Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}}}}, '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, Call Centre', 'organization': 'Boehringer Ingelheim'}, '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 study start until end of study, up to 1438 days. [Serious adverse events (AE) and other AE]:From time of the first drug intake until 7 days (Residual Effect Period) after the last drug intake, up to 1410 days.', 'description': '\\[All-cause mortality\\]: Randomised Set (RS), including all randomised patients. \\[Serious AE and other AE\\]: Treated Set (TS), including all patients treated with at least one dose of the study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': '1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).', 'otherNumAtRisk': 2989, 'deathsNumAtRisk': 2991, 'otherNumAffected': 1274, 'seriousNumAtRisk': 2989, 'deathsNumAffected': 427, 'seriousNumAffected': 1543}, {'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 chronic heart failure with preserved ejection fraction (HFpEF).', 'otherNumAtRisk': 2996, 'deathsNumAtRisk': 2997, 'otherNumAffected': 1191, 'seriousNumAtRisk': 2996, 'deathsNumAffected': 422, 'seriousNumAffected': 1436}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 164}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 119}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 156}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 137}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 160}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 207}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 193}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 189}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 200}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 139}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 194}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 170}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 208}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 131}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 181}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 177}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 248}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 212}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 176}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 212}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anaemia macrocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anaemia megaloblastic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypochromic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Immune thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lymphadenopathy mediastinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Splenic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 50}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Adams-Stokes syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 28}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 26}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 80}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 92}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bradyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac amyloidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 594}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 448}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 25}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 57}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac ventricular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiorenal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Chronic left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Chronotropic incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 22}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Coronary artery insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Left ventricular hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Mitral valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Mitral valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 37}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myocardial necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Angiomyolipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 17}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Benign gastric neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Benign neoplasm of bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Benign neoplasm of testis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Benign ovarian tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bladder papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bladder transitional cell carcinoma stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': "Bowen's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Brain cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Brain neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Breast cancer female', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cholesteatoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Clear cell renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Colon cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Colon cancer stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Endometrial adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Extranodal marginal zone B-cell lymphoma (MALT type)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastric adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastric neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastrointestinal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Gastrointestinal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Glomangiopericytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hepatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hepatic cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Intracranial tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Invasive ductal breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Invasive lobular breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Invasive papillary breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Keratinising squamous cell carcinoma of nasopharynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Laryngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Leiomyosarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lip squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lung adenocarcinoma stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lung carcinoma cell type unspecified recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 10}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lung squamous cell carcinoma stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Malignant neoplasm of renal pelvis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Malignant neoplasm of unknown primary site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Mantle cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Meningioma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Metastases to abdominal wall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Metastases to lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Metastases to peritoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Metastatic bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Metastatic malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Metastatic squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Monoclonal gammopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myxoid liposarcoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasal sinus cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngeal cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngeal tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Neuroendocrine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Neuroendocrine carcinoma of the skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Neuroendocrine tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Neuroendocrine tumour of the lung metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Non-small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oesophageal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oesophageal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oesophageal squamous cell carcinoma metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Ovarian neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pancreatic carcinoma', 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cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pituitary tumour benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 11}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Prostate cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Prostate cancer stage I', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Prostate cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Prostate cancer stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rectal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Rectal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Renal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Renal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Salivary gland cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Seminoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Skin cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Skin cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Small intestine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 7}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Squamous cell carcinoma of the oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Squamous cell carcinoma of the parotid gland', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'T-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thymoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thyroid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tongue neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tonsil cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Tumour haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vulval cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 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'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Heart valve replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Accelerated hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Angiodysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aortic thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bleeding varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dry gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Essential hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Femoral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Haemorrhagic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 26}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Iliac artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Penetrating aortic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Phlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2989, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2996, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2991', 'groupId': 'OG000'}, {'value': '2997', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).'}, {'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 chronic heart failure with preserved ejection fraction (HFpEF).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.67', 'groupId': 'OG000', 'lowerLimit': '7.94', 'upperLimit': '9.44'}, {'value': '6.86', 'groupId': 'OG001', 'lowerLimit': '6.22', 'upperLimit': '7.54'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.03', 'paramValue': '0.79', 'ciLowerLimit': '0.69', 'ciUpperLimit': '0.90', 'estimateComment': 'Comparison vs. Placebo \\[T/P\\]', 'groupDescription': 'Cox regression, with terms for treatment, region, baseline status of diabetes, age, sex, left ventricular ejection fraction (LVEF) and glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) at baseline.\n\nalpha=0.0497 (resulting from interim analysis).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'H0: There is no difference between the effect of placebo and the effect of empagliflozin.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until completion of the planned treatment phase, up to 1403 days.', 'description': 'Failure with preserved Ejection Fraction (HFpEF). The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:\n\nIncidence rate per 100 pt-yrs = 100 \\* number of patients with event / time at risk \\[years\\].\n\nTime at risk \\[years\\] = Sum of time at risk \\[days\\] over all patients in a treatment group / 365.25.