Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-31 @ 1:13 PM
Study NCT ID:
NCT04157751
Status:
COMPLETED
Last Update Posted:
2022-07-19
First Post:
2019-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Test the Effect of Empagliflozin in Patients Who Are in Hospital for Acute Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim', 'organization': 'Boehringer Ingelheim, Call Centre'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '[All-cause Mortality]: From first study drug intake until end of follow-up, up to 202 days. [Serious and Other Adverse Event]: From first study drug intake until 7 days after last intake of study medication, up to 127 days.', 'description': '\\[All-cause Mortality\\]: Randomised Set (RS) including all randomised patients. \\[Serious and Other Adverse Events\\]: Treated Set (TS), consisting of all patients treated with at least once dose of trial medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': '1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.', 'otherNumAtRisk': 264, 'deathsNumAtRisk': 265, 'otherNumAffected': 19, 'seriousNumAtRisk': 264, 'deathsNumAffected': 22, 'seriousNumAffected': 115}, {'id': 'EG001', 'title': '10 mg Empagliflozin', 'description': '1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.', 'otherNumAtRisk': 260, 'deathsNumAtRisk': 265, 'otherNumAffected': 20, 'seriousNumAtRisk': 260, 'deathsNumAffected': 11, 'seriousNumAffected': 84}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 20}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 25}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac ventricular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chronic left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Coronary ostial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Silent myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrointestinal arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Mesenteric arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vascular stent stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Congestive hepatopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infectious pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infective exacerbation of chronic obstructive airways disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Klebsiella infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dislocation of vertebra', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Eye injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Troponin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Carotid artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Carotid artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cauda equina syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Monoplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Paraplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 264, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 260, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Pairwise Comparisons With Wins of Clinical Benefit, a Composite of Death, Number of Heart Failure Events (HFEs), Time to the First HFE and ≥5-point Difference in CfB in KCCQ-TSS After 90 Days of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}, {'units': 'Pairwise comparisons', 'counts': [{'value': '39162', 'groupId': 'OG000'}, {'value': '39162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.'}, {'id': 'OG001', 'title': '10 mg Empagliflozin', 'description': '1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.'}], 'classes': [{'title': 'Time to death', 'categories': [{'measurements': [{'value': '4.01', 'groupId': 'OG000'}, {'value': '7.15', 'groupId': 'OG001'}]}]}, {'title': 'Frequency of HFEs', 'categories': [{'measurements': [{'value': '7.65', 'groupId': 'OG000'}, {'value': '10.59', 'groupId': 'OG001'}]}]}, {'title': 'Time to HFE', 'categories': [{'measurements': [{'value': '0.57', 'groupId': 'OG000'}, {'value': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'KCCQ-TSS change from baseline (>=5-point difference)', 'categories': [{'measurements': [{'value': '27.48', 'groupId': 'OG000'}, {'value': '35.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Win Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.36', 'ciLowerLimit': '1.09', 'ciUpperLimit': '1.68', 'pValueComment': 'p-value for WR\\<=1.0 (one-sided), variance calculated using the asymptotic normal U statistics approach.', 'estimateComment': 'WR estimate= \\[((a)+(c)+(e)+(g)) / ((b)+(d)+(f)+(h))\\]', 'groupDescription': 'Stratified win ratio (WR) was used, calculated as total number of wins in the empa group across all strata divided by total number of losses. Weights were applied analogous to a Mantel-Haenszel approach.\n\n1. death in pbo first;\n2. death in empa first;\n3. HFEs in pbo more frequently;\n4. HFEs in empa more frequently;\n5. HFEs in pbo first;\n6. HFEs in empa first;\n7. KCCQ-TSS change lower in pbo;\n8. KCCQ-TSS change lower in empa', 'statisticalMethod': 'Asymptotic normal U statistics approach', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 90 days. For KCCQ-TSS: at baseline and at day 90.', 'description': 'Clinical benefit, a composite of death, number of HFEs, time to first HFE and change from baseline (CfB) in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) after 90 days of treatment. All patients randomised to empagliflozin are compared to all patients randomised to placebo within strata. For any two patients, a patient will win, i.e. achieve a better clinical outcome, as determined by assessing the following criteria sequentially, stopping when an advantage for either patient is shown:\n\n1. Death: death is worse than no death; earlier death is worse; tied if not possible to determine.\n2. Number of HFEs: more HFEs is worse; tied, if same number of HFEs.\n3. Time to first HFE: earlier HFE is worse; tied, if not possible to determine.\n4. KCCQ-TSS CfB at Day 90: more positive CfB is better; the threshold for the difference is \\>= 5 for a win; tied, if difference \\< 5.\n\nThe KCCQ-TSS ranges from 0 to 100, where a higher score reflects a better outcome.\n\npct. = percentage', 'unitOfMeasure': 'pct. (%) of winning pairwise comparisons', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Pairwise comparisons', 'denomUnitsSelected': 'Pairwise comparisons', 'populationDescription': 'Randomised Set (RS), including all randomised patients.