Viewing Study NCT02807857

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Ignite Creation Date: 2025-12-24 @ 6:45 PM
Ignite Modification Date: 2026-02-23 @ 12:22 PM
Study NCT ID: NCT02807857
Status: COMPLETED
Last Update Posted: 2021-02-24
First Post: 2016-06-17
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The recruitment was to be regarded as completed once approx. 2400 patients had entered the prospective period. However it was decided by Novartis to terminate the study prematurely, in March 2018.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from FPFV to LPLV up to 2 years.', 'eventGroups': [{'id': 'EG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.', 'otherNumAtRisk': 1415, 'deathsNumAtRisk': 1415, 'otherNumAffected': 187, 'seriousNumAtRisk': 1415, 'deathsNumAffected': 32, 'seriousNumAffected': 117}, {'id': 'EG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.', 'otherNumAtRisk': 861, 'deathsNumAtRisk': 861, 'otherNumAffected': 181, 'seriousNumAtRisk': 861, 'deathsNumAffected': 30, 'seriousNumAffected': 114}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypertensive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Accommodation disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Sudden visual loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Functional gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gastroduodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gastrointestinal angiodysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Localised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pulpitis dental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Viral sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Epicondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 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'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Electric shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Neuroendocrine tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Uterovaginal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Orthopnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ischaemic skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Homicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Aortic valve repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cardiac ablation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cardiac pacemaker insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cardiac resynchronisation therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cardioversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 861, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'Level 1: Drug Type : Adherent', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Level 1: Drug type : Not Adherent', 'categories': [{'measurements': [{'value': '802', 'groupId': 'OG000'}, {'value': '523', 'groupId': 'OG001'}]}]}, {'title': 'Patients missing LVEF values', 'categories': [{'measurements': [{'value': '503', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Assessment of treatment regimen with respect to ESC guideline adherence at Visit 1 before referral to cardiologist. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \\> 35% at visit 1. Drug type \\& dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled and Follow-up Set included. Due to missing left ventricular ejection fraction (LVEF) values, some patients could not be classified.'}, {'type': 'PRIMARY', 'title': 'Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '861', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'Adherence at V2, not adherent at V1 for drug type', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Adherence at V2, not adherent at V1:drug type/dose', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Adherence at V2 and V1 for drug type', 'categories': [{'measurements': [{'value': '79.2', 'groupId': 'OG000'}]}]}, {'title': 'Adherence at Visit 1 for drug type & dose', 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': "Assessment of patients' adherence at Visit 2, for patients who were already adherent at Visit 1, and those who were not adherent at Visit 1, for both drug type and drug type and dose. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \\> 35% at visit 1. Drug type \\& dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose.", 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-Up set'}, {'type': 'SECONDARY', 'title': 'Duration of Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Patients', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe. Patients who were considered clinically stable an with NT-proBNP levels \\> 600 pg/ml were referred to a cardiologist for evaluation and were in the follow-up set.'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': '>3 years', 'categories': [{'measurements': [{'value': '896', 'groupId': 'OG000'}, {'value': '549', 'groupId': 'OG001'}]}]}, {'title': '≤3 years', 'categories': [{'measurements': [{'value': '517', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 1)', 'description': 'The duration of Heart Failure was collected at Baseline (Visit 1).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set and Follow-Up Set'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Current Use of Concomitant Compound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'Diuretics - without mineral corticoid antagonists', 'categories': [{'measurements': [{'value': '934', 'groupId': 'OG000'}, {'value': '625', 'groupId': 'OG001'}]}]}, {'title': 'Beta blocking agents', 'categories': [{'measurements': [{'value': '981', 'groupId': 'OG000'}, {'value': '602', 'groupId': 'OG001'}]}]}, {'title': 'Agents acting on the renin-angiotensin system', 'categories': [{'measurements': [{'value': '834', 'groupId': 'OG000'}, {'value': '491', 'groupId': 'OG001'}]}]}, {'title': 'Diuretics - mineral corticoid antagonists', 'categories': [{'measurements': [{'value': '664', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}]}]}, {'title': 'Antithrombotic agents', 'categories': [{'measurements': [{'value': '401', 'groupId': 'OG000'}, {'value': '256', 'groupId': 'OG001'}]}]}, {'title': 'Cardiac therapy', 