Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-24 @ 3:13 PM
Study NCT ID:
NCT02064868
Status:
TERMINATED
Last Update Posted:
2019-03-22
First Post:
2014-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Denmark', 'Sweden']}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C577649', 'term': 'serelaxin protein, human'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Cause Mortality: 30 days (additional deaths are included which occurred after the clinical trial reporting period of 30 days for up to 8 months post randomization); Serious Adverse Events: 14 days; Other non-serious Adverse Events (AEs): 5 days', 'eventGroups': [{'id': 'EG000', 'title': 'Serelaxin + Standard of Care', 'description': 'Serelaxin (30 μg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.', 'otherNumAtRisk': 1729, 'deathsNumAtRisk': 1729, 'otherNumAffected': 637, 'seriousNumAtRisk': 1729, 'deathsNumAffected': 63, 'seriousNumAffected': 214}, {'id': 'EG001', 'title': 'Standard of Care (SOC)', 'description': 'All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.', 'otherNumAtRisk': 894, 'deathsNumAtRisk': 894, 'otherNumAffected': 324, 'seriousNumAtRisk': 894, 'deathsNumAffected': 43, 'seriousNumAffected': 107}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 23}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 81}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 56}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Blood pressure systolic decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 35}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 73}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 18}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 18}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 18}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 26}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiac ventricular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiorenal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Diastolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Sinus arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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{'term': 'Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypercapnic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Anuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Nephropathy toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dermatitis exfoliative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Left atrial appendage occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Arterial disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Femoral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1729, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 894, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '1.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1756', 'groupId': 'OG000'}, {'value': '894', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serelaxin + Standard of Care', 'description': 'Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.95', 'groupId': 'OG000'}, {'value': '6.94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0172', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.51', 'ciUpperLimit': '0.98', 'pValueComment': 'One-sided p-value', 'statisticalMethod': "Gehan's generalized Wilcoxon test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '5 days', 'description': 'In-hospital WHF through Day 5 post-randomization included worsening signs and/or symptoms of heart failure that required an intensification of intravenous therapy for heart failure or mechanical ventilation, renal or circulatory support. A central event adjudication committee was appointed to oversee the WHF primary endpoint adjudication.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1756', 'groupId': 'OG000'}, {'value': '894', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serelaxin + Standard of Care', 'description': 'Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.49', 'groupId': 'OG000'}, {'value': '10.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0634', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.02', 'pValueComment': 'Two-sided p-value', 'statisticalMethod': "Gehan's generalized Wilcoxon test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '14 days', 'description': 'WHF/death/readmission for heart failure through Day 14. WHF/deaths through Day 5 were adjudicated and confirmed by the Clinical Endpoint Committee, WHF/deaths after Day 5 through Day 14 and readmission through Day 14 were as reported by the investigators.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1744', 'groupId': 'OG000'}, {'value': '894', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serelaxin + Standard of Care', 'description': 'Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '87'}, {'value': '91', 'groupId': 'OG001', 'lowerLimit': '89', 'upperLimit': '93'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '5 days', 'description': 'Persistent or non-improvement in any signs or symptoms of HF at any post baseline visit up to Day 5.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (only evaluable patients with non-missing information included)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1740', 'groupId': 'OG000'}, {'value': '889', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serelaxin + Standard of Care', 'description': 'Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '34', 'upperLimit': '38'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '47'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '14 days', 'description': 'Renal deterioration is defined as \\> or = 0.3 mg/dL increase from screening in serum creatinine.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (only evaluable patients with non-missing information included)'}, {'type': 'SECONDARY', 'title': 'Length of Index Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1756', 'groupId': 'OG000'}, {'value': '894', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serelaxin + Standard of Care', 'description': 'Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.'