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improvement of at Least 10 Points in KCCQ-TSS After 90 Days of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.'}, {'id': 'OG001', 'title': '10 mg Empagliflozin', 'description': '1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0970', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.522', 'ciLowerLimit': '0.927', 'ciUpperLimit': '2.501', 'pValueComment': 'p-value for OR=1.0 (two-sided).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.386', 'estimateComment': 'Comparison vs. Placebo.', 'groupDescription': 'Logistic regression including terms for baseline KCCQ-TSS, treatment and heart failure status', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Wald Confidence interval.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At baseline and at day 90.', 'description': 'Number of participants with improvement of at least 10 points in Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) from baseline after 90 days of treatment.\n\nThe Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire that includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy. The symptom frequency and symptom burden domains are merged into the total symptom score. Scores are represented on a 0-to-100-point scale, where a higher score reflects a better health status.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS), including all randomised patients.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in KCCQ-TSS After 90 Days of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.'}, {'id': 'OG001', 'title': '10 mg Empagliflozin', 'description': '1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.73', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '36.19', 'spread': '1.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0347', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of adjusted mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.45', 'ciLowerLimit': '0.32', 'ciUpperLimit': '8.59', 'pValueComment': 'p-value for difference = 0 (two-sided)', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.10', 'groupDescription': 'Restricted maximum likelihood estimation based on a mixed-effect model for repeated measures (MMRM) analysis to obtain adjusted means for the treatment effects. This model included discrete fixed effects for treatment group, and heart failure status at each visit and continuous fixed effects for baseline value at each visit. Missing data caused by patient withdrawal or other reasons were handled implicitly by the MMRM approach. Unstructured covariance structure was used.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline, at day 15, 30 and at day 90.', 'description': 'Change from baseline in Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS).\n\nThe Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire that includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy. The symptom frequency and symptom burden domains are merged into the total symptom score. The score is represented on a 0-to-100-point scale, where a higher score reflects a better health status.\n\nChange from baseline in KCCQ-TSS at day 90 was modeled using a MMRM with visit (day 15 and day 30) as repeated measures, adjusted mean (standard error) after 90 days of treatment is reported.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the randomised set (RS) and with non-missing data for this endpoint. Observed case including data after treatment discontinuation (OC-AD).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Log-transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) Area Under the Curve (AUC) Over 30 Days of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.'}, {'id': 'OG001', 'title': '10 mg Empagliflozin', 'description': '1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.77', 'groupId': 'OG000', 'lowerLimit': '25.15', 'upperLimit': '28.48'}, {'value': '24.07', 'groupId': 'OG001', 'lowerLimit': '22.61', 'upperLimit': '25.62'}]}]}], 'analyses': [{'pValue': '0.0176', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.82', 'ciUpperLimit': '0.98', 'estimateComment': 'Comparison vs. Placebo', 'groupDescription': 'Area under the curve (AUC) of change from baseline in log-transformed NT-proBNP level over 30 days of treatment was analysed by an analysis of covariance (ANCOVA). NT-proBNP level is regarded as log-normally distributed, therefore values were log-transformed prior to analysis. The linear trapezoidal rule was used to calculate the AUC after the log-transformation had been applied to each value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'ANCOVA with a discrete fixed effect for heart failure status and a continuous fixed effect for baseline NT-proBNP level.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline to day 30.', 'description': 'Change from baseline in log-transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) Area under the curve (AUC) over 30 days of treatment is reported.', 'unitOfMeasure': 'Picogram/milliliter * days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included the randomised set (RS), and with non-missing data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Days Alive and Out of Hospital (DAOH) From Study Drug Initiation Until 30 Days After Initial Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.'}, {'id': 'OG001', 'title': '10 mg Empagliflozin', 'description': '1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.90', 'spread': '21.25', 'groupId': 'OG000'}, {'value': '81.37', 'spread': '18.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 30 days after initial hospital discharge.', 'description': 'The follow-up time for DAOH analyses was defined as 30 days after initial hospital discharge, or time between initial hospital discharge and date of censoring for non-fatal events except for patients who died within the first 30 days, where 30 days was considered as the DAOH follow-up time.