Viewing Study NCT00094302

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Ignite Creation Date: 2025-12-25 @ 3:44 AM
Ignite Modification Date: 2025-12-26 @ 2:31 AM
Study NCT ID: NCT00094302
Status: COMPLETED
Last Update Posted: 2015-03-02
First Post: 2004-10-15
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D054144', 'term': 'Heart Failure, Diastolic'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013148', 'term': 'Spironolactone'}, {'id': 'D000451', 'term': 'Mineralocorticoid Receptor Antagonists'}], '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'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D062865', 'term': 'Diuretics, Potassium Sparing'}, {'id': 'D004232', 'term': 'Diuretics'}, {'id': 'D045283', 'term': 'Natriuretic Agents'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bharty@neriscience.com', 'phone': '617-972-3224', 'title': 'Brian Harty', 'organization': 'New England Research Institutes'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Reported Adverse Events (AEs) include any untoward medical occurrence which occurred after a subject gave informed consent and no later than 30 days after a subject permanently discontinued the study medication, for a maximum of 6 years per subject.', 'description': 'If a subject experiences more than 1 of a given AE within a system organ class (SOC), the subject was counted only once for that AE.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone', 'otherNumAtRisk': 1723, 'otherNumAffected': 1086, 'seriousNumAtRisk': 1723, 'seriousNumAffected': 855}, {'id': 'EG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.', 'otherNumAtRisk': 1722, 'otherNumAffected': 1152, 'seriousNumAtRisk': 1722, 'seriousNumAffected': 835}], 'otherEvents': [{'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 31, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 34, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABNORMAL BMP', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABNORMAL VAGINAL BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ACTINIC KERATOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ACUTE RESPIRATORY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ALLERGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ALTERED MENTAL STATUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 48, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 45, 'numAffected': 41}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANGINA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANGIOGRAPHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANGIOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANKLE INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARM INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARM INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARTERIAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ATAXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ATAXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ATHEROSCLEROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ATHEROSCLEROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ATHEROSCLEROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 123, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 97, 'numAffected': 74}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ATRIAL FLUTTER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AV BLOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BACK INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 74, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 76, 'numAffected': 67}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BLADDER CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BLADDER TUMOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BLEEDING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BLEEDING IN EYE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BLOOD IN STOOL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BLURRED VISION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BODY ACHES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BODY PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BRADYCARDIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BREAST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BREAST TENDERNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 69, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 75, 'numAffected': 63}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BRONCHOSPASM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BRUISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BRUISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BRUISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BUNDLE BRANCH BLOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BURSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BUTTOCK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'C-DIFF INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CANCER REMOVAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARDIOVERSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARPEL TUNNEL RELEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARPEL TUNNEL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CARPEL TUNNEL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CATARACTS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CHEMOTHERAPY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CHEST CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 130, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 1722, 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'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TEE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'THROAT CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'THROMBOEMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'THROMBOEMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'THROMBOEMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'THYROIDECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TOE AMPUTATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TOE AMPUTATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TOOTH ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TOOTHACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TOXIC ALLERGIC ALVEOLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TOXIC PNEUMONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TRANSIENT ISCHEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TRANSIENT ISCHEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TRANSURETHRAL PROSTATIC RESECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TRAUMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TREMOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TRICUSPID REGURGITATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'TUMOR REMOVAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UPPER RESPIRATORY INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UPPER RESPIRATORY INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URETER STONE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URETHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URINARY INCONTINENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URINARY RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 22, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URINARY TRACT STONES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URTICARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UTERINE CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UTERINE PROLAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UTERINE TUMOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VAGINITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VALVE REPLACEMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VALVE REPLACEMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VARICOSE VEINS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VENOUS INSUFFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VENOUS STASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VENTRICULAR FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VERTEBROBASILAR INSUFFICIENCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VISION CHANGES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VOLUME OVERLOAD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'WARFARIN ALLERGIC REACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'WARFARIN OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'WEAKNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'WEIGHT GAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'WORSENING HF', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'WOUND INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'XERODERMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1723, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1722, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0.1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '5.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.04', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': 'Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. This endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 320 subjects in the Spironolactone group and 351 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided log rand test (0.05 Type 1 error)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Cardiovascular Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.12', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': 'This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.\n\nThis endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 336 subjects (160 in the Spironolactone group and 176 in the Placebo group) with a confirmed event.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided log rand test (0.05 Type 1 error)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Aborted Cardiac Arrest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000'}, {'value': '0.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.14', 'ciUpperLimit': '2.50', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': 'This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.\n\nThis endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 8 subjects (3 in the Spironolactone group and 5 in the Placebo group) with a confirmed event.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided log rand test (0.05 Type 1 error)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of aborted cardiac arrest', 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Hospitalization for the Management of Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.69', 'ciUpperLimit': '0.99', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': 'This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.\n\nThis endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 451 subjects (206 in the Spironolactone group and 245 in the Placebo group) who have been confirmed to have experienced the event', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided log rand test (0.05 Type 1 error)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of a hospitalization for the management of heart failure', 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.08', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': "Endpoint compared by trial arm using logrank test of time to event from randomization. Subjects who did not experience endpoint were censored at time of last contact. Attempts were made to determine vital status as of each subject's last potential visit, based on randomization, even if the subject ended study participation before then. This outcome was adjudicated. There were 252 events over 6,022 patient-years in Spironolactone arm and 274 events over 5,981 patient-years in Placebo arm.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided log rand test (0.05 Type 1 error)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000'}, {'value': '7.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.06', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': 'Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 382 subjects in Spironolactone group and 404 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided log rank test (0.05 Type 1 error)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Cardiovascular-related Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000'}, {'value': '5.