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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 7:14 PM

Ignite Modification Date: 2026-02-23 @ 4:10 AM

Study NCT ID: NCT02556203

Status: TERMINATED

Last Update Posted: 2020-01-13

First Post: 2015-09-05

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'C008208', 'term': 'acarboxyprothrombin'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'phone': '(+)1-888-84 22937', 'title': 'Therapeutic Area Head', 'organization': 'Bayer'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Through study completion, on average 14 months. Timeframe for All-Cause Mortality: After study medication start until last contact date.', 'eventGroups': [{'id': 'EG000', 'title': 'Rivaroxaban Arm', 'description': 'Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.', 'otherNumAtRisk': 801, 'deathsNumAtRisk': 801, 'otherNumAffected': 359, 'seriousNumAtRisk': 801, 'deathsNumAffected': 70, 'seriousNumAffected': 296}, {'id': 'EG001', 'title': 'Antiplatelet Arm', 'description': 'Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.', 'otherNumAtRisk': 807, 'deathsNumAtRisk': 807, 'otherNumAffected': 302, 'seriousNumAtRisk': 807, 'deathsNumAffected': 43, 'seriousNumAffected': 282}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Normochromic normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 44, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 45, 'numAffected': 44}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Atrial tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Drug intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Eyelid operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cardiac pacemaker adjustment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Transcatheter arterial chemoembolisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Intermittent claudication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Undersensing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Device battery issue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 801, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 807, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'frequencyThreshold': '0.2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Death or First Thromboembolic Event (DTE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '801', 'groupId': 'OG000'}, {'value': '807', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Xarelto, BAY59-7939)', 'description': 'Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.'}, {'id': 'OG001', 'title': 'Antiplatelet', 'description': 'Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '1.2089302', 'ciUpperLimit': '1.7040824', 'groupDescription': 'H0: HR(t)\\>=1.20 for all time points t\\>=0, (i.e. "the hazard for the primary efficacy endpoint in the rivaroxaban-based treatment group is more than 20% larger than that in the antiplatelet-based control group")', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': '1-sided Confidence interval'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, on average 14 months', 'description': 'Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAF): Included all randomized subjects who had been exposed to study drug at least once (1608 subjects overall).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Death or First Thromboembolic Event (DTE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '826', 'groupId': 'OG000'}, {'value': '818', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Xarelto, BAY59-7939)', 'description': 'Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.'}, {'id': 'OG001', 'title': 'Antiplatelet', 'description': 'Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.04223', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.35', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.81', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': '2-sided Log Rank test'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, on average 16 months', 'description': 'Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall)'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Primary Bleeding Event (PBE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '826', 'groupId': 'OG000'}, {'value': '818', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Xarelto, BAY59-7939)', 'description': 'Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.'}, {'id': 'OG001', 'title': 'Antiplatelet', 'description': 'Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.07745', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'ciLowerLimit': '0.95', 'ciUpperLimit': '2.37', 'estimateComment': 'Estimates for HRs are based on Cox proportional hazards model. HRs \\>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive. 2-sided Log Rank test.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, on average 16 months', 'description': 'PBE is defined according to VARC (Valve Academic Research Consortium) definitions as the adjudicated composite of: Life-threatening, disabling or major bleeding.