Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-30 @ 12:27 AM
Study NCT ID:
NCT01176968
Status:
COMPLETED
Last Update Posted:
2020-12-22
First Post:
2010-08-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077545', 'term': 'Eplerenone'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.', 'otherNumAtRisk': 506, 'otherNumAffected': 151, 'seriousNumAtRisk': 505, 'seriousNumAffected': 100}, {'id': 'EG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.', 'otherNumAtRisk': 506, 'otherNumAffected': 153, 'seriousNumAtRisk': 505, 'seriousNumAffected': 101}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 18}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 506, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 506, 'numAffected': 19}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Spontaneous haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Arteriospasm coronary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiac asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiac perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Long QT syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pericardial disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': "Dieulafoy's vascular malformation", 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Erosive oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Peptic ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Proctitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 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{'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chronic obstructive pulmonary disease', 'notes': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Idiopathic pulmonary fibrosis', 'notes': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vocal cord polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Implantable defibrillator insertion', 'notes': 'Implantable defibrillator insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Inguinal hernia repair', 'notes': 'Inguinal hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Percutaneous coronary intervention', 'notes': 'Percutaneous coronary intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Peripheral arterial occlusive disease', 'notes': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 505, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 505, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'First Event of Cardiovascular Mortality, Re-hospitalization or Extended Initial Hospital Stay Due to Diagnosis of Heart Failure, Sustained Ventricular Tachycardia or Fibrillation, Ejection Fraction ≤40% or BNP Above Age Adjusted Cut Off', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'OG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.581', 'ciLowerLimit': '0.446', 'ciUpperLimit': '0.756', 'pValueComment': 'All analyses for primary endpoint were tested at two-sided, α-level of 0.05, without adjusting for multiplicity.', 'groupDescription': 'Hazard ratio, 95% confidence interval (CI) of hazard ratio, and p-value for the Primary Analysis based on a Cox proportional hazard model with treatment as the major factor, adjusted for baseline estimated glomerular filtration rate (eGFR), with/without previous MI, time of first dose administered post onset of index symptom, and location of index MI anterior or non-anterior.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '0-24 months', 'description': 'Cardiovascular mortality is defined as any mortality adjudicated as death due to sudden cardiac death, myocardial infarction (MI), worsening heart failure, cardiac arrhythmia, other cause (such as pulmonary embolism, peripheral arterial disease \\[PAD\\], etc.). Hospitalization due to congestive heart failure (CHF) and requires extended hospital stay or frequent visits to emergency room, observation unit or in-patient care, due to CHF as the primary or secondary diagnosis supported by a discharge report or clinical summary for hospitalization as determined by the endpoint adjudication committee (EAC). A composite of time to first event of cardiovascular mortality (CV), re-hospitalization or extended initial hospital stay due to diagnosis of heart failure, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40% after 1 month or BNP \\>200 pg/mL or NT-proBNP \\>450 pg/mL (age \\<50 years); \\>900 pg/mL (age 50 to 75 years) or \\>1800 pg/mL (age \\>75 years) after 1 month.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) using the intent-to-treat (ITT) principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints.'}, {'type': 'SECONDARY', 'title': 'Cardiovascular Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'OG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6406', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.562', 'ciLowerLimit': '0.050', 'ciUpperLimit': '6.308', 'groupDescription': 'Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '0-24 months', 'description': 'The occurrence of cardiovascular mortality from randomization. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.'}, {'type': 'SECONDARY', 'title': 'Diagnosis of Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'OG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5338', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.726', 'ciLowerLimit': '0.265', 'ciUpperLimit': '1.990', 'groupDescription': 'Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '0-24 months', 'description': 'The occurrence of first diagnosis of heart failure from the date of randomization. Time-to-event analyses were measured from the date of randomization, and a subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.'}, {'type': 'SECONDARY', 'title': 'First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'OG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-24 months', 'description': 'The occurrence of first and each subsequent episode (after an event-free interval of ≥ 48 hours) of sustained ventricular tachycardia or ventricular fibrillation. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.'}, {'type': 'SECONDARY', 'title': 'First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'OG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.083', 'ciLowerLimit': '0.575', 'ciUpperLimit': '2.040', 'groupDescription': 'Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '0-24 months', 'description': 'The occurrence of first recorded EF ≤40% (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints.'}, {'type': 'SECONDARY', 'title': 'Brain (B-type) Natriuretic Peptide (BNP) >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for Ages <50 Years, 50-75 Years and >75 Years, Respectively (Recorded 1 Month or Later Post-randomization).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'OG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.598', 'ciLowerLimit': '0.452', 'ciUpperLimit': '0.791', 'groupDescription': 'Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '0-24 months', 'description': 'The occurrence of first occurrence of BNP \\>200 pg/mL or NT-proBNP \\>450, \\>900 or \\>1800 pg/mL for ages \\<50 years, 50 to 75 years and \\>75 years, respectively (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.'}, {'type': 'SECONDARY', 'title': 'Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'OG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9353', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.069', 'ciLowerLimit': '0.213', 'ciUpperLimit': '5.371', 'groupDescription': 'Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as a factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '0-24 months', 'description': 'The decision to provide an ICD or CRT. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.'}, {'type': 'SECONDARY', 'title': 'Second or Subsequent Non-fatal Myocardial Infarction (MI).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'OG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3757', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.600', 'ciLowerLimit': '0.566', 'ciUpperLimit': '4.525', 'groupDescription': 'Hazard ratio, 95% CI of hazard ratio, p-value for all secondary endpoints based on Cox proportional hazard model with treatment as the major factor, adjusted for baseline eGFR, with/without previous MI, index MI location, time of first dose administered post onset of index symptom.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '0-24 months', 'description': 'The occurrence of second or subsequent nonfatal MI. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used. The efficacy analysis data sets for clinical events included all available study endpoints. Furthermore, only events confirmed by the EAC were used.'}, {'type': 'SECONDARY', 'title': 'Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '347', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'OG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.31', 'spread': '15.04', 'groupId': 'OG000'}, {'value': '94.62', 'spread': '16.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1744', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.45', 'ciLowerLimit': '-3.55', 'ciUpperLimit': '0.65', 'groupDescription': 'ANCOVA model was used with observed value as the dependent variable, treatment as a major factor, and baseline QRS duration, baseline eGFR, with/without previous MI, time (in hours) of first dose administered post onset of index symptom, and location of index MI (anterior versus all other locations) as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Electrocardiogram Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) duration at 6 months post-randomization. The continuous endpoints were assessed using analysis of covariance (ANCOVA) model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on last observation carried forward (LOCF) and also using all available data up to end of study.', 'unitOfMeasure': 'Milliseconds (msec)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.'}, {'type': 'SECONDARY', 'title': 'Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'OG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}], 'classes': [{'title': 'Month 6 (N = 268, 243)', 'categories': [{'measurements': [{'value': '3.92', 'spread': '0.654', 'groupId': 'OG000'}, {'value': '3.90', 'spread': '0.703', 'groupId': 'OG001'}]}]}, {'title': 'Final Visit (N = 393, 378)', 'categories': [{'measurements': [{'value': '3.91', 'spread': '0.641', 'groupId': 'OG000'}, {'value': '3.87', 'spread': '0.658', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7123', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.14', 'pValueComment': 'ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.', 'groupDescription': 'For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4105', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.13', 'pValueComment': 'ANCOVA was used for between-treatment comparisons of the LSMeans, 95% CI of LSMEANS, LSMeans difference, 95% CI of LSMeans difference, and p-value with observed value at the given time point as variable.', 'groupDescription': 'For the Between-Treatment difference for Eplerenone and Placebo groups of observed value taken at Month 6 visit, ANCOVA model was performed for LAD based on the LOCF method including treatment groups with/without adjustments for baseline eGFR (in mL/min/1.73 m2), previous MI (yes/no), time (in hours) of first dose administered post-onset of symptom, index MI location (anterior versus all others) as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': '0-24 months', 'description': 'LAD recorded each time an echocardiogram is conducted. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.', 'unitOfMeasure': 'Centimeters (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS using the ITT principle, regardless of compliance with the study drug and the protocol was used.'