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.15', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.04', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': 'Endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 291 subjects in Spironolactone group and 320 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided log rank test (0.05 Type 1 error)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Hospitalization for MI, stroke or the management of heart failure, whichever occurred first', 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.97', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': 'There were a total of 869 confirmed heart failure hospitalizations (394 in the Spironolactone group and 475 in the Placebo group) during the 11,471 person-years collected over the course of the TOPCAT trial (5,755 person-years in the Spironolactone group and 5,716 person-years in the Placebo group). The incidence rate of heart failure hospitalizations for each treatment group was compared using a negative binomial regression with a p-value threshold of 0.05 for statistical significance.', 'statisticalMethod': 'Negative binomial regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.82', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.38', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': 'Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 58 subjects in the Spironolactone group and 60 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided log rank test (0.05 Type 1 error)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1167', 'groupId': 'OG000'}, {'value': '1156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.83', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': 'This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.\n\nThis endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 56 subjects (29 in the Spironolactone group and 27 in the Placebo group) with confirmed events.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided log rank test (0.05 Type 1 error)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of new onset diabetes mellitus among subjects without a history of diabetes mellitus at baseline.', 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized and did not have a history of diabetes mellitus at baseline were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Development of Atrial Fibrillation, Among Subjects Without a History of Atrial Fibrillation at Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1117', 'groupId': 'OG000'}, {'value': '1111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.94', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio, log', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.50', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': 'This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.\n\nThis endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 103 subjects (52 in the Spironolactone group and 51 in the Placebo group) with confirmed events.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided log rank test (0.05 Type 1 error)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of atrial fibrillation among subjects without a history of atrial fibrillation at baseline', 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized and did not have a history of atrial fibrillation at baseline were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.98', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.42', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': 'This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.\n\nThis endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 129 subjects (65 in the Spironolactone group and 64 in the Placebo group) with confirmed events.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided log rand test (0.05 Type 1 error)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of myocardial infarction', 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.35', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': 'This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.\n\nThis endpoint was adjudicated by the TOPCAT clinical endpoints committee. There were 117 subjects (57 in the Spironolactone group and 60 in the Placebo group) with confirmed events.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided log rand test (0.05 Type 1 error)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of stroke', 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Deterioration of Renal Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.49', 'ciLowerLimit': '1.18', 'ciUpperLimit': '1.87', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': 'This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.\n\nThere were 295 subjects (175 in the Spironolactone group and 120 in the Placebo group) experiencing this endpoint. This endpoint did not undergo adjudication by the TOPCAT clinical endpoints committee.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided log rand test (0.05 Type 1 error)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of a deterioration of renal function. The TOPCAT protocol defines deterioration of renal function as occurring if a subject has a serum creatinine value which is at least double the baseline value for that subject, and is also above the upper limit of normal (assumed to be 1.0 mg/dL for females and 1.2 mg/dL for males.)', 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Composite Outcome of Sudden Death, Aborted Cardiac Arrest, or Hospitalization for the Management of Ventricular Tachycardia, Whichever Occurred First', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.35', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': 'Composite endpoint was compared by trial arm using logrank test of time to first event from time of randomization. Time to event was the time at which the first observed event component of the composite endpoint was observed. Component endpoints were adjudicated by the TOPCAT clinical endpoints committee. There were 58 subjects in the Spironolactone group and 61 subjects in Placebo group with a confirmed event. Subjects who did not experience this endpoint were censored at time of last contact.