\n\nDAOH for each patient was calculated as follow-up time subtracted by the number of days in hospital during the 30 days after initial hospital discharge as well as the number of days being dead within the 30 days. Percentage DAOH was defined as DAOH divided by the DAOH follow-up time of each patient multiplied by 100.', 'unitOfMeasure': 'DAOH in percentage (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included the treated set (TS), and with non-missing data for this endpoint. TS includes all patients treated with at least one dose of trial medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Days Alive and Out of Hospital (DAOH) From Study Drug Initiation Until 90 Days After Randomisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.'}, {'id': 'OG001', 'title': '10 mg Empagliflozin', 'description': '1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.79', 'spread': '22.76', 'groupId': 'OG000'}, {'value': '87.55', 'spread': '19.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 90 days after randomisation.', 'description': 'The follow-up time for DAOH analyses was defined as 90 days after randomisation, or time between randomisation and date of censoring for non-fatal events except for patients who died within the first 90 days, where 90 days was considered as the DAOH follow-up time. DAOH for each patient was calculated as follow-up time subtracted by the number of days in hospital during the 90 days after randomisation as well as the number of days being dead within the first 90 days.\n\nPercentage DAOH was defined as DAOH divided by the DAOH follow-up time of each patient multiplied by 100.', 'unitOfMeasure': 'DAOH in percentage (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the treated set (TS) and with non-missing data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of First Occurrence of Cardiovascular (CV) Death or Heart Failure Event (HFE) Until End of Trial Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.'}, {'id': 'OG001', 'title': '10 mg Empagliflozin', 'description': '1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.81', 'groupId': 'OG000', 'lowerLimit': '58.11', 'upperLimit': '102.62'}, {'value': '55.01', 'groupId': 'OG001', 'lowerLimit': '38.10', 'upperLimit': '74.99'}]}]}], 'analyses': [{'pValue': '0.1241', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.46', 'ciUpperLimit': '1.10', 'pValueComment': 'p-value for HR=1.0 (two sided)', 'estimateComment': 'Comparison vs. Placebo.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Cox proportional hazard model with terms for heart failure status and treatment.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 127 days.', 'description': 'Incidence rate of first occurrence of CV death or HFE until end of trial visit per 100 patient-year (pt-yrs) at risk is reported.\n\nIncidence rate per 100 pt-yrs = 100\\* number of patients with event / time at risk \\[years\\].', 'unitOfMeasure': 'Patients with events / 100pt-yrs at risk', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS), including all randomised patients.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hospitalization for Heart Failure (HHF) Until 30 Days After Initial Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.'}, {'id': 'OG001', 'title': '10 mg Empagliflozin', 'description': '1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 30 days after initial hospital discharge.', 'description': 'Number of participants with hospitalization for heart failure (HHF) until 30 days after initial hospital discharge.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS), including all randomised patients.'}, {'type': 'SECONDARY', 'title': 'Composite Renal Endpoint: Number of Participants With Chronic Dialysis, Renal Transplant, Sustained Reduction in eGFR(CKD-EPI)cr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.'}, {'id': 'OG001', 'title': '10 mg Empagliflozin', 'description': '1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 90 days.', 'description': 'The occurrence of the composite renal endpoint:\n\n* chronic dialysis (with a frequency of twice per week or more for at least 90 days), or\n* renal transplant, or\n* sustained reduction in Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) from baseline of ≥40%, or\n* sustained eGFR \\[mL/min/1.73 m2\\] \\<15 and baseline value ≥30, or\n* sustained eGFR \\<10 and baseline value \\<30; is reported by number of participants with component events. (These events may have occurred after the endpoint was already met. Combinations may not have occurred on the same day).\n\nSustained was determined by 2 or more consecutive post-baseline central laboratory measurements separated by at least 30 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS), including all randomised patients.'}, {'type': 'SECONDARY', 'title': 'Weight Change Per Mean Daily Loop Diuretic Dose After 15 Days of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.'}, {'id': 'OG001', 'title': '10 mg Empagliflozin', 'description': '1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.43', 'spread': '23.46', 'groupId': 'OG000'}, {'value': '-4.45', 'spread': '16.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and at day 15.', 'description': 'Diuretic effect as assessed by weight change per mean daily loop diuretic dose after 15 days of treatment.\n\nDiuretic dose = 40 mg intravenous furosemide or 80 mg oral furosemide.\n\nAbbreviation:\n\nKg: Kilogram', 'unitOfMeasure': 'Kg per loop diuretic dose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the randomised set (RS) and with non-missing values for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Weight Change Per Mean Daily Loop Diuretic Dose After 30 Days of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.'}, {'id': 'OG001', 'title': '10 mg Empagliflozin', 'description': '1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.69', 'spread': '21.74', 'groupId': 'OG000'}, {'value': '-6.91', 'spread': '25.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and at day 30.', 'description': 'Diuretic effect as assessed by weight change per mean daily loop diuretic dose after 30 days of treatment.\n\nDiuretic dose = 40 mg intravenous furosemide or 80 mg oral furosemide\n\nAbbreviation:\n\nKg: Kilogram', 'unitOfMeasure': 'Kg per loop diuretic dose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in the randomised set (RS) and with non-missing values for this endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.'