Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT05093933
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2021-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000603960', 'term': 'vericiguat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@msd.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 39 months (duration over which AEs were monitored at the participant level; from randomization to study completion data cutoff)', 'description': 'One participant was enrolled at 2 study sites and was excluded from all analyses due to GCP-noncompliant data. All-Cause Mortality: all randomized participants. SAEs and Other AEs: all participants who received ≥1 dose of study intervention. All SAEs were reported. As pre-specified in the protocol, only selected Other AEs were reported, related to potential DILI, hypotension, anemia, COVID-19-related AEs, and AEs causing study discontinuation or study drug dose modification or discontinuation.', 'eventGroups': [{'id': 'EG000', 'title': 'Vericiguat', 'description': 'Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).', 'otherNumAtRisk': 3049, 'deathsNumAtRisk': 3053, 'otherNumAffected': 530, 'seriousNumAtRisk': 3049, 'deathsNumAffected': 392, 'seriousNumAffected': 732}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).', 'otherNumAtRisk': 3049, 'deathsNumAtRisk': 3052, 'otherNumAffected': 423, 'seriousNumAtRisk': 3049, 'deathsNumAffected': 455, 'seriousNumAffected': 766}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 190, 'numAffected': 171}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 154, 'numAffected': 143}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 502, 'numAffected': 401}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 380, 'numAffected': 312}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 35, 'numAffected': 34}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Anaemia macrocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aplastic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypercoagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Immune thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Normochromic normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Splenic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arrhythmia supraventricular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arrhythmic storm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 134, 'numAffected': 122}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 136, 'numAffected': 117}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac ventricular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiorenal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Chronic coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dilated cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Heart failure with reduced ejection fraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Low cardiac output syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myocardial injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nodal arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 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'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Colorectal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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{'term': 'Invasive lobular breast carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 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[{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Distributive shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Embolism venous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Giant cell arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertensive end-organ damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 32, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 29, 'numAffected': 29}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Peripheral vascular haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Scalp haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3049, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3049, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization: Participants With an Event Per 100 Patient-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3053', 'groupId': 'OG000'}, {'value': '3052', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vericiguat', 'description': 'Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000'}, {'value': '12.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.219', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.04', 'estimateComment': 'Based on a Cox proportional hazard model controlling for the randomization stratification factor (NYHA FC)', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the randomization stratification factor (NYHA FC)'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'The time to first occurrence of the composite endpoint of CV death or HF hospitalization was defined as the time from randomization to the first event of CV death or HF hospitalization. Randomized participants without a HF hospitalization or CV death event at the time of analysis were censored at the last available information, when the protocol pre-specified number of total CV death events was achieved (primary completion analysis data cutoff), or the date of their non-CV death, whichever occurred first. Events were confirmed by a clinical events committee (CEC). Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with a CV death or HF hospitalization event per 100 patient-years at risk is presented.', 'unitOfMeasure': 'Pts. with event/100 patient-yrs at risk', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had GCP-compliant data collected.'}, {'type': 'SECONDARY', 'title': 'Time to CV Death: Participants With an Event Per 100 Patient-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3053', 'groupId': 'OG000'}, {'value': '3052', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vericiguat', 'description': 'Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '6.