}], 'classes': [{'categories': [{'measurements': [{'value': '251.28', 'spread': '162.368', 'groupId': 'OG000'}, {'value': '243.59', 'spread': '160.270', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1392', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '30 Days', 'description': 'Length of stay (in hours) is defined as the index hospitalization discharge date and time minus the index hospitalization start date and time.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1729', 'groupId': 'OG000'}, {'value': '894', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serelaxin + Standard of Care', 'description': 'Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.'}], 'classes': [{'title': 'Patients with any AE through Day 5', 'categories': [{'measurements': [{'value': '58.13', 'groupId': 'OG000'}, {'value': '56.04', 'groupId': 'OG001'}]}]}, {'title': 'Patients with any SAE through Day 14', 'categories': [{'measurements': [{'value': '12.38', 'groupId': 'OG000'}, {'value': '11.97', 'groupId': 'OG001'}]}]}, {'title': 'All cause deaths through Day 5', 'categories': [{'measurements': [{'value': '0.58', 'groupId': 'OG000'}, {'value': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'All cause deaths through Day 14', 'categories': [{'measurements': [{'value': '1.91', 'groupId': 'OG000'}, {'value': '2.01', 'groupId': 'OG001'}]}]}, {'title': 'All cause deaths through Day 30', 'categories': [{'measurements': [{'value': '3.30', 'groupId': 'OG000'}, {'value': '4.25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health-related Quality of Life Index Value, Assessed by EuroQoL EQ-5D-5L Questionnaire.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1545', 'groupId': 'OG000'}, {'value': '793', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Serelaxin + Standard of Care', 'description': 'Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.'}], 'classes': [{'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1545', 'groupId': 'OG000'}, {'value': '793', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.298', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.292', 'groupId': 'OG001'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1486', 'groupId': 'OG000'}, {'value': '756', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.328', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.317', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3115', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Day 5', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1236', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Day 14', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 5, Day 14', 'description': 'EQ-5D-5L is a questionnaire designed to assess health status in adults consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The results were converted into a single index value using UK as the reference country for all countries. Range -0.3 (worst possible state) to 1 (best possible state).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (only evaluable patients with non-missing information included)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Serelaxin + Standard of Care', 'description': 'Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.'}, {'id': 'FG001', 'title': 'Standard of Care (SOC)', 'description': 'All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'All Randomized Participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1756'}, {'groupId': 'FG001', 'numSubjects': '894'}]}, {'type': 'Full Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1756'}, {'groupId': 'FG001', 'numSubjects': '894'}]}, {'type': 'Safety Set', 'achievements': [{'comment': 'The Safety Set includes one patient not randomized but treated with serelaxin', 'groupId': 'FG000', 'numSubjects': '1729'}, {'groupId': 'FG001', 'numSubjects': '894'}]}, {'type': 'Per Protocol Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1155'}, {'groupId': 'FG001', 'numSubjects': '627'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1722'}, {'groupId': 'FG001', 'numSubjects': '881'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Technical Problems or Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'The initial target was to randomize 3183 patients. This study was prematurely terminated (due to the neutral read-out of study RELAX-AHF-2) after 2666 patients were randomized. 16 patients had not qualified for randomization but were inadvertently randomized. These 16 patients did not enter the treatment phase and were not counted as started.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1756', 'groupId': 'BG000'}, {'value': '894', 'groupId': 'BG001'}, {'value': '2650', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Serelaxin + Standard of Care', 'description': 'Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.'}, {'id': 'BG001', 'title': 'Standard of Care (SOC)', 'description': 'All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.24', 'spread': '10.349', 'groupId': 'BG000'}, {'value': '75.95', 'spread': '9.905', 'groupId': 'BG001'}, {'value': '75.48', 'spread': '10.205', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '760', 'groupId': 'BG000'}, {'value': '383', 'groupId': 'BG001'}, {'value': '1143', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '996', 'groupId': 'BG000'}, {'value': '511', 'groupId': 'BG001'}, {'value': '1507', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Full Analysis Set'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '1706', 'groupId': 'BG000'}, {'value': '869', 'groupId': 'BG001'}, {'value': '2575', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Full Analysis Set'}], 'populationDescription': 'Full Analysis Set'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-19', 'size': 884472, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-04-24T09:21', 'hasProtocol': True}, {'date': '2017-02-27', 'size': 