Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT04523220
Status:
COMPLETED
Last Update Posted:
2023-07-21
First Post:
2020-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China', 'France', 'Romania'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000657125', 'term': 'osocimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'phone': '(+) 1-888-8422937', 'title': 'Therapeutic Area Head', 'organization': 'Bayer AG'}, 'certainAgreement': {'otherDetails': "It's typically 30 days to review, and only if there is some need to file a patent application based on that review would there be an additional 60 days.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'After the first study intervention up until 30 days after last study intervention, with up to approximate 19 months. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, with up to approximate 21 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Higher-dose Osocimab', 'description': 'Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.\n\nParticipants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.', 'otherNumAtRisk': 224, 'deathsNumAtRisk': 224, 'otherNumAffected': 90, 'seriousNumAtRisk': 224, 'deathsNumAffected': 19, 'seriousNumAffected': 61}, {'id': 'EG001', 'title': 'Lower-dose Osocimab', 'description': 'Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.\n\nParticipants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.', 'otherNumAtRisk': 232, 'deathsNumAtRisk': 232, 'otherNumAffected': 85, 'seriousNumAtRisk': 232, 'deathsNumAffected': 24, 'seriousNumAffected': 67}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 230, 'otherNumAffected': 88, 'seriousNumAtRisk': 230, 'deathsNumAffected': 15, 'seriousNumAffected': 63}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 20, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 17, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 23, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 22, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 27, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 28, 'numAffected': 18}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': "Dressler's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Coronary artery insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Mitral valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hyperparathyroidism secondary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Gastrointestinal necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Intestinal dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 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'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dialysis device insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Arteriovenous graft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Bladder neoplasm surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Peritoneal catheter insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Iliac artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Arterial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Peripheral vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 232, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative Incidence Risk of the First Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) Events as Assessed by Blinded Central Independent Adjudication Committee (CIAC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Higher-dose Osocimab', 'description': 'Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.\n\nParticipants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.'}, {'id': 'OG001', 'title': 'Lower-dose Osocimab', 'description': 'Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.\n\nParticipants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.57', 'groupId': 'OG000', 'lowerLimit': '1.91', 'upperLimit': '6.04'}, {'value': '4.32', 'groupId': 'OG001', 'lowerLimit': '2.48', 'upperLimit': '6.91'}, {'value': '6.09', 'groupId': 'OG002', 'lowerLimit': '3.84', 'upperLimit': '9.04'}]}]}], 'analyses': [{'pValue': '= 0.222', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.59', 'ciLowerLimit': '0.28', 'ciUpperLimit': '1.21', 'pValueComment': 'Due to the explorative nature of these analyses, no multiplicity adjustment was done.', 'groupDescription': 'Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.427', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.72', 'ciLowerLimit': '0.36', 'ciUpperLimit': '1.42', 'pValueComment': 'Due to the explorative nature of these analyses, no multiplicity adjustment was done.', 'groupDescription': 'Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of study intervention up till 30 days after last study intervention in the main treatment period, up to 6 months', 'description': 'Cumulative incidence risk of the first Composite of MB and CRNMB (ISTH) at month 6 is reported in the table.\n\nDescriptive time to composite of MB and CRNMB Events is reported in statistical analysis.\n\nDescriptive time to composite of treatment emergent major and CRNMB events \\[in alignment with International Society on Thrombosis and Haemostatsis (ISTH) guidelines\\] analyses were performed. The cumulative incidence function for the event-of-interest together with the corresponding confidence interval were estimated for each treatment arm using Aalen-Johansen estimators. Cumulative incidence of events up to the day, inclusive.