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.71', 'ciUpperLimit': '0.97', 'estimateComment': 'Based on a Cox proportional hazard model controlling for the randomization stratification factor (NYHA FC)', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the randomization stratification factor (NYHA FC)'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'Time to CV death was defined as the time from randomization to CV death. Randomized participants without a CV death at the time of analysis were censored at their last available information, when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), or the date of their non-CV death, whichever occurred first. CV deaths were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with a CV death event per 100 patient-years at risk is presented.', 'unitOfMeasure': 'Pts. with event/100 patient-yrs at risk', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had GCP-compliant data collected.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of HF Hospitalization: Participants With an Event Per 100 Patient-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3053', 'groupId': 'OG000'}, {'value': '3052', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vericiguat', 'description': 'Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.509', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.10', 'estimateComment': 'Based on a Cox proportional hazard model controlling for the randomization stratification factor (NYHA FC)', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the randomization stratification factor (NYHA FC)'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'Time to first occurrence of HF hospitalization was defined as the time from randomization to the first event of HF hospitalization. Randomized participants without an HF hospitalization at the time of analysis were censored at their last available information, when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), or the date of their death, whichever occurred first. HF hospitalizations were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with an HF hospitalization event per 100 patient-years at risk is presented.', 'unitOfMeasure': 'Pts. with event/100 patient-yrs at risk', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had GCP-compliant data collected.'}, {'type': 'SECONDARY', 'title': 'Time to Total HF Hospitalizations (Including First and Recurrent Events): Total Events Per 100 Patient-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3053', 'groupId': 'OG000'}, {'value': '3052', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vericiguat', 'description': 'Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.094', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.02', 'estimateComment': 'Based on an Andersen-Gill model controlling for the randomization stratification factor (NYHA FC)', 'statisticalMethod': 'Andersen-Gill Model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'Time to total HF hospitalizations was defined as the time from randomization to all HF hospitalization events, including time to first event and time increments between events. Randomized participants without an HF hospitalization at the time of analysis were censored at their last available information, when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), or the date of their death, whichever occurred first. HF hospitalizations were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of total HF hospitalization events per 100 patient-years at risk is presented.', 'unitOfMeasure': 'Total events/100 patient-yrs at risk', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had GCP-compliant data collected.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization: Participants With an Event Per 100 Patient-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3053', 'groupId': 'OG000'}, {'value': '3052', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vericiguat', 'description': 'Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'groupId': 'OG000'}, {'value': '13.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.116', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.02', 'estimateComment': 'Based on a Cox proportional hazard model controlling for the randomization stratification factor (NYHA FC)', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the randomization stratification factor (NYHA FC)'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'The time to first occurrence of the composite endpoint of all-cause mortality or HF hospitalization was defined as the time from randomization to the first event of all-cause mortality or HF hospitalization. Randomized participants without an all-cause mortality or HF hospitalization event at the time of analysis were censored at the last available information or when the protocol pre-specified number of total CV death events is achieved (primary analysis database cutoff), whichever occurred first. Events were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with an all-cause mortality or HF hospitalization event per 100 patient-years at risk is presented.', 'unitOfMeasure': 'Pts. with event/100 patient-yrs at risk', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had GCP-compliant data collected.'}, {'type': 'SECONDARY', 'title': 'Time to All-Cause Mortality: Participants With an Event Per 100 Patient-Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3053', 'groupId': 'OG000'}, {'value': '3052', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vericiguat', 'description': 'Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000'}, {'value': '8.