}, {'id': 'FG001', 'title': '10 mg Empagliflozin', 'description': '1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomised', 'achievements': [{'groupId': 'FG000', 'numSubjects': '265'}, {'groupId': 'FG001', 'numSubjects': '265'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}, {'groupId': 'FG001', 'numSubjects': '260'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '202'}, {'groupId': 'FG001', 'numSubjects': '208'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other reason not stated above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'A multicentre, randomised, double-blind trial to assess whether in-hospital administration of empagliflozin results in improvement in heart failure-related outcomes compared to placebo in patients with acute heart failure.', 'preAssignmentDetails': 'All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '1 film-coated tablet of placebo matching 10 mg empagliflozin was administered orally once daily in patients with acute heart failure.'}, {'id': 'BG001', 'title': '10 mg Empagliflozin', 'description': '1 film-coated tablet of 10 milligram (mg) of empagliflozin was administered orally once daily in patients with acute heart failure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68.1', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '68.9', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '68.5', 'spread': '13.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '256', 'groupId': 'BG000'}, {'value': '259', 'groupId': 'BG001'}, {'value': '515', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '530', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '57', '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': '33', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '211', 'groupId': 'BG001'}, {'value': '413', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Kansas City cardiomyopathy questionnaire-Total symptom score (KCCQ-TSS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '526', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '41.91', 'spread': '23.98', 'groupId': 'BG000'}, {'value': '39.71', 'spread': '24.06', 'groupId': 'BG001'}, {'value': '40.81', 'spread': '24.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire that includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy. The symptom frequency and symptom burden domains are merged into a total symptom score. Scores are represented on a 0-to-100-point scale, where a higher score reflects a better health status. KCCQ-TSS at baseline is reported. Only participants in the randomised set and with non-missing data are included.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Only participants in the randomised set and with non-missing data are included.'}], 'populationDescription': 'Randomised Set (RS), including all randomised patients.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-04', 'size': 859019, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-05-09T03:55', 'hasProtocol': True}, {'date': '2021-03-11', 'size': 445386, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-05-09T03:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 530}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-28', 'studyFirstSubmitDate': '2019-11-04', 'resultsFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-10', 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Pairwise Comparisons With Wins of Clinical Benefit, a Composite of Death, Number of Heart Failure Events (HFEs), Time to the First HFE and ≥5-point Difference in CfB in KCCQ-TSS After 90 Days of Treatment', 'timeFrame': 'Up to 90 days. For KCCQ-TSS: at baseline and at day 90.', 'description': 'Clinical benefit, a composite of death, number of HFEs, time to first HFE and change from baseline (CfB) in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) after 90 days of treatment. All patients randomised to empagliflozin are compared to all patients randomised to placebo within strata. For any two patients, a patient will win, i.e. achieve a better clinical outcome, as determined by assessing the following criteria sequentially, stopping when an advantage for either patient is shown:\n\n1. Death: death is worse than no death; earlier death is worse; tied if not possible to determine.\n2. Number of HFEs: more HFEs is worse; tied, if same number of HFEs.\n3. Time to first HFE: earlier HFE is worse; tied, if not possible to determine.\n4. KCCQ-TSS CfB at Day 90: more positive CfB is better; the threshold for the difference is \\>= 5 for a win; tied, if difference \\< 5.\n\nThe KCCQ-TSS ranges from 0 to 100, where a higher score reflects a better outcome.\n\npct. = percentage'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Improvement of at Least 10 Points in KCCQ-TSS After 90 Days of Treatment', 'timeFrame': 'At baseline and at day 90.', 'description': 'Number of participants with improvement of at least 10 points in Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) from baseline after 90 days of treatment.\n\nThe Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire that includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy. The symptom frequency and symptom burden domains are merged into the total symptom score. Scores are represented on a 0-to-100-point scale, where a higher score reflects a better health status.'}, {'measure': 'Change From Baseline in KCCQ-TSS After 90 Days of Treatment', 'timeFrame': 'At baseline, at day 15, 30 and at day 90.', 'description': 'Change from baseline in Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS).\n\nThe Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire that includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life and self-efficacy. The symptom frequency and symptom burden domains are merged into the total symptom score. The score is represented on a 0-to-100-point scale, where a higher score reflects a better health status.\n\nChange from baseline in KCCQ-TSS at day 90 was modeled using a MMRM with visit (day 15 and day 30) as repeated measures, adjusted mean (standard error) after 90 days of treatment is reported.'}, {'measure': 'Change From Baseline in Log-transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) Area Under the Curve (AUC) Over 30 Days of Treatment', 'timeFrame': 'From baseline to day 30.', 'description': 'Change from baseline in log-transformed N-Terminal Pro-Brain Natriuretic Peptide (NTproBNP) Area under the curve (AUC) over 30 days of treatment is reported.'