'categories': [{'measurements': [{'value': '365', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}]}, {'title': 'Lipid modifying agents', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'Mineral supplements', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Calcium channel blockers', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Use of concomitant compounds were collected at baseline (Visit 1)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set and Follow-Up Set'}, {'type': 'SECONDARY', 'title': 'Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '753', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-Up Set Visit 2 (6 Months)', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml were referred to a cardiologist after 6 months (V2) for evaluation and were in the follow-up set'}], 'classes': [{'title': 'Diuretics - without mineral corticoid antagonists', 'categories': [{'measurements': [{'value': '581', 'groupId': 'OG000'}]}]}, {'title': 'Beta blocking agents', 'categories': [{'measurements': [{'value': '533', 'groupId': 'OG000'}]}]}, {'title': 'Agents acting on the renin-angiotensin system', 'categories': [{'measurements': [{'value': '476', 'groupId': 'OG000'}]}]}, {'title': 'Diuretics - mineral corticoid antagonists', 'categories': [{'measurements': [{'value': '423', 'groupId': 'OG000'}]}]}, {'title': 'Antithrombotic agents', 'categories': [{'measurements': [{'value': '221', 'groupId': 'OG000'}]}]}, {'title': 'Cardiac therapy', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}]}]}, {'title': 'Lipid modifying agents', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}]}]}, {'title': 'Mineral supplements', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}, {'title': 'Calcium channel blockers', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months (Visit 2)', 'description': 'Use of concomitant compounds were collected at 6 months (Visit 2)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-Up Set'}, {'type': 'SECONDARY', 'title': 'Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '861', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': "Cardiologist's advice-No change", 'categories': [{'measurements': [{'value': '45.1', 'groupId': 'OG000'}]}]}, {'title': "Cardiologist's advice-Treatment intensification", 'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000'}]}]}, {'title': "Cardiologist's advice-Treatment reduction", 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}]}]}, {'title': "Cardiologist's advice-Treatment adaption", 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'For patients who enter the prospective period of the study the post-referral treatment choice of cardiologists and/or primary care physicians was documented; for patients, for whom the cardiologist and/or primary care physician chose to prescribe a novel Heart Failure treatment, the treatment was assessed, if it fulfills the definition of adherence to European Society of Cardiology (ESC) guideline recommendation. The proportion of patients for whom an ESC guideline adherent treatment was de novo prescribed was assessed stratified according to different parameters.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-Up Set'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Different NT-proBNP Level Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': '<600 pg/ml', 'categories': [{'measurements': [{'value': '495', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '≥ 600 pg/ml to <800 pg/ml', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}, {'title': '≥ 800 pg/ml to <1000 pg/ml', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': '≥ 1000 pg/ml to <1200 pg/ml', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': '≥ 1200 pg/ml to <1400 pg/ml', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': '≥ 1400 pg/ml to <1600 pg/ml', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': '≥ 1600 pg/ml to <1800 pg/ml', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': '≥ 1800 pg/ml to <2000 pg/ml', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': '≥ 2000 pg/ml', 'categories': [{'measurements': [{'value': '465', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One measurement in all consecutive patients at baseline (Visit 1)', 'description': 'NT-proBNP levels (pg/ml) was measured at baseline in all consecutive patients who satisfy the inclusion and exclusion criteria. Measurements were performed on-site by means of a handheld device provided for the purposes of the study. NT-proBNP level categories could be 600 -799 pg/ml, 800 - 999 pg/ml, 1000 - 1200 pg/ml, \\> 1200 pg/ml).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set and Follow-Up Set'}, {'type': 'SECONDARY', 'title': 'Percentages of Clinically Stable Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.'}], 'classes': [{'title': 'Patients clinically stable', 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000'}]}]}, {'title': 'Patients not clinically stable', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Patients suitable for prospective period of study', 'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000'}]}]}, {'title': 'Patients not suitable for prospective period', 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Clinically stable patients in this study were defined as those patients for whom the primary care physician did not see a necessity (based on signs and symptoms of HF) to change the current pharmacological and/or device treatment of HF and who were on stable pharmacological and/or device treatment for HF for at least 3 months prior to inclusion.