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF (Safety analysis set): All participants randomly assigned to study intervention who took at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received.'}, {'type': 'PRIMARY', 'title': 'Cumulative Incidence Risk of Composite of Moderate and Severe Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Higher-dose Osocimab', 'description': 'Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.\n\nParticipants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.'}, {'id': 'OG001', 'title': 'Lower-dose Osocimab', 'description': 'Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.\n\nParticipants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.84', 'groupId': 'OG000', 'lowerLimit': '33.46', 'upperLimit': '44.17'}, {'value': '38.37', 'groupId': 'OG001', 'lowerLimit': '33.10', 'upperLimit': '43.60'}, {'value': '32.17', 'groupId': 'OG002', 'lowerLimit': '27.16', 'upperLimit': '37.28'}]}]}], 'analyses': [{'pValue': '= 0.128', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.27', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.64', 'pValueComment': 'Due to the explorative nature of these analyses, no multiplicity adjustment was done.', 'groupDescription': 'Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.166', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.24', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.61', 'pValueComment': 'Due to the explorative nature of these analyses, no multiplicity adjustment was done.', 'groupDescription': 'Two-sided log-rank tests and Cox proportional hazards model were used in the analyses.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of study intervention up until 30 days after last study intervention in the main treatment period, up to 6 months', 'description': 'Cumulative incidence risk of composite of moderate and severe AEs and SAEs at month 6 is reported in the table.\n\nDescriptive time to the composite of Moderate and Severe AEs and SAEs is reported in statistical analysis.\n\nAn AE was any untoward medical occurrence in a patient or clinical study participant, whether or not considered related to the study intervention.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF (Safety analysis set)'}, {'type': 'SECONDARY', 'title': 'Ratio of Activated Partial Thromboplastin Time (aPTT) at 6 Months Trough Levels Versus Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Higher-dose Osocimab', 'description': 'Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.\n\nParticipants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.'}, {'id': 'OG001', 'title': 'Lower-dose Osocimab', 'description': 'Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.\n\nParticipants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.26', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '1.11', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '1.08', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 6 months (Visit 19 / Day 30 of the 6th month)', 'description': 'The aPTT at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation).\n\naPTT was measured via the kaolin-trigger method (clotting assay).', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PDS (Pharmacodynamic analysis set): All participants with at least 1 PD sample in accordance with the PD sampling schedule and without deviation from the protocol that would have interfered with the evaluation of the PD data were included in the PD analysis. Participants in PDS with data available for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Ratio of Factor XI (FXI) Activity at 6 Months Trough Levels Versus Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}, {'value': '171', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Higher-dose Osocimab', 'description': 'Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.\n\nParticipants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.'}, {'id': 'OG001', 'title': 'Lower-dose Osocimab', 'description': 'Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.\n\nParticipants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '1.23', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '1.20', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 6 months (Visit 19 / Day 30 of the 6th month)', 'description': 'The Factor XI (FXI) activity at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation).\n\nFactor XI activity was assessed with an aPTT-based coagulation test using FXI deficient plasma.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PDS (Pharmacodynamic analysis set). Participants in PDS with data available for this outcome measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Higher-dose Osocimab', 'description': 'Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.\n\nParticipants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.'}, {'id': 'FG001', 'title': 'Lower-dose Osocimab', 'description': 'Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.\n\nParticipants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.'