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Net-clinical Benefit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '826', 'groupId': 'OG000'}, {'value': '818', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Xarelto, BAY59-7939)', 'description': 'Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.'}, {'id': 'OG001', 'title': 'Antiplatelet', 'description': 'Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.01156', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.39', 'ciLowerLimit': '1.08', 'ciUpperLimit': '1.80', 'estimateComment': 'Estimates for HRs are based on Cox proportional hazards model. HRs \\>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': '2-sided Log Rank test'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, on average 16 months', 'description': 'The net-clinical-benefit defined as the adjudicated composite of all-cause death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis, non-CNS systemic embolism (efficacy); VARC life-threatening, disabling and VARC major bleeds (safety).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Cardiovascular Death or Thromboembolic Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '826', 'groupId': 'OG000'}, {'value': '818', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Xarelto, BAY59-7939)', 'description': 'Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.'}, {'id': 'OG001', 'title': 'Antiplatelet', 'description': 'Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.21595', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.69', 'estimateComment': 'Estimates for HRs are based on Cox proportional hazards model. HRs \\>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': '2-sided Log Rank test'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, on average 16 months', 'description': 'Composite of CV-death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '826', 'groupId': 'OG000'}, {'value': '818', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Xarelto, BAY59-7939)', 'description': 'Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.'}, {'id': 'OG001', 'title': 'Antiplatelet', 'description': 'Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.02216', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.78', 'ciLowerLimit': '1.08', 'ciUpperLimit': '2.94', 'estimateComment': 'Estimates for HRs are based on Cox proportional hazards model. HRs \\>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive. 2-sided Log Rank test.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, on average 16 months', 'description': 'Composite of TIMI major and minor bleedings', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '826', 'groupId': 'OG000'}, {'value': '818', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Xarelto, BAY59-7939)', 'description': 'Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.'}, {'id': 'OG001', 'title': 'Antiplatelet', 'description': 'Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.02702', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.66', 'ciLowerLimit': '1.05', 'ciUpperLimit': '2.62', 'estimateComment': 'Estimates for HRs are based on Cox proportional hazards model. HRs \\>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive. 2-sided Log Rank test.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, on average 16 months', 'description': 'ISTH major bleeds', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '826', 'groupId': 'OG000'}, {'value': '818', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban (Xarelto, BAY59-7939)', 'description': 'Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.'}, {'id': 'OG001', 'title': 'Antiplatelet', 'description': 'Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '= 0.00001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.84', 'ciLowerLimit': '1.41', 'ciUpperLimit': '2.41', 'estimateComment': 'Estimates for HRs are based on Cox proportional hazards model. HRs \\>1 indicate a higher hazard rate in the rivaroxaban arm compared with the antiplatelet arm.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Descriptive. 2-sided Log Rank test.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through study completion, on average 16 months', 'description': 'Composite of BARC 2,3 or 5 bleedings', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rivaroxaban (Xarelto, BAY59-7939)', 'description': 'Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.'}, {'id': 'FG001', 'title': 'Antiplatelet', 'description': 'Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '826'}, {'groupId': 'FG001', 'numSubjects': '818'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '801'}, {'groupId': 'FG001', 'numSubjects': '807'}]}, {'type': 'COMPLETED', 'comment': 'Completed study procedures', 'achievements': [{'groupId': 'FG000', 'numSubjects': '799'}, {'groupId': 'FG001', 'numSubjects': '792'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Study was conducted at 136 centers world-wide between 16 Dec 2015 (first patient's first visit) and 27 Nov 2018 (last patient's last visit).", 'preAssignmentDetails': 'A total of 1674 subjects were screened, of which 1644 were randomly assigned to either of the two treatment arms and 1608 subjects started treatment with study medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '826', 'groupId': 'BG000'}, {'value': '818', 'groupId': 'BG001'}, {'value': '1644', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rivaroxaban (Xarelto, BAY59-7939)', 'description': 'Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (Acetylsalicylic Acid) (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.'