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided log rank test (0.05 Type 1 error)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, as Measured by the Kansas City Cardiomyopathy Questionnaire.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '64.4', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.\n\nThe Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The KCCQ was administered at the following study visits: baseline, month 4, month 12 and annually thereafter.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, as Measured by the EuroQOL Visual Analog Scale.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '66.4', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.\n\nThe EuroQOL visual analog scale (EQ5D) is a single-item, self-administered instrument that quantifies current health status. Scores can range from 0-100, in which higher scores reflect better health status. The EQ5D was administered at the following study visits: baseline, month 4, month 12 and annually thereafter.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Quality of Life, as Measured by McMaster Overall Treatment Evaluation Questionnaire.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '799', 'groupId': 'OG000'}, {'value': '801', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score and treatment group as predictor variables. This tests whether the value of the post-baseline quality of life parameter differs by treatment group.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline quality of life, taking into consideration baseline quality of life and treatment group.\n\nThe McMaster Overall Treatment Evaluation questionnaire is a self-administered 3-item instrument that measures a patient\'s perception of change in their health-related quality of life since the start of therapy. The questionnaire consists of a single question - "Since treatment started, has there been any change in your activity limitation, symptoms and/or feelings related to your heart condition?" Scores can range from -7 to +7, and higher scores reflect better health status. The questionnaire was administered at the following study visits: month 4 and month 12. Valid translations of this questionnaire were only available for subjects enrolled in the United States, Canada and Argentina.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants from United States, Canada and Argentina who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Depression Symptoms, as Measured by Patient Health Questionnaire.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '739', 'groupId': 'OG000'}, {'value': '738', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A generalized linear model was fit, with the post-baseline quality of life scores as the dependent variable, and the baseline quality of life score, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline quality of life parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline depression, taking into consideration baseline depression, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.\n\nThe Patient Health Questionnaire (PHQ) is a 10-item, self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores can range from 0-27, in which lower scores reflect better mental health status. The PH-Q was administered at the following study visits: baseline, month 12 and annually thereafter. Valid translations of this questionnaire were only available for subjects enrolled in the United States and Canada.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants from the United States and Canada who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Hospitalization for Any Reason', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.04', 'pValueComment': 'No covariate adjustment', 'estimateComment': 'Spironolactone compared to Placebo', 'groupDescription': 'This endpoint was compared by trial arm (spironolactone vs. placebo) using a logrank test of time to first event from the time of randomization. Subjects who did not experience this endpoint were censored at the time of their last contact.\n\nThere were a total of 1558 subjects (766 subjects in the Spironolactone group and 792 subjects in the Placebo) who were hospitalized for any cause while on study. This endpoint was not adjudicated by the TOPCAT clinical endpoints committee.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Two-sided log rand test (0.05 Type 1 error)', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of a hospitalization for any reason', 'unitOfMeasure': 'Events per 100 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.32', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '4.49', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline Potassium, taking into consideration baseline Potassium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Serum Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.11', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.53', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline serum creatinine, taking into consideration baseline serum creatinine, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '140.95', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '140.33', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline Sodium, taking into consideration baseline Sodium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Chloride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '102.33', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '102.26', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline Chloride, taking into consideration baseline Chloride, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}, {'type': 'SECONDARY', 'title': 'Estimated Glomerular Filtration Rate (GFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'OG000'}, {'value': '1722', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'OG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.50', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '65.20', 'spread': '0.