Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2026-06-30 @ 2:49 AM
Study NCT ID:
NCT02468232
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2015-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Efficacy and Safety of LCZ696 in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C549068', 'term': 'sacubitril and valsartan sodium hydrate drug combination'}, {'id': 'D004656', 'term': 'Enalapril'}], 'ancestors': [{'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Clinical Disclosure Office', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "Other disclosure agreement that restricts the right of the Pl to discuss or publish trial results after the trial is completed. 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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were reported from first dose of study treatment until end of treatment. Adverse events reported during double-blind treatment epoch (up to 41.59, 41.92 months for LCZ696 and Enalapril, respectively) were summarized. AEs during OLE epoch were summarized as well (24.80 months for LCZ696 (OLE epoch) and 24.15 months for Enalapril (OLE epoch).', 'description': 'Adverse Event (AE): Any sign or symptom that occurs during treatment plus 30 days.', 'eventGroups': [{'id': 'EG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 108, 'seriousNumAtRisk': 111, 'deathsNumAffected': 20, 'seriousNumAffected': 64}, {'id': 'EG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.', 'otherNumAtRisk': 112, 'deathsNumAtRisk': 112, 'otherNumAffected': 108, 'seriousNumAtRisk': 112, 'deathsNumAffected': 17, 'seriousNumAffected': 61}, {'id': 'EG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.', 'otherNumAtRisk': 79, 'deathsNumAtRisk': 79, 'otherNumAffected': 67, 'seriousNumAtRisk': 79, 'deathsNumAffected': 4, 'seriousNumAffected': 38}, {'id': 'EG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 64, 'seriousNumAtRisk': 71, 'deathsNumAffected': 3, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Anaemia macrocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Anaemia of malignant disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Nephrogenic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Polycythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Thrombotic microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cardiac dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': "Rathke's cleft cyst", 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Eustachian tube patulous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'External ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, 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'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Spondylitic myelopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Nephropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Scrotal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Ischaemic skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Cardiac pacemaker replacement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Arterial stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Had CEC (Clinical Endpoint Committee) Confirmed Composite Endpoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'Primary composite', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Cardiovascular (CV) Death', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '1st heart failure (HF) Hospitalization', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 40 months', 'description': 'Composite endpoint is defined as either cardiovascular (CV) death or heart failure (HF) hospitalization in Japanese patients with chronic heart failure (CHF) and reduced ejection fraction. The composite endpoint events occurred on and after End-of-study (EOS) declaration were reported by investigators but those events were not required to be adjudicated by Clinical Endpoint Committee (CEC) and not included in the efficacy analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.'}, {'type': 'PRIMARY', 'title': 'Exposure-adjusted Incident Rate (EAIR) of CEC Confirmed Composite Endpoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'Primary composite', 'categories': [{'measurements': [{'value': '11.376', 'groupId': 'OG000', 'lowerLimit': '7.676', 'upperLimit': '16.240'}, {'value': '10.497', 'groupId': 'OG001', 'lowerLimit': '6.975', 'upperLimit': '15.170'}]}]}, {'title': 'Cardiovascular (CV) Death', 'categories': [{'measurements': [{'value': '4.410', 'groupId': 'OG000', 'lowerLimit': '2.348', 'upperLimit': '7.542'}, {'value': '3.734', 'groupId': 'OG001', 'lowerLimit': '1.864', 'upperLimit': '6.681'}]}]}, {'title': '1st heart failure (HF) Hospitalization', 'categories': [{'measurements': [{'value': '9.480', 'groupId': 'OG000', 'lowerLimit': '6.135', 'upperLimit': '13.995'}, {'value': '7.498', 'groupId': 'OG001', 'lowerLimit': '4.580', 'upperLimit': '11.579'}]}]}], 'analyses': [{'pValue': '0.6260', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0881', 'ciLowerLimit': '0.6501', 'ciUpperLimit': '1.8212', 'groupDescription': 'For Primary Composite', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6493', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1701', 'ciLowerLimit': '0.5242', 'ciUpperLimit': '2.6122', 'groupDescription': 'For CV Death', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7851', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2673', 'ciLowerLimit': '0.7039', 'ciUpperLimit': '2.2818', 'groupDescription': 'For 1st HF Hospitalization', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 40 months', 'description': 'Composite endpoint is defined as either cardiovascular (CV) death or heart failure (HF) hospitalization in Japanese patients with chronic heart failure (CHF) and reduced ejection fraction. EAIR = n/T where n = Total number of events included in the analysis. T (100 patient years) = total up-to-event/censoring duration-time summarized over participants in the respective treatment group. The composite endpoint events occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.', 'unitOfMeasure': 'Events per 100 patient-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Key Secondary: Change From Baseline to the Pre-defined Time-points in Log-transformed Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'Week 4 (n = 111, 110, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.7672', 'groupId': 'OG000', 'lowerLimit': '0.6988', 'upperLimit': '0.8423'}, {'value': '0.8862', 'groupId': 'OG001', 'lowerLimit': '0.8071', 'upperLimit': '0.9731'}]}]}, {'title': 'Week 8 (n = 111, 108, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.7798', 'groupId': 'OG000', 'lowerLimit': '0.7123', 'upperLimit': '0.8537'}, {'value': '0.9134', 'groupId': 'OG001', 'lowerLimit': '0.8339', 'upperLimit': '1.0004'}]}]}, {'title': 'Month 6 (n= 110, 106, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.6947', 'groupId': 'OG000', 'lowerLimit': '0.6210', 'upperLimit': '0.7771'}, {'value': '0.8564', 'groupId': 'OG001', 'lowerLimit': '0.7646', 'upperLimit': '0.9592'}]}]}], 'analyses': [{'pValue': '0.0326', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM of ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8657', 'ciLowerLimit': '0.7585', 'ciUpperLimit': '0.9880', 'pValueComment': 'Indicates statistical significance (2-sided) with an alpha level of 0.05', 'groupDescription': 'Week 4 analysis', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Repeated measure ANCOVA model'}, {'pValue': '0.0161', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM of ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8538', 'ciLowerLimit': '0.7509', 'ciUpperLimit': '0.9708', 'pValueComment': 'Indicates statistical significance (2-sided) with an alpha level of 0.05', 'groupDescription': 'Week 8 analysis', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Repeated measure ANCOVA model'}, {'pValue': '0.0104', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM of ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8112', 'ciLowerLimit': '0.6916', 'ciUpperLimit': '0.9514', 'pValueComment': 'Indicates statistical significance (2-sided) with an alpha level of 0.05', 'groupDescription': 'Month 6 analysis', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Repeated measure of ANCOVA model'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and Month 6', 'description': 'NT-proBNP is small protein produced in large amounts when the heart senses it needs to work harder, such as in heart failure. Change from baseline to the pre-defined time-points in logarithmic scale were analyzed using a repeated measures ANCOVA model with treatment, the stratification factor screening NT-proBNP classification recorded in the Interactive Web Response System (IWRS), visit and treatment-by-visit interaction as fixed effect factors and the logarithmic baseline biomarker value as a covariate, with a common unstructured covariance matrix among visits for each treatment. The analysis is using all available data up to month 6 based on likelihood method with an assumption of missing at random (MAR) for missing data.