}, {'id': 'BG001', 'title': 'Antiplatelet', 'description': 'Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '80.38', 'spread': '7.12', 'groupId': 'BG000'}, {'value': '80.77', 'spread': '5.99', 'groupId': 'BG001'}, {'value': '80.57', 'spread': '6.58', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '400', 'groupId': 'BG000'}, {'value': '413', 'groupId': 'BG001'}, {'value': '813', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '426', 'groupId': 'BG000'}, {'value': '405', 'groupId': 'BG001'}, {'value': '831', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '677', 'groupId': 'BG000'}, {'value': '694', 'groupId': 'BG001'}, {'value': '1371', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '692', 'groupId': 'BG000'}, {'value': '693', 'groupId': 'BG001'}, {'value': '1385', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-17', 'size': 3270363, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-11-21T01:28', 'hasProtocol': True}, {'date': '2016-12-15', 'size': 985716, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-11-21T01:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1653}}, 'statusModule': {'whyStopped': 'Imbalance in the efficacy and safety endpoints between treatment arms in favor of comparator', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-23', 'studyFirstSubmitDate': '2015-09-05', 'resultsFirstSubmitDate': '2019-11-22', 'studyFirstSubmitQcDate': '2015-09-21', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-23', 'studyFirstPostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Death or First Thromboembolic Event (DTE)', 'timeFrame': 'Through study completion, on average 14 months', 'description': 'Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.'}, {'measure': 'Number of Participants With Death or First Thromboembolic Event (DTE)', 'timeFrame': 'Through study completion, on average 16 months', 'description': 'Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism.'}, {'measure': 'Number of Participants With Primary Bleeding Event (PBE)', 'timeFrame': 'Through study completion, on average 16 months', 'description': 'PBE is defined according to VARC (Valve Academic Research Consortium) definitions as the adjudicated composite of: Life-threatening, disabling or major bleeding.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Net-clinical Benefit', 'timeFrame': 'Through study completion, on average 16 months', 'description': 'The net-clinical-benefit defined as the adjudicated composite of all-cause death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis, non-CNS systemic embolism (efficacy); VARC life-threatening, disabling and VARC major bleeds (safety).'}, {'measure': 'Number of Participants With Cardiovascular Death or Thromboembolic Event', 'timeFrame': 'Through study completion, on average 16 months', 'description': 'Composite of CV-death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication).'}, {'measure': 'Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds', 'timeFrame': 'Through study completion, on average 16 months', 'description': 'Composite of TIMI major and minor bleedings'}, {'measure': 'Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds', 'timeFrame': 'Through study completion, on average 16 months', 'description': 'ISTH major bleeds'}, {'measure': 'Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds', 'timeFrame': 'Through study completion, on average 16 months', 'description': 'Composite of BARC 2,3 or 5 bleedings'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TAVR', 'TAVI', 'Transfemoral aortic valve implantation'], 'conditions': ['Transcatheter Aortic Valve Replacement']}, 'referencesModule': {'references': [{'pmid': '36040717', 'type': 'DERIVED', 'citation': 'Okuno T, Dangas GD, Hengstenberg C, Sartori S, Herrmann HC, de Winter R, Gilard M, Tchetche D, Mollmann H, Makkar RR, Baldus S, De Backer O, Bendz B, Kini A, von Lewinski D, Mack M, Moreno R, Schafer U, Wohrle J, Seeger J, Snyder C, Nicolas J, Tijssen JGP, Welsh RC, Vranckx P, Valgimigli M, Mehran R, Kapadia S, Sondergaard L, Windecker S. Two-year clinical outcomes after successful transcatheter aortic valve implantation with balloon-expandable versus self-expanding valves: A subanalysis of the GALILEO trial. Catheter Cardiovasc Interv. 2022 Oct;100(4):636-645. doi: 10.1002/ccd.30370. Epub 2022 Aug 30.'