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.98', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'A generalized linear model was fit, with the post-baseline laboratory value as the dependent variable, and the baseline laboratory value, treatment group, month of visit, and the interaction between treatment group and month of visit as predictor variables. This tests whether the slope of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Since the p-value for the preceding test (Statistical Analysis 1) was not significant at the 0.05 level, another generalized linear model was fit, omitting the interaction between treatment group and month of visit. This tests whether the value of the post-baseline laboratory parameter differs by treatment group, taking into account that measurements in the same subject over time may be correlated.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline GFR, taking into consideration baseline GFR, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.', 'unitOfMeasure': 'mL/min/1.73m2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'FG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1723'}, {'groupId': 'FG001', 'numSubjects': '1722'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1306'}, {'groupId': 'FG001', 'numSubjects': '1316'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '417'}, {'groupId': 'FG001', 'numSubjects': '406'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '266'}, {'groupId': 'FG001', 'numSubjects': '246'}]}]}], 'recruitmentDetails': 'TOPCAT enrolled 3445 patients with heart failure and preserved ejection fraction at 233 academic and community medical centers in 6 countries between August 2006 and January 2012. Trial follow-up ended in June 2013.', 'preAssignmentDetails': 'Trial randomization was stratified by whether patients were enrolled into the study on the basis of having a hospitalization for heart failure within the past year (N=2,464) or having an elevated natriuretic peptide level within 60 days before randomization (N=981). The second criterion was considered only for those who did not meet the first.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1723', 'groupId': 'BG000'}, {'value': '1722', 'groupId': 'BG001'}, {'value': '3445', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo of spironolactone'}, {'id': 'BG001', 'title': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '649', 'groupId': 'BG000'}, {'value': '654', 'groupId': 'BG001'}, {'value': '1303', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1074', 'groupId': 'BG000'}, {'value': '1068', 'groupId': 'BG001'}, {'value': '2142', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.7', 'groupId': 'BG000', 'lowerLimit': '60.7', 'upperLimit': '75.5'}, {'value': '68.7', 'groupId': 'BG001', 'lowerLimit': '61.0', 'upperLimit': '76.4'}, {'value': '68.7', 'groupId': 'BG002', 'lowerLimit': '60.9', 'upperLimit': '75.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '887', 'groupId': 'BG000'}, {'value': '888', 'groupId': 'BG001'}, {'value': '1775', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '836', 'groupId': 'BG000'}, {'value': '834', 'groupId': 'BG001'}, {'value': '1670', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1537', 'groupId': 'BG000'}, {'value': '1525', 'groupId': 'BG001'}, {'value': '3062', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '579', 'groupId': 'BG000'}, {'value': '572', 'groupId': 'BG001'}, {'value': '1151', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '537', 'groupId': 'BG000'}, {'value': '529', 'groupId': 'BG001'}, {'value': '1066', 'groupId': 'BG002'}]}]}, {'title': 'Georgia', 'categories': [{'measurements': [{'value': '305', 'groupId': 'BG000'}, {'value': '307', 'groupId': 'BG001'}, {'value': '612', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Eligibility Stratum', 'classes': [{'title': 'Hospitalization in previous year for heart failure', 'categories': [{'measurements': [{'value': '1232', 'groupId': 'BG000'}, {'value': '1232', 'groupId': 'BG001'}, {'value': '2464', 'groupId': 'BG002'}]}]}, {'title': 'Elevated natriuretic peptide in previous 60 days', 'categories': [{'measurements': [{'value': '491', 'groupId': 'BG000'}, {'value': '490', 'groupId': 'BG001'}, {'value': '981', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Eligible patients were assigned to one of two strata before randomization, according to whether they had at least one hospitalization within the previous 12 months in which management of heart failure was a major component of the care provided, or in absence of that criterion, an elevated brain natriuretic peptide (BNP) level within 60 days prior to randomization (a brain natriuretic peptide \\[BNP\\] level ≥100 pg per milliliter or an N-terminal pro-BNP \\[NTproBNP\\] level ≥360 pg per milliliter).', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3445}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-11', 'studyFirstSubmitDate': '2004-10-15', 'resultsFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2004-10-14', 'lastUpdatePostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-11', 'studyFirstPostDateStruct': {'date': '2004-10-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject."}], 'secondaryOutcomes': [{'measure': 'Cardiovascular Mortality', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject."}, {'measure': 'Aborted Cardiac Arrest', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of aborted cardiac arrest'}, {'measure': 'Hospitalization for the Management of Heart Failure', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of a hospitalization for the management of heart failure'}, {'measure': 'All-cause Mortality', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject."}, {'measure': 'Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject."}, {'measure': 'Cardiovascular-related Hospitalization', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Hospitalization for MI, stroke or the management of heart failure, whichever occurred first'}, {'measure': 'Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject."}, {'measure': 'Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject."}, {'measure': 'New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline.', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of new onset diabetes mellitus among subjects without a history of diabetes mellitus at baseline.'}, {'measure': 'Development of Atrial Fibrillation, Among Subjects Without a History of Atrial Fibrillation at Baseline.', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of atrial fibrillation among subjects without a history of atrial fibrillation at baseline'}, {'measure': 'Myocardial Infarction', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of myocardial infarction'}, {'measure': 'Stroke', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of stroke'}, {'measure': 'Deterioration of Renal Function', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of a deterioration of renal function. The TOPCAT protocol defines deterioration of renal function as occurring if a subject has a serum creatinine value which is at least double the baseline value for that subject, and is also above the upper limit of normal (assumed to be 1.0 mg/dL for females and 1.2 mg/dL for males.)'}, {'measure': 'Composite Outcome of Sudden Death, Aborted Cardiac Arrest, or Hospitalization for the Management of Ventricular Tachycardia, Whichever Occurred First', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject."}, {'measure': 'Quality of Life, as Measured by the Kansas City Cardiomyopathy Questionnaire.', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.\n\nThe Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The KCCQ was administered at the following study visits: baseline, month 4, month 12 and annually thereafter.'}, {'measure': 'Quality of Life, as Measured by the EuroQOL Visual Analog Scale.', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.\n\nThe EuroQOL visual analog scale (EQ5D) is a single-item, self-administered instrument that quantifies current health status. Scores can range from 0-100, in which higher scores reflect better health status. The EQ5D was administered at the following study visits: baseline, month 4, month 12 and annually thereafter.'}, {'measure': 'Quality of Life, as Measured by McMaster Overall Treatment Evaluation Questionnaire.', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline quality of life, taking into consideration baseline quality of life and treatment group.\n\nThe McMaster Overall Treatment Evaluation questionnaire is a self-administered 3-item instrument that measures a patient\'s perception of change in their health-related quality of life since the start of therapy. The questionnaire consists of a single question - "Since treatment started, has there been any change in your activity limitation, symptoms and/or feelings related to your heart condition?" Scores can range from -7 to +7, and higher scores reflect better health status. The questionnaire was administered at the following study visits: month 4 and month 12. Valid translations of this questionnaire were only available for subjects enrolled in the United States, Canada and Argentina.'}, {'measure': 'Depression Symptoms, as Measured by Patient Health Questionnaire.', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline depression, taking into consideration baseline depression, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.\n\nThe Patient Health Questionnaire (PHQ) is a 10-item, self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores can range from 0-27, in which lower scores reflect better mental health status. The PH-Q was administered at the following study visits: baseline, month 12 and annually thereafter. Valid translations of this questionnaire were only available for subjects enrolled in the United States and Canada.'}, {'measure': 'Hospitalization for Any Reason', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'First incidence of a hospitalization for any reason'}, {'measure': 'Potassium', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline Potassium, taking into consideration baseline Potassium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.'}, {'measure': 'Serum Creatinine', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline serum creatinine, taking into consideration baseline serum creatinine, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.'}, {'measure': 'Sodium', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline Sodium, taking into consideration baseline Sodium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.'}, {'measure': 'Chloride', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline Chloride, taking into consideration baseline Chloride, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.'}, {'measure': 'Estimated Glomerular Filtration Rate (GFR)', 'timeFrame': "Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.", 'description': 'Average post-baseline GFR, taking into consideration baseline GFR, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Heart Failure', 'Diastolic Heart Failure', 'Preserved Ejection Fraction'], 'conditions': ['Cardiovascular Diseases', 'Heart Diseases', 'Heart Failure, Congestive']}, 'referencesModule': {'references': [{'pmid': '22137068', 'type': 'BACKGROUND', 'citation': "Desai AS, Lewis EF, Li R, Solomon SD, Assmann SF, Boineau R, Clausell N, Diaz R, Fleg JL, Gordeev I, McKinlay S, O'Meara E, Shaburishvili T, Pitt B, Pfeffer MA. Rationale and design of the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial: a randomized, controlled study of spironolactone in patients with symptomatic heart failure and preserved ejection fraction. Am Heart J. 2011 Dec;162(6):966-972.e10. doi: 10.1016/j.ahj.2011.09.007. Epub 2011 Nov 8."}, {'pmid': '23258572', 'type': 'RESULT', 'citation': "Shah SJ, Heitner JF, Sweitzer NK, Anand IS, Kim HY, Harty B, Boineau R, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Lewis EF, Markov V, O'Meara E, Kobulia B, Shaburishvili T, Solomon SD, Pitt B, Pfeffer MA, Li R. Baseline characteristics of patients in the treatment of preserved cardiac function heart failure with an aldosterone antagonist trial. Circ Heart Fail. 2013 Mar;6(2):184-92. doi: 10.1161/CIRCHEARTFAILURE.112.972794. Epub 2012 Dec 20."