}], 'periods': [{'title': 'Main Treatment Period', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '234'}, {'groupId': 'FG001', 'numSubjects': '235'}, {'groupId': 'FG002', 'numSubjects': '235'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}, {'groupId': 'FG001', 'numSubjects': '232'}, {'groupId': 'FG002', 'numSubjects': '230'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '199'}, {'groupId': 'FG002', 'numSubjects': '206'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Subject Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Study drug never adminstered', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}, {'title': 'Extension Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '194'}, {'groupId': 'FG001', 'numSubjects': '199'}, {'groupId': 'FG002', 'numSubjects': '206'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '178'}, {'groupId': 'FG002', 'numSubjects': '176'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Subject Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Study drug never administered', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study was conducted at multiple centers in 19 countries/regions, between 28-Aug-2020 (first participant first visit) and 30-May-2022 (last participant last visit).', 'preAssignmentDetails': 'A total of 859 participants were screened; 155 participants were not randomized. Most common reason for not being randomized was screen failure (144 participants). 704 participants were randomized to treatment; 18 participants did not receive treatment. The remaining 686 participants were treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}, {'value': '704', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Higher-dose Osocimab', 'description': 'Participants were randomized to receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg for 6 months in main treatment phase.\n\nParticipants received Osocimab (BAY1213790) at monthly maintenance doses of 105 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.'}, {'id': 'BG001', 'title': 'Lower-dose Osocimab', 'description': 'Participants were randomized to receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg for 6 months in main treatment phase.\n\nParticipants received Osocimab (BAY1213790) at monthly maintenance doses of 52.5 mg up to a maximum of 12 months or until the last participant randomized to the study has performed the end of main treatment (EOMT) visit (whichever comes first) in extension treatment period.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants were randomized to receive matching placebo subcutaneously in the same manner as Osocimab.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}, {'value': '704', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '61.0', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '61.1', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '59.5', 'spread': '13.3', 'groupId': 'BG002'}, {'value': '60.5', 'spread': '13.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}, {'value': '704', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '256', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '448', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}, {'value': '704', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}, {'value': '577', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Activated partial thromboplastin time (aPTT) value at baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}, {'value': '628', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '31.49', 'spread': '1.10', 'groupId': 'BG000'}, {'value': '31.32', 'spread': '1.10', 'groupId': 'BG001'}, {'value': '31.65', 'spread': '1.09', 'groupId': 'BG002'}, {'value': '31.49', 'spread': '1.09', 'groupId': 'BG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'description': 'aPTT was measured via the kaolin-trigger method (clotting assay). Furthermore, the aPTT assay was conducted after in vitro- neutralization of heparin in order to separate potential heparin effects from the PD effect of osocimab.', 'unitOfMeasure': 'seconds', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in PDS with evaluable assessment for this measurement.'}, {'title': 'Factor XI (FXI) activity at baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '202', 'groupId': 'BG002'}, {'value': '622', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '100.54', 'spread': '1.29', 'groupId': 'BG000'}, {'value': '102.27', 'spread': '1.28', 'groupId': 'BG001'}, {'value': '103.09', 'spread': '1.25', 'groupId': 'BG002'}, {'value': '101.96', 'spread': '1.27', 'groupId': 'BG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'description': 'Factor XI activity was assessed with an aPTT-based coagulation test using FXI deficient plasma. Furthermore, the assay was conducted after in vitro-neutralization of heparin in order to separate potential heparin effects from the PD effect of osocimab.', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in PDS with evaluable assessment for this measurement.'