Viewing Study NCT04304534

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Ignite Creation Date: 2025-12-25 @ 2:30 AM
Ignite Modification Date: 2025-12-26 @ 1:06 AM
Study NCT ID: NCT04304534
Status: COMPLETED
Last Update Posted: 2023-04-05
First Post: 2020-03-08
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'phone': '(+) 1-888-8422937', 'title': 'Therapeutic Area Head', 'organization': 'Bayer AG'}, 'certainAgreement': {'otherDetails': 'Contracts Partners shall ensure that all patentable Results made by employees of Center or other parties involved by Contract Partners in connection with the performance of the Study, will be notified to Bayer without delay.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'After the first administration of study intervention for up to 52 weeks (but not starting after more than 2 days after the last administration). Reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, for up to 54 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Asundexian 10 mg', 'description': 'Subjects received Asundexian (BAY2433334) 10 mg for 26 weeks at least and up to 52 weeks', 'otherNumAtRisk': 395, 'deathsNumAtRisk': 397, 'otherNumAffected': 89, 'seriousNumAtRisk': 395, 'deathsNumAffected': 10, 'seriousNumAffected': 74}, {'id': 'EG001', 'title': 'Asundexian 20 mg', 'description': 'Subjects received Asundexian (BAY2433334) 20 mg for 26 weeks at least and up to 52 weeks', 'otherNumAtRisk': 397, 'deathsNumAtRisk': 401, 'otherNumAffected': 118, 'seriousNumAtRisk': 397, 'deathsNumAffected': 7, 'seriousNumAffected': 82}, {'id': 'EG002', 'title': 'Asundexian 50 mg', 'description': 'Subjects received Asundexian (BAY2433334) 50 mg for 26 weeks at least and up to 52 weeks', 'otherNumAtRisk': 402, 'deathsNumAtRisk': 402, 'otherNumAffected': 94, 'seriousNumAtRisk': 402, 'deathsNumAffected': 10, 'seriousNumAffected': 67}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Subjects received Asundexian (BAY2433334) placebo for 26 weeks at least and up to 52 weeks', 'otherNumAtRisk': 399, 'deathsNumAtRisk': 401, 'otherNumAffected': 107, 'seriousNumAtRisk': 399, 'deathsNumAffected': 7, 'seriousNumAffected': 82}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 32, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 25, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 25, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 45, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 29, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 26, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Coronary artery embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Coronary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': "Dressler's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Interventricular septum rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Intracardiac thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Coronary artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cardiac ventricular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Coronary artery perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Stress cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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{'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Henoch-Schonlein purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Coronary arterial stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Transurethral bladder resection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Polypectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Sigmoidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Cardiac resynchronisation therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Percutaneous coronary intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Revascularisation procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Arterial rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Giant cell arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Vascular stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 395, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 397, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 402, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (24.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy - Number of Participants With Composite of CV Death, MI, Stroke and Stent Thrombosis (ST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '401', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Asundexian 10 mg', 'description': 'Participants received Asundexian (BAY2433334) 10 mg'}, {'id': 'OG001', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg'}, {'id': 'OG002', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '= 0.8439', 'groupIds': ['OG001', 'OG002', 'OG003'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.052', 'ciLowerLimit': '0.687', 'ciUpperLimit': '1.612', 'groupDescription': 'Comparison of the Asundexian 20 mg group and 50 mg group versus Placebo group', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.'