}, {'pmid': '24249049', 'type': 'RESULT', 'citation': "Shah AM, Shah SJ, Anand IS, Sweitzer NK, O'Meara E, Heitner JF, Sopko G, Li G, Assmann SF, McKinlay SM, Pitt B, Pfeffer MA, Solomon SD; TOPCAT Investigators. Cardiac structure and function in heart failure with preserved ejection fraction: baseline findings from the echocardiographic study of the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial. Circ Heart Fail. 2014 Jan;7(1):104-15. doi: 10.1161/CIRCHEARTFAILURE.113.000887. Epub 2013 Nov 18."}, {'pmid': '24716680', 'type': 'RESULT', 'citation': "Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, Clausell N, Desai AS, Diaz R, Fleg JL, Gordeev I, Harty B, Heitner JF, Kenwood CT, Lewis EF, O'Meara E, Probstfield JL, Shaburishvili T, Shah SJ, Solomon SD, Sweitzer NK, Yang S, McKinlay SM; TOPCAT Investigators. Spironolactone for heart failure with preserved ejection fraction. 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Epub 2015 Sep 15."}, {'pmid': '26130119', 'type': 'DERIVED', 'citation': 'Shah AM, Claggett B, Sweitzer NK, Shah SJ, Anand IS, Liu L, Pitt B, Pfeffer MA, Solomon SD. Prognostic Importance of Impaired Systolic Function in Heart Failure With Preserved Ejection Fraction and the Impact of Spironolactone. Circulation. 2015 Aug 4;132(5):402-14. doi: 10.1161/CIRCULATIONAHA.115.015884. Epub 2015 Jun 30.'}, {'pmid': '25782985', 'type': 'DERIVED', 'citation': 'Borlaug BA, Lewis GD, McNulty SE, Semigran MJ, LeWinter M, Chen H, Lin G, Deswal A, Margulies KB, Redfield MM. Effects of sildenafil on ventricular and vascular function in heart failure with preserved ejection fraction. Circ Heart Fail. 2015 May;8(3):533-41. doi: 10.1161/CIRCHEARTFAILURE.114.001915. Epub 2015 Mar 17.'}, {'pmid': '25648577', 'type': 'DERIVED', 'citation': 'Hamo CE, Heitner JF, Pfeffer MA, Kim HY, Kenwood CT, Assmann SF, Solomon SD, Boineau R, Fleg JL, Spertus JA, Lewis EF. Baseline distribution of participants with depression and impaired quality of life in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist Trial. Circ Heart Fail. 2015 Mar;8(2):268-77. doi: 10.1161/CIRCHEARTFAILURE.114.001838. Epub 2015 Feb 3.'}, {'pmid': '19850207', 'type': 'DERIVED', 'citation': 'Mak GJ, Ledwidge MT, Watson CJ, Phelan DM, Dawkins IR, Murphy NF, Patle AK, Baugh JA, McDonald KM. Natural history of markers of collagen turnover in patients with early diastolic dysfunction and impact of eplerenone. J Am Coll Cardiol. 2009 Oct 27;54(18):1674-82. doi: 10.1016/j.jacc.2009.08.021.'}], 'seeAlsoLinks': [{'url': 'http://circheartfailure.ahajournals.org/content/7/1/104.long', 'label': 'Link to PubMed ID #24249049 publication in Circulation: Heart Failure'}, {'url': 'http://www.nejm.org/doi/full/10.1056/NEJMoa1313731', 'label': 'Link to PubMed ID #24716680 publication in the New England Journal of Medicine'}, {'url': 'http://circheartfailure.ahajournals.org/content/7/5/740.long', 'label': 'Link to PubMed ID #25122186 publication in Circulation: Heart Failure'}, {'url': 'http://circ.ahajournals.org/content/early/2014/11/18/CIRCULATIONAHA.114.013255.long', 'label': 'Link to PubMed ID #25406305 publication in Circulation'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure hospitalization in patients who have heart failure with preserved systolic function.', 'detailedDescription': 'BACKGROUND:\n\nHeart failure (HF) is a major cause of morbidity and mortality, particularly in older people. Indeed, it is the most common discharge diagnosis in patients older than 65 years. As the United States population ages, heart failure will continue to grow as a public health concern. Therapeutic trials of heart failure have dealt almost exclusively with patients who have systolic dysfunction. However, there is now an emerging awareness that nearly half of the patients with heart failure have preserved systolic function and that the survival of these patients is adversely affected. This study is a randomized clinical trial of a novel therapeutic approach, specifically the use of spironolactone, an aldosterone antagonist, in treating these patients. While this treatment has been shown to be useful in treating heart failure with reduced systolic function, it has not been studied in patients with preserved systolic function.\n\nPatients with heart failure and preserved systolic function have a poor prognosis. The annual mortality rate is intermediate between the prognosis for those without heart failure and for those with heart failure and reduced systolic function. For instance, Family Health Study participants with heart failure and preserved systolic function had a mortality rate of 9% compared to 3% for their age- and gender-matched controls. The mortality rate was 19% in heart failure patients with reduced systolic function heart failure compared to 4% for their matched controls.\n\nAs heart failure develops, neurohormones are released that initially improve cardiac output but ultimately contribute to progression of left ventricular dysfunction. The renin-angiotensin-aldosterone system is an important part of this compensatory response. Aldosterone levels may rise to 20 times normal levels in heart failure and aldosterone contributes to the development of myocardial fibrosis. Spironolactone is a potassium-sparing diuretic that acts on the distal tubule, inhibiting sodium and potassium ion exchange. There are several potential beneficial actions, including prevention of cardiac fibrosis. A recent trial evaluated spironolactone in patients with systolic dysfunction heart failure. Spironolactone treatment caused a 30% reduction in mortality compared to placebo (p\\< 0.001). The improvement resulted from a reduction in all cause mortality. More recently, the Eplerenone Post-Myocardial Infarction (MI) study showed that this aldosterone antagonist significantly reduces mortality despite background treatment with an angiotensin-converting enzyme (ACE) inhibitor and beta-blocker. Advantages of using spironolactone in this study are that it is commercially available, inexpensive, and no longer under patent (therefore this study will not be done by industry). Also, there is a clear physiologic rationale for its use, and the side effect profile is well understood. The study enrolled subjects who had preserved systolic function with heart failure and who met clearly defined eligibility criteria that were selected to make the results widely generalizable to clinical practice.