\n\nThis record summarizes the estimates of ratio Post-baseline /Baseline NT-proBNP.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.\n\nThis analysis is a longitudinal data analysis and all available data up to month 6 for each patient was used. Number of participants at each post-time point indicates the number of patients who have both baseline and post-time point values.'}, {'type': 'SECONDARY', 'title': 'Key Secondary: Number of Participants With CEC-confirmed First Triple Composite Endpoint (Cardiovascular (CV) Death, Heart Failure (HF) Hospitalization, or Worsening of HF in Outpatients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'First triple composite endpoint', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'CV death', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'First HF Hospitalization', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'First worsening of HF in outpatient', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 40 months', 'description': 'Composite endpoint is defined as either cardiovascular (CV) death or heart failure (HF) hospitalization in Japanese patients with chronic heart failure (CHF) and reduced ejection fraction. Worsening HF defined as: worsening signs and symptoms of HF requiring addition of a new drug for HF treatment, initiation of IV treatment, increase of diuretic dose for persistent use for ≥4 consecutive weeks, or institution of mechanical or circulatory support such as mechanical ventilation, ultrafiltration, hemodialysis, intra-aortic balloon pump or ventricular assist device. The composite endpoint events occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Key Secondary: EAIR of CEC-confirmed First Triple Composite Endpoint (Cardiovascular (CV) Death, Heart Failure (HF) Hospitalization, or Worsening of HF in Outpatients)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'First triple composite endpoint', 'categories': [{'measurements': [{'value': '14.725', 'groupId': 'OG000', 'lowerLimit': '10.368', 'upperLimit': '20.297'}, {'value': '14.479', 'groupId': 'OG001', 'lowerLimit': '10.194', 'upperLimit': '19.957'}]}]}, {'title': 'CV death', 'categories': [{'measurements': [{'value': '4.410', 'groupId': 'OG000', 'lowerLimit': '2.348', 'upperLimit': '7.542'}, {'value': '3.734', 'groupId': 'OG001', 'lowerLimit': '1.864', 'upperLimit': '6.681'}]}]}, {'title': 'First HF Hospitalization', 'categories': [{'measurements': [{'value': '9.480', 'groupId': 'OG000', 'lowerLimit': '6.135', 'upperLimit': '13.995'}, {'value': '7.498', 'groupId': 'OG001', 'lowerLimit': '4.580', 'upperLimit': '11.579'}]}]}, {'title': 'First worsening of HF in outpatient', 'categories': [{'measurements': [{'value': '4.372', 'groupId': 'OG000', 'lowerLimit': '2.259', 'upperLimit': '7.638'}, {'value': '5.095', 'groupId': 'OG001', 'lowerLimit': '2.786', 'upperLimit': '8.549'}]}]}], 'analyses': [{'pValue': '0.5406', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0240', 'ciLowerLimit': '0.6492', 'ciUpperLimit': '1.6152', 'groupDescription': 'First triple composite endpoint', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6493', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1701', 'ciLowerLimit': '0.5242', 'ciUpperLimit': '2.6122', 'groupDescription': 'CV health', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3448', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8546', 'ciLowerLimit': '0.3952', 'ciUpperLimit': '1.8479', 'groupDescription': 'First worsening of HF in outpatient', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 40 months', 'description': 'Worsening HF defined as: worsening signs and symptoms of HF requiring addition of a new drug for HF treatment, initiation of IV treatment, increase of diuretic dose for persistent use for ≥4 consecutive weeks, or institution of mechanical or circulatory support such as mechanical ventilation, ultrafiltration, hemodialysis, intra-aortic balloon pump or ventricular assist device.\n\nEAIR(Exposure-adjusted incidence rate per 100 patient years)= n/T:\n\nn: Total number of events included in the analysis. T(100 patient years): total up-to-event/censoring duration-time summarized over patients in the respective treatment group. The composite endpoint events occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.', 'unitOfMeasure': 'Events per 100 patient-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Key Secondary: Number of Participants by Changes in New York Heart Association (NYHA) Classification From Baseline at Predefined Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'Week 4 Improved (n = 111, 111, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Unchanged (n = 111, 111, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Worsened (n = 111, 111, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 Improved (n = 111, 111, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 Unchanged (n = 111, 111, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 Worsened (n = 111, 111, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 Improved (n = 111, 110, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 Unchanged (n = 111, 110, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 Worsened (n = 111, 110, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7115', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 4 analysis', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'based on modified ridit scores'}, {'pValue': '0.1752', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 8 analysis', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'based on modified ridit scores'}, {'pValue': '0.2688', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Month 6 analysis', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'based on modified ridit scores'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Weeks 4, 8 and Month 6', 'description': 'NYHA classification is a subjective physician\'s assessment of heart failure patient\'s functional capacity and symptomatic status.\n\nClass I - No limitation of physical activity. Class II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV - Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.\n\nThe NYHA class change was analyzed as a three category ordinal variable with levels: "improved", "unchanged", and "worsened", defined by at least one class improvement, no change, at least one class worsening, in NYHA class, respectively. NYHA class after patients who died was categorized into "worsened".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. Number of participants at post-time point (i.e., n) indicates the number of patients who have post-time point values.'