Viewing Study NCT02293395

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Ignite Creation Date: 2025-12-24 @ 2:00 PM
Ignite Modification Date: 2026-01-03 @ 7:26 AM
Study NCT ID: NCT02293395
Status: COMPLETED
Last Update Posted: 2017-12-26
First Post: 2014-11-13
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000789', 'term': 'Angina, Unstable'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'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': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'title': 'Associate Director', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study population was homogenous with limited participation of non-Caucasian participants. Randomization was not performed for use of P2Y12 inhibitor; strata comparisons between bleeding and efficacy endpoints are confounded and were not planned.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 390 days', 'description': 'Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.', 'eventGroups': [{'id': 'EG000', 'title': 'Rivaroxaban 2.5 mg Twice Daily (BID)', 'description': 'Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.', 'otherNumAtRisk': 1510, 'otherNumAffected': 81, 'seriousNumAtRisk': 1510, 'seriousNumAffected': 125}, {'id': 'EG001', 'title': 'Acetylsalicylic Acid 100 mg Once Daily (OD)', 'description': 'Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.', 'otherNumAtRisk': 1506, 'otherNumAffected': 84, 'seriousNumAtRisk': 1506, 'seriousNumAffected': 138}], 'otherEvents': [{'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 39}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 22}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Acute Left Ventricular Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Aortic Valve Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Atrioventricular Block Second Degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cardiac Failure Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cardiac Ventricular Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cardiovascular Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Coronary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Intracardiac Thrombus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Mitral Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Myocardial Fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Myocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Myocardial Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pleuropericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Postinfarction Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Sinus Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Ventricular Extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Vertigo Positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Chronic Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Colitis Ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Diverticulum Intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Erosive Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Gastroduodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pancreatic Necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pancreatitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pancreatitis Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Implant Site Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Multiple Organ Dysfunction Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Stent-Graft Endoleak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Vascular Stent Restenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Vascular Stent Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Drug-Induced Liver Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Gastrointestinal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'H1n1 Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'MedDRA Version 19.0'}, {'term': 'Postoperative Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pyelonephritis Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Spinal Cord Infection', 'stats': [{'groupId': 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Ligament Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Lower Limb Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Lumbar Vertebral Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Radius Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Spinal Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Ulna Fracture', 'stats': 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'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Liver Function Test Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Mediastinoscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Diabetes 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'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Intervertebral Disc Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Ligamentitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Musculoskeletal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Rapidly Progressive Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Rheumatoid Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Brain Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cervix Carcinoma Recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Colon Cancer Recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl 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and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Laryngeal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Lung Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pancreatic Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Neoplasms 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'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Salivary Gland Cancer Recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Squamous Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Uterine Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Uterine Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Vascular Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Carotid Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Facial Paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Intracranial Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Vertebral Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Alcohol Withdrawal Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Panic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Nephropathy Toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Renal Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Renal Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Urinary Tract Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Benign Prostatic Hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Acute Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pulmonary Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Inguinal Hernia Repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Lung Neoplasm Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Lymphadenectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Aortic Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Brachiocephalic Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Hypertensive Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Peripheral Arterial Occlusive Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Peripheral Artery Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Peripheral Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Peripheral Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Subclavian Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}, {'term': 'Vascular Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1510, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1506, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 19.