}, {'pValue': '= 0.7562', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.096', 'ciLowerLimit': '0.674', 'ciUpperLimit': '1.781', 'groupDescription': 'Comparison of the Asundexian 20 mg group versus Placebo group', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.'}, {'pValue': '= 0.978', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.008', 'ciLowerLimit': '0.614', 'ciUpperLimit': '1.656', 'groupDescription': 'Comparison of the Asundexian 50 mg group versus Placebo group', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to 52 weeks', 'description': 'CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included.\n\nAcute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia.\n\nStroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction.\n\nST was defined incorporating diagnostic certainty as well as timing: "Definite" ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. "Probable" ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'PRIMARY', 'title': 'Safety - Number of Participants With BARC Bleeding Definition Type 2, 3 and 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '399', 'groupId': 'OG003'}, {'value': '1194', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Asundexian 10 mg', 'description': 'Participants received Asundexian (BAY2433334) 10 mg'}, {'id': 'OG001', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg'}, {'id': 'OG002', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo'}, {'id': 'OG004', 'title': 'Pooled Asundexian', 'description': 'Asundexian 10 mg group and Asundexian 20 mg group and Asundexian 50 mg group'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '104', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '= 0.9158', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.98', 'ciLowerLimit': '0.713', 'ciUpperLimit': '1.347', 'groupDescription': 'Comparison of the Pooled Asundexian group versus Placebo group', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.'}, {'pValue': '= 0.5633', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.867', 'ciLowerLimit': '0.577', 'ciUpperLimit': '1.302', 'groupDescription': 'Comparison of the Asundexian 10 mg group versus Placebo group', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.'}, {'pValue': '= 0.584', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.875', 'ciLowerLimit': '0.587', 'ciUpperLimit': '1.306', 'groupDescription': 'Comparison of the Asundexian 20 mg group versus Placebo group', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.'}, {'pValue': '= 0.417', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.202', 'ciLowerLimit': '0.828', 'ciUpperLimit': '1.747', 'groupDescription': 'Comparison of the Asundexian 50 mg group versus Placebo group', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'HR was only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to 52 weeks', 'description': "Type 2: any overt, actionable sign of hemorrhage that doesn't fit the criteria for type 3 or 5 but meets at least one of the following criteria: 1) requires nonsurgical, med intervention by a HCP, 2) leads to hospital or rise in level of care, or 3) prompt eval. Type 3a: 1) overt bleed + Hg drop of 3 to \\<5 g/dl (provided Hg drop is related to bleed); 2 any transfusion with overt bleed. Type 3b: 1) overt bleed + Hg drop ≥5 g/dL (provided Hg drop is related to bleed); 2) cardiac tamponade; 3) bleed requiring surgical intervention for control (exclude dental/nasal /skin/hemorrhoid); 4) bleed requiring IV vasoactive agents. Type 3c: 1) ICH hemorrhage (doesn't include microbleeds or HT, does include intraspinal); subcategories confirmed by autopsy or imaging or LP; 2) intraocular bleed compromising vision. Type 5: fatal bleed. Type 5a: probable fatal bleed; no autopsy or image confirmation but clinical suspicion. Type 5b: definite fatal bleed; overt bleed or autopsy or image confirmation.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Efficacy - Number of Participants With CV Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '401', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Asundexian 10 mg', 'description': 'Participants received Asundexian (BAY2433334) 10 mg'}, {'id': 'OG001', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg'}, {'id': 'OG002', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002', 'OG003'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.275', 'ciLowerLimit': '0.322', 'ciUpperLimit': '5.050', 'groupDescription': 'Comparison of the Asundexian 20 mg group and Asundexian 50 mg group versus Placebo group', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.991', 'ciLowerLimit': '0.479', 'ciUpperLimit': '8.273', 'groupDescription': 'Comparison of the Asundexian 50 mg group versus Placebo group', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to 52 weeks', 'description': 'CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Efficacy - Number of Participants With MI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '401', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Asundexian 10 mg', 'description': 'Participants received Asundexian (BAY2433334) 10 mg'}, {'id': 'OG001', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg'}, {'id': 'OG002', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002', 