}, {'type': 'SECONDARY', 'title': 'Key Secondary: Change From Baseline in Clinical Summary Score for Heart Failure Symptoms and Physical Limitations Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'Week 8 (n = 111, 111, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.0491', 'spread': '1.3522', 'groupId': 'OG000'}, {'value': '-2.5946', 'spread': '1.3504', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n = 111, 110, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.2216', 'spread': '1.5898', 'groupId': 'OG000'}, {'value': '-3.4910', 'spread': '1.5911', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1854', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5455', 'ciLowerLimit': '-1.2306', 'ciUpperLimit': '6.3216', 'groupDescription': 'Week 8 analysis', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Repeated measure ANCOVA model'}, {'pValue': '0.5737', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM of difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2695', 'ciLowerLimit': '-3.1715', 'ciUpperLimit': '5.7104', 'groupDescription': 'Month 6 analysis', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Repeated measure ANCOVA model'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8 and Month 6', 'description': 'The KCCQ is a self-administered questionnaire and requires, on average, 4-6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL), each with different Likert scaling wording, including limitations, frequency, bother, change in condition, understanding, etc. The clinical summary score is a mean of the physical limitation and total symptom scores. The total symptom score is the mean of the symptom frequency and symptom burden scores. Each scale score (the physical limitation, symptom frequency or symptom burden) is calculated as the mean of its item scores and transformed to a 0-100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents dead. A change of 5 points on the scale scores, either as a group mean difference or an intra-individual change appears to be clinically significant.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. FAS included all patients with at least one KCCQ data. This is a longitudinal data analysis and all available data for each patient was used. Number of patients at each post-time point (n) indicates the number of patients who have both baseline and post-time point values.'}, {'type': 'SECONDARY', 'title': 'Total Number of CEC Confirmed Composite of CV Death and Total (First and Recurrent) HF Hospitalizations for Heart Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1734', 'groupId': 'OG000', 'lowerLimit': '0.1123', 'upperLimit': '0.2680'}, {'value': '0.1994', 'groupId': 'OG001', 'lowerLimit': '0.1295', 'upperLimit': '0.3070'}]}]}], 'analyses': [{'pValue': '0.6501', 'groupIds': ['OG000', 'OG001'], 'paramType': 'rate ratio', 'ciPctValue': '95', 'paramValue': '0.8699', 'ciLowerLimit': '0.4763', 'ciUpperLimit': '1.5887', 'statisticalMethod': 'Negative binomial (NB) regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for treatment and stratification of screening NT-proBNP'}], 'paramType': 'NUMBER', 'timeFrame': 'up tp 40 months', 'description': 'Total number of CEC-confirmed CV death and total (first and recurrent) HF hospitalizations per patient was analyzed using the negative binomial regression model. CV deaths and HF hospitalizations occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.', 'unitOfMeasure': 'Events per patient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants by Changes in Clinical Composite Score (as Assessed by NYHA Classification and Patient Global Assessment) at Predefined Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'Clinical composite assessment: Improved', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Clinical composite assessment: Unchanged', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Clinical composite assessment: Worsened', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6211', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Month 6', 'description': 'The global assessment was derived from the 7-category classification of the global assessment of disease activity to a three-category classification: Improved (Markedly improved; moderately improved), Unchanged (Slightly improved, unchanged, slightly worsened), and Worsened (Moderately worsened, markedly worsened).\n\nThe clinical composite assessment was defined as follows:\n\n* Improved: 1) If NYHA class decreased at least one level and Global Assessment was not worse at the selected visit and there was no major AE up to the selected visit; or 2) Global assessment was improved and NYHA class did not increase at the selected visit, and there was no major AE up to the selected visit.\n* Worsened: 1) If NYHA class increased at the selected visit; or 2) Global Assessment was worse at the selected visit; or 3) experienced a major AE up to the selected visit.\n* Unchanged: If neither "Improved" nor "Worsened".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. Overall Number of Participants Analyzed' indicates the number of patients who have post-time point values."}, {'type': 'SECONDARY', 'title': 'Number of Participants With All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 40 months', 'description': 'The number of participants who died due to any cause. Deaths occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': 'EAIR of All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.445', 'groupId': 'OG000', 'lowerLimit': '3.881', 'upperLimit': '10.065'}, {'value': '5.431', 'groupId': 'OG001', 'lowerLimit': '3.104', 'upperLimit': '8.820'}]}]}], 'analyses': [{'pValue': '0.6955', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1895', 'ciLowerLimit': '0.6116', 'ciUpperLimit': '2.3134', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 40 months', 'description': 'EAIR (Exposure-adjusted incidence rate per 100 patient years)= n/T:\n\nn: Total number of events included in the analysis. T(100 patient years): total up-to-event/censoring duration-time summarized over patients in the respective treatment group. Deaths occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.', 'unitOfMeasure': 'Events per 100 patient-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Hospitalized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 40 months', 'description': 'Percentage of participants with hospitalized admissions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Hospitalization Admissions Events Per-participant Per Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5881', 'groupId': 'OG000', 'lowerLimit': '0.4439', 'upperLimit': '0.7792'}, {'value': '0.5771', 'groupId': 'OG001', 'lowerLimit': '0.4376', 'upperLimit': '0.7610'}]}]}], 'analyses': [{'pValue': '0.9233', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0192', 'ciLowerLimit': '0.6925', 'ciUpperLimit': '1.4999', 'statisticalMethod': 'Negative binomial (NB) regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for treatment and stratification of screening NT-proBNP'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 40 months', 'description': 'The number of hospital admission events per-participant per year was calculated as total number of hospital admission divided by total up-to-event/censoring duration-time summarized over patients.', 'unitOfMeasure': 'Hospitalization admissions per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Days in Intensive Care Unit (ICU) Per Participant Per Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8542', 'groupId': 'OG000', 'lowerLimit': '0.2662', 'upperLimit': '2.7409'}, {'value': '0.7943', 'groupId': 'OG001', 'lowerLimit': '0.2929', 'upperLimit': '2.1541'}]}]}], 'analyses': [{'pValue': '0.9272', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0754', 'ciLowerLimit': '0.2264', 'ciUpperLimit': '5.1067', 'statisticalMethod': 'Negative binomial (NB) regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for treatment and stratification of screening NT-proBNP'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 40 months', 'description': 'The number of days in ICU per participant per year was calculated as total number of days in ICU divided by total up-to-event/censoring duration-time summarized over patients.', 'unitOfMeasure': 'Days per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Re-hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': '2 Events', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '3 Events', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '4 Events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '>= 5 Events', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 40 months', 'description': 'The percentage of participants who had re-hospitalizations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Emergency Department/Urgent Care Facility Visits for HF Per Patient Per Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0533', 'groupId': 'OG000', 