}], 'populationDescription': 'FAS (full analysis set): All participants randomly assigned to study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-16', 'size': 1084976, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-05T01:10', 'hasProtocol': True}, {'date': '2022-06-23', 'size': 484166, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-05T01:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 704}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'dispFirstSubmitDate': '2022-06-28', 'completionDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-13', 'studyFirstSubmitDate': '2020-08-20', 'resultsFirstSubmitDate': '2023-05-05', 'studyFirstSubmitQcDate': '2020-08-20', 'dispFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-13', 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Incidence Risk of the First Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) Events as Assessed by Blinded Central Independent Adjudication Committee (CIAC)', 'timeFrame': 'From the first dose of study intervention up till 30 days after last study intervention in the main treatment period, up to 6 months', 'description': 'Cumulative incidence risk of the first Composite of MB and CRNMB (ISTH) at month 6 is reported in the table.\n\nDescriptive time to composite of MB and CRNMB Events is reported in statistical analysis.\n\nDescriptive time to composite of treatment emergent major and CRNMB events \\[in alignment with International Society on Thrombosis and Haemostatsis (ISTH) guidelines\\] analyses were performed. The cumulative incidence function for the event-of-interest together with the corresponding confidence interval were estimated for each treatment arm using Aalen-Johansen estimators. Cumulative incidence of events up to the day, inclusive.'}, {'measure': 'Cumulative Incidence Risk of Composite of Moderate and Severe Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From the first dose of study intervention up until 30 days after last study intervention in the main treatment period, up to 6 months', 'description': 'Cumulative incidence risk of composite of moderate and severe AEs and SAEs at month 6 is reported in the table.\n\nDescriptive time to the composite of Moderate and Severe AEs and SAEs is reported in statistical analysis.\n\nAn AE was any untoward medical occurrence in a patient or clinical study participant, whether or not considered related to the study intervention.'}], 'secondaryOutcomes': [{'measure': 'Ratio of Activated Partial Thromboplastin Time (aPTT) at 6 Months Trough Levels Versus Baseline.', 'timeFrame': 'At 6 months (Visit 19 / Day 30 of the 6th month)', 'description': 'The aPTT at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation).\n\naPTT was measured via the kaolin-trigger method (clotting assay).'}, {'measure': 'Ratio of Factor XI (FXI) Activity at 6 Months Trough Levels Versus Baseline', 'timeFrame': 'At 6 months (Visit 19 / Day 30 of the 6th month)', 'description': 'The Factor XI (FXI) activity at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation).\n\nFactor XI activity was assessed with an aPTT-based coagulation test using FXI deficient plasma.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['End-stage renal disease (ESRD)', 'Hemodialysis'], 'conditions': ['End-stage Renal Disease', 'Prevention of Thromboembolic Events', 'Hemodialysis', 'Hemodiafiltration']}, 'referencesModule': {'references': [{'pmid': '38365952', 'type': 'DERIVED', 'citation': 'Weitz JI, Tanko LB, Floege J, Fox KAA, Bhatt DL, Thadhani R, Hung J, Pap AF, Kubitza D, Winkelmayer WC; CONVERT Investigators. Anticoagulation with osocimab in patients with kidney failure undergoing hemodialysis: a randomized phase 2 trial. Nat Med. 2024 Feb;30(2):435-442. doi: 10.1038/s41591-023-02794-7. Epub 2024 Feb 16.'}], 'seeAlsoLinks': [{'url': 'https://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.'}, {'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe.'}]}, 'descriptionModule': {'briefSummary': 'In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels diseases. Osocimab is a human monoclonal antibody under development for the prevention of events caused by blood clots like heart attack, stroke and death due to heart or blood vessels diseases. It works by binding to and blocking the activated form of clotting factor XI which increases the formation and stability of clots. Researchers also want to find out how drug Osocimab works in human body and how the body absorbs, distributes and excretes the drug.\n\nParticipants in this study will receive monthly injection of either Osocimab at a lower-dose or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be at least 18 years of age\n* Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for ≥3 months, receiving dialysis at least 9 hours a week and stable in the view of the investigator\n* Body weight of at least 50 kg\n* Male and/or female. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* Recent (\\<6 months before screening) clinically significant bleeding\n* Hemoglobin (Hb) \\< 9.0 g/dL at screening\n* Platelet count \\< 100 x 10\\^9/L\n* aPTT or PT \\> ULN (upper limit of normal)\n* Hepatic disease associated with ALT \\> 3x ULN, or total bilirubin \\>2x ULN with direct bilirubin \\> 20% of the total\n* Sustained uncontrolled hypertension (diastolic blood pressure ≥100 mmHg and/or systolic blood pressure ≥ 180 mmHg)\n* Known intracranial neoplasm, arteriovenous malformation or aneurysm\n* Known bleeding disorders e.g. von-Willebrand disease or Hemophilia A, B or C\n* Recent (\\<3 months before screening) thromboembolic event, e.g. acute coronary syndrome, stroke or VTE (except dialysis access thrombosis)\n* Recent (\\<3 months before screening) major