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set'}, {'type': 'SECONDARY', 'title': 'Number of Patients by Cardiologist Prescription Practice Per Country/Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '861', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'Western EU', 'categories': [{'measurements': [{'value': '198', 'groupId': 'OG000'}]}]}, {'title': 'Eastern EU', 'categories': [{'measurements': [{'value': '525', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': "The cardiologists' suggestions for pharmacological and/or device therapy for the treatment of clinically stable CHF patients was documented and assessed by means of descriptive statistical measures stratified by country/region 6 months after baseline.", 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-Up Set'}, {'type': 'SECONDARY', 'title': 'Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '861', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'NT-proBNP [pg/ml] at Visit 1 (Baseline)', 'categories': [{'measurements': [{'value': '2753', 'spread': '2530', 'groupId': 'OG000'}]}]}, {'title': 'NT-proBNP [pg/ml] at Visit 3 (10 months)', 'categories': [{'measurements': [{'value': '2245', 'spread': '2303', 'groupId': 'OG000'}]}]}, {'title': 'Absolute change in NT-proBNP (V3-V1)', 'categories': [{'measurements': [{'value': '-504', 'spread': '2607', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 months', 'description': "At 10 months after baseline (end of study) NT-proBNP was assessed in clinically stable CHF patients with baseline NT-proBNP levels ≥ 600 pg/ml. Thus, for those patients two NT-proBNP measurements were available: at baseline and 10 months later. The individual change of NT-proBNP between both time points were assessed in accordance to the patients' treatment history during the study, i.e. baseline Heart Failure treatment and therapeutic decision taken 6 months after baseline.", 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-Up Set'}, {'type': 'SECONDARY', 'title': 'Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'EQ-5D Visual Analog Scale (VAS) - Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1411', 'groupId': 'OG000'}, {'value': '860', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '100'}]}]}, {'title': 'EQ5D Utility index - Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1411', 'groupId': 'OG000'}, {'value': '860', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '-0.17', 'upperLimit': '1.00'}, {'value': '0.79', 'groupId': 'OG001', 'lowerLimit': '-0.17', 'upperLimit': '1.00'}]}]}, {'title': 'EQ5D Utility index - Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '747', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG001', 'lowerLimit': '-0.11', 'upperLimit': '1.00'}]}]}, {'title': 'EQ5D Utility index absolute change (V2-V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '747', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.47', 'upperLimit': '0.83'}]}]}, {'title': 'EQ5D Utility index - Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '569', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.78', 'groupId': 'OG001', 'lowerLimit': '0.28', 'upperLimit': '1.00'}]}]}, {'title': 'EQ5D Utility index absolute change (V3-V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '567', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-0.82', 'upperLimit': '0.80'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3)', 'description': 'Quality of life (QoL) was assessed by EQ-5D including the dimensions mobility, self-care, usual activity, pain/discomfort, anxiety/depression. A utility index based on UK value sets was built to summarize the information of these five dimensions into a single scale. The utility index can range between -0.281 and 1.0 where a higher number indicates a better health status. In addition, a visual analog scale (VAS) was applied with a possible range between 0 (=worst imaginable health state) and 100 (=best imaginable health state). Scores collected for all patients at baseline (Visit 1) and at Visit 2 and Visit 3 (only patients who entered the prospective period of the study, i.e. clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to fill out the EuroQol 5D (EQ-5D) quality of life (QoL) questionnaire validated for heart failure (HF).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set for Visit 1 (Baseline) and Follow-Up Set (Visit 2 and 3) for those clinically stable patients who entered the prospective period of the study'}, {'type': 'SECONDARY', 'title': 'Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'KCCQ Total Symptom Score - Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1413', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '74.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'KCCQ Clinical Summary Score - Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1413', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '68.8', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'KCCQ Overall Summary Score - Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1413', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.1', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '100'}, {'value': '66.1', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '100'}]}]}, {'title': 'KCCQ Overall Summary Score absolute change (V2-V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '747', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-48.4', 'upperLimit': '70.8'}]}]}, {'title': 'KCCQ Overall Summary Score - Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '568', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '100'}]}]}, {'title': 'KCCQ Overall Summary Score absolute change (V3-V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '568', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '-66.1', 'upperLimit': '66.8'}]}]}, {'title': 'KCCQ Clinical Summary Score - Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '747', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '100.0'}]}]}, {'title': 'KCCQ Clinical Summary Score abs. change (V2-V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '747', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-61.5', 'upperLimit': '65.6'}]}]}, {'title': 'KCCQ Clinical Summary Score - Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '568', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '100.0'}]}]}, {'title': 'KCCQ Summary Score absolute change (V3-V1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '568', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-53.1', 'upperLimit': '69.