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.74', 'ciUpperLimit': '0.97', 'estimateComment': 'Based on a Cox proportional hazard model controlling for the randomization stratification factor (NYHA FC)', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by the randomization stratification factor (NYHA FC)'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'Time to all-cause mortality was defined as the time from randomization to all-cause mortality. Randomized participants without an all-cause mortality event at the time of analysis were censored at their last available information or when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), whichever occurred first. All-cause mortality was confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with an all-cause mortality event per 100 patient-years at risk is presented.', 'unitOfMeasure': 'Pts. with event/100 patient-yrs at risk', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who had GCP-compliant data collected.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced One or More Selected Nonserious Adverse Events (NSAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3049', 'groupId': 'OG000'}, {'value': '3049', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vericiguat', 'description': 'Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}, {'value': '16.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Selected NSAEs are defined as nonserious AEs that meet any of the following criteria: AEs that lead to study intervention dose modification or discontinuation, AEs that lead to withdrawal from the study, or Coronavirus Disease 2019 (COVID-19) disease-related AEs. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more selected NSAEs is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced One or More Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3049', 'groupId': 'OG000'}, {'value': '3049', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vericiguat', 'description': 'Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000'}, {'value': '24.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical events as determined by the investigator. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more SAEs is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced One or More Events of Clinical Interest (ECIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3049', 'groupId': 'OG000'}, {'value': '3049', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vericiguat', 'description': 'Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '14.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'ECIs were determined and reported based on the clinical judgment of the investigator. As pre-specified in the protocol, ECIs included the following: 1) Events of potential drug-induced liver injury (DILI), defined as an elevated aspartate aminotransferase or alanine aminotransferase laboratory value that is greater than or equal to 3X the upper limit of normal (ULN) and an elevated total bilirubin laboratory value that is greater than or equal to 2X the ULN and, at the same time, an alkaline phosphatase laboratory value that is less than 2X the ULN, 2) Events associated with symptomatic hypotension, or 3) Events associated with anemia, regardless of etiology. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more ECIs is presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced One or More Potential DILI ECIs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3049', 'groupId': 'OG000'}, {'value': '3049', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vericiguat', 'description': 'Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.512', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '0.2', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'Potential DILI ECIs were determined and reported based on the clinical judgment of the investigator. Potential DILI ECIs were defined as an elevated aspartate aminotransferase or alanine aminotransferase laboratory value that is greater than or equal to 3X the ULN and an elevated total bilirubin laboratory value that is greater than or equal to 2X the ULN and, at the same time, an alkaline phosphatase laboratory value that is less than 2X the ULN. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more potential DILI ECIs is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced One or More Symptomatic Hypotension ECIs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3049', 'groupId': 'OG000'}, {'value': '3049', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vericiguat', 'description': 'Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'groupId': 'OG000'}, {'value': '9.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.1', 'ciLowerLimit': '0.6', 'ciUpperLimit': '3.6', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'Symptomatic hypotension ECIs were determined and reported based on the clinical judgment of the investigator. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more symptomatic hypotension ECIs is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Experienced One or More Anemia ECIs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3049', 'groupId': 'OG000'}, {'value': '3049', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vericiguat', 'description': 'Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.045', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '0.0', 'ciUpperLimit': '2.6', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'Anemia ECIs were determined and reported based on the clinical judgment of the investigator, regardless of etiology. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more anemia ECIs is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study intervention and who had GCP-compliant data collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vericiguat', 'description': 'Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3053'}, {'groupId': 'FG001', 'numSubjects': '3052'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3049'}, {'groupId': 'FG001', 'numSubjects': '3049'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2648'}, {'groupId': 'FG001', 'numSubjects': '2571'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '405'}, {'groupId': 'FG001', 'numSubjects': '481'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '372'}, {'groupId': 'FG001', 'numSubjects': '434'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '25'}]}]}], 'preAssignmentDetails': 'Of 10923 participants screened, 6106 participants were randomized in a 1:1 ratio to receive either vericiguat or matching placebo.