'OG003'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.125', 'ciLowerLimit': '0.696', 'ciUpperLimit': '1.819', 'groupDescription': 'Comparison of the Asundexian 20 mg group and Asundexian 50 mg versus Placebo group', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.181', 'ciLowerLimit': '0.686', 'ciUpperLimit': '2.031', 'groupDescription': 'Comparison of the Asundexian 20 mg group versus Placebo group', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.070', 'ciLowerLimit': '0.613', 'ciUpperLimit': '1.866', 'groupDescription': 'Comparison of the Asundexian 50 mg group versus Placebo group', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'HRs were only calculated if at least three events occurred in one of the compared groups and at least one event in each of the compared treatment groups. The competing event was non-CV death for events that include CV death.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to 52 weeks', 'description': 'Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. According to MI Universal Definition from 2018 the diagnosis of MI requires combination of: 1. Presence of acute myocardial injury. 2. Evidence of acute myocardial ischemia derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging, or in case of post-mortem pathological findings irrespective of biomarker values.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Efficacy - Number of Participants With Stroke', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '401', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Asundexian 10 mg', 'description': 'Participants received Asundexian (BAY2433334) 10 mg'}, {'id': 'OG001', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg'}, {'id': 'OG002', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to 52 weeks', 'description': 'Stroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Efficacy - Number of Participants With Stent Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '401', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Asundexian 10 mg', 'description': 'Participants received Asundexian (BAY2433334) 10 mg'}, {'id': 'OG001', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg'}, {'id': 'OG002', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to 52 weeks', 'description': 'ST was defined incorporating diagnostic certainty as well as timing: "Definite" ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. "Probable" ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Efficacy - Number of Participants With All Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'OG000'}, {'value': '401', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '401', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Asundexian 10 mg', 'description': 'Participants received Asundexian (BAY2433334) 10 mg'}, {'id': 'OG001', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg'}, {'id': 'OG002', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '= 0.6016', 'groupIds': ['OG001', 'OG002', 'OG003'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.266', 'ciLowerLimit': '0.603', 'ciUpperLimit': '2.658', 'groupDescription': 'Comparison of the Asundexian 20 mg group and Asundexian 50 mg group versus Placebo group', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'For all-cause mortality there is no competing event.'}, {'pValue': '= 0.9945', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.996', 'ciLowerLimit': '0.414', 'ciUpperLimit': '2.401', 'groupDescription': 'Comparison of the Asundexian 20 mg group versus Placebo group', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.4085', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.506', 'ciLowerLimit': '0.667', 'ciUpperLimit': '3.405', 'groupDescription': 'Comparison of the Asundexian 50 mg group versus Placebo group', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to 52 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Safety - Number of Participants With All Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '399', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Asundexian 10 mg', 'description': 'Participants received Asundexian (BAY2433334) 10 mg'}, {'id': 'OG001', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg'}, {'id': 'OG002', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to 52 weeks', 'description': 'All bleeding events occurred from first intake of study intervention until 2 days after the last intake of study intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Safety - Number of Participants With BARC Bleeding Definition Type 3, 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '399', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Asundexian 10 mg', 'description': 'Participants received Asundexian (BAY2433334) 10 mg'}, {'id': 'OG001', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg'}, {'id': 'OG002', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to 52 weeks', 'description': "Type 3a: 1) overt bleed + Hg drop of 3 to \\<5 g/dl (provided Hg drop is related to bleed); 2 any transfusion with overt bleed. Type 3b: 1) overt bleed + Hg drop ≥5 g/dL (provided Hg drop is related to bleed); 2) cardiac tamponade; 3) bleed requiring surgical intervention for control (exclude dental/nasal /skin/hemorrhoid); 4) bleed requiring IV vasoactive agents. Type 3c: 1) ICH hemorrhage (doesn't include microbleeds or HT, does include intraspinal); subcategories confirmed by autopsy or imaging or LP; 2) intraocular bleed compromising vision. Type 5: fatal bleed. Type 5a: probable fatal bleed; no autopsy or image confirmation but clinical suspicion. Type 5b: definite fatal bleed; overt bleed or autopsy or image confirmation.