Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-28 @ 9:29 PM
Study NCT ID:
NCT00362232
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2006-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Hungary']}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D017984', 'term': 'Enoxaparin'}], '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': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)', 'description': 'Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.', 'otherNumAtRisk': 1526, 'otherNumAffected': 1167, 'seriousNumAtRisk': 1526, 'seriousNumAffected': 106}, {'id': 'EG001', 'title': 'Enoxaparin 30 mg Twice a Day (Bid)', 'description': 'Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.', 'otherNumAtRisk': 1508, 'otherNumAffected': 1152, 'seriousNumAtRisk': 1508, 'seriousNumAffected': 131}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 51}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Thrombocythaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 35}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 16}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 95}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 258}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 266}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hyperchlorhydria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 272}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 282}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 157}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 131}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 84}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 79}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 235}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 256}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 320}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 310}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 39}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 178}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 187}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 31}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Post procedural swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Procedural nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 22}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 172}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 186}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Wound secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 45}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 21}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 81}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Breath sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 52}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 33}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 28}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 53}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 67}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 39}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Joint warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 88}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 131}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 119}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 102}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 46}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 58}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 39}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 35}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 163}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 168}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 65}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 39}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 36}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 26}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 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'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Occult blood positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 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'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 1}], 'organSystem': 'Musculoskeletal 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 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failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1526, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1508, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 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'NUMBER', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism'}, {'type': 'SECONDARY', 'title': 'Incidence of Symptomatic VTE During Follow-up Per Protocol Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '864', 'groupId': 'OG000'}, {'value': '878', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)', 'description': 'Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.'}, {'id': 'OG001', 'title': 'Enoxaparin 30 mg Twice a Day (Bid)', 'description': 'Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.35', 'groupId': 'OG000'}, {'value': '0.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.71', 'estimateComment': 'Mantel-Haenszel weighted difference to Enoxaparin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 47 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations'}, {'type': 'SECONDARY', 'title': 'Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '965', 'groupId': 'OG000'}, {'value': '959', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)', 'description': 'Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.'}, {'id': 'OG001', 'title': 'Enoxaparin 30 mg Twice a Day (Bid)', 'description': 'Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'groupId': 'OG000'}, {'value': '0.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.56', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 47 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism'}, {'type': 'SECONDARY', 'title': 'The Composite Endpoint Comprising Major VTE and Treatment-emergent Major Bleeding Per Subjects Valid for Analysis of Net Clinical Benefit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1130', 'groupId': 'OG000'}, {'value': '1114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)', 'description': 'Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.'}, {'id': 'OG001', 'title': 'Enoxaparin 30 mg Twice a Day (Bid)', 'description': 'Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.04', 'groupId': 'OG000'}, {'value': '2.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-1.56', 'ciUpperLimit': '0.94', 'estimateComment': 'Exact methods for difference to Enoxaparin', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 47 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography, anesthesia and surgery reports, number of transfusions', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The net clinical benefit population comprised all subjects either valid for MITT analysis of major VTE or who showed treatment-emergent major bleeding.'}, {'type': 'SECONDARY', 'title': 'Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Protocol Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '864', 'groupId': 'OG000'}, {'value': '878', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)', 'description': 'Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.'