'lowerLimit': '0.0277', 'upperLimit': '0.1025'}, {'value': '0.1183', 'groupId': 'OG001', 'lowerLimit': '0.0667', 'upperLimit': '0.2097'}]}]}], 'analyses': [{'pValue': '0.0697', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4504', 'ciLowerLimit': '0.1902', 'ciUpperLimit': '1.0665', 'pValueComment': 'Negative binomial (NB) regression model', 'statisticalMethod': 'Negative binomial (NB) regression model', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'adjusted for treatment and stratification of screening NT-proBNP'}], 'paramType': 'NUMBER', 'timeFrame': 'up to 40 months', 'description': 'The number of emergency department/urgent care facility visits for HF per patient per year was calculated as total number of emergency department/urgent care facility visits for HF divided by total up-to-event/censoring duration-time summarized over patients.', 'unitOfMeasure': 'Visits per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Change in Blood NT-proBNP From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'Week 2 (n = 111, 108, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-366.5766', 'spread': '611.8846', 'groupId': 'OG000'}, {'value': '-86.2222', 'spread': '1997.9885', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 ( n = 111, 110, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-233.9279', 'spread': '725.9590', 'groupId': 'OG000'}, {'value': '-224.8545', 'spread': '2023.1202', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n = 111, 108, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-252.0090', 'spread': '590.5862', 'groupId': 'OG000'}, {'value': '-234.2963', 'spread': '1840.3993', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (110, 106, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-327.5000', 'spread': '731.9563', 'groupId': 'OG000'}, {'value': '-240.7264', 'spread': '2041.3829', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and Month 6', 'description': 'NT-proBNP is small protein produced in large amounts when the heart senses it needs to work harder, such as in heart failure. Mean change from baseline (post-baseline value - baseline value) in plasma NT-proBNP was caluculated.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study. Number of participants at each post-time point (i.e., n) indicates the number of patients who have both baseline and post-time point values.'}, {'type': 'SECONDARY', 'title': 'Change in Procollagen Type III N-Terminal Propeptide From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2914', 'spread': '1.9105', 'groupId': 'OG000'}, {'value': '-0.0583', 'spread': '1.7774', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Month 18', 'description': 'Procollagen Type III N-Terminal Propeptide (PIIINP) is a serum marker of collagen turnover, generated during the synthesis of type III collagen. Increased circulating PIIINP is a marker not only of muscle growth, but also of muscle repair and fibrosis. Mean change from baseline (post-baseline value - baseline value) in serum PIIINP was calculated.', 'unitOfMeasure': 'ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': "Changes in Urine Cyclic Guanosine 3',5'-Monophosphate (cGMP) From Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'Week 4 (n = 110, 109, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '556.3182', 'spread': '663.8357', 'groupId': 'OG000'}, {'value': '-25.9725', 'spread': '552.6414', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n = 111, 107, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '587.4414', 'spread': '886.4691', 'groupId': 'OG000'}, {'value': '-52.7944', 'spread': '503.1090', 'groupId': 'OG001'}]}]}, {'title': 'Month 6 (n = 110, 102, 0, 0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '507.9182', 'spread': '1169.4057', 'groupId': 'OG000'}, {'value': '-41.9706', 'spread': '512.6963', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and Month 6', 'description': 'Urinary Cyclic GMP (cGMP) is a biomarker measured in the urine that reflects the activity of biomarkers such as BNP (Brain Natriuretic Peptide). First morning void (FMV) urine samples were collected. Mean change from baseline (post-baseline value - baseline value) in urine cGMP was calculated.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization and have not received investigational drug, but have been inadvertently randomized into the study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reaching Target Dose Level 3 at Week 8 and Maintained at Month 4 (Open Label Extension (OLE))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 4 of OLE', 'description': 'The percentage of participants who reached target dose level (200 mg b.i.d.) at Week 8 and maintained at Month 4(OLE). This indicates how tolerabile to LCZ696 at target dose.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug.'}, {'type': 'SECONDARY', 'title': 'Change in NYHA Classification From OLE Baseline (OLE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Unchanged', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'OLE Baseline, Month 12 (OLE)', 'description': 'NYHA classification is a subjective physician\'s assessment of heart failure patient\'s functional capacity and symptomatic status.\n\nClass I - No limitation of physical activity. Class II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV - Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.\n\nThe NYHA class change was analyzed as a three category ordinal variable with levels: "improved", "unchanged", and "worsened", defined by at least one class improvement, no change, at least one class worsening, in NYHA class, respectively. NYHA class after patients who died was categorized into "worsened".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug.'}, {'type': 'SECONDARY', 'title': 'Change in Key Echocardiographic Parameters From OLE Baseline at Month 12 (OLE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'LAVi (n = 0, 0, 67, 55)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.31', 'spread': '11.679', 'groupId': 'OG002'}, {'value': '-1.47', 'spread': '12.389', 'groupId': 'OG003'}]}]}, {'title': 'LVEDVi (n = 0, 0, 62, 53)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.54', 'spread': '18.712', 'groupId': 'OG002'}, {'value': '0.99', 'spread': '25.919', 'groupId': 'OG003'}]}]}, {'title': 'LVESVi (n = 0, 0, 62, 53)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2.32', 'spread': '14.801', 'groupId': 'OG002'}, {'value': '-2.65', 'spread': '20.619', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12 (OLE)', 'description': 'Key echocardiographic parameters:\n\nLAVi- left atrial volume index, LVEDVi- left ventricular end diastolic volume index, LVESVi- left ventricular end systolic volume index.\n\nA two-dimensional and doppler echo examination was done to assess echo parameters. Mean changes from baseline (post-baseline value - baseline value) in each parameter were calculated. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'mL/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug.'}, {'type': 'SECONDARY', 'title': 'Change in Cardiac Measurements by Key Echocardiographic Parameter LVEF, From OLE Baseline at Month 12 (OLE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.97', 'spread': '6.647', 'groupId': 'OG002'}, {'value': '3.46', 'spread': '5.984', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 12 (OLE)', 'description': 'Key echocardiographic parameter:\n\nLVEF- left ventricular ejection fraction. LVEF is a measurement expressed as a percentage of how much blood the left ventricle pumps out with each contraction. Mean changes from baseline (post-baseline value - baseline value) in LVEF were calculated.', 'unitOfMeasure': 'Percentage of ejected blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug.'