\n\nPatients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.', 'unitOfMeasure': 'Patients with event/100 pt-yrs at risk', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS), including all randomised patients.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2991', 'groupId': 'OG000'}, {'value': '2997', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).'}, {'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 chronic heart failure with preserved ejection fraction (HFpEF).'}], 'classes': [{'categories': [{'measurements': [{'value': '541', 'groupId': 'OG000'}, {'value': '407', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.03', 'paramValue': '0.73', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.88', 'estimateComment': 'Comparison vs. Placebo \\[T/P\\]', 'groupDescription': 'Joint frailty model that accounts for dependence between recurrent HHF and cardiovascular death, with terms for age, baseline eGFR (CKD-EPK)cr, baseline LVEF, region, baseline diabetes status, sex, and treatment. eGFR (CKP-EPI)cr: Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement LVEF: Left ventricular ejection fraction. alpha=0.0497 (resulting from interim analysis).', 'statisticalMethod': 'Joint frailty model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'H0: There is no difference between the effect of placebo and the effect of empagliflozin.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until completion of the planned treatment phase, up to 1403 days.', 'description': 'Reported is the total number of adjudicated HHF events (first and recurrent) which occurred.', 'unitOfMeasure': 'HHF events', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS), including all randomised patients.'}, {'type': 'SECONDARY', 'title': 'eGFR (CKD-EPI) cr Slope of Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2911', 'groupId': 'OG000'}, {'value': '2925', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).'}, {'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 chronic heart failure with preserved ejection fraction (HFpEF).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.616', 'spread': '0.108', 'groupId': 'OG000'}, {'value': '-1.253', 'spread': '0.108', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment by time interaction', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '99.9', 'paramValue': '1.363', 'ciLowerLimit': '0.861', 'ciUpperLimit': '1.865', 'estimateComment': 'Empa 10 mg vs. Placebo slope \\[/year\\]', 'groupDescription': "Random coefficient model allowing for random intercept and random slope per patient, with factors age, baseline eGFR (CKD-EPI), baseline LVEF as linear covariate(s) and region, baseline diabetes status, sex, baseline-by-time interaction, treatment-by-time interaction and treatment as fixed effects.\n\nOnly 'on-treatment' data from treated patients were used. alpha=0.001. covariance structure: Unstructured.", 'statisticalMethod': 'Random intercept random coeff. model', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'H0: There is no difference between the effect of placebo and the effect of empagliflozin.'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline, week 4, 12, 32, 52, 76, 100, 124, 148, 172 and week 196, up to 1043 days.', 'description': 'Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR(CKD-EPI)cr) slope of change from baseline.\n\nAvailable on-treatment change-from-baseline data were used. The slope represents the long term effect of eGFR change from baseline and provides the yearly rate of decline.\n\nTimepoints after baseline were included in calculation of slope of change from baseline.\n\nThe slope per patient was calculated using a random coefficient model with terms for treatment, region, baseline status of diabetes, age, sex, left ventricular ejection fraction (LVEF) and glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)cr) at baseline and in addition the factors "time", "treatment-by-time interaction", and "baseline eGFR (CKD-EPI)cr-by-time interaction".', 'unitOfMeasure': 'mL/min/ 1.73 meters squared/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients included in the treated set (TS) and with available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Time to the First Event in the Composite Renal Endpoint: Chronic Dialysis, Renal Transplant, or Sustained Reduction in eGFR (CKD-EPI)cr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2991', 'groupId': 'OG000'}, {'value': '2997', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).'}, {'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 chronic heart failure with preserved ejection fraction (HFpEF).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.23', 'groupId': 'OG000', 'lowerLimit': '1.84', 'upperLimit': '2.66'}, {'value': '2.13', 'groupId': 'OG001', 'lowerLimit': '1.74', 'upperLimit': '2.54'}]}]}], 'analyses': [{'pValue': '0.7243', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.24', 'estimateComment': 'Comparison vs Placebo \\[T/P\\]', 'groupDescription': 'Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until completion of the planned treatment phase, up to 1403 days.', 'description': 'Chronic dialysis was defined as dialysis with a frequency of twice per week or more for at least 90 days.\n\nSustained was determined by two or more consecutive post-baseline central laboratory measurement separated by at least 30 days.\n\nReduction in glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) was defined as reduction in eGFR from baseline ≥40%, eGFR \\<15 mL/min/1.73 m\\^2 for patients with baseline eGFR ≥30 mL/min/1.73 m\\^2, or eGFR \\<10 mL/min/1.73 m\\^2 for patients with baseline eGFR \\<30 mL/min/1.73 m\\^2.\n\nThe incidence rate per 100 patient years (100 \\* number of patients with event / time at risk \\[years\\]) is reported. Time at risk \\[year\\] is calculated as: Sum of time at risk \\[days\\] over all patients in a treatment group / 365.25.\n\nAbbreviation:\n\nPatient-years (pt-yrs).', 'unitOfMeasure': 'Patients with event /100 pt-yrs at risk', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS), including all randomised patients.'}, {'type': 'SECONDARY', 'title': 'Time to First Adjudicated Hospitalisation for Heart Failure (HHF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2991', 'groupId': 'OG000'}, {'value': '2997', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).'