\n\nOne participant was randomized in the study at 2 different clinical study sites. Due to double enrolment and study site noncompliance with Good Clinical Practice (GCP), this participant was excluded from all efficacy and safety analyses. Results are presented based on 6105 randomized participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3053', 'groupId': 'BG000'}, {'value': '3052', 'groupId': 'BG001'}, {'value': '6105', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vericiguat', 'description': 'Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily for 2 weeks. The vericiguat dose was titrated to 5 mg for 2 weeks and then to the target dose of 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received a placebo matched to the vericiguat dose of 2.5 mg taken orally once daily for 2 weeks. The placebo dose was sham titrated to 5 mg for 2 weeks and then to 10 mg for the remainder of treatment (total treatment of up to approximately 37 months).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.1', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '67.0', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '67.0', 'spread': '11.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '727', 'groupId': 'BG000'}, {'value': '713', 'groupId': 'BG001'}, {'value': '1440', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2326', 'groupId': 'BG000'}, {'value': '2339', 'groupId': 'BG001'}, {'value': '4665', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '968', 'groupId': 'BG000'}, {'value': '953', 'groupId': 'BG001'}, {'value': '1921', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2044', 'groupId': 'BG000'}, {'value': '2068', 'groupId': 'BG001'}, {'value': '4112', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '301', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '383', 'groupId': 'BG000'}, {'value': '363', 'groupId': 'BG001'}, {'value': '746', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '469', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1942', 'groupId': 'BG000'}, {'value': '1992', 'groupId': 'BG001'}, {'value': '3934', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '313', 'groupId': 'BG000'}, {'value': '330', 'groupId': 'BG001'}, {'value': '643', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'New York Heart Association (NYHA) Functional Classification (FC) of Heart Failure', 'classes': [{'title': 'NYHA Class II', 'categories': [{'measurements': [{'value': '2411', 'groupId': 'BG000'}, {'value': '2411', 'groupId': 'BG001'}, {'value': '4822', 'groupId': 'BG002'}]}]}, {'title': 'NYHA Class III/IV', 'categories': [{'measurements': [{'value': '642', 'groupId': 'BG000'}, {'value': '641', 'groupId': 'BG001'}, {'value': '1283', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were stratified by: NYHA FC II versus NYHA FC III/IV. Participants were assessed for 1 of 4 NYHA functional classes based on symptoms: Class I (No limitation of physical activity \\[PA\\]); Class II (Slight limitation of PA, comfortable at rest, ordinary PA causes fatigue, palpitation, dyspnea, or anginal pain); Class III (Marked limitation of PA, comfortable at rest, less-than-ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain); Class IV (Unable to carry on any PA without discomfort, symptoms of heart failure at rest).', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-25', 'size': 2833404, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-11-04T09:51', 'hasProtocol': True}]}}, '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': 6106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2021-10-18', 'resultsFirstSubmitDate': '2025-11-04', 'studyFirstSubmitQcDate': '2021-10-18', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-04', 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Occurrence of Composite Endpoint of Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization: Participants With an Event Per 100 Patient-Years', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'The time to first occurrence of the composite endpoint of CV death or HF hospitalization was defined as the time from randomization to the first event of CV death or HF hospitalization. Randomized participants without a HF hospitalization or CV death event at the time of analysis were censored at the last available information, when the protocol pre-specified number of total CV death events was achieved (primary completion analysis data cutoff), or the date of their non-CV death, whichever occurred first. Events were confirmed by a clinical events committee (CEC). Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with a CV death or HF hospitalization event per 100 patient-years at risk is presented.'}], 'secondaryOutcomes': [{'measure': 'Time to CV Death: Participants With an Event Per 100 Patient-Years', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'Time to CV death was defined as the time from randomization to CV death. Randomized participants without a CV death at the time of analysis were censored at their last available information, when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), or the date of their non-CV death, whichever occurred first. CV deaths were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with a CV death event per 100 patient-years at risk is presented.'}, {'measure': 'Time to First Occurrence of HF Hospitalization: Participants With an Event Per 100 Patient-Years', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'Time to first occurrence of HF hospitalization was defined as the time from randomization to the first event of HF hospitalization. Randomized participants without an HF hospitalization at the time of analysis were censored at their last available information, when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), or the date of their death, whichever occurred first. HF hospitalizations were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with an HF hospitalization event per 100 patient-years at risk is presented.'