}, {'type': 'SECONDARY', 'title': 'Change in B-type Natriuretic Peptide (BNP) From OLE Baseline to Predefined Timepoints (OLE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'Weeks 2-4 (n = 0, 0, 78, 70)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-81.78', 'spread': '402.754', 'groupId': 'OG002'}, {'value': '89.77', 'spread': '336.742', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 (n = 0, 0, 78, 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-34.86', 'spread': '509.893', 'groupId': 'OG002'}, {'value': '170.87', 'spread': '492.707', 'groupId': 'OG003'}]}]}, {'title': 'Month 4 (n = 0,0, 76, 69)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.86', 'spread': '515.351', 'groupId': 'OG002'}, {'value': '200.87', 'spread': '672.071', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 (n = 0,0, 71, 66)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '115.11', 'spread': '600.797', 'groupId': 'OG002'}, {'value': '153.06', 'spread': '479.813', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2-4, Week 8, Months 4 and 12 (OLE)', 'description': 'BNP is small protein produced in large amounts when the heart senses it needs to work harder, such as in heart failure. Mean change from baseline (post-baseline value - OLE baseline value) in plasma BNP was calculated.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug.\n\nNumber of participants at each post-time point (i.e., n) indicates the number of patients who have both baseline and post-time point values.'}, {'type': 'SECONDARY', 'title': 'Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From OLE Baseline to Predefined Timepoints (OLE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'Weeks 2-4 (n = 0, 0, 78, 70)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-235.73', 'spread': '1642.510', 'groupId': 'OG002'}, {'value': '-333.12', 'spread': '829.689', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 (n = 0, 0, 78, 68', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-219.47', 'spread': '1876.166', 'groupId': 'OG002'}, {'value': '-279.53', 'spread': '806.447', 'groupId': 'OG003'}]}]}, {'title': 'Month 4 (n = 0,0, 76, 69)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-83.49', 'spread': '798.424', 'groupId': 'OG002'}, {'value': '-280.35', 'spread': '930.407', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 (n = 0,0, 71, 66)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '266.43', 'spread': '1201.239', 'groupId': 'OG002'}, {'value': '-358.98', 'spread': '995.833', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 2-4, Week 8, Months 4 and 12 (OLE)', 'description': 'NT-proBNP is small protein produced in large amounts when the heart senses it needs to work harder, such as in heart failure. Mean change from baseline (post-baseline value - OLE baseline value) in plasma NT-proBNP was calculated.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug.\n\nNumber of participants at each post-time point (i.e., n) indicates the number of patients who have both baseline and post-time point values.'}, {'type': 'SECONDARY', 'title': 'Change in Urine cGMP From OLE Baseline to Predefined Timepoints (OLE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'Weeks 2-4 (n = 0, 0, 78, 69)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '106.78', 'spread': '1139.886', 'groupId': 'OG002'}, {'value': '411.16', 'spread': '956.355', 'groupId': 'OG003'}]}]}, {'title': 'Week 8 (n = 0, 0, 78, 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '142.59', 'spread': '1005.718', 'groupId': 'OG002'}, {'value': '356.41', 'spread': '885.854', 'groupId': 'OG003'}]}]}, {'title': 'Month 4 (n = 0, 0, 76, 68)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '176.50', 'spread': '1023.525', 'groupId': 'OG002'}, {'value': '580.40', 'spread': '1021.542', 'groupId': 'OG003'}]}]}, {'title': 'Month 12 (n = 0, 0, 71, 66)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-131.86', 'spread': '1284.239', 'groupId': 'OG002'}, {'value': '493.21', 'spread': '1024.247', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2-4, Week 8, Months 4 and 12 (OLE)', 'description': 'Urinary Cyclic GMP (cGMP) is a biomarker measured in the urine that reflects the activity of biomarkers such as BNP (Brain Natriuretic Peptide). Spot urine samples were collected. Mean change from baseline (post-baseline value - OLE baseline value) in urine cGMP was calculated.', 'unitOfMeasure': 'nmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug. Number of participants at each post-time point (i.e., n) indicates the number of patients who have both baseline and post-time point values.'}, {'type': 'SECONDARY', 'title': 'Association Between Change in NT-proBNP Concentration and Change in Echocardiographic Parameters From OLE Baseline at Month 12 (OLE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'OG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'OG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'classes': [{'title': 'NT-proBNP / LAVi( =0,0, 67, 55)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0178', 'groupId': 'OG002', 'lowerLimit': '-0.2235', 'upperLimit': '0.2567'}, {'value': '0.0640', 'groupId': 'OG003', 'lowerLimit': '-0.2054', 'upperLimit': '0.3232'}]}]}, {'title': 'NT-proBNP/ LVEDVi (n = 0, 0, 62, 53)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.1869', 'groupId': 'OG002', 'lowerLimit': '-0.4159', 'upperLimit': '0.0675'}, {'value': '-0.0059', 'groupId': 'OG003', 'lowerLimit': '-0.2757', 'upperLimit': '0.2649'}]}]}, {'title': 'NT-proBNP / LVESVi (n = 0, 0, 62, 53)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.0775', 'groupId': 'OG002', 'lowerLimit': '-0.3205', 'upperLimit': '0.1762'}, {'value': '0.0047', 'groupId': 'OG003', 'lowerLimit': '-0.2660', 'upperLimit': '0.2746'}]}]}, {'title': 'NT-proBNP / LVEF (n = 0, 0, 62, 53)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.2582', 'groupId': 'OG002', 'lowerLimit': '-0.4756', 'upperLimit': '-0.0069'}, {'value': '0.0233', 'groupId': 'OG003', 'lowerLimit': '-0.2488', 'upperLimit': '0.2915'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Association (using the Pearson correlation coefficient) between change from OLE baseline in log-transformed NT-proBNP and echocardiographic parameters (LAVi, LVEDVi, LVESVi \\& LVEF)', 'unitOfMeasure': "Peason's correlation", 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS-Ext: The full analysis set for OLE epoch (FAS-Ext) included all subjects in the extension population who received at least one dose of the extension study drug. Number of participants at each post-time point (i.e., n) indicates the number of patients who have both baseline and post-time point values.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'FG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'FG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'FG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}], 'periods': [{'title': 'Core Part of Study', 'milestones': [{'type': 'STARTED', 'comment': 'Started = Enrolled in Core', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '113'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Randomized Patients', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '113'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Mis-randomized Patients', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Discont. From Randomized Treatment (Rand. Set)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Discont. From Rand. Treatment (Full Analysis Set)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Completed = Completed Core', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Technical Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'OLE Part of Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '79'}, {'groupId': 'FG003', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '65'}, {'groupId': 'FG003', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Subject/Guardian decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'It was estimated that approximately 370 patients would be screened in order to randomize 220 patients (110 patients in each arm), as the screen or run-in failure rate was anticipated to be approximately 40%. It was anticipated that approximately 180 subjects would complete the core part of the study \\& majority of them would be enrolled into the open-label extension (OLE).', 'preAssignmentDetails': 'Overall, 307 patients were screened, and 71 patients discontinued prior to the screening epoch completion. Thus, 236 patients entered the run-in epoch, with 11 patients being run-in failures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '223', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'BG001', 'title': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.'