surgery or scheduled major surgery during study participation\n* Scheduled living donor renal transplant during study participation\n* Persistent heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher\n* Receiving antiplatelet therapy except daily ASA ≤ 150 mg/day\n* Receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure'}, 'identificationModule': {'nctId': 'NCT04523220', 'acronym': 'CONVERT', 'briefTitle': 'Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study to Assess the Safety and Tolerability of Monthly Subcutaneous Administrations of a Low and High Dose Cohort of Osocimab to ESRD Patients on Regular Hemodialysis', 'orgStudyIdInfo': {'id': '20115'}, 'secondaryIdInfos': [{'id': '2019-003957-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAY1213790 low dose', 'description': 'Participants will receive Osocimab (BAY1213790) 105 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 52.5 mg until the end of the extension treatment period.', 'interventionNames': ['Drug: BAY1213790 (Osocimab)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo low dose', 'description': 'Placebo will be administered subcutaneously in the same manner as Osocimab.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BAY1213790 high dose', 'description': 'Participants will receive Osocimab (BAY1213790) 210 mg single loading dose as subcutaneous abdominal injection, followed by monthly maintenance doses of 105 mg until the end of the extension treatment period.', 'interventionNames': ['Drug: BAY1213790 (Osocimab)']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo high dose', 'description': 'Placebo will be administered subcutaneously in the same manner as Osocimab.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BAY1213790 (Osocimab)', 'type': 'DRUG', 'description': 'Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.', 'armGroupLabels': ['BAY1213790 high dose', 'BAY1213790 low dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subcutaneous administration in the same manner as Osocimab.', 'armGroupLabels': ['Placebo high dose', 'Placebo low dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91702', 'city': 'Azusa', 'state': 'California', 'country': 'United States', 'facility': 'North America Research Institute - Azusa', 'geoPoint': {'lat': 34.13362, 'lon': -117.90756}}, {'zip': '92227', 'city': 'Brawley', 'state': 'California', 'country': 'United States', 'facility': 'Fresenius Kidney Care - Brawley', 'geoPoint': {'lat': 32.97866, 'lon': -115.53027}}, {'zip': '91316', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'DaVita South Valley Dialysis', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Fresenius Kidney Care - La Mesa', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90022', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'East L.A. Dialysis Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92503', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Van Buren Dialysis Center', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '92111', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Fresenius Kidney Care Kearny Mesa', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92154', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'FMC San Ysidro', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '91790', 'city': 'West Covina', 'state': 'California', 'country': 'United States', 'facility': "Queen's Dialysis Unit", 'geoPoint': {'lat': 34.06862, 'lon': -117.93895}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'DaVita Greater Waterbury Dialysis', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '34222', 'city': 'Ellenton', 'state': 'Florida', 'country': 'United States', 'facility': 'ARA Plantation Dialysis, LLC', 'geoPoint': {'lat': 27.52171, 'lon': -82.5276}}, {'zip': '30901', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'ARA Augusta', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '83605', 'city': 'Caldwell', 'state': 'Idaho', 'country': 'United States', 'facility': 'Liberty Dialysis- Caldwell', 'geoPoint': {'lat': 43.66294, 'lon': -116.68736}}, {'zip': '60805', 'city': 'Evergreen Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Fresenius Kidney Care Evergreen Park', 'geoPoint': {'lat': 41.72059, 'lon': -87.70172}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Fresenius Kidney Care Baton Rouge Mancuso Lane', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '71106', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Fresenius Kidney Care South Dialysis', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '01040', 'city': 'Holyoke', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'ARA Holyoke Dialysis Center', 'geoPoint': {'lat': 42.20426, 'lon': -72.6162}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Davita Hospital Hill Dialysis', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Renal Medicine Associates', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham Nephrology Associates, Pa', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Waterloo Dialysis', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Fresenius North Austin Dialysis Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77083', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Fresenius Kidney Care - 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