}, {'type': 'SECONDARY', 'title': 'Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'OG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}], 'classes': [{'title': 'Aldosterone', 'categories': [{'measurements': [{'value': '0.355', 'groupId': 'OG000', 'lowerLimit': '0.210', 'upperLimit': '0.540'}, {'value': '0.210', 'groupId': 'OG001', 'lowerLimit': '0.150', 'upperLimit': '0.310'}]}]}, {'title': 'Serum Cortisol', 'categories': [{'measurements': [{'value': '379.0', 'groupId': 'OG000', 'lowerLimit': '292.0', 'upperLimit': '492.0'}, {'value': '366.0', 'groupId': 'OG001', 'lowerLimit': '271.0', 'upperLimit': '482.0'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.', 'statisticalMethod': 'Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.5552', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- Aldosterone, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.', 'statisticalMethod': 'Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- Aldosterone, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.', 'statisticalMethod': 'Wilcoxon Rank-Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.', 'statisticalMethod': 'Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.0001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- Serum Cortisol, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.', 'statisticalMethod': 'Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3347', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- Serum Cortisol, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.', 'statisticalMethod': 'Wilcoxon Rank-Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Change in serum levels of aldosterone and cortisol at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (carboxyterminal telopeptide of type I collagen \\[ICTP\\], procollagen type I N-terminal peptide \\[PINP\\], procollagen type III N-terminal peptide \\[PIIINP\\], Interleukin-6, aldosterone, cortisol, and Galactin 3) available.'}, {'type': 'SECONDARY', 'title': 'Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'OG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}], 'classes': [{'title': 'PIIINP', 'categories': [{'measurements': [{'value': '4.20', 'groupId': 'OG000', 'lowerLimit': '3.50', 'upperLimit': '4.90'}, {'value': '4.30', 'groupId': 'OG001', 'lowerLimit': '3.60', 'upperLimit': '5.10'}]}]}, {'title': 'Galectin 3', 'categories': [{'measurements': [{'value': '11.20', 'groupId': 'OG000', 'lowerLimit': '9.20', 'upperLimit': '13.50'}, {'value': '10.60', 'groupId': 'OG001', 'lowerLimit': '9.10', 'upperLimit': '12.40'}]}]}, {'title': 'PINP', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '39.0'}, {'value': '32.0', 'groupId': 'OG001', 'lowerLimit': '24.0', 'upperLimit': '42.0'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.', 'statisticalMethod': 'Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.0001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- PIIINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.', 'statisticalMethod': 'Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1558', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- PIIINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.', 'statisticalMethod': 'Wilcoxon-Rank Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0008', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.', 'statisticalMethod': 'Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.0001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- Galecting 3, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.', 'statisticalMethod': 'Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0293', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- Galecting 3, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.', 'statisticalMethod': 'Wilcoxon Rank-Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1723', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.', 'statisticalMethod': 'Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0295', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- PINP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.', 'statisticalMethod': 'Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0865', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- PINP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.', 'statisticalMethod': 'Wilcoxon Rank-Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Change in serum levels of PIIINP, Galectin 3, and PINP at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.'}, {'type': 'SECONDARY', 'title': 'Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'OG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.70', 'groupId': 'OG000', 'lowerLimit': '3.20', 'upperLimit': '4.50'}, {'value': '3.70', 'groupId': 'OG001', 'lowerLimit': '3.20', 'upperLimit': '4.80'}]}]}], 'analyses': [{'pValue': '0.0944', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.', 'statisticalMethod': 'Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0360', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- ICTP, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.', 'statisticalMethod': 'Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.6459', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- ICTP, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.', 'statisticalMethod': 'Wilcoxon Rank-Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Change in serum level of ICTP at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.', 'unitOfMeasure': 'μg/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.'