}, {'id': 'BG002', 'title': 'LCZ696 (Core) OLE Epoch', 'description': 'The patients who received LCZ696 in the core part of the study and continued to receive LCZ696 in the open-label extension (OLE) are referred to as LCZ (core) group. These patients received open-label LCZ696 in the OLE phase.'}, {'id': 'BG003', 'title': 'Enalapril (Core) OLE Epoch', 'description': 'The subjects who received enalapril in the core part and then switched to LCZ696 in the OLE are referred to as ENA (core) group. These patients switched from enalapril and received open-label LCZ696 in the OLE phase.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.97', 'spread': '9.717', 'groupId': 'BG000'}, {'value': '66.70', 'spread': '10.938', 'groupId': 'BG001'}, {'value': '67.83', 'spread': '10.388', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Full Analysis Set (FAS) consists of all randomized patients with the exception for those patients who have not been qualified for randomization (mis-randomized) and have not received investigational drug, but have been inadvertently randomized into the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-19', 'size': 1089404, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-02-17T03:25', 'hasProtocol': True}, {'date': '2021-03-11', 'size': 276121, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-17T12:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2015-06-08', 'resultsFirstSubmitDate': '2022-02-17', 'studyFirstSubmitQcDate': '2015-06-08', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-13', 'studyFirstPostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Had CEC (Clinical Endpoint Committee) Confirmed Composite Endpoints', 'timeFrame': 'up to 40 months', 'description': 'Composite endpoint is defined as either cardiovascular (CV) death or heart failure (HF) hospitalization in Japanese patients with chronic heart failure (CHF) and reduced ejection fraction. The composite endpoint events occurred on and after End-of-study (EOS) declaration were reported by investigators but those events were not required to be adjudicated by Clinical Endpoint Committee (CEC) and not included in the efficacy analysis.'}, {'measure': 'Exposure-adjusted Incident Rate (EAIR) of CEC Confirmed Composite Endpoints', 'timeFrame': 'up to 40 months', 'description': 'Composite endpoint is defined as either cardiovascular (CV) death or heart failure (HF) hospitalization in Japanese patients with chronic heart failure (CHF) and reduced ejection fraction. EAIR = n/T where n = Total number of events included in the analysis. T (100 patient years) = total up-to-event/censoring duration-time summarized over participants in the respective treatment group. The composite endpoint events occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.'}], 'secondaryOutcomes': [{'measure': 'Key Secondary: Change From Baseline to the Pre-defined Time-points in Log-transformed Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)', 'timeFrame': 'Baseline, Weeks 4, 8 and Month 6', 'description': 'NT-proBNP is small protein produced in large amounts when the heart senses it needs to work harder, such as in heart failure. Change from baseline to the pre-defined time-points in logarithmic scale were analyzed using a repeated measures ANCOVA model with treatment, the stratification factor screening NT-proBNP classification recorded in the Interactive Web Response System (IWRS), visit and treatment-by-visit interaction as fixed effect factors and the logarithmic baseline biomarker value as a covariate, with a common unstructured covariance matrix among visits for each treatment. The analysis is using all available data up to month 6 based on likelihood method with an assumption of missing at random (MAR) for missing data.\n\nThis record summarizes the estimates of ratio Post-baseline /Baseline NT-proBNP.'}, {'measure': 'Key Secondary: Number of Participants With CEC-confirmed First Triple Composite Endpoint (Cardiovascular (CV) Death, Heart Failure (HF) Hospitalization, or Worsening of HF in Outpatients)', 'timeFrame': 'up to 40 months', 'description': 'Composite endpoint is defined as either cardiovascular (CV) death or heart failure (HF) hospitalization in Japanese patients with chronic heart failure (CHF) and reduced ejection fraction. Worsening HF defined as: worsening signs and symptoms of HF requiring addition of a new drug for HF treatment, initiation of IV treatment, increase of diuretic dose for persistent use for ≥4 consecutive weeks, or institution of mechanical or circulatory support such as mechanical ventilation, ultrafiltration, hemodialysis, intra-aortic balloon pump or ventricular assist device. The composite endpoint events occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.'}, {'measure': 'Key Secondary: EAIR of CEC-confirmed First Triple Composite Endpoint (Cardiovascular (CV) Death, Heart Failure (HF) Hospitalization, or Worsening of HF in Outpatients)', 'timeFrame': 'up to 40 months', 'description': 'Worsening HF defined as: worsening signs and symptoms of HF requiring addition of a new drug for HF treatment, initiation of IV treatment, increase of diuretic dose for persistent use for ≥4 consecutive weeks, or institution of mechanical or circulatory support such as mechanical ventilation, ultrafiltration, hemodialysis, intra-aortic balloon pump or ventricular assist device.\n\nEAIR(Exposure-adjusted incidence rate per 100 patient years)= n/T:\n\nn: Total number of events included in the analysis. T(100 patient years): total up-to-event/censoring duration-time summarized over patients in the respective treatment group. The composite endpoint events occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.'}, {'measure': 'Key Secondary: Number of Participants by Changes in New York Heart Association (NYHA) Classification From Baseline at Predefined Timepoints', 'timeFrame': 'Baseline, Weeks 4, 8 and Month 6', 'description': 'NYHA classification is a subjective physician\'s assessment of heart failure patient\'s functional capacity and symptomatic status.\n\nClass I - No limitation of physical activity. Class II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV - Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.\n\nThe NYHA class change was analyzed as a three category ordinal variable with levels: "improved", "unchanged", and "worsened", defined by at least one class improvement, no change, at least one class worsening, in NYHA class, respectively. NYHA class after patients who died was categorized into "worsened".'}, {'measure': 'Key Secondary: Change From Baseline in Clinical Summary Score for Heart Failure Symptoms and Physical Limitations Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ).', 'timeFrame': 'Baseline, Week 8 and Month 6', 'description': 'The KCCQ is a self-administered questionnaire and requires, on average, 4-6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL), each with different Likert scaling wording, including limitations, frequency, bother, change in condition, understanding, etc. The clinical summary score is a mean of the physical limitation and total symptom scores. The total symptom score is the mean of the symptom frequency and symptom burden scores. Each scale score (the physical limitation, symptom frequency or symptom burden) is calculated as the mean of its item scores and transformed to a 0-100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents dead. A change of 5 points on the scale scores, either as a group mean difference or an intra-individual change appears to be clinically significant.'}, {'measure': 'Total Number of CEC Confirmed Composite of CV Death and Total (First and Recurrent) HF Hospitalizations for Heart Failure', 'timeFrame': 'up tp 40 months', 'description': 'Total number of CEC-confirmed CV death and total (first and recurrent) HF hospitalizations per patient was analyzed using the negative binomial regression model. CV deaths and HF hospitalizations occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.'