}, {'measure': 'Percentage of Days Alive and Out of Hospital (DAOH) From Study Drug Initiation Until 30 Days After Initial Hospital Discharge', 'timeFrame': 'Up to 30 days after initial hospital discharge.', 'description': 'The follow-up time for DAOH analyses was defined as 30 days after initial hospital discharge, or time between initial hospital discharge and date of censoring for non-fatal events except for patients who died within the first 30 days, where 30 days was considered as the DAOH follow-up time.\n\nDAOH for each patient was calculated as follow-up time subtracted by the number of days in hospital during the 30 days after initial hospital discharge as well as the number of days being dead within the 30 days. Percentage DAOH was defined as DAOH divided by the DAOH follow-up time of each patient multiplied by 100.'}, {'measure': 'Percentage of Days Alive and Out of Hospital (DAOH) From Study Drug Initiation Until 90 Days After Randomisation', 'timeFrame': 'Up to 90 days after randomisation.', 'description': 'The follow-up time for DAOH analyses was defined as 90 days after randomisation, or time between randomisation and date of censoring for non-fatal events except for patients who died within the first 90 days, where 90 days was considered as the DAOH follow-up time. DAOH for each patient was calculated as follow-up time subtracted by the number of days in hospital during the 90 days after randomisation as well as the number of days being dead within the first 90 days.\n\nPercentage DAOH was defined as DAOH divided by the DAOH follow-up time of each patient multiplied by 100.'}, {'measure': 'Incidence Rate of First Occurrence of Cardiovascular (CV) Death or Heart Failure Event (HFE) Until End of Trial Visit', 'timeFrame': 'Up to 127 days.', 'description': 'Incidence rate of first occurrence of CV death or HFE until end of trial visit per 100 patient-year (pt-yrs) at risk is reported.\n\nIncidence rate per 100 pt-yrs = 100\\* number of patients with event / time at risk \\[years\\].'}, {'measure': 'Number of Participants With Hospitalization for Heart Failure (HHF) Until 30 Days After Initial Hospital Discharge', 'timeFrame': 'Up to 30 days after initial hospital discharge.', 'description': 'Number of participants with hospitalization for heart failure (HHF) until 30 days after initial hospital discharge.'}, {'measure': 'Composite Renal Endpoint: Number of Participants With Chronic Dialysis, Renal Transplant, Sustained Reduction in eGFR(CKD-EPI)cr', 'timeFrame': 'Up to 90 days.', 'description': 'The occurrence of the composite renal endpoint:\n\n* chronic dialysis (with a frequency of twice per week or more for at least 90 days), or\n* renal transplant, or\n* sustained reduction in Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) from baseline of ≥40%, or\n* sustained eGFR \\[mL/min/1.73 m2\\] \\<15 and baseline value ≥30, or\n* sustained eGFR \\<10 and baseline value \\<30; is reported by number of participants with component events. (These events may have occurred after the endpoint was already met. Combinations may not have occurred on the same day).\n\nSustained was determined by 2 or more consecutive post-baseline central laboratory measurements separated by at least 30 days.'}, {'measure': 'Weight Change Per Mean Daily Loop Diuretic Dose After 15 Days of Treatment', 'timeFrame': 'At baseline and at day 15.', 'description': 'Diuretic effect as assessed by weight change per mean daily loop diuretic dose after 15 days of treatment.\n\nDiuretic dose = 40 mg intravenous furosemide or 80 mg oral furosemide.\n\nAbbreviation:\n\nKg: Kilogram'}, {'measure': 'Weight Change Per Mean Daily Loop Diuretic Dose After 30 Days of Treatment', 'timeFrame': 'At baseline and at day 30.', 'description': 'Diuretic effect as assessed by weight change per mean daily loop diuretic dose after 30 days of treatment.\n\nDiuretic dose = 40 mg intravenous furosemide or 80 mg oral furosemide\n\nAbbreviation:\n\nKg: Kilogram'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '40526444', 'type': 'DERIVED', 'citation': 'Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Jun 17. doi: 10.1681/ASN.0000000766. Online ahead of print. No abstract available.'}, {'pmid': '37540060', 'type': 'DERIVED', 'citation': 'Ferreira JP, Blatchford JP, Teerlink JR, Kosiborod MN, Angermann CE, Biegus J, Collins SP, Tromp J, Nassif ME, Psotka MA, Comin-Colet J, Mentz RJ, Brueckmann M, Nordaby M, Ponikowski P, Voors AA. Mineralocorticoid receptor antagonist use and the effects of empagliflozin on clinical outcomes in patients admitted for acute heart failure: Findings from EMPULSE. Eur J Heart Fail. 2023 Oct;25(10):1797-1805. doi: 10.1002/ejhf.2982. Epub 2023 Aug 22.'}, {'pmid': '35377706', 'type': 'DERIVED', 'citation': 'Kosiborod MN, Angermann CE, Collins SP, Teerlink JR, Ponikowski P, Biegus J, Comin-Colet J, Ferreira JP, Mentz RJ, Nassif ME, Psotka MA, Tromp J, Brueckmann M, Blatchford JP, Salsali A, Voors AA. Effects of Empagliflozin on Symptoms, Physical Limitations, and Quality of Life in Patients Hospitalized for Acute Heart Failure: Results From the EMPULSE Trial. Circulation. 2022 Jul 26;146(4):279-288. doi: 10.1161/CIRCULATIONAHA.122.059725. Epub 2022 Apr 4.'}, {'pmid': '35228754', 'type': 'DERIVED', 'citation': 'Voors AA, Angermann CE, Teerlink JR, Collins SP, Kosiborod M, Biegus J, Ferreira JP, Nassif ME, Psotka MA, Tromp J, Borleffs CJW, Ma C, Comin-Colet J, Fu M, Janssens SP, Kiss RG, Mentz RJ, Sakata Y, Schirmer H, Schou M, Schulze PC, Spinarova L, Volterrani M, Wranicz JK, Zeymer U, Zieroth S, Brueckmann M, Blatchford JP, Salsali A, Ponikowski P. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: a multinational randomized trial. Nat Med. 2022 Mar;28(3):568-574. doi: 10.1038/s41591-021-01659-1. Epub 2022 Feb 28.'}], 'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a study in adults who are in hospital for acute heart failure. The purpose of this study is to find out whether starting to take a medicine called empagliflozin soon after first being treated in hospital helps people with acute heart failure.\n\nParticipants are in the study for about 3 months. At the beginning, participants are still in hospital. Later, they visit the hospital about 3 times and get 1 phone call. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes\n\n1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. It is used to treat type 2 diabetes.