}, {'pmid': '35934563', 'type': 'DERIVED', 'citation': 'Wohrle J, Gilard M, Didier R, Kini A, Tavenier AH, Tijssen JGP, Sartori S, Snyder C, Nicolas J, Seeger J, Landmesser U, Tarantini G, Asgar A, Mollmann H, Thiele H, Capranzano P, Reimers B, Stefanini G, Moreno R, Petronio AS, Mikhail G, Kapadia S, Hildick-Smith D, Hengstenberg C, Mehran R, Windecker S, Dangas GD; GALILEO Investigator. Outcomes After Transcatheter Aortic Valve Implantation in Men Versus Women. Am J Cardiol. 2022 Oct 1;180:108-115. doi: 10.1016/j.amjcard.2022.06.035. Epub 2022 Aug 4.'}, {'pmid': '31733180', 'type': 'DERIVED', 'citation': 'Dangas GD, Tijssen JGP, Wohrle J, Sondergaard L, Gilard M, Mollmann H, Makkar RR, Herrmann HC, Giustino G, Baldus S, De Backer O, Guimaraes AHC, Gullestad L, Kini A, von Lewinski D, Mack M, Moreno R, Schafer U, Seeger J, Tchetche D, Thomitzek K, Valgimigli M, Vranckx P, Welsh RC, Wildgoose P, Volkl AA, Zazula A, van Amsterdam RGM, Mehran R, Windecker S; GALILEO Investigators. A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement. N Engl J Med. 2020 Jan 9;382(2):120-129. doi: 10.1056/NEJMoa1911425. Epub 2019 Nov 16.'}, {'pmid': '29536857', 'type': 'DERIVED', 'citation': 'Piayda K, Zeus T, Sievert H, Kelm M, Polzin A. Subclinical leaflet thrombosis. Lancet. 2018 Mar 10;391(10124):937-938. doi: 10.1016/S0140-6736(18)30534-8. No abstract available.'}, {'pmid': '27892890', 'type': 'DERIVED', 'citation': 'Windecker S, Tijssen J, Giustino G, Guimaraes AH, Mehran R, Valgimigli M, Vranckx P, Welsh RC, Baber U, van Es GA, Wildgoose P, Volkl AA, Zazula A, Thomitzek K, Hemmrich M, Dangas GD. Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study. Am Heart J. 2017 Feb;184:81-87. doi: 10.1016/j.ahj.2016.10.017. Epub 2016 Oct 31.'}], 'seeAlsoLinks': [{'url': 'http://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer products'}]}, 'descriptionModule': {'briefSummary': 'To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE).\n\nTo assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an antiplatelet-based strategy, following TAVR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Successful TAVR (Transcatheter Aortic Valve Replacement) of an aortic valve stenosis (either native or valve-in-valve)\n\n * By iliofemoral or subclavian access\n * With any approved/marketed device\n\nExclusion Criteria:\n\n* Atrial fibrillation (AF), current or previous, with an ongoing indication for oral anticoagulant treatment\n* Any other indication for continued treatment with any oral anticoagulant (OAC)\n* Known bleeding diathesis (such as but not limited to active internal bleeding, clinically significant bleeding, platelet count ≤ 50,000/mm3 at screening, hemoglobin level \\< 8.5 g/dL, active peptic ulcer or known gastrointestinal (GI) bleeding, history of intracranial hemorrhage or subdural hematoma)\n* Any ongoing absolute indication for dual antiplatelet therapy (DAPT) at time of screening that is unrelated to the TAVR procedure\n* Clinically overt stroke within the last 3 months\n* Planned coronary or vascular intervention or major surgery\n* Severe renal impairment (eGFR \\< 30 mL/min/1.73 m2) or on dialysis, or post-TAVR unresolved acute kidney injury with renal dysfunction stage 2 or higher\n* Moderate and severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy'}, 'identificationModule': {'nctId': 'NCT02556203', 'acronym': 'GALILEO', 'briefTitle': 'Global Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement to Optimize Clinical Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Global Multicenter, Open-label, Randomized, Event-driven, Active-controlled Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement (TAVR) to Optimize Clinical Outcomes', 'orgStudyIdInfo': {'id': '17938'}, 'secondaryIdInfos': [{'id': '2015-001975-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rivaroxaban (Xarelto, BAY59-7939)', 'description': 'Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.', 'interventionNames': ['Drug: Rivaroxaban (Xarelto, BAY59-7939)', 'Drug: Acetylsalicylic Acid (ASA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antiplatelet', 'description': 'Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA to target INR 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.', 'interventionNames': ['Drug: Acetylsalicylic Acid (ASA)', 'Drug: Clopidogrel', 'Drug: Vitamin K antagonist (VKA)']}], 'interventions': [{'name': 'Rivaroxaban (Xarelto, BAY59-7939)', 'type': 'DRUG', 'description': '10mg OD (once-daily)', 'armGroupLabels': ['Rivaroxaban (Xarelto, BAY59-7939)']}, {'name': 'Acetylsalicylic Acid (ASA)', 'type': 'DRUG', 'description': '75-100mg OD', 'armGroupLabels': ['Antiplatelet', 'Rivaroxaban (Xarelto, BAY59-7939)']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'description': '75mg OD', 'armGroupLabels': ['Antiplatelet']}, {'name': 'Rivaroxaban (Xarelto, BAY59-7939)', 'type': 'DRUG', 'description': 'In case of NOAF, 20/15 mg OD (once-daily)', 'armGroupLabels': ['Rivaroxaban (Xarelto, BAY59-7939)']}, {'name': 'Vitamin K antagonist (VKA)', 'type': 'DRUG', 'description': 'In case of NOAF, Open-label VKA therapy to target international normalized ratio (INR) 2-3, according to guidelines', 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