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3)', 'description': 'The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement. Scores were collected for all patients at baseline and Visit 2 and Visit 3 (only patients who had entered the prospective period of the study (clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to complete Kansas City Cardiomyopathy Questionnaire (KCCQ) validated for Heart Failure.', 'unitOfMeasure': 'Utility Index Score', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set for Visit 1 (Baseline) and Follow-Up Set (Visit 2 and 3) for those clinically stable patients who entered the prospective period of the study'}, {'type': 'SECONDARY', 'title': 'Number of Patients in Different Living Conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'Living independently in household (alone)', 'categories': [{'measurements': [{'value': '313', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}]}, {'title': 'Living with spouse or significant other', 'categories': [{'measurements': [{'value': '817', 'groupId': 'OG000'}, {'value': '481', 'groupId': 'OG001'}]}]}, {'title': 'Living in residence with other family member', 'categories': [{'measurements': [{'value': '264', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}, {'title': 'Living in a long term care facility', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Transient housing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Living conditions were collected at Baseline (Visit 1).', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set and Follow-Up Set'}, {'type': 'SECONDARY', 'title': 'Number of Patients in Different Employment Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'Student', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Employed (part-time)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Employed (full-time)', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Homemaker', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Retired', 'categories': [{'measurements': [{'value': '1034', 'groupId': 'OG000'}, {'value': '680', 'groupId': 'OG001'}]}]}, {'title': 'Unemployed', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Sustained Sick Leave', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Employment status was collected at Baseline (Visit 1).', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set and Follow-Up Set'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Smoking Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '779', 'groupId': 'OG000'}, {'value': '500', 'groupId': 'OG001'}]}]}, {'title': 'Current', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}, {'title': 'Former', 'categories': [{'measurements': [{'value': '427', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Smoking status was collected at baseline (visit 1).', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set and Follow-Up Set'}, {'type': 'SECONDARY', 'title': 'Number of Patients From Different Geographical Regions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'RUS', 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}]}, {'title': 'BEL', 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}]}, {'title': 'HRV', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}, {'title': 'SVN', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'POL', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'LTU', 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'HUN', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': 'FRA', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'ESP', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'NOR', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'CYP', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'LVA', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'MLT', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'EST', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'DNK', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'PRT', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (visit 1)', 'description': 'Geographic regions were collected at Baseline (Visit 1).', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Health Insurance Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'Statutory Health Insurance', 'categories': [{'measurements': [{'value': '1168', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}]}, {'title': 'Private Health Insurance', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Combined statutory and private health insurance', 'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Health insurance status was collected at Baseline (Visit 1).', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set and Follow-Up Set'}, {'type': 'SECONDARY', 'title': 'Number of Patients at Different Educational Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'Primary Education', 'categories': [{'measurements': [{'value': '396', 'groupId': 'OG000'}, {'value': '248', 'groupId': 'OG001'}]}]}, {'title': 'Secondary Education', 'categories': [{'measurements': [{'value': '730', 'groupId': 'OG000'}, {'value': '421', 'groupId': 'OG001'}]}]}, {'title': 'University', 'categories': [{'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Educational level was collected at Baseline (Visit 1).', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set and Follow-Up Set'}, {'type': 'SECONDARY', 'title': 'Number of Patients Per Primary Etiology of Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'Primary Etiology- Ischemic', 'categories': [{'measurements': [{'value': '860', 'groupId': 'OG000'}, {'value': '541', 'groupId': 'OG001'}]}]}, {'title': 'Primary Etiology-Non-Ischemic', 'categories': [{'measurements': [{'value': '553', 'groupId': 'OG000'}, {'value': '320', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 1)', 'description': 'The primary etiology of Heart Failure was collected at Baseline (Visit 1).', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set and Follow-Up Set'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'Visit 1- Up to Baseline', 'categories': [{'measurements': [{'value': '383', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}]}, {'title': 'Visit 2-6 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3-10 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 1), 6 months, 10 months', 'description': 'HF-related hospitalizations was collected in the previous 12 months prior to baseline at baseline visit, at 6 and 10 months post-baseline.', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set and