\n\nDuring the study, the doctors check whether participants have additional heart failure events like needing to go to the hospital again because of heart failure. The participants answer questions about how their heart failure affects their life. We then compare the results between the empagliflozin and placebo groups. The doctors also regularly check the general health of the participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently hospitalised for the primary diagnosis of acute heart failure (de novo or decompensated chronic HF), regardless of ejection fraction (EF). Patients with a diagnosis of hospitalized heart failure must have HF symptoms at the time of hospital admission\n* Evidence of left ventricular ejection fraction (LVEF, either reduced or preserved EF) as per local reading preferably measured during current hospitalisation or in the 12 months prior to randomisation\n* Patients must be randomised after at least 24 hours and no later than 5 days after admission, as early as possible after stabilization and while still in hospital\n* Patients must fulfil the following stabilisation criteria (while in the hospital):\n\n * SBP ≥100mm Hg and no symptoms of hypotension in the preceding 6 hours,\n * no increase in i.v. diuretic dose for 6 hours prior to randomisation,\n * no i.v. vasodilators including nitrates within the last 6 hours prior to randomisation\n * no i.v. inotropic drugs for 24 hours prior to randomisation.\n* Elevated NT-proBNP ≥ 1600pg/mL or BNP ≥400 pg/mL according to the local lab, for patients without atrial fibrillation (AF); or elevated NT-proBNP ≥ 2400pg/mL or BNP ≥600 pg/mL for patients with AF, measured during the current hospitalization or in the 72 hours prior to hospital admission,. For patients treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the previous 4 weeks prior to randomisation, only NT-proBNP values should be used\n* HF episode leading to hospitalisation must have been treated with a minimum single dose of 40 mg of i.v. furosemide (or equivalent i.v. loop diuretic defined as 20 mg of torasemide or 1 mg of bumetanide)\n* Further Inclusion Criteria Apply\n\nExclusion Criteria:\n\n* Cardiogenic shock\n* Current hospitalisation for acute heart failure primarily triggered by pulmonary embolism, cerebrovascular accident, or acute myocardial infarction (AMI)\n* Current hospitalisation for acute heart failure not caused primarily by intravascular volume overload;\n* Below interventions in the past 30 days prior to randomisation or planned during the study:\n\n * Major cardiac surgery, or TAVI (Transcatheter Aortic Valve Implantation), or PCI, or Mitraclip\n * All other surgeries that are considered major according to investigator judgement\n * Implantation of cardiac resynchronisation therapy (CRT) device\n * cardiac mechanical support implantation\n * Carotid artery disease revascularisation (stent or surgery)\n* Acute coronary syndrome / myocardial infarction, stroke or transient ischemic attack (TIA) in the past 90 days prior to randomisation\n* Heart transplant recipient, or listed for heart transplant with expectation to receive a transplant during the course of this trial (according to investigator judgement), or planned for palliative care for HF, or currently using left ventricular assist device (LVAD) or intra-aortic balloon pump (IABP) or any other type of mechanical circulatory support, or patients on mechanical ventilation, or patients with planned inotropic support in an outpatient setting\n* Haemodynamically significant (severe) uncorrected primary cardiac valvular disease planned for surgery or intervention during the course of the study (note: secondary mitral regurgitation or tricuspid regurgitation due to dilated cardiomyopathy is not excluded unless planned for surgery or intervention during the course of the study)\n* Impaired renal function, defined as eGFR \\< 20 mL/min/1.73 m2 as measured during hospitalization (latest local lab measurement before randomisation) or requiring dialysis\n* Type 1 Diabetes Mellitus (T1DM)\n* History of ketoacidosis, including diabetic ketoacidosis (DKA)\n* Further Exclusion Criteria Apply'}, 'identificationModule': {'nctId': 'NCT04157751', 'briefTitle': 'A Study to Test the Effect of Empagliflozin in Patients Who Are in Hospital for Acute Heart Failure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Multicentre, Randomised, Double-blind, 90-day Superiority Trial to Evaluate the Effect on Clinical Benefit, Safety and Tolerability of Once Daily Oral EMPagliflozin 10 mg Compared to Placebo, Initiated in Patients Hospitalised for acUte Heart faiLure (de Novo or Decompensated Chronic HF) Who Have Been StabilisEd (EMPULSE)', 'orgStudyIdInfo': {'id': '1245-0204'}, 'secondaryIdInfos': [{'id': '2019-002946-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Empagliflozin', 'interventionNames': ['Drug: Empagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo to Empagliflozin']}], 'interventions': [{'name': 'Empagliflozin', 'type': 'DRUG', 'description': 'Film-coated tablet', 'armGroupLabels': ['Empagliflozin']}, {'name': 'Placebo to Empagliflozin', 'type': 'DRUG', 'description': 'Film-coated tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92865', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Cardiology Associates Research Co.', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '61603', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Methodist Medical Center', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'United Hospital', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '39216-4505', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University Of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Hospital of Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08318', 'city': 'Elmer', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cardiovascular Associates of the Delaware Valley', 'geoPoint': {'lat': 39.59511, 'lon': -75.17018}}, {'zip': '08080', 'city': 'Washington Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Jefferson Washington Township Hospital', 'geoPoint': {'lat': 40.98832, 'lon': -74.06358}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Erie County Medical Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11548', 'city': 'Greenvale', 'state': 'New York', 'country': 