}, {'measure': 'Number of Participants by Changes in Clinical Composite Score (as Assessed by NYHA Classification and Patient Global Assessment) at Predefined Timepoints', 'timeFrame': 'Baseline, Month 6', 'description': 'The global assessment was derived from the 7-category classification of the global assessment of disease activity to a three-category classification: Improved (Markedly improved; moderately improved), Unchanged (Slightly improved, unchanged, slightly worsened), and Worsened (Moderately worsened, markedly worsened).\n\nThe clinical composite assessment was defined as follows:\n\n* Improved: 1) If NYHA class decreased at least one level and Global Assessment was not worse at the selected visit and there was no major AE up to the selected visit; or 2) Global assessment was improved and NYHA class did not increase at the selected visit, and there was no major AE up to the selected visit.\n* Worsened: 1) If NYHA class increased at the selected visit; or 2) Global Assessment was worse at the selected visit; or 3) experienced a major AE up to the selected visit.\n* Unchanged: If neither "Improved" nor "Worsened".'}, {'measure': 'Number of Participants With All-cause Mortality', 'timeFrame': 'up to 40 months', 'description': 'The number of participants who died due to any cause. Deaths occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.'}, {'measure': 'EAIR of All-cause Mortality', 'timeFrame': 'up to 40 months', 'description': 'EAIR (Exposure-adjusted incidence rate per 100 patient years)= n/T:\n\nn: Total number of events included in the analysis. T(100 patient years): total up-to-event/censoring duration-time summarized over patients in the respective treatment group. Deaths occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis.'}, {'measure': 'Percentage of Participants Hospitalized', 'timeFrame': 'up to 40 months', 'description': 'Percentage of participants with hospitalized admissions'}, {'measure': 'Hospitalization Admissions Events Per-participant Per Year', 'timeFrame': 'up to 40 months', 'description': 'The number of hospital admission events per-participant per year was calculated as total number of hospital admission divided by total up-to-event/censoring duration-time summarized over patients.'}, {'measure': 'Days in Intensive Care Unit (ICU) Per Participant Per Year', 'timeFrame': 'up to 40 months', 'description': 'The number of days in ICU per participant per year was calculated as total number of days in ICU divided by total up-to-event/censoring duration-time summarized over patients.'}, {'measure': 'Percentage of Re-hospitalizations', 'timeFrame': 'up to 40 months', 'description': 'The percentage of participants who had re-hospitalizations.'}, {'measure': 'Emergency Department/Urgent Care Facility Visits for HF Per Patient Per Year', 'timeFrame': 'up to 40 months', 'description': 'The number of emergency department/urgent care facility visits for HF per patient per year was calculated as total number of emergency department/urgent care facility visits for HF divided by total up-to-event/censoring duration-time summarized over patients.'}, {'measure': 'Change in Blood NT-proBNP From Baseline', 'timeFrame': 'Baseline, Weeks 2, 4, 8 and Month 6', 'description': 'NT-proBNP is small protein produced in large amounts when the heart senses it needs to work harder, such as in heart failure. Mean change from baseline (post-baseline value - baseline value) in plasma NT-proBNP was caluculated.'}, {'measure': 'Change in Procollagen Type III N-Terminal Propeptide From Baseline', 'timeFrame': 'Baseline and Month 18', 'description': 'Procollagen Type III N-Terminal Propeptide (PIIINP) is a serum marker of collagen turnover, generated during the synthesis of type III collagen. Increased circulating PIIINP is a marker not only of muscle growth, but also of muscle repair and fibrosis. Mean change from baseline (post-baseline value - baseline value) in serum PIIINP was calculated.'}, {'measure': "Changes in Urine Cyclic Guanosine 3',5'-Monophosphate (cGMP) From Baseline", 'timeFrame': 'Baseline, Weeks 4, 8 and Month 6', 'description': 'Urinary Cyclic GMP (cGMP) is a biomarker measured in the urine that reflects the activity of biomarkers such as BNP (Brain Natriuretic Peptide). First morning void (FMV) urine samples were collected. Mean change from baseline (post-baseline value - baseline value) in urine cGMP was calculated.'}, {'measure': 'Percentage of Participants Reaching Target Dose Level 3 at Week 8 and Maintained at Month 4 (Open Label Extension (OLE))', 'timeFrame': 'Month 4 of OLE', 'description': 'The percentage of participants who reached target dose level (200 mg b.i.d.) at Week 8 and maintained at Month 4(OLE). This indicates how tolerabile to LCZ696 at target dose.'}, {'measure': 'Change in NYHA Classification From OLE Baseline (OLE)', 'timeFrame': 'OLE Baseline, Month 12 (OLE)', 'description': 'NYHA classification is a subjective physician\'s assessment of heart failure patient\'s functional capacity and symptomatic status.\n\nClass I - No limitation of physical activity. Class II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV - Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.\n\nThe NYHA class change was analyzed as a three category ordinal variable with levels: "improved", "unchanged", and "worsened", defined by at least one class improvement, no change, at least one class worsening, in NYHA class, respectively. NYHA class after patients who died was categorized into "worsened".'}, {'measure': 'Change in Key Echocardiographic Parameters From OLE Baseline at Month 12 (OLE)', 'timeFrame': 'Baseline, Month 12 (OLE)', 'description': 'Key echocardiographic parameters:\n\nLAVi- left atrial volume index, LVEDVi- left ventricular end diastolic volume index, LVESVi- left ventricular end systolic volume index.\n\nA two-dimensional and doppler echo examination was done to assess echo parameters. Mean changes from baseline (post-baseline value - baseline value) in each parameter were calculated. A negative change from baseline indicates improvement.'}, {'measure': 'Change in Cardiac Measurements by Key Echocardiographic Parameter LVEF, From OLE Baseline at Month 12 (OLE)', 'timeFrame': 'Baseline, Month 12 (OLE)', 'description': 'Key echocardiographic parameter:\n\nLVEF- left ventricular ejection fraction. LVEF is a measurement expressed as a percentage of how much blood the left ventricle pumps out with each contraction. Mean changes from baseline (post-baseline value - baseline value) in LVEF were calculated.'}, {'measure': 'Change in B-type Natriuretic Peptide (BNP) From OLE Baseline to Predefined Timepoints (OLE)', 'timeFrame': 'Baseline, Weeks 2-4, Week 8, Months 4 and 12 (OLE)', 'description': 'BNP is small protein produced in large amounts when the heart senses it needs to work harder, such as in heart failure. Mean change from baseline (post-baseline value - OLE baseline value) in plasma BNP was calculated.'}, {'measure': 'Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From OLE Baseline to Predefined Timepoints (OLE)', 'timeFrame': 'Baseline, Weeks 2-4, Week 8, Months 4 and 12 (OLE)', 'description': 'NT-proBNP is small protein produced in large amounts when the heart senses it needs to work harder, such as in heart failure. Mean change from baseline (post-baseline value - OLE baseline value) in plasma NT-proBNP was calculated.'}, {'measure': 'Change in Urine cGMP From OLE Baseline to Predefined Timepoints (OLE)', 'timeFrame': 'Weeks 2-4, Week 8, Months 4 and 12 (OLE)', 'description': 'Urinary Cyclic GMP (cGMP) is a biomarker measured in the urine that reflects the activity of biomarkers such as BNP (Brain Natriuretic Peptide). Spot urine samples were collected. Mean change from baseline (post-baseline value - OLE baseline value) in urine cGMP was calculated.'