}, {'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 chronic heart failure with preserved ejection fraction (HFpEF).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.97', 'groupId': 'OG000', 'lowerLimit': '5.37', 'upperLimit': '6.62'}, {'value': '4.28', 'groupId': 'OG001', 'lowerLimit': '3.78', 'upperLimit': '4.82'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.83', 'estimateComment': 'Comparison vs. Placebo \\[T/P\\]', 'groupDescription': 'Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until completion of the planned treatment phase, up to 1403 days.', 'description': 'Time to first adjudicated HHF. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:\n\nIncidence rate per 100 pt-yrs = 100 \\* number of patients with event / time at risk \\[years\\].\n\nTime at risk \\[years\\] = Sum of time at risk \\[days\\] over all patients in a treatment group / 365.25.\n\nPatients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.', 'unitOfMeasure': 'Patients with event /100 pt-yrs at risk', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS), including all randomised patients.'}, {'type': 'SECONDARY', 'title': 'Time to Adjudicated Cardiovascular (CV) Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2991', 'groupId': 'OG000'}, {'value': '2997', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).'}, {'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 chronic heart failure with preserved ejection fraction (HFpEF).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.81', 'groupId': 'OG000', 'lowerLimit': '3.35', 'upperLimit': '4.31'}, {'value': '3.42', 'groupId': 'OG001', 'lowerLimit': '2.98', 'upperLimit': '3.89'}]}]}], 'analyses': [{'pValue': '0.2951', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.09', 'estimateComment': 'Comparison vs. Placebo \\[T/P\\]', 'groupDescription': 'Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until completion of the planned treatment phase, up to 1403 days.', 'description': 'Time to adjudicated CV death. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:\n\nIncidence rate per 100 pt-yrs = 100 \\* number of patients with event / time at risk \\[years\\].\n\nTime at risk \\[years\\] = Sum of time at risk \\[days\\] over all patients in a treatment group / 365.25.\n\nPatients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.', 'unitOfMeasure': 'Patients with event /100 pt-yrs at risk', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS), including all randomised patients.'}, {'type': 'SECONDARY', 'title': 'Time to All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2991', 'groupId': 'OG000'}, {'value': '2997', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).'}, {'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 chronic heart failure with preserved ejection fraction (HFpEF).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.67', 'groupId': 'OG000', 'lowerLimit': '6.05', 'upperLimit': '7.32'}, {'value': '6.60', 'groupId': 'OG001', 'lowerLimit': '5.98', 'upperLimit': '7.24'}]}]}], 'analyses': [{'pValue': '0.9893', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.15', 'estimateComment': 'Comparison vs. Placebo \\[T/P\\]', 'groupDescription': 'Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until completion of the planned treatment phase, up to 1403 days.', 'description': 'Time to all-cause mortality. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:\n\nIncidence rate per 100 pt-yrs = 100 \\* number of patients with event / time at risk \\[years\\].\n\nTime at risk \\[years\\] = Sum of time at risk \\[days\\] over all patients in a treatment group / 365.25.\n\nPatients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.', 'unitOfMeasure': 'Patients with event /100 pt-yrs at risk', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS), including all randomised patients.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Diabetes Mellitus (DM) in Patients With Pre-DM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '979', 'groupId': 'OG000'}, {'value': '1001', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).'}, {'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 chronic heart failure with preserved ejection fraction (HFpEF).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.39', 'groupId': 'OG000', 'lowerLimit': '6.21', 'upperLimit': '8.68'}, {'value': '6.12', 'groupId': 'OG001', 'lowerLimit': '5.07', 'upperLimit': '7.26'}]}]}], 'analyses': [{'pValue': '0.1539', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.07', 'estimateComment': 'Comparison vs. Placebo \\[T/P\\]', 'groupDescription': 'Cox regression model included terms age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr), region, baseline diabetes status, sex, baseline Left ventricular ejection fraction (LVEF) and treatment.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until completion of the planned treatment phase, to 1403 days.', 'description': 'Time to onset of DM (defined as HbA1c ≥6.5% or as diagnosed by the investigator) in patients with pre-DM.\n\nPre-DM was defined as no history of DM and no HbA1c ≥6.5% before treatment, and a pre-treatment HbA1c value of ≥5.7% and \\<6.5%.\n\nThe incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:\n\nIncidence rate per 100 pt-yrs = 100 \\* number of patients with event / time at risk \\[years\\].\n\nTime at risk \\[years\\] = Sum of time at risk \\[days\\] over all patients in a treatment group / 365.25.\n\nPatients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.', 'unitOfMeasure': 'Patients with event /100 pt-yrs at risk', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS), including all randomised patients and with available data for this endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Kansas City Cardiomyopathy Questionaire (KCCQ) Clinical Summary Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2335', 'groupId': 'OG000'}, {'value': '2333', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).'}, {'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 chronic heart failure with preserved ejection fraction (HFpEF).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.18', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '4.51', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0028', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '0.45', 'ciUpperLimit': '2.