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1519', 'groupId': 'OG000'}, {'value': '1518', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban 2.5 mg Twice Daily (BID)', 'description': 'Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.'}, {'id': 'OG001', 'title': 'Acetylsalicylic Acid 100 mg Once Daily (OD)', 'description': 'Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.584', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.5', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From start of study treatment until follow-up (up to 390 days)', 'description': 'Non CABG-related TIMI clinically significant bleeding events are sum of non CABG-related TIMI major bleeding events, TIMI minor bleeding events and TIMI bleeding events requiring medical attention. Major: any symptomatic intracranial bleeding: clinically overt signs of hemorrhage with hemoglobin (Hb) drop of greater than or equal to (\\>=)5 gram per deciliter (g/dl) (or absolute drop in hematocrit of \\>=15%) and fatal bleeding (results in death within 7 days); Minor: clinically overt sign of hemorrhage with Hb drop of 3 - \\<5 g/dl (or drop in hematocrit of 9 - \\<15%); requiring medical attention: bleeding event that required medical, surgical treatment/laboratory evaluation and did not meet criteria for major/minor bleeding event.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population analyzed included all randomized participants who had received at least one dose of study agent and had events that occurred between randomization and the last dose of the study agent plus 2 days or untreated participants who had events that occurred between randomization to 2 days thereafter.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rivaroxaban 2.5 mg Twice Daily (BID)', 'description': 'Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.'}, {'id': 'FG001', 'title': 'Acetylsalicylic Acid 100 mg Once Daily (OD)', 'description': 'Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1519'}, {'groupId': 'FG001', 'numSubjects': '1518'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1510'}, {'groupId': 'FG001', 'numSubjects': '1506'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1510'}, {'groupId': 'FG001', 'numSubjects': '1511'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'preAssignmentDetails': 'A total of 3,145 participants were screened for eligibility, of these 108 participants were screening failures and the remaining 3,037 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1519', 'groupId': 'BG000'}, {'value': '1518', 'groupId': 'BG001'}, {'value': '3037', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rivaroxaban 2.5 mg Twice Daily (BID)', 'description': 'Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.'}, {'id': 'BG001', 'title': 'Acetylsalicylic Acid 100 mg Once Daily (OD)', 'description': 'Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.7', 'spread': '9.14', 'groupId': 'BG000'}, {'value': '62.9', 'spread': '8.82', 'groupId': 'BG001'}, {'value': '62.8', 'spread': '8.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '385', 'groupId': 'BG000'}, {'value': '377', 'groupId': 'BG001'}, {'value': '762', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1134', 'groupId': 'BG000'}, {'value': '1141', 'groupId': 'BG001'}, {'value': '2275', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '1417', 'groupId': 'BG000'}, {'value': '1407', 'groupId': 'BG001'}, {'value': '2824', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Others', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'ARGENTINA', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}, {'title': 'AUSTRALIA', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'BELGIUM', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}, {'title': 'BRAZIL', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}]}, {'title': 'BULGARIA', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}, {'title': 'CANADA', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}, {'title': 'CZECH REPUBLIC', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': 'DENMARK', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'FRANCE', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'HUNGARY', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}]}, {'title': 'ITALY', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}, {'title': 'JAPAN', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'NETHERLANDS', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}, {'title': 'POLAND', 'categories': [{'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}]}, {'title': 'RUSSIA', 'categories': [{'measurements': [{'value': '237', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}]}]}, {'title': 'SPAIN', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}]}, {'title': 'SWEDEN', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'TURKEY', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}]}, {'title': 'UKRAINE', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}]}, {'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}]}, {'title': 'Korea, Republic Of', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3037}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-30', 'studyFirstSubmitDate': '2014-11-13', 'resultsFirstSubmitDate': '2017-10-11', 'studyFirstSubmitQcDate': '2014-11-13', 'lastUpdatePostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-11', 'studyFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events', 'timeFrame': 'From start of study treatment until follow-up (up to 390 days)', 'description': 'Non CABG-related TIMI clinically significant bleeding events are sum of non CABG-related TIMI major bleeding events, TIMI minor bleeding events and TIMI bleeding events requiring medical attention. Major: any symptomatic intracranial bleeding: clinically overt signs of hemorrhage with hemoglobin (Hb) drop of greater than or equal to (\\>=)5 gram per deciliter (g/dl) (or absolute drop in hematocrit of \\>=15%) and fatal bleeding (results in death within 7 days); Minor: clinically overt sign of hemorrhage with Hb drop of 3 - \\<5 g/dl (or drop in hematocrit of 9 - \\<15%); requiring medical attention: bleeding event that required medical, surgical treatment/laboratory evaluation and did not meet criteria for major/minor bleeding event.