Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT01181102
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2010-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552171', 'term': 'edoxaban'}, {'id': 'C000711671', 'term': 'enoxaparin sodium'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ibusuki.kei.tx@daiichisankyo.co.jp', 'phone': '81-90-2732-9505', 'title': 'Kei Ibusuki, Associate Director', 'organization': 'Daiichi Sankyo.,LTD'}, 'certainAgreement': {'otherDetails': 'PI shall not publish the results of the Study at any time without the prior written approval of Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The Safety Analysis Set was defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'DU-176b', 'description': 'DU-176b oral tablets, 30 mg., taken once daily for 2 weeks\n\nedoxaban', 'otherNumAtRisk': 354, 'otherNumAffected': 237, 'seriousNumAtRisk': 354, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Enoxaparin Sodium', 'description': 'enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks\n\nenoxaparin sodium', 'otherNumAtRisk': 349, 'otherNumAffected': 256, 'seriousNumAtRisk': 349, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'wound haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Haemorrhage subcutaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 30, 'numAffected': 28}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 94, 'numAffected': 94}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 87, 'numAffected': 87}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 65, 'numAffected': 64}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 35, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 32, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 35, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 32, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 35, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 32, 'numAffected': 31}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}], 'seriousEvents': [{'term': 'postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'stitch abcess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'retinal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'pyoderma gangrenosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'joint contracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 354, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 349, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA JV12.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Subjects With Venous Thromboembolism Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b', 'description': 'DU-176b oral tablets, 30 mg., taken once daily for 2 weeks\n\nedoxaban'}, {'id': 'OG001', 'title': 'Enoxaparin Sodium', 'description': 'enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks\n\nenoxaparin sodium'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '10.3'}, {'value': '13.9', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '17.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.5', 'ciLowerLimit': '-11.5', 'ciUpperLimit': '-1.6', 'pValueComment': 'non-inferiority:P \\< 0.001 superiority:P = 0.010', 'groupDescription': 'The incidence proportion of thromboembolic events in the DU-176b group (P˅DU) = The incidence proportion of thromboembolic events in the enoxaparin group (P˅E) + Δ (5%). Alternative hypothesis H˅11: P˅DU \\< P˅E + Δ (level of significance, 0.025; one-sided). If the null hypothesis H˅01 was rejected, the following analysis had to be sequentially performed using the χ2 test statistic. Null hypothesis H˅02: P˅DU = P˅E Alternative hypothesis H˅12: P˅DU ≠ P˅E (level of significance, 0.05; two-sided).', 'statisticalMethod': 'non-inferiority:Z test. superiority:χ2 t', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': '(non-inferiority) When analyzed using the Z test at a one-sided 0.025 significance level, with the addition of a non-inferiority margin of 5% to the incidence in the enoxaparin group.\n\n(superiority) The incidence of thromboembolic events for the FAS was compared using the χ2 test (two-sided significance level: 0.05)'}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.\n\n* Lower extremity Deep Vein Thrombosis (DVT) confirmed by unilateral venography at the end of study treatment\n* Definite diagnosis of symptomatic Pulmonary Embolism (PE)\n* Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of venous Thromboembolism (VTE)', 'unitOfMeasure': 'percent of participants with VTE events', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Analysis population. 22 (7.4%) - DU-176b 41 (13.9%) - enoxaparin'}, {'type': 'SECONDARY', 'title': 'Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b', 'description': 'DU-176b oral tablets, 30 mg., taken once daily for 2 weeks\n\nedoxaban'}, {'id': 'OG001', 'title': 'Enoxaparin Sodium', 'description': 'enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks\n\nenoxaparin sodium'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '9.2'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '6.