Follow-Up Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'Hypertension', 'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000'}, {'value': '75.8', 'groupId': 'OG001'}]}]}, {'title': 'Dyslipidemia', 'categories': [{'measurements': [{'value': '61.6', 'groupId': 'OG000'}, {'value': '58.8', 'groupId': 'OG001'}]}]}, {'title': 'History of myocardial infarction', 'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000'}, {'value': '44.4', 'groupId': 'OG001'}]}]}, {'title': 'Atrial fibrillation', 'categories': [{'measurements': [{'value': '40.8', 'groupId': 'OG000'}, {'value': '52.3', 'groupId': 'OG001'}]}]}, {'title': 'Obesity', 'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000'}, {'value': '30.8', 'groupId': 'OG001'}]}]}, {'title': 'Stable angina pectoris', 'categories': [{'measurements': [{'value': '31.4', 'groupId': 'OG000'}, {'value': '33.8', 'groupId': 'OG001'}]}]}, {'title': 'Diabetes mellitus type 2', 'categories': [{'measurements': [{'value': '29.9', 'groupId': 'OG000'}, {'value': '31.5', 'groupId': 'OG001'}]}]}, {'title': 'Other Comorbidities', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '14.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Cardiovascular and non-cardiovascular co-morbidities were collected at baseline (Visit 1)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set and Follow-Up Set'}, {'type': 'SECONDARY', 'title': 'Mean Dose of Previously Taken and Current Use of Concomitant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Set', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe.'}, {'id': 'OG001', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'timeFrame': 'Baseline (Visit 1), 6 months, 10 months', 'description': 'Mean Dose of previously taken and current use of concomitant medications was to be collected at Visit 1, 6 months, 10 months post-baseline', 'reportingStatus': 'POSTED', 'populationDescription': 'Enrolled Set and Follow-Up Set (Mean dose of concomitant medications was not collected/provided and could not be alternately computed based upon the information listed).'}, {'type': 'SECONDARY', 'title': 'Number of Heart Failure (HF) Treatment Combinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '861', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'One ACEi or one ARB and one beta-blocker(V1)', 'categories': [{'measurements': [{'value': '178', 'groupId': 'OG000'}]}]}, {'title': 'Exactly one beta-blocker and one MRA(V1)', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}]}]}, {'title': 'Exactly one ACEi or one ARB and one MRA(V1)', 'categories': [{'measurements': [{'value': '165', 'groupId': 'OG000'}]}]}, {'title': 'One ACEi or (1)ARB & (1)MRA & (1)beta-blocker(V1)', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Exactly one beta-blocker and ARNi(V1)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Exactly one MRA and ARNi(V1)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Exactly one MRA and one beta-blocker and ARNi(V1)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'One ACEi or one ARB and one beta-blocker(V2)', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}]}]}, {'title': 'Exactly one beta-blocker and one MRA(V2)', 'categories': [{'measurements': [{'value': '160', 'groupId': 'OG000'}]}]}, {'title': 'Exactly one ACEi or one ARB and one MRA(V2)', 'categories': [{'measurements': [{'value': '177', 'groupId': 'OG000'}]}]}, {'title': 'One ACEi or (1)ARB & (1)MRA & (1)beta-blocker(V2)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}, {'title': 'Exactly one beta-blocker and ARNi(V2)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Exactly one MRA and ARNi(V2)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Exactly one MRA and one beta-blocker and ARNi(V2)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'One ACEi or one ARB and one beta-blocker(V3)', 'categories': [{'measurements': [{'value': '120', 'groupId': 'OG000'}]}]}, {'title': 'Exactly one beta-blocker and one MRA(V3)', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}]}]}, {'title': 'Exactly one ACEi or one ARB and one MRA(V3)', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}]}]}, {'title': 'One ACEi or (1)ARB & (1)MRA & (1)beta-blocker(V3)', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}]}]}, {'title': 'Exactly one beta-blocker and ARNi(V3)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Exactly one MRA and ARNi(V3)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Exactly one MRA and one beta-blocker and ARNi(V3)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 1)', 'description': 'The types and number of participants with HF treatment combinations were collected at Baseline (Visit 1).', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-Up Set: Patients who were considered clinically stable and had NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Baseline (Visit 1) for evaluation.'}, {'type': 'SECONDARY', 'title': 'Duration of Treatment With Device Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'timeFrame': 'Baseline (Visit 1)', 'description': 'The duration of treatment with device type was collected at baseline (Visit 1)', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-Up Set (Data was not collected for this endpoint)'}, {'type': 'SECONDARY', 'title': 'Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '861', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'classes': [{'title': 'Antithrombotic agents -≤1 and >3 years', 'categories': [{'measurements': [{'value': '0.65', 'groupId': 'OG000'}]}]}, {'title': 'Lipid modifying agents -≤1 and >3 years', 'categories': [{'measurements': [{'value': '0.57', 'groupId': 'OG000'}]}]}, {'title': 'Drugs for acid related disorders-≤1 and >3 years', 'categories': [{'measurements': [{'value': '0.31', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Duration of most common previously taken and current use of most common Non-HF concomitant compounds were collected', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-Up Set'}, {'type': 'SECONDARY', 'title': "Number of Patients by Primary Care Physicians' Prescription Practice Per Country/Region", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Follow-Up Set', 'description': 'Patients who were considered clinically stable and with NT-proBNP levels \\> 600 pg/ml who were referred to a cardiologist at Visit 1 for evaluation were in the follow-up set.'