'United States', 'facility': 'The DeMatteis Center for Cardiac Research and Education', 'geoPoint': {'lat': 40.81066, 'lon': -73.62846}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook Medicine', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina Heart and Vascular', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73135', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'South Oklahoma Heart Research Group', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29401', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Ralph H. Johnson VA Medical Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '79109', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'Pharmatex Research', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Advanced Cardiac Care - Heart Failure Clinic', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Medical Campus', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Sentara Norfolk General Hospital', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '9300', 'city': 'Aalst', 'country': 'Belgium', 'facility': 'Aalst - HOSP Onze-Lieve-Vrouw', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Brussels - UNIV UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9200', 'city': 'Dendermonde', 'country': 'Belgium', 'facility': 'AZ Sint-Blasius', 'geoPoint': {'lat': 51.02869, 'lon': 4.10106}}, {'zip': '3600', 'city': 'Genk', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost-Limburg - Campus Sint-Jan', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Liège - HOSP CHR de la Citadelle', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '7000', 'city': 'Mons', 'country': 'Belgium', 'facility': 'UNIV Ambroise Paré', 'geoPoint': {'lat': 50.45413, 'lon': 3.95229}}, {'zip': 'V8R 1J8', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Royal Jubilee Hospital', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'R2H 2A6', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'St. Boniface General Hospital', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '100020', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Chao-Yang Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100029', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing AnZhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '130021', 'city': 'Changchun', 'country': 'China', 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '610041', 'city': 'Chengdu', 'country': 'China', 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '710061', 'city': "Xi'an", 'country': 'China', 'facility': "First Affiliated Hospital of Xi'an JiaoTong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '361004', 'city': 'Xiamen', 'country': 'China', 'facility': 'Xiamen Cardiovascular Hospital Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '639 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'University Hospital Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '65691', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Univ.Hosp U Svate Anny, I.Internal Clinic-Cardiology,Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '15006', 'city': 'Prague', 'country': 'Czechia', 'facility': 'University Hospital Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '390 03', 'city': 'Tábor', 'country': 'Czechia', 'facility': 'District Hospital, Tabor', 'geoPoint': {'lat': 49.41441, 'lon': 14.6578}}, {'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Aalborg Universitetsshospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '2000', 'city': 'Frederiksberg', 'country': 'Denmark', 'facility': 'Frederiksberg Hospital', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}, {'zip': '2733', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev and Gentofte Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Hvidovre Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '8800', 'city': 'Viborg', 'country': 'Denmark', 'facility': 'Viborg Regionhospital', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}, {'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '28277', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Herzzentrum Dresden GmbH Universitätsklinik', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '35392', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Universitätsklinikum Gießen und Marburg GmbH', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '07743', 'city': 'Jena', 'country': 'Germany', 'facility': 'Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '63225', 'city': 'Langen', 'country': 'Germany', 'facility': 'Asklepios Klinik Langen-Seligenstadt GmbH', 'geoPoint': {'lat': 49.98955, 'lon': 8.66852}}, {'zip': '51375', 'city': 'Leverkusen', 'country': 'Germany', 'facility': 'Klinikum Leverkusen gGmbH, Leverkusen', 'geoPoint': {'lat': 51.0303, 'lon': 6.98432}}, {'zip': '67063', 'city': 'Ludwigshafen', 'country': 'Germany', 'facility': 'Klinikum der Stadt Ludwigshafen am Rhein gGmbH', 'geoPoint': {'lat': 47.81663, 'lon': 9.06138}}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitätsklinikum Schleswig-Holstein, Campus Lübeck', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '97080', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Würzburg AÖR', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '1088', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis University', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'University Debrecen Hospital', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '7624', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'University of Pecs', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '6600', 'city': 'Szentes', 'country': 'Hungary', 'facility': 'Csongrad Country Dr Bugyi Istvan Hosp.', 'geoPoint': {'lat': 46.65834, 'lon': 20.2608}}, {'zip': '8000', 'city': 'Székesfehérvár', 'country': 'Hungary', 'facility': 'Fejer County Saint George University Teaching Hospital', 'geoPoint': {'lat': 47.18995, 'lon': 18.41034}}, {'zip': '25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'ASST degli Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '88100', 'city': 'Catanzaro', 'country': 'Italy', 'facility': 'Università degli Studi "Magna Grecia" - Campus "S. Venuta"', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'zip': '52040', 'city': 'Cortona', 'country': 'Italy', 'facility': 'Ospedale della Val di Chiana Santa Margherita', 'geoPoint': {'lat': 43.27467, 