}, {'measure': 'Time to Total HF Hospitalizations (Including First and Recurrent Events): Total Events Per 100 Patient-Years', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'Time to total HF hospitalizations was defined as the time from randomization to all HF hospitalization events, including time to first event and time increments between events. Randomized participants without an HF hospitalization at the time of analysis were censored at their last available information, when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), or the date of their death, whichever occurred first. HF hospitalizations were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of total HF hospitalization events per 100 patient-years at risk is presented.'}, {'measure': 'Time to First Occurrence of Composite Endpoint of All-Cause Mortality or HF Hospitalization: Participants With an Event Per 100 Patient-Years', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'The time to first occurrence of the composite endpoint of all-cause mortality or HF hospitalization was defined as the time from randomization to the first event of all-cause mortality or HF hospitalization. Randomized participants without an all-cause mortality or HF hospitalization event at the time of analysis were censored at the last available information or when the protocol pre-specified number of total CV death events is achieved (primary analysis database cutoff), whichever occurred first. Events were confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with an all-cause mortality or HF hospitalization event per 100 patient-years at risk is presented.'}, {'measure': 'Time to All-Cause Mortality: Participants With an Event Per 100 Patient-Years', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'Time to all-cause mortality was defined as the time from randomization to all-cause mortality. Randomized participants without an all-cause mortality event at the time of analysis were censored at their last available information or when the protocol pre-specified number of total CV death events was achieved (primary analysis database cutoff), whichever occurred first. All-cause mortality was confirmed by a CEC. Protocol-specified final analyses are reported here with a primary completion data cutoff. Time-to-event methodology was used to evaluate the results and the number of participants with an all-cause mortality event per 100 patient-years at risk is presented.'}, {'measure': 'Percentage of Participants Who Experienced One or More Selected Nonserious Adverse Events (NSAEs)', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Selected NSAEs are defined as nonserious AEs that meet any of the following criteria: AEs that lead to study intervention dose modification or discontinuation, AEs that lead to withdrawal from the study, or Coronavirus Disease 2019 (COVID-19) disease-related AEs. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more selected NSAEs is presented.'}, {'measure': 'Percentage of Participants Who Experienced One or More Serious Adverse Events (SAEs)', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or other important medical events as determined by the investigator. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more SAEs is presented.'}, {'measure': 'Percentage of Participants Who Experienced One or More Events of Clinical Interest (ECIs)', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'ECIs were determined and reported based on the clinical judgment of the investigator. As pre-specified in the protocol, ECIs included the following: 1) Events of potential drug-induced liver injury (DILI), defined as an elevated aspartate aminotransferase or alanine aminotransferase laboratory value that is greater than or equal to 3X the upper limit of normal (ULN) and an elevated total bilirubin laboratory value that is greater than or equal to 2X the ULN and, at the same time, an alkaline phosphatase laboratory value that is less than 2X the ULN, 2) Events associated with symptomatic hypotension, or 3) Events associated with anemia, regardless of etiology. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more ECIs is presented.'}, {'measure': 'Percentage of Participants Who Experienced One or More Potential DILI ECIs', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'Potential DILI ECIs were determined and reported based on the clinical judgment of the investigator. Potential DILI ECIs were defined as an elevated aspartate aminotransferase or alanine aminotransferase laboratory value that is greater than or equal to 3X the ULN and an elevated total bilirubin laboratory value that is greater than or equal to 2X the ULN and, at the same time, an alkaline phosphatase laboratory value that is less than 2X the ULN. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more potential DILI ECIs is presented.'}, {'measure': 'Percentage of Participants Who Experienced One or More Symptomatic Hypotension ECIs', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'Symptomatic hypotension ECIs were determined and reported based on the clinical judgment of the investigator. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more symptomatic hypotension ECIs is presented.'