}], 'timeFrame': 'Baseline (Visit 1)', 'description': "For clinically stable CHF patients, the primary care physicians' prescription of pharmacological and device treatment for HF was to be documented prior to baseline and post cardiologist-referral. At the post-referral visit the degree of implementation of cardiologist-recommendations and the medical decision making (e.g. reasons for non-implementation) were to be documented.", 'reportingStatus': 'POSTED', 'populationDescription': 'Follow-Up Set (Data was not collected for this endpoint.)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enrolled Patients', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe. Patients who were considered clinically stable with NT-proBNP levels \\> 600 pg/ml were described and analyzed in the Follow-Up set.'}], 'periods': [{'title': 'Enrolled Set', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1415'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '864'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '551'}]}], 'dropWithdraws': [{'type': 'Patients not suitable for follow-up.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '551'}]}]}, {'title': 'Follow-Up Set', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '864'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '680'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}]}], 'dropWithdraws': [{'type': 'Study Terminated By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '131'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The enrolled set consisted of 1415 patients. 861 patients were referred to a cardiologist within this study and Based on findings from the interim-analysis, Novartis decided to terminate the study prematurely in March 2018.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1415', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrolled Patients', 'description': 'Adult male and female patients with chronic heart failure with reduced ejection fraction (LVEF ≤ 40%) who were managed in a primary care setting in sites across Europe. Patients who were considered clinically stable an with NT-proBNP levels \\> 600 pg/ml were referred to a cardiologist for evaluation and were in the follow-up set.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.8', 'spread': '11.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 years', 'categories': [{'measurements': [{'value': '482', 'groupId': 'BG000'}]}]}, {'title': '≥65 years to <75 years', 'categories': [{'measurements': [{'value': '408', 'groupId': 'BG000'}]}]}, {'title': '≥75 years to <85 years', 'categories': [{'measurements': [{'value': '401', 'groupId': 'BG000'}]}]}, {'title': '≥85 years', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants', 'populationDescription': 'Enrolled Set'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '436', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '979', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1282', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '126', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-15', 'size': 558694, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-03-21T14:32', 'hasProtocol': True}, {'date': '2018-06-22', 'size': 710979, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-03-21T14:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1415}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2016-06-17', 'resultsFirstSubmitDate': '2019-03-21', 'studyFirstSubmitQcDate': '2016-06-17', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-08', 'studyFirstPostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Clinically Stable Patients Whose Therapy Regimen Adheres to ESC Guideline Recommendations for Drug Types (Level 1) and Drug Type and Dose (Level 2) at Visit 1 (Before Referral to a Cardiologist)', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Assessment of treatment regimen with respect to ESC guideline adherence at Visit 1 before referral to cardiologist. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \\> 35% at visit 1. Drug type \\& dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose.'}, {'measure': 'Adherence to ESC Guideline at Visit 2 (After Referral to a Cardiologist, Month 6), for Follow-up Set: Drug Type and Drug Type and Dose', 'timeFrame': 'Month 6', 'description': "Assessment of patients' adherence at Visit 2, for patients who were already adherent at Visit 1, and those who were not adherent at Visit 1, for both drug type and drug type and dose. ESC Criteria for adherence: Drug Types: Treatment with (1) ACEi or (1) ARB in combination with (1) beta-blocker and (1) MRA for patients w/an LVEF ≤ 35% at V1. Treatment w/(1) ACEi or (1) ARB, in combination with (1) beta-blocker+ without treatment with an MRA for patients with an LVEF \\> 35% at visit 1. Drug type \\& dose: Guideline adherent with respect to drug types and dosage of all respective guideline drugs ≥ 50% of the recommended target dose."}], 'secondaryOutcomes': [{'measure': 'Duration of Heart Failure', 'timeFrame': 'Baseline (Visit 1)', 'description': 'The duration of Heart Failure was collected at Baseline (Visit 1).'}, {'measure': 'Number of Patients With Current Use of Concomitant Compound', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Use of concomitant compounds were collected at baseline (Visit 1)'}, {'measure': 'Number of Follow-Up Patients With Current Use of Concomitant Compound at Visit 2', 'timeFrame': '6 months (Visit 2)', 'description': 'Use of concomitant compounds were collected at 6 months (Visit 2)'}, {'measure': 'Percentages of Clinically Stable Patients for Whom the Cardiologist and/or Primary Care Physician Optimizes Treatment Post Referral, Stratified According to Key Baseline Characteristics', 'timeFrame': '6 months', 'description': 'For patients who enter the prospective period of the study the post-referral treatment choice of cardiologists and/or primary care physicians was documented; for patients, for whom the cardiologist and/or primary care physician chose to prescribe a novel Heart Failure treatment, the treatment was assessed, if it fulfills the definition of adherence to European Society of Cardiology (ESC) guideline recommendation. The proportion of patients for whom an ESC guideline adherent treatment was de novo prescribed was assessed stratified according to different parameters.'