}, {'measure': 'Association Between Change in NT-proBNP Concentration and Change in Echocardiographic Parameters From OLE Baseline at Month 12 (OLE)', 'timeFrame': 'Month 12', 'description': 'Association (using the Pearson correlation coefficient) between change from OLE baseline in log-transformed NT-proBNP and echocardiographic parameters (LAVi, LVEDVi, LVESVi \\& LVEF)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic heart failure', 'cardiovascular death', 'hospitalization', 'outcome study', 'worsening heart failure', 'NT-proBNP', 'NYHA', 'KCCQ', 'HF-rEF'], 'conditions': ['Heart Failure With Reduced Ejection Fraction (HF-rEF)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the effect of LCZ696 at a target dose of 200 mg b.i.d. compared to enalapril 10 mg b.i.d., in addition to the background heart failure (HF) treatment, on delaying time to first occurrence of either cardiovascular (CV) death or HF hospitalization events in Japanese patients with stable chronic heart failure (CHF), New York Heart Association (NYHA) classes II-IV and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤ 35%).', 'detailedDescription': 'The study consisted of two parts: the core part and the Open label extension (OLE) epoch.\n\nThe core part of this study was a multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled study to assess the effect of LCZ696 at a target dose of 200 mg b.i.d. and enalapril 10 mg b.i.d. on CV mortality and morbidity reduction in Japanese HF patients with reduced ejection fraction. Patients who met the eligibility criteria at screening entered a 2 week, single-blind, active treatment run-in epoch in which they received LCZ696 50 mg b.i.d. Patients who tolerated LCZ696 50 mg b.i.d. for 2 weeks were randomized in a 1:1 ratio to receive LCZ696 100 mg b.i.d. or enalapril 5 mg b.i.d. for 4 weeks during the double-blind treatment epoch. The patient randomization was stratified by using NT-proBNP measured at the screening visit as a stratification factor. The patients were then titrated up to the target dose of LCZ696 200 mg b.i.d. or enalapril 10 mg b.i.d. if they tolerated 4 weeks treatment of LCZ696 100 mg b.i.d. or enalapril 5 mg b.i.d. Dose adjustment (LCZ696 50-100 mg b.i.d. \\& enalapril 2.5-5 mg b.i.d.) was permitted if not tolerated at the target dose of study drugs during the double-blind treatment epoch.\n\nThis was an event-driven study in which subjects remained on the study (regardless of whether receiving investigational medications) until the projected number of patients with primary events (approximately 57 events) had been reached.\n\nThe Open label extension (OLE) epoch was conducted following the completion of the core part, with the aim to provide access to LCZ696 for eligible subjects until the marketed product was available in Japan or 2 years from the date of the first subject enrolled in the OLE epoch, whichever occurred first, and also to obtain the safety and tolerability data of long-term treatment with LCZ696.\n\nUpon completion of the core part, the eligibility of the subjects to enter the OLE epoch was assessed by the investigator at OLE baseline (Visit 301), which occurred on the same day as the end of study (EOS) visit of the core part (Visit 299). At this visit, subjects were switched to open-label LCZ696.\n\nAt Visit 302 (2 to 4 weeks after Visit 301), subjects who tolerated the open-label LCZ696 and met the safety monitoring criteria were up-titrated to the next higher level of daily dose. Thereafter, subject visits occurred at 8 weeks, and then every 4 months until EOS visit for OLE epoch.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent must be obtained before any assessment is performed.\n* Outpatients with a diagnosis of CHF NYHA class II-IV and reduced ejection fraction:\n* LVEF ≤ 35% at Visit 1 (any local measurement, made within the past 6 months using echocardiography, MUGA, CT scanning, MRI or ventricular angiography is also acceptable, provided no subsequent measurement above 35%)\n* NT-proBNP ≥ 600 pg/ml at Visit 1 OR NT-proBNP ≥ 400 pg/ml at Visit 1 and a hospitalization for HF within the last 12 months (according to central laboratory measurements)\n* Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks before Visit 1.\n* Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to Visit 1 (reason should be documented if patients reported contraindications or intolerance).\n* An aldosterone antagonist should also be considered in all patients, taking account of renal function, serum potassium and tolerability. If given, the dose of aldosterone antagonist should be optimized according to guideline recommendations and patient tolerability, and should be stable for at least 4 weeks prior to Visit 1. Other evidence-based therapy for HF should also be considered e.g. cardiac resynchronization therapy and an implantable cardioverter-defibrillator in selected patients, as recommended by guidelines.\n\nExclusion Criteria:\n\n* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes, ACEIs, ARBs, NEP inhibitors as well as known or suspected contraindications to the study drugs.\n* Previous documented history of intolerance to ACEIs or ARBs.\n* Known history of angioedema.\n* Requirement of treatment with both ACEIs and ARBs.\n* Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).\n* Symptomatic hypotension and/or a SBP \\< 100 mmHg at screening or \\< 95 mmHg at the end of run-in.\n* Estimated GFR \\< 30 mL/min/1.73 m2 as measured by the Japanese formula at screening, or the end of run-in or \\> 35% decline in eGFR between screening and end of run-in (according to local measurements).\n* Serum potassium \\> 5.2 mmol/L (mEq/L) at screening or \\> 5.4 mmol/L (mEq/L) at the end of run-in (according to local measurements).\n* Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major CV surgery, percutaneous coronary intervention (PCI) or carotid angioplasty within the 3 months prior to Visit 1.\n* Documented untreated ventricular arrhythmia with syncopal episodes within the 3 months prior to Visit 1.\n* Symptomatic bradycardia or second (except asymptomatic Wenckebach block) or third degree heart block without a pacemaker.\n* Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation.\n* Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis.\n* Presence of bilateral renal artery stenosis.'}, 'identificationModule': {'nctId': 'NCT02468232', 'acronym': 'PARALLEL-HF', 'briefTitle': 'Study of Efficacy and Safety of LCZ696 in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality in Japanese Patients With Chronic Heart Failure and Reduced Ejection Fraction.', 'orgStudyIdInfo': {'id': 'CLCZ696B1301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LCZ696', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind epoch, randomized patients in this arm started with 100 mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 200 mg b.i.d. at week 4 if they were tolerant to 100 mg b.i.d. Total duration of treatment was up to approximately 40 months.', 'interventionNames': ['Drug: LCZ696', 'Drug: Placebo to Enalapril']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enalapril', 'description': 'Before randomization, all patients received 2 week LCZ696 50 mg twice daily (b.i.d) as single blind run-in active treatment epoch. In double blind period, all randomized patients in this arm received enalapril 5mg twice daily (b.i.d.) for 4 weeks. Patients were then up-titrated to 10 mg b.i.d. at week 4 if they were tolerant to 5 mg b.i.d. Total duration of treatment was up to approximately 40 months.', 'interventionNames': ['Drug: Enalapril', 'Drug: Placebo to LCZ696']}], 'interventions': [{'name': 'LCZ696', 'type': 'DRUG', 'description': 'The target dose during the study was LCZ696 200 mg bid given orally. LCZ696 was supplied as 50 mg, 100 mg and 200 mg film-coated tablets.', 'armGroupLabels': ['LCZ696']}, {'name': 'Enalapril', 'type': 'DRUG', 'description': 'The target dose during the study was enalapril 10 mg bid given orally. Enalapril was provided as 2.5 mg, 5 mg, and 10 mg tablets.', 'armGroupLabels': ['Enalapril']}, {'name': 'Placebo to LCZ696', 'type': 'DRUG', 'description': 'LCZ696 Placebo 50 mg, 100 mg and 200 mg film-coated tablets', 'armGroupLabels': ['Enalapril']}, {'name': 'Placebo to Enalapril', 'type': 'DRUG', 'description': 'Enalapril Placebo 2.5 mg, 5 mg and 10 mg tablets', 'armGroupLabels': ['LCZ696']}]}, 'contactsLocationsModule': {'locations': [{'zip': '453-8511', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '489-8642', 'city': 'Seto', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.23333, 'lon': 137.1}}, {'zip': '818-8516', 'city': 'Chikushino-shi', 'state': 'Fukuka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.49631, 'lon': 130.5156}}, {'zip': '810-0001', 'city': 'Fukuoka', 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