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Coronary Syndrome', 'Myocardial infarction', 'Unstable angina', 'Acetylsalicylic acid', 'Rivaroxaban', 'JNJ-39039039', 'Bay 59-7939', 'Xarelto', 'Clopidogrel', 'Ticagrelor', 'Plavix', 'Brilinta', 'Effient'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '31535314', 'type': 'DERIVED', 'citation': 'Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.'}, {'pmid': '31141104', 'type': 'DERIVED', 'citation': 'Povsic TJ, Ohman EM, Roe MT, White J, Rockhold FW, Montalescot G, Cornel JH, Nicolau JC, Steg PG, James S, Bode C, Welsh RC, Plotnikov AN, Mundl H, Gibson CM. P2Y12 Inhibitor Switching in Response to Routine Notification of CYP2C19 Clopidogrel Metabolizer Status Following Acute Coronary Syndromes. JAMA Cardiol. 2019 Jul 1;4(7):680-684. doi: 10.1001/jamacardio.2019.1510.'}, {'pmid': '28325638', 'type': 'DERIVED', 'citation': 'Ohman EM, Roe MT, Steg PG, James SK, Povsic TJ, White J, Rockhold F, Plotnikov A, Mundl H, Strony J, Sun X, Husted S, Tendera M, Montalescot G, Bahit MC, Ardissino D, Bueno H, Claeys MJ, Nicolau JC, Cornel JH, Goto S, Kiss RG, Guray U, Park DW, Bode C, Welsh RC, Gibson CM. Clinically significant bleeding with low-dose rivaroxaban versus aspirin, in addition to P2Y12 inhibition, in acute coronary syndromes (GEMINI-ACS-1): a double-blind, multicentre, randomised trial. Lancet. 2017 May 6;389(10081):1799-1808. doi: 10.1016/S0140-6736(17)30751-1. Epub 2017 Mar 18.'}, {'pmid': '26995378', 'type': 'DERIVED', 'citation': 'Povsic TJ, Roe MT, Ohman EM, Steg PG, James S, Plotnikov A, Mundl H, Welsh R, Bode C, Gibson CM. A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study. Am Heart J. 2016 Apr;174:120-8. doi: 10.1016/j.ahj.2016.01.004. Epub 2016 Jan 18.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction \\[STEMI\\] and non-ST-segment elevation acute coronary syndrome \\[NSTE-ACS\\]).', 'detailedDescription': "This is a prospective, randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel group (each group of participants will be treated at the same time), multicenter (when more than one hospital or medical school team work on a medical research study) study in participants with a recent ACS (STEMI or NSTE-ACS). All the eligible participants receiving background treatment of ASA plus clopidogrel (Stratum 1) or ASA plus ticagrelor (Stratum 2) will be randomly assigned to either receive ASA or rivaroxaban on background of P2Y12 receptor antagonists treatment. This study will include 3 phases: Screening Phase (up to 10 days, before study start on Day 1), Double-blind Treatment Phase (up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier), and Follow-up Phase (up to 30 days). Participants' safety will be monitored throughout the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants, 18 years or older, must have symptoms suggestive of acute coronary syndrome (ACS) (angina, or symptoms thought to be equivalent) within 48 hours of hospital presentation, or developed ACS while being hospitalized, and has a diagnosis of: a) ST segment elevation myocardial infarction (STEMI); b) non-ST-segment elevation acute coronary syndrome (NSTE-ACS). However, participant who is 54 years of age or younger must also have either diabetes mellitus or a history of a prior myocardial infarction (MI), in addition to the presenting ACS event\n* Participant must be randomized within the screening window of 10 days after hospital admission for the index ACS event. Participant should have received acute phase treatment for the index ACS, such as intravenous anticoagulant or antiplatelet, and are receiving maintenance dual antiplatelet therapy (DAPT) with either clopidogrel plus acetyl salicylic acid (ASA), or ticagrelor plus ASA, with the intent to continue the treatment with a platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor) after randomization\n* Participants must agree to provide a pharmacogenomics deoxyribonucleic acid (DNA) sample\n\nExclusion Criteria:\n\n* Participant has any conditions that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk\n* Participant with a prior stroke of any etiology or transient ischemic attack (TIA)\n* Participant who received thrombolytic therapy as treatment for the index ACS event cannot be enrolled in the ticagrelor stratum\n* Participant has anticipated need for chronic administration of omeprazole or esomeprazole concomitantly with clopidogrel\n* Participant has known allergy or intolerance to ASA or rivaroxaban'}, 'identificationModule': {'nctId': 'NCT02293395', 'acronym': 'GEMINI ACS 1', 'briefTitle': 'A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Randomized, Double-Blind, Double-Dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects With Acute Coronary Syndrome', 'orgStudyIdInfo': {'id': 'CR106261'}, 'secondaryIdInfos': [{'id': 'RIVAROXACS2002', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2014-004266-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stratum 1/ASA', 'description': 'Acetylsalicylic acid (ASA) 100 milligram (mg) enteric-coated tablet once daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.', 'interventionNames': ['Drug: Acetylsalicylic acid', 'Drug: Clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum 1/Rivaroxaban', 'description': 'Rivaroxaban 2.5 mg tablet twice daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.', 'interventionNames': ['Drug: Rivaroxaban', 'Drug: Clopidogrel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stratum 2/ASA', 'description': 'ASA 100 mg enteric-coated tablet once daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.', 'interventionNames': ['Drug: Acetylsalicylic acid', 'Drug: Ticagrelor']}, {'type': 'EXPERIMENTAL', 'label': 'Stratum 2/Rivaroxaban', 'description': 'Rivaroxaban 2.5 mg tablet twice daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.', 'interventionNames': ['Drug: Rivaroxaban', 'Drug: Ticagrelor']}], 'interventions': [{'name': 'Acetylsalicylic acid', 'type': 'DRUG', 'otherNames': ['Aspirin'], 'description': 'ASA 100 mg enteric-coated tablet once daily orally.', 'armGroupLabels': ['Stratum 1/ASA', 'Stratum 2/ASA']}, {'name': 'Rivaroxaban', 'type': 'DRUG', 'otherNames': ['JNJ-39039039', 'Bay 59-7939', 'Xarelto'], 'description': 'Rivaroxaban 2.5 mg tablet twice daily orally.', 'armGroupLabels': ['Stratum 1/Rivaroxaban', 'Stratum 2/Rivaroxaban']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'otherNames': ['Plavix'], 'description': 'Clopidogrel 75 mg once daily orally.', 'armGroupLabels': ['Stratum 1/ASA', 'Stratum 1/Rivaroxaban']}, {'name': 'Ticagrelor', 'type': 'DRUG', 'otherNames': ['Brilinta'], 'description': 'Ticagrelor 90 mg twice daily orally.', 'armGroupLabels': ['Stratum 2/ASA', 'Stratum 2/Rivaroxaban']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexander City', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 32.94401, 'lon': -85.95385}}, {'city': 'Banning', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.92557, 'lon': -116.87641}}, {'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'city': 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