}, {'measure': 'Number of Patients With Different NT-proBNP Level Categories', 'timeFrame': 'One measurement in all consecutive patients at baseline (Visit 1)', 'description': 'NT-proBNP levels (pg/ml) was measured at baseline in all consecutive patients who satisfy the inclusion and exclusion criteria. Measurements were performed on-site by means of a handheld device provided for the purposes of the study. NT-proBNP level categories could be 600 -799 pg/ml, 800 - 999 pg/ml, 1000 - 1200 pg/ml, \\> 1200 pg/ml).'}, {'measure': 'Percentages of Clinically Stable Patients', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Clinically stable patients in this study were defined as those patients for whom the primary care physician did not see a necessity (based on signs and symptoms of HF) to change the current pharmacological and/or device treatment of HF and who were on stable pharmacological and/or device treatment for HF for at least 3 months prior to inclusion.'}, {'measure': 'Number of Patients by Cardiologist Prescription Practice Per Country/Region', 'timeFrame': '6 months', 'description': "The cardiologists' suggestions for pharmacological and/or device therapy for the treatment of clinically stable CHF patients was documented and assessed by means of descriptive statistical measures stratified by country/region 6 months after baseline."}, {'measure': 'Change of NT-proBNP Levels in Clinically Stable Chronic Heart Failure Patients With and Without Treatment Optimization 10 Months After Baseline', 'timeFrame': '10 months', 'description': "At 10 months after baseline (end of study) NT-proBNP was assessed in clinically stable CHF patients with baseline NT-proBNP levels ≥ 600 pg/ml. Thus, for those patients two NT-proBNP measurements were available: at baseline and 10 months later. The individual change of NT-proBNP between both time points were assessed in accordance to the patients' treatment history during the study, i.e. baseline Heart Failure treatment and therapeutic decision taken 6 months after baseline."}, {'measure': 'Change in EuroQol Five Dimensions Questionnaire (EQ-5D) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)', 'timeFrame': 'Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3)', 'description': 'Quality of life (QoL) was assessed by EQ-5D including the dimensions mobility, self-care, usual activity, pain/discomfort, anxiety/depression. A utility index based on UK value sets was built to summarize the information of these five dimensions into a single scale. The utility index can range between -0.281 and 1.0 where a higher number indicates a better health status. In addition, a visual analog scale (VAS) was applied with a possible range between 0 (=worst imaginable health state) and 100 (=best imaginable health state). Scores collected for all patients at baseline (Visit 1) and at Visit 2 and Visit 3 (only patients who entered the prospective period of the study, i.e. clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to fill out the EuroQol 5D (EQ-5D) quality of life (QoL) questionnaire validated for heart failure (HF).'}, {'measure': 'Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total and Individual Sub-scores at Visit 1 (Baseline), Visit 2 (6 Months) and Visit 3 (10 Months)', 'timeFrame': 'Baseline (Visit 1), 6 months (Visit 2), 10 months (Visit 3)', 'description': 'The KCCQ is a self-administered questionnaire. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and quality of life, each with different Likert scale wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. A positive change from baseline indicates improvement. Scores were collected for all patients at baseline and Visit 2 and Visit 3 (only patients who had entered the prospective period of the study (clinically stable patients with a NT-proBNP level ≥ 600 pg/ml) were asked to complete Kansas City Cardiomyopathy Questionnaire (KCCQ) validated for Heart Failure.'}, {'measure': 'Number of Patients in Different Living Conditions', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Living conditions were collected at Baseline (Visit 1).'}, {'measure': 'Number of Patients in Different Employment Status', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Employment status was collected at Baseline (Visit 1).'}, {'measure': 'Number of Patients With Smoking Status', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Smoking status was collected at baseline (visit 1).'}, {'measure': 'Number of Patients From Different Geographical Regions', 'timeFrame': 'Baseline (visit 1)', 'description': 'Geographic regions were collected at Baseline (Visit 1).'}, {'measure': 'Number of Patients With Health Insurance Status', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Health insurance status was collected at Baseline (Visit 1).'}, {'measure': 'Number of Patients at Different Educational Level', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Educational level was collected at Baseline (Visit 1).'}, {'measure': 'Number of Patients Per Primary Etiology of Heart Failure', 'timeFrame': 'Baseline (Visit 1)', 'description': 'The primary etiology of Heart Failure was collected at Baseline (Visit 1).'}, {'measure': 'Number of Patients With Heart Failure (HF)-Related Hospitalizations in the Previous 12 Months Prior to Baseline, and During the Study', 'timeFrame': 'Baseline (Visit 1), 6 months, 10 months', 'description': 'HF-related hospitalizations was collected in the previous 12 months prior to baseline at baseline visit, at 6 and 10 months post-baseline.'}, {'measure': 'Percentage of Patients With Cardiovascular and Non-cardiovascular Co-morbidities', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Cardiovascular and non-cardiovascular co-morbidities were collected at baseline (Visit 1)'}, {'measure': 'Mean Dose of Previously Taken and Current Use of Concomitant Medications', 'timeFrame': 'Baseline (Visit 1), 6 months, 10 months', 'description': 'Mean Dose of previously taken and current use of concomitant medications was to be collected at Visit 1, 6 months, 10 months post-baseline'}, {'measure': 'Number of Heart Failure (HF) Treatment Combinations', 'timeFrame': 'Baseline (Visit 1)', 'description': 'The types and number of participants with HF treatment combinations were collected at Baseline (Visit 1).'