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'χ2 test', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '5.9', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'unitOfMeasure': 'percentage of subjects with bleeds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set was defined as all subjects who were enrolled in the study, but excluded those who had significant GCP violations, who did not receive any doses of the study drug, or who had no safety data after the start of study treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DU-176b', 'description': 'DU-176b oral tablets, 30 mg., taken once daily for 2 weeks\n\nedoxaban'}, {'id': 'FG001', 'title': 'Enoxaparin Sodium', 'description': 'enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks\n\nenoxaparin sodium'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '360'}, {'groupId': 'FG001', 'numSubjects': '356'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '354'}, {'groupId': 'FG001', 'numSubjects': '349'}]}, {'type': 'Efficacy Analysis Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '295'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '309'}, {'groupId': 'FG001', 'numSubjects': '310'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '46'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}, {'value': '295', 'groupId': 'BG001'}, {'value': '594', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DU-176b', 'description': 'DU-176b oral tablets, 30 mg., taken once daily for 2 weeks\n\nedoxaban'}, {'id': 'BG001', 'title': 'Enoxaparin Sodium', 'description': 'enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks\n\nenoxaparin sodium'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.6', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '72.1', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '72.4', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '245', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '474', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '299', 'groupId': 'BG000'}, {'value': '295', 'groupId': 'BG001'}, {'value': '594', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '273', 'groupId': 'BG000'}, {'value': '270', 'groupId': 'BG001'}, {'value': '543', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Number of baseline participants reflects the efficacy analysis population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 716}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-08', 'studyFirstSubmitDate': '2010-08-12', 'resultsFirstSubmitDate': '2015-01-15', 'studyFirstSubmitQcDate': '2010-08-12', 'lastUpdatePostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-02-03', 'studyFirstPostDateStruct': {'date': '2010-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Subjects With Venous Thromboembolism Events.', 'timeFrame': '2 weeks', 'description': 'The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment.\n\n* Lower extremity Deep Vein Thrombosis (DVT) confirmed by unilateral venography at the end of study treatment\n* Definite diagnosis of symptomatic Pulmonary Embolism (PE)\n* Symptomatic DVT confirmed before the venography at the end of study treatment The objectives were to verify the non-inferiority of edoxaban to enoxaparin with regard to prevention of venous Thromboembolism (VTE)'}], 'secondaryOutcomes': [{'measure': 'Incidence of Major Bleeding or Clinically Relevant Non-major Bleeding.', 'timeFrame': '2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['anticoagulant', 'venus thromboembolism', 'thrombosis', 'thromboembolism', 'embolism and thrombosis', 'deep vein thrombosis', 'DU-176b', 'Edoxaban', 'factor Xa', 'total knee arthroplasty', 'Enoxaparin sodium'], 'conditions': ['Venous Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '27980462', 'type': 'DERIVED', 'citation': 'Kawai Y, Fuji T, Fujita S, Kimura T, Ibusuki K, Abe K, Tachibana S. Edoxaban versus enoxaparin for the prevention of venous thromboembolism after total knee or hip arthroplasty: pooled analysis of coagulation biomarkers and primary efficacy and safety endpoints from two phase 3 trials. Thromb J. 2016 Dec 1;14:48. doi: 10.1186/s12959-016-0121-1. eCollection 2016.'}, {'pmid': '27284271', 'type': 'DERIVED', 'citation': 'Fuji T, Fujita S, Kimura T, Ibusuki K, Abe K, Tachibana S, Nakamura M. Clinical benefit of graduated compression stockings for prevention of venous thromboembolism after total knee arthroplasty: post hoc analysis of a phase 3 clinical study of edoxaban. Thromb J. 2016 Jun 8;14:13. doi: 10.1186/s12959-016-0087-z. eCollection 2016.'}, {'pmid': '25294589', 'type': 'DERIVED', 'citation': 'Fuji T, Wang CJ, Fujita S, Kawai Y, Nakamura M, Kimura T, Ibusuki K, Ushida H, Abe K, Tachibana S. Safety and efficacy of edoxaban, an oral factor Xa inhibitor, versus enoxaparin for thromboprophylaxis after total knee arthroplasty: the STARS E-3 trial. Thromb Res. 2014 Dec;134(6):1198-204. doi: 10.1016/j.thromres.2014.09.011. Epub 2014 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing unilateral total knee arthroplasty\n\nExclusion Criteria:\n\n* Subjects with risks of hemorrhage\n* Subjects with thromboembolic risks\n* Subjects who weigh less than 40 kg\n* Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant.'}, 'identificationModule': {'nctId': 'NCT01181102', 'briefTitle': 'A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Double-Dummy Efficacy and Safety Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty (STARS E-3 Trial)', 'orgStudyIdInfo': {'id': 'DU176b-B-J302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DU-176b', 'description': 'DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery.', 'interventionNames': ['Drug: edoxaban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'enoxaparin sodium', 'description': 'enoxaparin sodium 20mg (=2000IU) 0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery.', 'interventionNames': ['Drug: enoxaparin sodium']}], 'interventions': [{'name': 'edoxaban', 'type': 'DRUG', 'armGroupLabels': ['DU-176b']}, {'name': 'enoxaparin sodium', 'type': 'DRUG', 'armGroupLabels': ['enoxaparin sodium']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Takeshi Fuji', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osaka Koseinenkin Hospital'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/ourmember/daiichi-sankyo/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/', 'accessCriteria': "Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}