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Safety - Number of Participants With BARC Bleeding Definition Type 1,2,3,5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '397', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '399', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Asundexian 10 mg', 'description': 'Participants received Asundexian (BAY2433334) 10 mg'}, {'id': 'OG001', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg'}, {'id': 'OG002', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '82', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to 52 weeks', 'description': 'Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consulting a healthcare professional. For BARC bleeding definition 2,3 and 5, please refer to second primary endpoint.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Asundexian 10 mg', 'description': 'Participants received Asundexian (BAY2433334) 10 mg'}, {'id': 'FG001', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg'}, {'id': 'FG002', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants received placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Full analysis set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '397'}, {'groupId': 'FG001', 'numSubjects': '401'}, {'groupId': 'FG002', 'numSubjects': '402'}, {'groupId': 'FG003', 'numSubjects': '401'}]}, {'type': 'Treated', 'comment': 'Safety analysis set (SAF)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '395'}, {'groupId': 'FG001', 'numSubjects': '397'}, {'groupId': 'FG002', 'numSubjects': '402'}, {'groupId': 'FG003', 'numSubjects': '399'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Treatment completed', 'groupId': 'FG000', 'numSubjects': '303'}, {'comment': 'Treatment completed', 'groupId': 'FG001', 'numSubjects': '317'}, {'comment': 'Treatment completed', 'groupId': 'FG002', 'numSubjects': '309'}, {'comment': 'Treatment completed', 'groupId': 'FG003', 'numSubjects': '309'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '84'}, {'groupId': 'FG002', 'numSubjects': '93'}, {'groupId': 'FG003', 'numSubjects': '92'}]}], 'dropWithdraws': [{'type': 'Subject decision COVID-19 pandemic related', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Non-Compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Unspecific', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Technical Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Subject Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '44'}]}]}], 'recruitmentDetails': 'Study was conducted at 157 centers in 14 countries or regions, between 17-Jun-2020 (first participant first visit) and 21-Feb-2022 (last participant last visit)', 'preAssignmentDetails': '1664 participants were screened, 63 participants were screening failures. 1601 participants were randomized in a 1:1:1:1 ratio to 4 treatment groups: 397, 401, and 402 participants to the asundexian 10 mg, 20 mg and 50 mg groups and 401 participants to the placebo group'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '397', 'groupId': 'BG000'}, {'value': '401', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}, {'value': '401', 'groupId': 'BG003'}, {'value': '1601', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Asundexian 10 mg', 'description': 'Participants received Asundexian (BAY2433334) 10 mg'}, {'id': 'BG001', 'title': 'Asundexian 20 mg', 'description': 'Participants received Asundexian (BAY2433334) 20 mg'}, {'id': 'BG002', 'title': 'Asundexian 50 mg', 'description': 'Participants received Asundexian (BAY2433334) 50 mg'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received placebo'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '136', 'groupId': 'BG003'}, {'value': '499', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '278', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}, {'value': '265', 'groupId': 'BG003'}, {'value': '1102', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}, {'value': '370', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '304', 'groupId': 'BG000'}, {'value': '314', 'groupId': 'BG001'}, {'value': '302', 'groupId': 'BG002'}, {'value': '311', 'groupId': 'BG003'}, {'value': '1231', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '203', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '334', 'groupId': 'BG000'}, {'value': '345', 'groupId': 'BG001'}, {'value': '347', 'groupId': 'BG002'}, {'value': '339', 'groupId': 'BG003'}, {'value': '1365', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'FAS(Full data analysis)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-22', 'size': 788440, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-19T05:08', 'hasProtocol': True}, {'date': '2022-01-26', 'size': 467724, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-19T05:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1601}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-03', 'studyFirstSubmitDate': '2020-03-08', 'resultsFirstSubmitDate': '2023-02-19', 'studyFirstSubmitQcDate': '2020-03-08', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-03', 'studyFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy - Number of Participants With Composite of CV Death, MI, Stroke and Stent Thrombosis (ST)', 'timeFrame': 'From baseline up to 52 weeks', 'description': 'CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included.