}, {'measure': 'Duration of Treatment With Device Type', 'timeFrame': 'Baseline (Visit 1)', 'description': 'The duration of treatment with device type was collected at baseline (Visit 1)'}, {'measure': 'Duration of Previously Taken and Currently Use of Most Common Non-Heart Failure Concomitant Compounds', 'timeFrame': 'Baseline (Visit 1)', 'description': 'Duration of most common previously taken and current use of most common Non-HF concomitant compounds were collected'}, {'measure': "Number of Patients by Primary Care Physicians' Prescription Practice Per Country/Region", 'timeFrame': 'Baseline (Visit 1)', 'description': "For clinically stable CHF patients, the primary care physicians' prescription of pharmacological and device treatment for HF was to be documented prior to baseline and post cardiologist-referral. At the post-referral visit the degree of implementation of cardiologist-recommendations and the medical decision making (e.g. reasons for non-implementation) were to be documented."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low-interventional observational study,', 'CHF,', 'heart failure,', 'primary care,', 'ESC guidelines,', 'Europe,', 'NT-proBNP,', 'reduced ventricular ejection fraction (EF),'], 'conditions': ['Chronic Heart Failure (CHF)']}, 'descriptionModule': {'briefSummary': 'This low interventional study, whose unique intervention was to measure the blood level of a biomarker called NT-proBNP in chronic heart failure patients daily followed-up by Primary Care Physicians (PCPs) in Europe, assessed if the cardiologist referral guided by NT-proBNP measurement in patients who were currently judged by PCPs as being stable, would lead to optimization of HF treatment, defined in adherence to treatment recommendations of the current European Society of Cardiology guidelines for the treatment of heart failure.', 'detailedDescription': 'In the majority of European countries, the primary management of chronic heart failure patients was performed by General Practitioners in collaboration with cardiologists (specialists). Previous studies had shown that many patients suffering from CHF do not receive optimal pharmacological and/or device treatment for their disease. An increase in natriuretic peptides (BNP, NT-proBNP) was associated with increased risk of cardiovascular events in heart failure patients. The purpose of the present study was to assess if a referral of clinical stable chronic heart failure patients with reduced ventricular ejection fraction (EF \\< or = 40%) and NT-proBNP level \\> or = 600 pg/mL to a specialist (cardiologist) led to treatment optimization, defined as adherence to the treatment recommendations according to the European Society of Cardiology (ESC) guidelines. In addition, data obtained in this study was used to describe demographic, clinical (including NT-proBNP levels) and treatment characteristics of CHF patients who were managed in the primary care setting across Europe..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willing and able to provide written informed consent and accept study procedures and time schedule.\n* Age ≥ 18 years.\n* Patients suffering from chronic heart failure (the heart failure diagnosis must have been made or confirmed by a cardiologist and/or hospital physician at any time in the patient's medical history).\n* Patients with reduced ejection fraction (≤ 40%) as confirmed at any time point in the patient's medical history.\n\nExclusion Criteria:\n\n* Use of investigational drugs either within 5 half-lives of enrollment, or within 30 days, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.\n* Major surgery in the last 3 months prior to baseline or planned major surgery or cardiac intervention during the study.\n* Cancer or other significant co-morbidities implying that the patient's condition is unstable.\n* Comorbidities that can be associated with elevated natriuretic peptide (NP) levels: renal insufficiency, (eGFR \\< 25 ml/min/1.73 m² calculated according to MDRD formula), recent (less than 3 months) cerebral trauma or recent (less than 3 months) cerebrovascular incident, novel diagnosis or acute exacerbation of COPD within the last 3 months.\n* Patients who are primarily managed and regularly followed-up by a cardiologist for their HF\n* Highly frail patients whose estimated lifespan due to comorbidities by the judgement of the investigator is less than 6 months."}, 'identificationModule': {'nctId': 'NCT02807857', 'acronym': 'PREFER', 'briefTitle': 'A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Prospective Evaluation of Natriuretic Peptide Based Referral of CHF Patients in Primary Care', 'orgStudyIdInfo': {'id': 'CLCZ696B3402'}, 'secondaryIdInfos': [{'id': '2016-000473-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': "Patients' heart failure and non-heart failure", 'description': "No treatments are stipulated by this protocol - patients' HF and non-HF treatments will be observed throughout the study. The patients' treatment is entirely in the discretion of the primary care physicians", 'interventionNames': ['Procedure: Standard care']}], 'interventions': [{'name': 'Standard care', 'type': 'PROCEDURE', 'description': 'Patients will receive the treatment that their primary care physician has decided to prescribe for their disease', 'armGroupLabels': ["Patients' heart failure and non-heart failure"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '9690', 'city': 'Kluisbergen', 'state': 'Belgium', 'country': 'Belgium', 'facility': 'Novartis Investigative Site'}, {'zip': '3211', 'city': 'Binkom', 'state': 'BEL', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.87163, 'lon': 4.88414}}, {'zip': '6534', 'city': 'Gozée', 'state': 'BEL', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.33461, 'lon': 4.35273}}, {'zip': '1630', 'city': 'Linkebeek', 'state': 'BEL', 'country': 'Belgium', 'facility': 'Novartis 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