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.44', 'estimateComment': 'Comparison vs Placebo \\[T-P\\]', 'groupDescription': 'Model includes age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)), baseline Left ventricular ejection fraction (LVEF) as linear covariate(s) and region, baseline diabetes status, sex, week reachable, treatment-by-visit interaction, baseline KCCQ-Clinical-Summary-Score-by-visit interaction as fixed effect(s).\n\nUnstructured covariance structure.', 'statisticalMethod': 'Mixed Model Repeated Measures (MMRM)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At baseline and at week 12, week 32 and week 52.', 'description': 'The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, self-efficacy, and quality of life in patients with Heart Failure. The KCCQ-clinical summary score comprises the following domains: Symptom frequency, symptom burden and physical limitation. The score is calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.\n\nFor patients who died, a worst score (score of 0) was imputed for the score at all subsequent scheduled visits after the date of death where the score would have been assessed.\n\nChange from baseline in KCCQ-score at week 52 was modeled using a MMRM with visit (week 12, 32 and 52) as repeated measures, adjusted mean (standard error) at week 52 is reported.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only Patients included in the treated set (TS) including values obtained on treatment. The number of patients analysed displays the number of patients with available data at the timepoint of interests.'}, {'type': 'SECONDARY', 'title': 'Occurrence of All-cause Hospitalisation (First and Recurrent)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2991', 'groupId': 'OG000'}, {'value': '2997', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': '1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).'}, {'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 chronic heart failure with preserved ejection fraction (HFpEF).'}], 'classes': [{'categories': [{'measurements': [{'value': '2769', 'groupId': 'OG000'}, {'value': '2566', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1012', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.01', 'estimateComment': 'Comparison vs. Placebo \\[T/P\\]', 'groupDescription': 'Joint frailty model that accounts for the dependence between recurrent all-cause hospitalisation and all-cause mortality was used. Joint frailty model with terms for age, baseline glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)), baseline Left ventricular ejection fraction (LVEF), treatment, region, baseline diabetes status and sex.', 'statisticalMethod': 'Joint frailty model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization until completion of the planned treatment phase, up to 1403 days.', 'description': 'Occurrence of all-cause hospitalisation (first and recurrent). Total number of all cause hospitalisations is reported.', 'unitOfMeasure': 'Events of all-cause hospitialisations', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomised Set (RS), including all randomised patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': '1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).'}, {'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 chronic heart failure with preserved ejection fraction (HFpEF).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomised', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2991'}, {'groupId': 'FG001', 'numSubjects': '2997'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2989'}, {'groupId': 'FG001', 'numSubjects': '2996'}]}, {'type': 'COMPLETED', 'comment': 'Patients who did not prematurely discontinue from trial medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2046'}, {'groupId': 'FG001', 'numSubjects': '2051'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '945'}, {'groupId': 'FG001', 'numSubjects': '946'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '553'}, {'groupId': 'FG001', 'numSubjects': '575'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Patient refusal to continue, not due to AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '304'}, {'groupId': 'FG001', 'numSubjects': '284'}]}, {'type': 'Study drug stopped, reason missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Medical advice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Due to Covid-19 Pandemic', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Not attending study visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient moved away', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other reason than stated above', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A randomised, double-blind trial to demonstrate superiority of empagliflozin versus placebo in patients with symptomatic, chronic heart failure and preserved left ventricular ejection fraction (LVEF\\>40%) under stable treatment of heart failure symptoms.', 'preAssignmentDetails': 'Patients were included in the trial after they had signed the informed consent form (ICF). Patients who met all of the inclusion and none of the exclusion criteria were to be included in the trial. All patients were informed that they were free to withdraw their consent at any time during the trial without penalty or prejudice.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2991', 'groupId': 'BG000'}, {'value': '2997', 'groupId': 'BG001'}, {'value': '5988', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': '1 film-coated tablet of matching placebo was administered orally once daily in patients with chronic heart failure with preserved ejection fraction (HFpEF).'}, {'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 chronic heart failure with preserved ejection fraction (HFpEF).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.9', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '71.8', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '71.9', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1338', 'groupId': 'BG000'}, {'value': '1338', 'groupId': 'BG001'}, {'value': '2676', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1653', 'groupId': 'BG000'}, {'value': '1659', 'groupId': 'BG001'}, {'value': '3312', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '754', 'groupId': 'BG000'}, {'value': '770', 'groupId': 'BG001'}, {'value': '1524', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2236', 'groupId': 'BG000'}, {'value': '2227', 'groupId': 'BG001'}, {'value': '4463', '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': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '411', 'groupId': 'BG000'}, {'value': '413', 'groupId': 'BG001'}, {'value': '824', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2256', 'groupId': 'BG000'}, {'value': '2286', 'groupId': 'BG001'}, {'value': '4542', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomised Set (RS), including all randomised patients.