}, {'id': 'OG001', 'title': 'Enoxaparin 30 mg Twice a Day (Bid)', 'description': 'Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.71', 'groupId': 'OG000'}, {'value': '9.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-2.47', 'ciLowerLimit': '-4.99', 'ciUpperLimit': '0.04', 'estimateComment': 'Mantel-Haenszel weighted difference to Enoxaparin', 'groupDescription': 'Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'weighted treatment differences', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-2.47', 'ciLowerLimit': '-4.49', 'ciUpperLimit': '0.04', 'groupDescription': 'Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'weighted treatment differences', 'testedNonInferiority': True, 'nonInferiorityComment': 'P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations'}, {'type': 'SECONDARY', 'title': 'Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Modified Intent to Treat Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '965', 'groupId': 'OG000'}, {'value': '959', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)', 'description': 'Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.'}, {'id': 'OG001', 'title': 'Enoxaparin 30 mg Twice a Day (Bid)', 'description': 'Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.84', 'groupId': 'OG000'}, {'value': '9.80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-2.97', 'ciLowerLimit': '-5.42', 'ciUpperLimit': '-0.53', 'estimateComment': 'Mantel-Haenszel weighted difference to Enoxaparin', 'groupDescription': 'Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'weighted treatment differences', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-2.97', 'ciLowerLimit': '-5.42', 'ciUpperLimit': '-0.53', 'groupDescription': 'Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'weighted treatment differences', 'testedNonInferiority': True, 'nonInferiorityComment': 'P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism'}, {'type': 'SECONDARY', 'title': 'Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Protocol of Major VTE Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1011', 'groupId': 'OG000'}, {'value': '1020', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)', 'description': 'Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.'}, {'id': 'OG001', 'title': 'Enoxaparin 30 mg Twice a Day (Bid)', 'description': 'Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000'}, {'value': '1.67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.270', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-1.57', 'ciUpperLimit': '0.44', 'estimateComment': 'Mantel-Haenszel weighted difference to Enoxaparin', 'groupDescription': 'Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'weighted treatment differences', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-0.57', 'ciLowerLimit': '-1.57', 'ciUpperLimit': '0.44', 'groupDescription': 'Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'weighted treatment differences', 'testedNonInferiority': True, 'nonInferiorityComment': 'P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations'}, {'type': 'SECONDARY', 'title': 'Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Modified Intent to Treat of Major VTE Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1122', 'groupId': 'OG000'}, {'value': '1112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)', 'description': 'Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.'}, {'id': 'OG001', 'title': 'Enoxaparin 30 mg Twice a Day (Bid)', 'description': 'Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.25', 'groupId': 'OG000'}, {'value': '2.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.074', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-0.98', 'ciLowerLimit': '-2.06', 'ciUpperLimit': '0.10', 'estimateComment': 'Mantel-Haenszel weighted difference to Enoxaparin', 'groupDescription': 'Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'weighted treatment differences', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-0.98', 'ciLowerLimit': '-2.06', 'ciUpperLimit': '0.10', 'groupDescription': 'Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence rate in the rivaroxaban group is larger by more than 1.5% (absolute) compared to the comparator group.', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'weighted treatment differences', 'testedNonInferiority': True, 'nonInferiorityComment': 'P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided) .'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism'}, {'type': 'SECONDARY', 'title': 'Treatment-emergent Major Bleedings Per Safety Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1526', 'groupId': 'OG000'}, {'value': '1508', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)', 'description': 'Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.'}, {'id': 'OG001', 'title': 'Enoxaparin 30 mg Twice a Day (Bid)', 'description': 'Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'groupId': 'OG000'}, {'value': '0.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.110', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.88', 'estimateComment': 'Mantel-Haenszel weighted difference to Enoxaparin', 'groupDescription': 'Null hypothesis: The incidence rate is equal in the rivaroxaban group and the comparator group. P-values were calculated based on the Mantel-Haenszel weighted estimator (two-sided)', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'weighted treatment differences', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'from start of double-blind study medication to last dose of double-blind study medication plus two days. The average duration of double-blind treatment was 12 days in each treatment group (safety population).', 'description': 'Blinded, adjudicated assessments of all available information (eg, anesthesia and surgery reports, laboratory results, number of transfusions, autopsy report)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population comprised those subjects who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)', 'description': 'Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.'}, {'id': 'FG001', 'title': 'Enoxaparin 30 mg Twice a Day (Bid)', 'description': 'Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.'}], 'periods': [{'title': 'Treatment (12 +/- 2 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1584'}, {'groupId': 'FG001', 'numSubjects': '1564'}]}, {'type': 'Received Treatment', 'achievements': [{'comment': 'Safety population', 'groupId': 'FG000', 'numSubjects': '1526'}, {'comment': 'Safety population', 'groupId': 'FG001', 'numSubjects': '1508'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1425'}, {'groupId': 'FG001', 'numSubjects': '1413'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '151'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'Noncompliance to Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Technical Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Clinical Endpoint Reached', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}, {'title': 'Follow-up (30 (+ 5) Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1471'}, {'groupId': 'FG001', 'numSubjects': '1455'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1433'}, {'groupId': 'FG001', 'numSubjects': '1416'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'The recruitment period was from 16 Jun 2006 to 31 Jan 2008.', 'preAssignmentDetails': '3418 subjects were screened; 270 subjects were screening failures and were not randomized; 3148 subjects were randomized; 114 subjects did not receive medication; 3034 subjects received medication and were included in the safety population'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1526', 'groupId': 'BG000'}, {'value': '1508', 'groupId': 'BG001'}, {'value': '3034', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)', 'description': 'Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.'