\n\nAcute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia.\n\nStroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction.\n\nST was defined incorporating diagnostic certainty as well as timing: "Definite" ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. "Probable" ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause'}, {'measure': 'Safety - Number of Participants With BARC Bleeding Definition Type 2, 3 and 5', 'timeFrame': 'From baseline up to 52 weeks', 'description': "Type 2: any overt, actionable sign of hemorrhage that doesn't fit the criteria for type 3 or 5 but meets at least one of the following criteria: 1) requires nonsurgical, med intervention by a HCP, 2) leads to hospital or rise in level of care, or 3) prompt eval. Type 3a: 1) overt bleed + Hg drop of 3 to \\<5 g/dl (provided Hg drop is related to bleed); 2 any transfusion with overt bleed. Type 3b: 1) overt bleed + Hg drop ≥5 g/dL (provided Hg drop is related to bleed); 2) cardiac tamponade; 3) bleed requiring surgical intervention for control (exclude dental/nasal /skin/hemorrhoid); 4) bleed requiring IV vasoactive agents. Type 3c: 1) ICH hemorrhage (doesn't include microbleeds or HT, does include intraspinal); subcategories confirmed by autopsy or imaging or LP; 2) intraocular bleed compromising vision. Type 5: fatal bleed. Type 5a: probable fatal bleed; no autopsy or image confirmation but clinical suspicion. Type 5b: definite fatal bleed; overt bleed or autopsy or image confirmation."}], 'secondaryOutcomes': [{'measure': 'Efficacy - Number of Participants With CV Death', 'timeFrame': 'From baseline up to 52 weeks', 'description': 'CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included.'}, {'measure': 'Efficacy - Number of Participants With MI', 'timeFrame': 'From baseline up to 52 weeks', 'description': 'Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. According to MI Universal Definition from 2018 the diagnosis of MI requires combination of: 1. Presence of acute myocardial injury. 2. Evidence of acute myocardial ischemia derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging, or in case of post-mortem pathological findings irrespective of biomarker values.'}, {'measure': 'Efficacy - Number of Participants With Stroke', 'timeFrame': 'From baseline up to 52 weeks', 'description': 'Stroke was defined as an acute episode of focal or global neurological dysfunction caused by an injury of the brain, spinal cord, or retina as a result of hemorrhage or infarction.'}, {'measure': 'Efficacy - Number of Participants With Stent Thrombosis', 'timeFrame': 'From baseline up to 52 weeks', 'description': 'ST was defined incorporating diagnostic certainty as well as timing: "Definite" ST: The highest level of certainty. Either angiographic or pathological confirmation of stent thrombosis. "Probable" ST: Regardless of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause'}, {'measure': 'Efficacy - Number of Participants With All Cause Mortality', 'timeFrame': 'From baseline up to 52 weeks'}, {'measure': 'Safety - Number of Participants With All Bleeding', 'timeFrame': 'From baseline up to 52 weeks', 'description': 'All bleeding events occurred from first intake of study intervention until 2 days after the last intake of study intervention'}, {'measure': 'Safety - Number of Participants With BARC Bleeding Definition Type 3, 5', 'timeFrame': 'From baseline up to 52 weeks', 'description': "Type 3a: 1) overt bleed + Hg drop of 3 to \\<5 g/dl (provided Hg drop is related to bleed); 2 any transfusion with overt bleed. Type 3b: 1) overt bleed + Hg drop ≥5 g/dL (provided Hg drop is related to bleed); 2) cardiac tamponade; 3) bleed requiring surgical intervention for control (exclude dental/nasal /skin/hemorrhoid); 4) bleed requiring IV vasoactive agents. Type 3c: 1) ICH hemorrhage (doesn't include microbleeds or HT, does include intraspinal); subcategories confirmed by autopsy or imaging or LP; 2) intraocular bleed compromising vision. Type 5: fatal bleed. Type 5a: probable fatal bleed; no autopsy or image confirmation but clinical suspicion. Type 5b: definite fatal bleed; overt bleed or autopsy or image confirmation."}, {'measure': 'Safety - Number of Participants With BARC Bleeding Definition Type 1,2,3,5', 'timeFrame': 'From baseline up to 52 weeks', 'description': 'Type 1: bleeding that is not actionable and does not cause the patient to seek unscheduled performance of studies, hospitalization, or treatment by a healthcare professional; may include episodes leading to self-discontinuation of medical therapy by the patient without consulting a healthcare professional. For BARC bleeding definition 2,3 and 5, please refer to second primary endpoint.