\n\nDESIGN NARRATIVE:\n\nThis is a randomized, double-blinded, placebo-controlled trial of aldosterone antagonist therapy (15 mg dose spironolactone or placebo; titrated up to 30 or 45 mg/day) in 3,445 adult patients with heart failure and preserved systolic function. Patients were recruited from August 2006 through January 2012, treated, and will be followed through June 2013. Approximately 270 clinical sites in six countries were subcontracted by the clinical trial coordinating center. Subject visits to a clinical center will occur every four or six months. Data collected include demographic and clinical data, including the results of history and physical exams, laboratory and imaging data, repository specimens for special physiology studies, and genetic studies. Additionally, data regarding quality of life and compliance with assigned treatment will also be collected and assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* Heart failure as defined by at least one of symptom (paroxysmal nocturnal dyspnea; orthopnea; or dyspnea on mild or moderate exertion) at the time of screening and at least one sign (any rales post cough; jugular venous pressure(JVP) greater than or equal to 10cm of water(H2O); lower extremity edema; or chest x-ray demonstrating pleural effusion, pulmonary congestion, or cardiomegaly) within 12 months prior to study entry:\n* left ventricular ejection fraction greater than or equal to 45% (per local reading); the ejection fraction must have been obtained within 6 months prior to randomization and after any MI or other event that would affect ejection fraction\n* Controlled systolic blood pressure(BP), defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP\n* Serum potassium less than 5.0 mmol/L prior to randomization\n* At least one hospital admission for which heart failure was a major component of the hospitalization some time within the 12 months prior to study entry OR brain natriuretic peptide (BNP) greater than or equal to 100pg/ml or N-terminal pro-BNP greater than or equal to 360pg/ml within the 60 days prior to study entry\n* Women of child-bearing potential must have a negative serum/urine pregnancy test within 72 hours prior to randomization, must not be lactating, and must agree to use an effective method of contraception during the entire course of study participation\n* Willing to comply with scheduled visits\n* Informed consent form signed by the subject prior to participation in the trial\n\nEXCLUSION CRITERIA:\n\n* Severe systemic illness with an expected life expectancy of less than 3 years\n* Chronic pulmonary disease requiring home O2, oral steroid therapy, or hospitalization for exacerbation within 12 months of study entry, or significant chronic pulmonary disease in the opinion of the investigator\n* Known infiltrative or hypertrophic obstructive cardiomyopathy or known pericardial constriction\n* Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial\n* Atrial fibrillation with a resting heart rate greater than 90 bpm\n* MI in the past 90 days\n* Coronary artery bypass graft surgery in the past 90 days\n* Percutaneous coronary intervention in the past 30 days\n* Heart transplant recipient\n* Currently implanted left ventricular assist device\n* Stroke in past 90 days\n* Systolic BP (SBP) greater than 160 mm Hg\n* Known orthostatic hypotension\n* Gastrointestinal disorder that could interfere with study drug absorption\n* Use of any aldosterone antagonist or potassium sparing medication in the last 14 days or any known condition that would require the use of an aldosterone antagonist during study participation;\n* Known intolerance to aldosterone antagonists\n* Current lithium use\n* Current participation (including prior 30 days) in any other therapeutic trial\n* Any condition that, in the opinion of the investigator, may prevent the participant from adhering to the trial protocol\n* History of hyperkalemia (serum potassium greater than or equal to 5.5mmol/L) in the past 6 months or serum potassium greater than or equal to 5.0mmol/L within the past 2 weeks\n* Severe renal dysfunction, defined as an estimated glomerular filtration rate(GFR) less than 30ml/min. Participants with serum creatinine greater than or equal to 2.5mg/dl are also excluded even if their GFR is greater than or equal to 30ml/min\n* Known chronic hepatic disease, defined as aspartate aminotransferase(AST) and alanine aminotransferase(ALT) levels greater than 3.0 times the upper limit of normal as read at the local lab.'}, 'identificationModule': {'nctId': 'NCT00094302', 'acronym': 'TOPCAT', 'briefTitle': 'Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function', 'organization': {'class': 'OTHER', 'fullName': 'Carelon Research'}, 'officialTitle': 'Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT)', 'orgStudyIdInfo': {'id': '160'}, 'secondaryIdInfos': [{'id': 'HHSN268200425207C', 'type': 'OTHER_GRANT', 'domain': 'NIH contract'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo of spironolactone', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Spironolactone', 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.', 'interventionNames': ['Drug: Spironolactone']}], 'interventions': [{'name': 'Spironolactone', 'type': 'DRUG', 'otherNames': ['aldosterone antagonist'], 'description': 'Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.', 'armGroupLabels': ['Spironolactone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo of spironolactone', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Cardiovascular Consultants, Ltd.', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85012', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Carl T. 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