'lon': 11.98533}}, {'zip': '71100', 'city': 'Foggia', 'country': 'Italy', 'facility': 'Az.Osp. Universitaria "Ospedali Riuniti"', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'zip': '20138', 'city': 'Milan', 'country': 'Italy', 'facility': 'Centro Cardiologico Monzino-IRCCS', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'ASST Grande Ospedale Metropolitano Niguarda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '29121', 'city': 'Piacenza', 'country': 'Italy', 'facility': 'Osp. Guglielmo da Saliceto AUSL di Piacenza', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'zip': '00163', 'city': 'Roma', 'country': 'Italy', 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'AO Città della Salute e della', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '34124', 'city': 'Trieste', 'country': 'Italy', 'facility': 'Azienda Sanitaria Universitaria Giuliano Isontina', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'zip': '806-8501', 'city': 'Fukuoka, Kitakyushu', 'country': 'Japan', 'facility': 'Japan Community Health Care Organization Kyushu Hospital'}, {'zip': '311-3193', 'city': 'Ibaraki, Higashiibaraki-gun', 'country': 'Japan', 'facility': 'Mito Medical Center', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'zip': '236-0051', 'city': 'Kanagawa, Yokohama', 'country': 'Japan', 'facility': 'Kanagawa Cardiovascular and Respiratory Center'}, {'zip': '390-8621', 'city': 'Nagano, Matsumoto', 'country': 'Japan', 'facility': 'Shinshu University Hospital'}, {'zip': '700-0804', 'city': 'Okayama, Okayama', 'country': 'Japan', 'facility': 'The Sakakibara Heart Institute of Okayama'}, {'zip': '565-0871', 'city': 'Osaka, Suita', 'country': 'Japan', 'facility': 'Osaka University Hospital'}, {'zip': '333-0842', 'city': 'Saitama, Kawaguchi', 'country': 'Japan', 'facility': 'Kawaguchi Cardiovascular and Respiratory Hospital'}, {'zip': '350-1305', 'city': 'Saitama, Sayama', 'country': 'Japan', 'facility': 'Saitama Sekishikai Hospital'}, {'zip': '173-8610', 'city': 'Tokyo, Itabashi-ku', 'country': 'Japan', 'facility': 'Nihon University Itabashi Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '5223 GZ', 'city': "'s-Hertogenbosch", 'country': 'Netherlands', 'facility': 'Jeroen Bosch Ziekenhuis-Hertogenbosch', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'zip': '7334 DZ', 'city': 'Apeldoorn', 'country': 'Netherlands', 'facility': 'Gelre Ziekenhuizen Apeldoorn', 'geoPoint': {'lat': 52.21, 'lon': 5.96944}}, {'zip': '7824 AA', 'city': 'Emmen', 'country': 'Netherlands', 'facility': 'TREANT Zorggroep', 'geoPoint': {'lat': 52.77917, 'lon': 6.90694}}, {'zip': '2803 HH', 'city': 'Gouda', 'country': 'Netherlands', 'facility': 'Groene Hart ziekenhuis', 'geoPoint': {'lat': 52.01667, 'lon': 4.70833}}, {'zip': '9713 GZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '3844 DG', 'city': 'Harderwijk', 'country': 'Netherlands', 'facility': 'Sint Jansdal Ziekenhuis', 'geoPoint': {'lat': 52.34167, 'lon': 5.62083}}, {'zip': '2353 GA', 'city': 'Leiderdorp', 'country': 'Netherlands', 'facility': 'Alrijne Leiderdorp', 'geoPoint': {'lat': 52.15833, 'lon': 4.52917}}, {'zip': '4708 AE', 'city': 'Roosendaal', 'country': 'Netherlands', 'facility': 'Bravis ziekenhuis, locatie Roosendaal', 'geoPoint': {'lat': 51.53083, 'lon': 4.46528}}, {'zip': '2545 AA', 'city': 'The Hague', 'country': 'Netherlands', 'facility': 'HagaZiekenhuis', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '3582 KE', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Diakonessenhuis Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': 'N-6812', 'city': 'Førde', 'country': 'Norway', 'facility': 'Helse Førde HF, Førde Sentralsjukehus', 'geoPoint': {'lat': 61.45217, 'lon': 5.85717}}, {'zip': 'N-2609', 'city': 'Lillehammer', 'country': 'Norway', 'facility': 'Sykehuset Innlandet HF, Avd. Lillehammer', 'geoPoint': {'lat': 61.11514, 'lon': 10.46628}}, {'zip': 'N-1478', 'city': 'Lørenskog', 'country': 'Norway', 'facility': 'Akershus Universitetssykehus HF'}, {'zip': 'N-4011', 'city': 'Stavanger', 'country': 'Norway', 'facility': 'Helse Stavanger, Stavanger Universitetssykehus', 'geoPoint': {'lat': 58.97005, 'lon': 5.73332}}, {'zip': 'N-9019', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'Universitetssykehuset Nord-Norge, Tromsø', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'zip': '81348', 'city': 'Gdynia', 'country': 'Poland', 'facility': 'Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia', 'geoPoint': {'lat': 54.51889, 'lon': 18.53188}}, {'zip': '90549', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Card.Cli.Mil.Med.Ac.Uni.Cli.Hosp. Cent.Vetera.Hosp.Lodz', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '92-213', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Cent.Clin.Hosp.Med.Univ.Lodz,Electrocard', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '93-513', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Provincial Specialist M. Kopernik Hospital', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '30120', 'city': 'El Palmar', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 39.31305, 'lon': -0.3174}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'country': 'Spain', 'facility': 'Hospital de Bellvitge', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '28222', 'city': 'Majadahonda', 'country': 'Spain', 'facility': 'Hospital Puerta de Hierro', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '08970', 'city': 'Sant Joan Despí', 'country': 'Spain', 'facility': 'Hospital Moises Broggi', 'geoPoint': {'lat': 41.36718, 'lon': 2.0574}}, {'zip': '41014', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Nuestra Señora de Valme', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska US, Göteborg', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '416 85', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska Universitetssjukhuset, Östra', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}]}, 'ipdSharingStatementModule': {'url': 'https://www.mystudywindow.com/msw/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.', 'ipdSharing': 'YES', 'description': 'After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".\n\nAlso, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.\n\nThe data shared are the raw clinical study data sets.', 'accessCriteria': "For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}