}, {'type': 'SECONDARY', 'title': 'Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'OG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.845', 'groupId': 'OG000', 'lowerLimit': '1.235', 'upperLimit': '2.955'}, {'value': '1.755', 'groupId': 'OG001', 'lowerLimit': '1.180', 'upperLimit': '2.480'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.', 'statisticalMethod': 'Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '< 0.0001', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- Interleukin-6, signed rank test for change from baseline at Month 6 within treatment difference was used to derive p-value.', 'statisticalMethod': 'Signed Rank Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0801', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'For Biomarker- Interleukin-6, Wilconxon rank-sum test for between treatment difference at Month 6 was used to derive p-value.', 'statisticalMethod': 'Wilcoxon Rank-Sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Change in serum level of Interleukin-6 at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Biomarker Analysis Set is a subset of FAS subjects who have the biomarker data (ICTP, PINP, PIIINP, Interleukin-6, aldosterone, cortisol, and Galactin 3) available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'FG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '506'}, {'groupId': 'FG001', 'numSubjects': '506'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '505'}, {'groupId': 'FG001', 'numSubjects': '505'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '422'}, {'groupId': 'FG001', 'numSubjects': '424'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '82'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did Not Meet Entrance Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Reason not defined', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'A total of 1012 subjects were enrolled for participation in this study. A total of 505 subjects were randomized to treatment with eplerenone and 505 subjects were randomized to the placebo group; a total of 422 and 424 subjects in the eplerenone and placebo groups, respectively, completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}, {'value': '506', 'groupId': 'BG001'}, {'value': '1012', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Eplerenone Plus Standard of Care', 'description': 'Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium \\<5.0 mmol/L and with normal renal function.'}, {'id': 'BG001', 'title': 'Placebo Plus Standard of Care', 'description': 'Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.5', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '57.8', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '58.2', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '420', 'groupId': 'BG000'}, {'value': '403', 'groupId': 'BG001'}, {'value': '823', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1012}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-19', 'studyFirstSubmitDate': '2010-08-04', 'resultsFirstSubmitDate': '2013-10-18', 'studyFirstSubmitQcDate': '2010-08-04', 'lastUpdatePostDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-01', 'studyFirstPostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First Event of Cardiovascular Mortality, Re-hospitalization or Extended Initial Hospital Stay Due to Diagnosis of Heart Failure, Sustained Ventricular Tachycardia or Fibrillation, Ejection Fraction ≤40% or BNP Above Age Adjusted Cut Off', 'timeFrame': '0-24 months', 'description': 'Cardiovascular mortality is defined as any mortality adjudicated as death due to sudden cardiac death, myocardial infarction (MI), worsening heart failure, cardiac arrhythmia, other cause (such as pulmonary embolism, peripheral arterial disease \\[PAD\\], etc.). Hospitalization due to congestive heart failure (CHF) and requires extended hospital stay or frequent visits to emergency room, observation unit or in-patient care, due to CHF as the primary or secondary diagnosis supported by a discharge report or clinical summary for hospitalization as determined by the endpoint adjudication committee (EAC). A composite of time to first event of cardiovascular mortality (CV), re-hospitalization or extended initial hospital stay due to diagnosis of heart failure, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40% after 1 month or BNP \\>200 pg/mL or NT-proBNP \\>450 pg/mL (age \\<50 years); \\>900 pg/mL (age 50 to 75 years) or \\>1800 pg/mL (age \\>75 years) after 1 month.'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular Mortality', 'timeFrame': '0-24 months', 'description': 'The occurrence of cardiovascular mortality from randomization. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.'}, {'measure': 'Diagnosis of Heart Failure', 'timeFrame': '0-24 months', 'description': 'The occurrence of first diagnosis of heart failure from the date of randomization. Time-to-event analyses were measured from the date of randomization, and a subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.'}, {'measure': 'First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.', 'timeFrame': '0-24 months', 'description': 'The occurrence of first and each subsequent episode (after an event-free interval of ≥ 48 hours) of sustained ventricular tachycardia or ventricular fibrillation. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.'}, {'measure': 'First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).', 'timeFrame': '0-24 months', 'description': 'The occurrence of first recorded EF ≤40% (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.'}, {'measure': 'Brain (B-type) Natriuretic Peptide (BNP) >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for Ages <50 Years, 50-75 Years and >75 Years, Respectively (Recorded 1 Month or Later Post-randomization).', 'timeFrame': '0-24 months', 'description': 'The occurrence of first occurrence of BNP \\>200 pg/mL or NT-proBNP \\>450, \\>900 or \\>1800 pg/mL for ages \\<50 years, 50 to 75 years and \\>75 years, respectively (recorded 28 days or later post-randomization). Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.'}, {'measure': 'Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT).', 'timeFrame': '0-24 months', 'description': 'The decision to provide an ICD or CRT. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.'}, {'measure': 'Second or Subsequent Non-fatal Myocardial Infarction (MI).', 'timeFrame': '0-24 months', 'description': 'The occurrence of second or subsequent nonfatal MI. Time-to-event analyses were measured from the date of randomization. A subject who did not experience the endpoint(s) of interest was censored on the last day the subject was confirmed by the investigator to be endpoint-free. The time-to-event distributions were summarized by treatment group using Kaplan-Meier estimates of cumulative incidence.'}, {'measure': 'Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization.', 'timeFrame': '6 months', 'description': 'Electrocardiogram Q wave to the end of the S wave corresponding to ventricle depolarization (QRS) duration at 6 months post-randomization. The continuous endpoints were assessed using analysis of covariance (ANCOVA) model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on last observation carried forward (LOCF) and also using all available data up to end of study.'}, {'measure': 'Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted).', 'timeFrame': '0-24 months', 'description': 'LAD recorded each time an echocardiogram is conducted. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.'}, {'measure': 'Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization.', 'timeFrame': '6 months', 'description': 'Change in serum levels of aldosterone and cortisol at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.'}, {'measure': 'Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization.', 'timeFrame': '6 months', 'description': 'Change in serum levels of PIIINP, Galectin 3, and PINP at 6 months post-randomization. The continuous endpoints were assessed using ANCOVA model, fitted with corresponding baseline and treatment. These were analyzed at 6 months based on LOCF and also using all available data up to end of study.'}, {'measure': 'Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization.', 'timeFrame': '6 months', 'description': 'Change in serum level of ICTP at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.'}, {'measure': 'Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization.', 'timeFrame': '6 months', 'description': 'Change in serum level of Interleukin-6 at 6 months post-randomization. The continuous endpoint was assessed using ANCOVA model, fitted with corresponding baseline and treatment. It was analyzed at 6 months based on LOCF and also using all available data up to end of study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Eplerenone', 'myocardial infarction', 'mortality', 'morbidity'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '24780614', 'type': 'DERIVED', 'citation': 'Montalescot G, Pitt B, Lopez de Sa E, Hamm CW, Flather M, Verheugt F, Shi H, Turgonyi E, Orri M, Vincent J, Zannad F; REMINDER Investigators; REMINDER Investigators. Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: the Randomized Double-Blind Reminder Study. Eur Heart J. 2014 Sep 7;35(34):2295-302. doi: 10.1093/eurheartj/ehu164. Epub 2014 Apr 29.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6141116&StudyName=Impact%20Of%20Eplerenone%20On%20Cardiovascular%20Outcomes%20In%20Patients%20Post%20Myocardial%20Infarction', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction, in patients without heart failure, reduces cardiovascular mortality / morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have experienced a myocardial infarction (STEMI) within the previous 24 hours confirmed by symptoms and ECG.\n\nExclusion Criteria:\n\n* Subjects with a known low ejection fraction of less than 40% or any previous history of heart failure.\n* Subjects treated with eplerenone or other aldosterone antagonists within the past 1 month.\n* The subject has uncontrolled hypotension (SBP\\<90mmHg).\n* Subjects with eGFR ≤30ml/min (based on admission serum creatinine and the MDRD formula) or serum creatinine ≥220µmol/L.'}, 'identificationModule': {'nctId': 'NCT01176968', 'acronym': 'REMINDER', 'briefTitle': 'Impact Of Eplerenone On Cardiovascular Outcomes In Patients Post Myocardial Infarction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled Trial Evaluating The Safety And Efficacy Of Early Treatment With Eplerenone In Patients With Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'A6141116'}, 'secondaryIdInfos': [{'id': '2010-019844-38', 'type': 'EUDRACT_NUMBER'}, {'id': 'REMINDER', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eplerenone plus standard of care', 'interventionNames': ['Drug: Eplerenone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo plus standard of care', 'description': 'Matching placebo for eplerenone 25mg film coated tablets.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Eplerenone', 'type': 'DRUG', 'otherNames': ['Inspra'], 'description': 'Maximum dose of 2x25 mg film coated tablets per day for the duration of the study (approximately 18 months maximum). Lower doses may be administered determined by blood biochemistry data.', 'armGroupLabels': ['Eplerenone plus standard of care']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo tablets', 'armGroupLabels': ['Placebo plus standard of care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Walter C Mackenzie Health Sciences Centre (WCM)', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Diamond Health Care Centre (DHCC)', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital - Centennial Pavilion', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital, Vancouver Coastal Health Authority', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Health Sciences Center, Eastern Health', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G7H 5H6', 'city': 'Chicoutimi', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Sante