}, {'measure': 'Percentage of Participants Who Experienced One or More Anemia ECIs', 'timeFrame': 'Up to approximately 36 months (from randomization to the primary completion data cutoff)', 'description': 'Anemia ECIs were determined and reported based on the clinical judgment of the investigator, regardless of etiology. Protocol-specified final analyses are reported here with a primary completion data cutoff. The percentage of participants who experienced one or more anemia ECIs is presented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Heart Failure With Reduced Ejection Fraction']}, 'referencesModule': {'references': [{'pmid': '36250238', 'type': 'RESULT', 'citation': "Butler J, Usman MS, Anstrom KJ, Blaustein RO, Bonaca MP, Ezekowitz JA, Freitas C, Lam CSP, Lewis EF, Lindenfeld J, McMullan CJ, Mentz RJ, O'Connor C, Rosano GMC, Saldarriaga CI, Senni M, Udelson J, Voors AA, Zannad F. Soluble guanylate cyclase stimulators in patients with heart failure with reduced ejection fraction across the risk spectrum. Eur J Heart Fail. 2022 Nov;24(11):2029-2036. doi: 10.1002/ejhf.2720. Epub 2022 Nov 16."}, {'pmid': '39473305', 'type': 'RESULT', 'citation': "Reddy YNV, Butler J, Anstrom KJ, Blaustein RO, Bonaca MP, Corda S, Ezekowitz JA, Lam CSP, Lewis EF, Lindenfeld J, McMullan CJ, Mentz RJ, O'Connor C, Patel M, Ponikowski P, Rosano GMC, Saldarriaga CI, Senni M, Udelson J, Voors AA, Zannad F. Vericiguat Global Study in Participants with Chronic Heart Failure: Design of the VICTOR trial. Eur J Heart Fail. 2025 Feb;27(2):209-218. doi: 10.1002/ejhf.3501. Epub 2024 Oct 30."}, {'pmid': '40897189', 'type': 'RESULT', 'citation': "Butler J, McMullan CJ, Anstrom KJ, Barash I, Bonaca MP, Borentain M, Corda S, Ezekowitz JA, Felker GM, Gates D, Lam CSP, Lewis EF, Lindenfeld J, Mentz RJ, O'Connor CM, Ponikowski P, Reddy YNV, Rosano GMC, Saldarriaga C, Senni M, She L, Teixeira PP, Udelson J, Urbinati A, Vlajnic V, Voors AA, Xing A, Patel MJ, Zannad F; VICTOR Study Group. Vericiguat in patients with chronic heart failure and reduced ejection fraction (VICTOR): a double-blind, placebo-controlled, randomised, phase 3 trial. Lancet. 2025 Sep 27;406(10510):1341-1350. doi: 10.1016/S0140-6736(25)01665-4. Epub 2025 Aug 30."}, {'pmid': '37191077', 'type': 'DERIVED', 'citation': 'Khan MS, Grayburn PA, Butler J. Cardiac reverse remodelling with vericiguat: Victory or no victory? Eur J Heart Fail. 2023 Jul;25(7):1022-1024. doi: 10.1002/ejhf.2883. Epub 2023 May 25. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26239&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of chronic HF \\[New York Heart Association (NYHA) Class II to IV\\] on guideline-directed medical therapy for heart failure (GDMT) with no HF hospitalization within 6 months or outpatient IV diuretic use within 3 months before randomization.\n* Left ventricular ejection fraction (LVEF) of ≤40%, assessed within 12 months before randomization by any imaging method.\n* Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP), or is a WOCBP and agrees to follow contraceptive guidance during the study intervention period and for at least 1 month after the last dose of study intervention.\n\nExclusion Criteria:\n\n* Has SBP \\<100 mm Hg or symptomatic hypotension.\n* Awaiting heart transplantation, is receiving continuous IV infusion of an inotrope, or has or anticipates receiving an implanted ventricular assist device.\n* Amyloidosis or sarcoidosis.\n* Primary valvular heart disease requiring surgical procedure or intervention or has undergone a valvular surgical procedure or intervention within 3 months before randomization.\n* Hypertrophic cardiomyopathy.\n* Acute myocarditis or Takotsubo cardiomyopathy.\n* History of heart transplant.\n* Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia.\n* Acute coronary syndrome, or undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within 3 months before randomization.\n* History of symptomatic carotid stenosis, transient ischemic attack (TIA), or stroke within 3 months before randomization.\n* Malignancy or other noncardiac condition limiting life expectancy to \\<3 years.\n* Requires continuous home oxygen for severe pulmonary disease.\n* Interstitial lung disease.\n* Discontinuation or dose modification of GDMT or vericiguat within 4 weeks before randomization.\n* Recent history (within the last year) of drug or alcohol abuse or dependence.'}, 'identificationModule': {'nctId': 'NCT05093933', 'acronym': 'VICTOR', 'briefTitle': 'A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction', 'orgStudyIdInfo': {'id': '1242-035'}, 'secondaryIdInfos': [{'id': 'MK-1242-035', 'type': 'OTHER', 'domain': 'MSD'}, {'id': '2022-500881-80-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1278-5066', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': '2020-005941-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vericiguat', 'description': 'Participants receive a starting dose of 2.5 mg of vericiguat taken orally once daily. The vericiguat dose will be titrated to 5 mg and to 10 mg.', 'interventionNames': ['Drug: Vericiguat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive a starting matching placebo to vericiguat dose of 2.5 mg taken orally once daily. The matching placebo dose will be sham titrated to 5 mg and to 10 mg.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vericiguat', 'type': 'DRUG', 'otherNames': ['MK-1242', 'BAY 1021189'], 'description': '2.5, 5.0, or 10.0 mg orally once daily', 'armGroupLabels': ['Vericiguat']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0 mg matching placebo for 2.5 mg, 5 mg, and 10 mg of vericiguat', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35010', 'city': 'Alexander City', 'state': 'Alabama', 'country': 'United States', 'facility': 'Advanced Cardiovascular - Alexander City ( Site 0038)', 'geoPoint': {'lat': 32.94401, 'lon': -85.95385}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham - School of Medicine-Cardiology ( Site 0153)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Heart Center Research, LLC ( Site 0156)', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85297', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mercy Gilbert Medical Center-Dignity Health Cardiology ( Site 0075)', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '91723', 'city': 'Covina', 'state': 'California', 'country': 'United States', 'facility': 'Valley Clinical Trials, Inc. 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