang Y, Shao Q, Tarnesby G, Massie BM; ATMOSPHERE Committees Investigators. Aliskiren, Enalapril, or Aliskiren and Enalapril in Heart Failure. N Engl J Med. 2016 Apr 21;374(16):1521-32. doi: 10.1056/NEJMoa1514859. Epub 2016 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients eligible for inclusion in this study had to fulfill all of the following criteria:\n\n1. Patients ≥ 18 years of age, male or female.\n2. Patients with a diagnosis of chronic heart failure (NYHA\n\n Class II - IV):\n 1. LVEF ≤ 35% at Visit 1 (local measurement, within the past 6 months assessed by echocardiography, multiple uptake gated acquisition scan (MUGA), computerized tomography(CT) scan, magnetic resonance imaging (MRI) or ventricular angiography)\n 2. Elevated BNP or NT-proBNP at Visit 1:\n\n BNP ≥ 150 pg/mL (or BNP ≥ 100 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement). OR NT-proBNP ≥ 600 pg/mL (or NT-proBNP ≥ 400 pg/mL and unplanned hospitalization for HF within the last 12 months prior to Visit 1) (according to local measurement).\n3. Patients had to be treated with an ACEI at a stable dose enalapril 10 mg daily at least or any other ACEI, e.g. ramipril, quinapril, lisinopril, fosinopril, perindopril, trandolapril; based on equivalent doses, for at least 4 weeks prior to Visit 1\n4. Patients had to be treated with a beta-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to visit 1 (for patients not on target dose, according to local guidelines, or in absence of that medication, the reason should be documented).\n5. Written informed consent to participate in the study and ability to comply with all requirements.\n\nExclusion Criteria\n\nPatients with any of the following were to be excluded from participation in the study:\n\n1. History of hypersensitivity to any of the study drugs including history or allergy to ACEIs as well as known or suspected contraindications to the study drugs or previous history of intolerance to high doses of ACEIs during up- titration process.\n2. Patients treated concomitantly with both an ARB and an aldosterone antagonist in addition to study drug at Visit 1.\n3. Current acute decompensated HF (defined as an acute exacerbation of a chronic heart failure status manifested by typical signs and symptoms of HF like dyspnea, fatigue etc., that may require IV therapy with diuretics, vasodilators and/or inotropic drugs).\n4. Symptomatic hypotension and/or less than 95 mmHg systolic blood pressure (SBP) at Visit 1 and/or less than 90 mmHg SBP at Visit 4.\n5. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty, within the past 3 months prior to Visit 1.\n6. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after Visit 1.\n7. Right heart failure due to severe pulmonary disease.\n8. Patients with Diabetes Mellitus.'}, 'identificationModule': {'nctId': 'NCT00853658', 'acronym': 'ATMOSPHERE', 'briefTitle': 'Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV). The Study is Also Known as Aliskiren Trial of Minimizing OutcomeS in Patients With HEart Failure (ATMOSPHERE).', 'orgStudyIdInfo': {'id': 'CSPP100F2301'}, 'secondaryIdInfos': [{'id': '2008-004104-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination Aliskiren / Enalapril', 'description': 'Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.', 'interventionNames': ['Drug: Enalapril', 'Drug: Aliskiren']}, {'type': 'EXPERIMENTAL', 'label': 'Aliskiren', 'description': 'Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.', 'interventionNames': ['Drug: Aliskiren']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enalapril', 'description': 'Enalapril monotherapy -10 mg film-coated tablet and administered orally.', 'interventionNames': ['Drug: Enalapril']}], 'interventions': [{'name': 'Enalapril', 'type': 'DRUG', 'description': 'Enalapril 10 mg film-coated tablet and administered orally.', 'armGroupLabels': ['Combination Aliskiren / Enalapril', 'Enalapril']}, {'name': 'Aliskiren', 'type': 'DRUG', 'otherNames': ['SPP100'], 'description': 'Aliskiren 150 mg titrated to 300 mg film-coated tablet and administered orally.', 'armGroupLabels': ['Aliskiren', 'Combination Aliskiren / Enalapril']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36693', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85723-0001', 'city': 'Tucson', 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