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-09', 'size': 2131132, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-25T06:31', 'hasProtocol': True}, {'date': '2017-02-21', 'size': 926871, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-03-25T06:31', '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': 5988}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-03', 'studyFirstSubmitDate': '2017-02-16', 'resultsFirstSubmitDate': '2022-04-20', 'studyFirstSubmitQcDate': '2017-02-16', 'lastUpdatePostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-03', 'studyFirstPostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)', 'timeFrame': 'From randomization until completion of the planned treatment phase, up to 1403 days.', 'description': 'Failure with preserved Ejection Fraction (HFpEF). The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:\n\nIncidence rate per 100 pt-yrs = 100 \\* number of patients with event / time at risk \\[years\\].\n\nTime at risk \\[years\\] = Sum of time at risk \\[days\\] over all patients in a treatment group / 365.25.\n\nPatients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)', 'timeFrame': 'From randomization until completion of the planned treatment phase, up to 1403 days.', 'description': 'Reported is the total number of adjudicated HHF events (first and recurrent) which occurred.'}, {'measure': 'eGFR (CKD-EPI) cr Slope of Change From Baseline', 'timeFrame': 'At baseline, week 4, 12, 32, 52, 76, 100, 124, 148, 172 and week 196, up to 1043 days.', 'description': 'Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR(CKD-EPI)cr) slope of change from baseline.\n\nAvailable on-treatment change-from-baseline data were used. The slope represents the long term effect of eGFR change from baseline and provides the yearly rate of decline.\n\nTimepoints after baseline were included in calculation of slope of change from baseline.\n\nThe slope per patient was calculated using a random coefficient model with terms for treatment, region, baseline status of diabetes, age, sex, left ventricular ejection fraction (LVEF) and glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)cr) at baseline and in addition the factors "time", "treatment-by-time interaction", and "baseline eGFR (CKD-EPI)cr-by-time interaction".'}, {'measure': 'Time to the First Event in the Composite Renal Endpoint: Chronic Dialysis, Renal Transplant, or Sustained Reduction in eGFR (CKD-EPI)cr', 'timeFrame': 'From randomization until completion of the planned treatment phase, up to 1403 days.', 'description': 'Chronic dialysis was defined as dialysis with a frequency of twice per week or more for at least 90 days.\n\nSustained was determined by two or more consecutive post-baseline central laboratory measurement separated by at least 30 days.\n\nReduction in glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) was defined as reduction in eGFR from baseline ≥40%, eGFR \\<15 mL/min/1.73 m\\^2 for patients with baseline eGFR ≥30 mL/min/1.73 m\\^2, or eGFR \\<10 mL/min/1.73 m\\^2 for patients with baseline eGFR \\<30 mL/min/1.73 m\\^2.\n\nThe incidence rate per 100 patient years (100 \\* number of patients with event / time at risk \\[years\\]) is reported. Time at risk \\[year\\] is calculated as: Sum of time at risk \\[days\\] over all patients in a treatment group / 365.25.\n\nAbbreviation:\n\nPatient-years (pt-yrs).'}, {'measure': 'Time to First Adjudicated Hospitalisation for Heart Failure (HHF)', 'timeFrame': 'From randomization until completion of the planned treatment phase, up to 1403 days.', 'description': 'Time to first adjudicated HHF. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:\n\nIncidence rate per 100 pt-yrs = 100 \\* number of patients with event / time at risk \\[years\\].\n\nTime at risk \\[years\\] = Sum of time at risk \\[days\\] over all patients in a treatment group / 365.25.\n\nPatients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.'}, {'measure': 'Time to Adjudicated Cardiovascular (CV) Death', 'timeFrame': 'From randomization until completion of the planned treatment phase, up to 1403 days.', 'description': 'Time to adjudicated CV death. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:\n\nIncidence rate per 100 pt-yrs = 100 \\* number of patients with event / time at risk \\[years\\].\n\nTime at risk \\[years\\] = Sum of time at risk \\[days\\] over all patients in a treatment group / 365.25.\n\nPatients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.'}, {'measure': 'Time to All-cause Mortality', 'timeFrame': 'From randomization until completion of the planned treatment phase, up to 1403 days.', 'description': 'Time to all-cause mortality. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:\n\nIncidence rate per 100 pt-yrs = 100 \\* number of patients with event / time at risk \\[years\\].\n\nTime at risk \\[years\\] = Sum of time at risk \\[days\\] over all patients in a treatment group / 365.25.\n\nPatients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.'}, {'measure': 'Time to Onset of Diabetes Mellitus (DM) in Patients With Pre-DM', 'timeFrame': 'From randomization until completion of the planned treatment phase, to 1403 days.', 'description': 'Time to onset of DM (defined as HbA1c ≥6.5% or as diagnosed by the investigator) in patients with pre-DM.\n\nPre-DM was defined as no history of DM and no HbA1c ≥6.5% before treatment, and a pre-treatment HbA1c value of ≥5.7% and \\<6.5%.\n\nThe incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed:\n\nIncidence rate per 100 pt-yrs = 100 \\* number of patients with event / time at risk \\[years\\].\n\nTime at risk \\[years\\] = Sum of time at risk \\[days\\] over all patients in a treatment group / 365.25.\n\nPatients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.'