}, {'id': 'BG001', 'title': 'Enoxaparin 30 mg Twice a Day (Bid)', 'description': 'Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.4', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '64.7', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '64.5', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1007', 'groupId': 'BG000'}, {'value': '967', 'groupId': 'BG001'}, {'value': '1974', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '519', 'groupId': 'BG000'}, {'value': '541', 'groupId': 'BG001'}, {'value': '1060', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '1008', 'groupId': 'BG000'}, {'value': '1032', 'groupId': 'BG001'}, {'value': '2040', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '289', 'groupId': 'BG000'}, {'value': '289', 'groupId': 'BG001'}, {'value': '578', 'groupId': 'BG002'}]}]}, {'title': 'American Indian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}]}, {'title': 'Uncodable', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': 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'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '347', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'One subject in each treatment group was missing baseline weight.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-28', 'studyFirstSubmitDate': '2006-08-08', 'resultsFirstSubmitDate': '2012-05-10', 'studyFirstSubmitQcDate': '2006-08-08', 'lastUpdatePostDateStruct': {'date': '2014-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-10', 'studyFirstPostDateStruct': {'date': '2006-08-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography'}, {'measure': 'Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population.', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography'}], 'secondaryOutcomes': [{'measure': 'Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography'}, {'measure': 'Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE.', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography'}, {'measure': 'Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population.', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography'}, {'measure': 'Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population.', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography'}, {'measure': 'Incidence of DVT (Proximal, Distal) Per Protocol Population.', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography'}, {'measure': 'Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population.', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography'}, {'measure': 'Incidence of Symptomatic VTE During Follow-up Per Protocol Population.', 'timeFrame': 'Up to 47 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography'}, {'measure': 'Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population.', 'timeFrame': 'Up to 47 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography'}, {'measure': 'The Composite Endpoint Comprising Major VTE and Treatment-emergent Major Bleeding Per Subjects Valid for Analysis of Net Clinical Benefit', 'timeFrame': 'Up to 47 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography, anesthesia and surgery reports, number of transfusions'}, {'measure': 'Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Protocol Population.', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography'}, {'measure': 'Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Modified Intent to Treat Population.', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography'}, {'measure': 'Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Protocol of Major VTE Population.', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography'}, {'measure': 'Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Modified Intent to Treat of Major VTE Population.', 'timeFrame': 'Up to 16 days after surgery', 'description': 'Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography'}, {'measure': 'Treatment-emergent Major Bleedings Per Safety Population.', 'timeFrame': 'from start of double-blind study medication to last dose of double-blind study medication plus two days. The average duration of double-blind treatment was 12 days in each treatment group (safety population).', 'description': 'Blinded, adjudicated assessments of all available information (eg, anesthesia and surgery reports, laboratory results, number of transfusions, autopsy report)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prevention of venous thromboembolism'], 'conditions': ['Venous Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '19411100', 'type': 'RESULT', 'citation': 'Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009 May 16;373(9676):1673-80. doi: 10.1016/S0140-6736(09)60734-0. Epub 2009 May 4.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu', 'label': 'Click here and search for information of Bayer products for Europe'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients aged 18 years or above\n* Patients scheduled for elective total knee replacement\n\nExclusion Criteria:\n\n* Active bleeding or high risk of bleeding contraindicating treatment with Low Molecular Weight Heparin (LMWH)\n* Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)\n* Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)'}, 'identificationModule': {'nctId': 'NCT00362232', 'acronym': 'RECORD 4', 'briefTitle': 'Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'RECORD 4 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled, Double-blind, Randomized Study of BAY59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement', 'orgStudyIdInfo': {'id': '11355'}, 'secondaryIdInfos': [{'id': '2006-002402-60', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rivaroxaban 10 mg Once Daily (OD) ((Xarelto, BAY59-7939))', 'description': 'Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.', 'interventionNames': ['Drug: Rivaroxaban (Xarelto, BAY59-7939)', 'Drug: Placebo: syringes of Enoxaparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enoxaparin 30 mg twice a day (bid)', 'description': 'Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.', 'interventionNames': ['Drug: Enoxaparin', 'Drug: Placebo: tablet of Rivaroxaban']}], 'interventions': [{'name': 'Rivaroxaban (Xarelto, BAY59-7939)', 'type': 'DRUG', 'description': 'Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening.', 'armGroupLabels': ['Rivaroxaban 10 mg Once Daily (OD) ((Xarelto, BAY59-7939))']}, {'name': 'Enoxaparin', 'type': 'DRUG', 'description': 'Syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.', 'armGroupLabels': ['Enoxaparin 30 mg twice a day (bid)']}, {'name': 'Placebo: tablet of Rivaroxaban', 'type': 'DRUG', 'description': 'Placebo tablet of rivaroxaban 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