928873, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-04-24T09:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2666}}, 'statusModule': {'whyStopped': 'Study was terminated based on results from pivotal adult AHF study CRLX030A2301', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-18', 'studyFirstSubmitDate': '2014-02-14', 'resultsFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2014-02-14', 'lastUpdatePostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-18', 'studyFirstPostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Worsening Heart Failure (WHF) / All Cause of Deaths Through Day 5', 'timeFrame': '5 days', 'description': 'In-hospital WHF through Day 5 post-randomization included worsening signs and/or symptoms of heart failure that required an intensification of intravenous therapy for heart failure or mechanical ventilation, renal or circulatory support. A central event adjudication committee was appointed to oversee the WHF primary endpoint adjudication.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With In-hospital Worsening Heart Failure/All-Cause Death/Readmission for Heart Failure Through Day 14', 'timeFrame': '14 days', 'description': 'WHF/death/readmission for heart failure through Day 14. WHF/deaths through Day 5 were adjudicated and confirmed by the Clinical Endpoint Committee, WHF/deaths after Day 5 through Day 14 and readmission through Day 14 were as reported by the investigators.'}, {'measure': 'Percentage of Participants With Persistent Sign or Symptoms of Heart Failure / Non-Improvement at Any Post Baseline Visit Through Day 5', 'timeFrame': '5 days', 'description': 'Persistent or non-improvement in any signs or symptoms of HF at any post baseline visit up to Day 5.'}, {'measure': 'Percentage of Participants With Renal Deterioration at Any Post Baseline Visit Through Day 14', 'timeFrame': '14 days', 'description': 'Renal deterioration is defined as \\> or = 0.3 mg/dL increase from screening in serum creatinine.'}, {'measure': 'Length of Index Hospital Stay', 'timeFrame': '30 Days', 'description': 'Length of stay (in hours) is defined as the index hospitalization discharge date and time minus the index hospitalization start date and time.'}, {'measure': 'Percentage of Participants With Adverse Events as Assessment of Safety and Tolerability of Serelaxin in AHF Patients', 'timeFrame': 'Adverse Events (AE): 5 Days / Serious Adverse Events (SAE): 14 days / All cause deaths 30 days'}, {'measure': 'Change From Baseline in Health-related Quality of Life Index Value, Assessed by EuroQoL EQ-5D-5L Questionnaire.', 'timeFrame': 'Baseline, Day 5, Day 14', 'description': 'EQ-5D-5L is a questionnaire designed to assess health status in adults consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The results were converted into a single index value using UK as the reference country for all countries. Range -0.3 (worst possible state) to 1 (best possible state).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AHF,', 'RLX030,', 'SOC,', 'WHF,', 'RELAX-AHF-EU', 'Renal Impairment'], 'conditions': ['Acute Heart Failure (AHF)']}, 'referencesModule': {'references': [{'pmid': '35184572', 'type': 'DERIVED', 'citation': 'Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.'}, {'pmid': '34514815', 'type': 'DERIVED', 'citation': 'Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.'}]}, 'descriptionModule': {'briefSummary': 'This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF).', 'detailedDescription': 'This study was aimed at generating clinical evidence, especially on the short term period (in-hospital and at 30 days) to complement existing and future serelaxin data sets in Acute Heart Failure (AHF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Systolic blood pressure ≥ 125 mmHg\n* Admitted for Acute Heart Failure (AHF)\n* Received intravenous furosemide (or equivalent) at any time between presentation and the start of screening\n* eGFR on admission: ≥ 25 and ≤75 mL/min/1.73 m\\^2\n\nExclusion Criteria:\n\n* Dyspnea (non-cardiac causes)\n* T \\> 38.5°C\n* Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.\n* Significant left ventricular outflow obstruction, uncorrected, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area \\<1.0 cm\\^2 or mean gradient \\>50 mmHg on prior or current echocardiogram), severe aortic regurgitation and severe mitral stenosis.\n* AHF due to significant arrhythmias\n* Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).'}, 'identificationModule': {'nctId': 'NCT02064868', 'acronym': 'RELAX-AHF-EU', 'briefTitle': 'Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Prospective, Randomized, Open-label Study to Assess the Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients', 'orgStudyIdInfo': {'id': 'CRLX030A3301'}, 'secondaryIdInfos': [{'id': '2013-002513-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Serelaxin + Standard of Care', 'description': 'Serelaxin (30 µg/kg/day) as continuous 48 hour intravenous infusion plus standard of care.', 'interventionNames': ['Drug: Serelaxin', 'Drug: Standard of Care']}, {'type': 'OTHER', 'label': 'Standard of Care (SOC)', 'description': 'All patients were required to receive standard of care background heart failure (HF) management during the study, according to local guidelines/international standards. This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.', 'interventionNames': ['Drug: Standard of Care']}], 'interventions': [{'name': 'Serelaxin', 'type': 'DRUG', 'otherNames': ['RLX030'], 'description': '30 µg/kg/day IV infusion', 'armGroupLabels': ['Serelaxin + Standard of Care']}, {'name': 'Standard of Care', 'type': 'DRUG', 'description': 'This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.', 'armGroupLabels': ['Serelaxin + Standard of Care', 'Standard of Care (SOC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-6807', 'city': 'Feldkirch', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.23306, 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