}, {'measure': 'Change From Baseline in Kansas City Cardiomyopathy Questionaire (KCCQ) Clinical Summary Score at Week 52', 'timeFrame': 'At baseline and at week 12, week 32 and week 52.', 'description': 'The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, self-efficacy, and quality of life in patients with Heart Failure. The KCCQ-clinical summary score comprises the following domains: Symptom frequency, symptom burden and physical limitation. The score is calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.\n\nFor patients who died, a worst score (score of 0) was imputed for the score at all subsequent scheduled visits after the date of death where the score would have been assessed.\n\nChange from baseline in KCCQ-score at week 52 was modeled using a MMRM with visit (week 12, 32 and 52) as repeated measures, adjusted mean (standard error) at week 52 is reported.'}, {'measure': 'Occurrence of All-cause Hospitalisation (First and Recurrent)', 'timeFrame': 'From randomization until completion of the planned treatment phase, up to 1403 days.', 'description': 'Occurrence of all-cause hospitalisation (first and recurrent). Total number of all cause hospitalisations is reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '39895437', 'type': 'DERIVED', 'citation': 'Carson P, Teerlink JR, Komajda M, Anand I, Packer M, Butler J, Doehner W, Ferreira JP, Filippatos G, Haass M, Miller A, Pehrson S, Pocock SJ, Iwata T, Brueckmann M, Gasior T, Zannad F, Anker SD. Comparison of Investigator-Reported and Centrally Adjudicated Heart Failure Outcomes in the EMPEROR-Preserved Trial. JACC Heart Fail. 2025 May;13(5):710-721. doi: 10.1016/j.jchf.2024.10.021. Epub 2025 Jan 29.'}, {'pmid': '38770818', 'type': 'DERIVED', 'citation': 'Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.'}, {'pmid': '38439582', 'type': 'DERIVED', 'citation': 'Ferreira JP, Packer M, Sattar N, Butler J, Pocock SJ, Anker SD, Maldonado SG, Panova-Noeva M, Sumin M, Masson S, Zannad F, Januzzi JL. Carbohydrate antigen 125 concentrations across the ejection fraction spectrum in chronic heart failure: The EMPEROR programme. Eur J Heart Fail. 2024 Apr;26(4):788-802. doi: 10.1002/ejhf.3166. Epub 2024 Mar 4.'}, {'pmid': '37942723', 'type': 'DERIVED', 'citation': 'Zannad F, Macari S. Drug treatment with empagliflozin was beneficial in people with heart failure with preserved ejection fraction: plain language summary of the EMPEROR-Preserved study. Future Cardiol. 2023 Nov;19(14):671-677. doi: 10.2217/fca-2023-0091. Epub 2023 Nov 9.'}, {'pmid': '37621153', 'type': 'DERIVED', 'citation': 'Packer M, Butler J, Zeller C, Pocock SJ, Brueckmann M, Ferreira JP, Filippatos G, Usman MS, Zannad F, Anker SD. Blinded Withdrawal of Long-Term Randomized Treatment With Empagliflozin or Placebo in Patients With Heart Failure. Circulation. 2023 Sep 26;148(13):1011-1022. doi: 10.1161/CIRCULATIONAHA.123.065748. Epub 2023 Aug 24.'}, {'pmid': '37223933', 'type': 'DERIVED', 'citation': 'Butler J, Usman MS, Filippatos G, Ferreira JP, Bohm M, Brueckmann M, Januzzi JL, Kaul S, Pina IL, Ponikowski P, Senni M, Sumin M, Verma S, Zaremba-Pechmann L, Pocock SJ, Packer M, Anker S. Safety and Efficacy of Empagliflozin and Diuretic Use in Patients with Heart Failure and Preserved Ejection Fraction: A Post Hoc Analysis of the EMPEROR-Preserved Trial. JAMA Cardiol. 2023 Jul 1;8(7):640-649. doi: 10.1001/jamacardio.2023.1090.'}, {'pmid': '36478225', 'type': 'DERIVED', 'citation': 'Bhm M, Anker S, Mahfoud F, Lauder L, Filippatos G, Ferreira JP, Pocock SJ, Brueckmann M, Saloustros I, Schler E, Wanner C, Zannad F, Packer M, Butler J. Empagliflozin, irrespective of blood pressure, improves outcomes in heart failure with preserved ejection fraction: the EMPEROR-Preserved trial. Eur Heart J. 2023 Feb 1;44(5):396-407. doi: 10.1093/eurheartj/ehac693.'}, {'pmid': '36129693', 'type': 'DERIVED', 'citation': 'Ferreira JP, Zannad F, Butler J, Filippatos G, Pocock SJ, Brueckmann M, Steubl D, Schueler E, Anker SD, Packer M. Association of Empagliflozin Treatment With Albuminuria Levels in Patients With Heart Failure: A Secondary Analysis of EMPEROR-Pooled. JAMA Cardiol. 2022 Nov 1;7(11):1148-1159. doi: 10.1001/jamacardio.2022.2924.'}, {'pmid': '36098051', 'type': 'DERIVED', 'citation': 'Butler J, Filippatos G, Siddiqi TJ, Ferreira JP, Brueckmann M, Bocchi E, Bohm M, Chopra VK, Giannetti N, Iwata T, Januzzi JL, Kaul S, Pina IL, Ponikowski P, Rauch-Krohnert U, Shah SJ, Senni M, Sumin M, Verma S, Zhang J, Pocock SJ, Zannad F, Packer M, Anker SD. Effects of Empagliflozin in Women and Men With Heart Failure and Preserved Ejection Fraction. Circulation. 2022 Oct 4;146(14):1046-1055. doi: 10.1161/CIRCULATIONAHA.122.059755. Epub 2022 Sep 13.'}, {'pmid': '36017745', 'type': 'DERIVED', 'citation': 'Zannad F, Ferreira JP, Butler J, Filippatos G, Januzzi JL, Sumin M, Zwick M, Saadati M, Pocock SJ, Sattar N, Anker SD, Packer M. Effect of empagliflozin on circulating proteomics in heart failure: mechanistic insights into the EMPEROR programme. Eur Heart J. 2022 Dec 21;43(48):4991-5002. doi: 10.1093/eurheartj/ehac495.'}, {'pmid': '35762322', 'type': 'DERIVED', 'citation': 'Filippatos G, Butler J, Farmakis D, Zannad F, Ofstad AP, Ferreira JP, Green JB, Rosenstock J, Schnaidt S, Brueckmann M, Pocock SJ, Packer M, Anker SD; EMPEROR-Preserved Trial Committees and Investigators. Empagliflozin for Heart Failure With Preserved Left Ventricular Ejection Fraction With and Without Diabetes. Circulation. 2022 Aug 30;146(9):676-686. doi: 10.1161/CIRCULATIONAHA.122.059785. Epub 2022 Jun 28.'}, {'pmid': '35687107', 'type': 'DERIVED', 'citation': 'Ferreira JP, Zannad F, Butler J, Filipattos G, Ritter I, Schuler E, Kraus BJ, Pocock SJ, Anker SD, Packer M. Empagliflozin and serum potassium in heart failure: an analysis from EMPEROR-Pooled. Eur Heart J. 2022 Aug 14;43(31):2984-2993. doi: 10.1093/eurheartj/ehac306.'}, {'pmid': '35670067', 'type': 'DERIVED', 'citation': 'Januzzi JL Jr, Butler J, Zannad F, Filippatos G, Ferreira JP, Pocock SJ, Sattar N, Verma S, Vedin O, Iwata T, Brueckmann M, Packer M, Anker SD; EMPEROR-Preserved Trial Study Group. Prognostic Implications of N-Terminal Pro-B-Type Natriuretic Peptide and High-Sensitivity Cardiac Troponin T in EMPEROR-Preserved. JACC Heart Fail. 2022 Jul;10(7):512-524. doi: 10.1016/j.jchf.2022.05.004. Epub 2022 Jun 1.'