et de Services Sociaux de Chicoutimi (CSSSC) (Complexe Hospitalier de la Sagamie)', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}, {'zip': 'G7H 7P2', 'city': 'Chicoutimi', 'state': 'Quebec', 'country': 'Canada', 'facility': 'ECOGENE-21 / Centre de sante et de services sociaux de Chicoutimi', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleurimont', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': '62500', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '500 05', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '50005', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '775 20', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'I.Interni klinika-kardiologie FN Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '77520', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'I. Interni klinika - kardiologie FN Olomouc', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '140 21', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Klinika kardiologie IKEM', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '150 30', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Nemocnice Na Homolce - kardiologicke oddeleni', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '31403', 'city': 'Toulouse', 'state': 'Cedex 4', 'country': 'France', 'facility': 'Chu Rangueil Service de Cardiologie, A - Bat H1', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '21034', 'city': 'Dijon', 'state': 'Cedex', 'country': 'France', 'facility': 'Chu du Bocage - Centre de Cardiologie', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '75013', 'city': 'Paris', 'state': 'Cedex', 'country': 'France', 'facility': 'Hopital De La Pitie Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '06401', 'city': 'Cannes', 'country': 'France', 'facility': 'Service Cardiologie, Centre Hospitalier de Cannes', 'geoPoint': {'lat': 43.55135, 'lon': 7.01275}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Hôpital Henri Mondor - Pysiologie explorations fonctionnelles', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Hôpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '78740', 'city': 'Évecquemont', 'country': 'France', 'facility': "Centre de Cardiologie d'Evecquemont", 'geoPoint': {'lat': 49.01439, 'lon': 1.94425}}, {'zip': '33500', 'city': 'Libourne', 'country': 'France', 'facility': 'Service Cardiologie Hopital Robert Boulin', 'geoPoint': {'lat': 44.91449, 'lon': -0.24186}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Cardiologie Interventionnelle', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '79189', 'city': 'Bad Krozingen', 'country': 'Germany', 'facility': 'Universitaets-Herzzentrum Freiburg Bad Krozingen', 'geoPoint': {'lat': 47.91667, 'lon': 7.7}}, {'zip': '12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite - Universitaetsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '53127', 'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '28277', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Klinikum Links der Weser gGmbH', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '44137', 'city': 'Dortmund', 'country': 'Germany', 'facility': 'Sankt Johannes Hospital Medizinische Klinik I', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '44137', 'city': 'Dortmund', 'country': 'Germany', 'facility': 'Sankt Johannes Hospital', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '01309', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Georg-August-Universitaet Goettingen, Zentrum f. Innere Medizin / Kardiologie u. Pneumologie', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitaeres Herzzentrum Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '65549', 'city': 'Limburg', 'country': 'Germany', 'facility': 'St. Vincenz Krankenhaus', 'geoPoint': {'lat': 48.03138, 'lon': 12.18221}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '81737', 'city': 'Munich', 'country': 'Germany', 'facility': 'Staedtisches Klinikum Muenchen GmbH Klinikum Neuperlach', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'General Hospital of Athens "Georgios Gennimatas"', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '14561', 'city': 'Athens', 'country': 'Greece', 'facility': 'General Hospital of Attiki KAT', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '26500', 'city': 'Rio Patra', 'country': 'Greece', 'facility': 'University General Hospital of Patra'}, {'zip': '1027', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Budai Irgalmasrendi Korhaz, Kardiologia', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '9024', 'city': 'Győr', 'country': 'Hungary', 'facility': 'Petz Aladar Megyei Oktato Korhaz, Kardiologiai Osztaly', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Josa Andras Oktato Korhaz Egeszsegugyi Szolgaltato Nonprofit Kft., Kardiologia', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '8900', 'city': 'Zalaegerszeg', 'country': 'Hungary', 'facility': 'Zala Megyei Korhaz, Kardiologia', 'geoPoint': {'lat': 46.83695, 'lon': 16.84401}}, {'zip': '1091 AC', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Onze Lieve Vrouwe Gasthuis, Locatie Oosterpark', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3435 CM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '85-094', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Katedra i Klinika Kardiologii i Chorob Wewnetrznych', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '10-561', 'city': 'Olsztyn', 'country': 'Poland', 'facility': 'Oddzial Kardiologiczny Wojewodzki Szpital Specjalistyczny w Olsztynie', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'zip': '32-600', 'city': 'Oświęcim', 'country': 'Poland', 'facility': 'Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii NZOZ w Oswiecimiu G.V.M CARINT Sp. zo.o.', 'geoPoint': {'lat': 50.03437, 'lon': 19.21037}}, {'zip': '51-124', 'city': 'Wroclaw', 'country': 'Poland', 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