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '38038437', 'type': 'DERIVED', 'citation': 'Whiteson HZ, Frishman WH. Factor XI/XIa Inhibitors: A New Approach to Anticoagulation. Cardiol Rev. 2025 Jul-Aug 01;33(4):306-311. doi: 10.1097/CRD.0000000000000624. Epub 2023 Dec 1.'}, {'pmid': '36030390', 'type': 'DERIVED', 'citation': 'Rao SV, Kirsch B, Bhatt DL, Budaj A, Coppolecchia R, Eikelboom J, James SK, Jones WS, Merkely B, Keller L, Hermanides RS, Campo G, Ferreiro JL, Shibasaki T, Mundl H, Alexander JH; PACIFIC AMI Investigators. A Multicenter, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Trial of the Oral Factor XIa Inhibitor Asundexian to Prevent Adverse Cardiovascular Outcomes After Acute Myocardial Infarction. Circulation. 2022 Oct 18;146(16):1196-1206. doi: 10.1161/CIRCULATIONAHA.122.061612. Epub 2022 Aug 27.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe.'}, {'url': 'http://clinicaltrials.bayer.com/', 'label': 'Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of a dual antiplatelet therapy (acetylsalicylic acid +/- clopidogrel) in patients following a recent heart attack (myocardial infarction) that happens when a blood vessel in the heart suddenly becomes blocked. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be 45 years of age or older, at the time of signing the informed consent\n* Acute myocardial infarction (excluding MI associated with PCI or CABG revascularization procedures) with:\n\n * clinical symptoms of acute myocardial infarction AND\n * elevated biomarkers of myocardial necrosis (creatine kinase-muscle and brain isoenzyme \\[CK-MB\\] or cardiac troponins) AND\n * at least one of the following risk factors need to be fulfilled:\n\n * Age ≥ 65 years\n * Prior MI (before the index AMI event)\n * Prior peripheral arterial disease\n * Diabetes Mellitus\n * Prior coronary artery bypass grafting (CABG) AND\n * initial angiography and revascularization procedures, either PCI or CABG, as treatment for the index event performed before randomization. (Note: a planned, staged PCI procedure can be performed after randomization)\n* Plan for dual antiplatelet therapy (ASA + P2Y12 inhibitor) after hospital discharge for the index AMI\n* Randomization during hospitalization for the index AMI event and latest within 5 days of hospital admission\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent has to be signed before any study-specific procedure.\n\nExclusion Criteria:\n\n* Hemodynamically significant ventricular arrhythmias or cardiogenic shock at time of randomization\n* Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization\n* Planned use or requirement of full dose and long term anticoagulation therapy during study conduct.'}, 'identificationModule': {'nctId': 'NCT04304534', 'acronym': 'PACIFIC-AMI', 'briefTitle': 'Study to Gather Information About the Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following an Acute Heart Attack', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Multicenter, Randomized, Placebo Controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate the Efficacy and Safety of BAY 2433334 in Patients Following an Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': '20603'}, 'secondaryIdInfos': [{'id': '2019-003244-79', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAY 2433334 high dose', 'interventionNames': ['Drug: BAY2433334']}, {'type': 'EXPERIMENTAL', 'label': 'BAY 2433334 medium dose', 'interventionNames': ['Drug: BAY2433334']}, {'type': 'EXPERIMENTAL', 'label': 'BAY 2433334 low dose', 'interventionNames': ['Drug: BAY2433334']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'BAY2433334 matching placebo', 'interventionNames': ['Other: BAY2433334 matching placebo']}], 'interventions': [{'name': 'BAY2433334', 'type': 'DRUG', 'description': 'Tablet, taken orally once a day.', 'armGroupLabels': ['BAY 2433334 high dose', 'BAY 2433334 low dose', 'BAY 2433334 medium dose']}, {'name': 'BAY2433334 matching placebo', 'type': 'OTHER', 'description': 'Tablet, taken orally once a day.', 'armGroupLabels': ['BAY2433334 matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91723', 'city': 'Covina', 'state': 'California', 'country': 'United States', 'facility': 'Valley Clinical Trials, Inc. - Covina', 'geoPoint': {'lat': 34.09001, 'lon': -117.89034}}, {'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Premier Cardiology', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clearwater Cardiovascular Associates | Clearwater, FL', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Cardiology Associates Research Company', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Southwest Florida Research', 'geoPoint': {'lat': 26.14234, 'lon': 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This pertains to scope, timepoint and process of data access.\n\nAs such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.\n\nInterested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}