}, {'pmid': '35603667', 'type': 'DERIVED', 'citation': 'Vaduganathan M, Claggett BL, Inciardi RM, Fonarow GC, McMurray JJV, Solomon SD. Estimating the Benefits of Combination Medical Therapy in Heart Failure With Mildly Reduced and Preserved Ejection Fraction. Circulation. 2022 Jun 7;145(23):1741-1743. doi: 10.1161/CIRCULATIONAHA.121.058929. Epub 2022 May 23. No abstract available.'}, {'pmid': '35331406', 'type': 'DERIVED', 'citation': 'Ferreira JP, Butler J, Zannad F, Filippatos G, Schueler E, Steubl D, Zeller C, Januzzi JL, Pocock S, Packer M, Anker SD. Mineralocorticoid Receptor Antagonists and Empagliflozin in Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2022 Mar 29;79(12):1129-1137. doi: 10.1016/j.jacc.2022.01.029.'}, {'pmid': '34779658', 'type': 'DERIVED', 'citation': 'Butler J, Filippatos G, Jamal Siddiqi T, Brueckmann M, Bohm M, Chopra VK, Pedro Ferreira J, Januzzi JL, Kaul S, Pina IL, Ponikowski P, Shah SJ, Senni M, Vedin O, Verma S, Peil B, Pocock SJ, Zannad F, Packer M, Anker SD. Empagliflozin, Health Status, and Quality of Life in Patients With Heart Failure and Preserved Ejection Fraction: The EMPEROR-Preserved Trial. Circulation. 2022 Jan 18;145(3):184-193. doi: 10.1161/CIRCULATIONAHA.121.057812. Epub 2021 Nov 15.'}, {'pmid': '34693515', 'type': 'DERIVED', 'citation': 'Kanie T, Mizuno A, Takaoka Y, Suzuki T, Yoneoka D, Nishikawa Y, Tam WWS, Morze J, Rynkiewicz A, Xin Y, Wu O, Providencia R, Kwong JS. Dipeptidyl peptidase-4 inhibitors, glucagon-like peptide 1 receptor agonists and sodium-glucose co-transporter-2 inhibitors for people with cardiovascular disease: a network meta-analysis. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD013650. doi: 10.1002/14651858.CD013650.pub2.'}, {'pmid': '34449189', 'type': 'DERIVED', 'citation': 'Anker SD, Butler J, Filippatos G, Ferreira JP, Bocchi E, Bohm M, Brunner-La Rocca HP, Choi DJ, Chopra V, Chuquiure-Valenzuela E, Giannetti N, Gomez-Mesa JE, Janssens S, Januzzi JL, Gonzalez-Juanatey JR, Merkely B, Nicholls SJ, Perrone SV, Pina IL, Ponikowski P, Senni M, Sim D, Spinar J, Squire I, Taddei S, Tsutsui H, Verma S, Vinereanu D, Zhang J, Carson P, Lam CSP, Marx N, Zeller C, Sattar N, Jamal W, Schnaidt S, Schnee JM, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Preserved Trial Investigators. Empagliflozin in Heart Failure with a Preserved Ejection Fraction. N Engl J Med. 2021 Oct 14;385(16):1451-1461. doi: 10.1056/NEJMoa2107038. Epub 2021 Aug 27.'}, {'pmid': '31081589', 'type': 'DERIVED', 'citation': 'Nassif ME, Kosiborod M. Effects of sodium glucose cotransporter type 2 inhibitors on heart failure. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:19-23. doi: 10.1111/dom.13678.'}], 'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "This is a study in adults with chronic heart failure. People with chronic heart failure may need to be hospitalised for their condition. Some people with chronic heart failure may eventually die from their condition. The purpose of the study is to find out whether a medicine called empagliflozin lowers the chances of patients having to go to hospital for heart failure and whether it improves their survival. The study is open to patients with a type of chronic heart failure called chronic heart failure with preserved ejection fraction.\n\nParticipants stay in the study until researchers have enough information about how effective empagliflozin is. It is expected that participants who enter at the very beginning of the enrolment period may be in the study for over 3 years, while participants who enter near the end of the enrolment period may be in the study for less than 2 years. The participants are put into 2 groups. It is decided by chance who gets into which group. One group gets empagliflozin tablets every day and the other group gets placebo tablets every day. Placebo tablets look like empagliflozin tablets but contain no medicine.\n\nParticipants visit the doctors regularly. During these visits, the doctors collect information about the participant's health. The doctors want to know how many patients had to go to hospital because of heart failure or who died from cardiovascular disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Male or female patient, age \\>= 18 years at screening. For Japan only: Age \\>=20 years at screening\n* Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) \\> 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) \\> 300 pg/ml for patients without AF, OR \\> 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1\n* Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1\n* Stable dose of oral diuretics, if prescribed\n* Signed and dated written ICF (informed consent form)\n* Further inclusion criteria apply\n\nExclusion criteria:\n\n* Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1\n* Heart transplant recipient or listed for heart transplant\n* Acute decompensated HF (Heart Failure)\n* Systolic blood pressure (SBP) \\>= 180 mmHg at Visit 2.\n* Symptomatic hypotension and/or a SBP \\< 100 mmHg\n* Indication of liver disease,\n* Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) \\< 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr or requiring dialysis\n* History of ketoacidosis\n* Current use or prior use of a SGLT (Sodium-glucose co-transporter) -2 inhibitor or combined SGLT-1 and 2 inhibitor\n* Currently enrolled in another investigational device or drug trial\n* Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors\n* Women who are pregnant, nursing, or who plan to become pregnant while in the trial\n* Further exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03057951', 'briefTitle': 'EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF)', 'orgStudyIdInfo': {'id': '1245.110'}, 'secondaryIdInfos': [{'id': '2016-002278-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '10 mg Empagliflozin', 'interventionNames': ['Drug: Empagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Empagliflozin', 'type': 'DRUG', 'otherNames': ['JARDIANCE, JARDIANZ, GIBTULIO'], 'description': 'once daily', 'armGroupLabels': ['10 mg Empagliflozin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pinnacle Research Group, LLC', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Heart Center Research, LLC', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '93701', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'La Mesa Cardiac Center', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 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