Viewing Study NCT00107900

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Ignite Creation Date: 2025-12-26 @ 12:18 PM
Ignite Modification Date: 2026-02-03 @ 5:24 AM
Study NCT ID: NCT00107900
Status: COMPLETED
Last Update Posted: 2019-02-26
First Post: 2005-04-11
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552171', 'term': 'edoxaban'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vfernandez@dsi.com', 'phone': '732-590-5000', 'title': 'Victor Fernandez', 'organization': 'Daiichi Sankyo, Inc.'}, 'certainAgreement': {'otherDetails': "A study site may not publish results of a study until after a coordinated multicenter publication has been submitted for publication or until one year after the study has ended, whichever occurs first. The study site will have the opportunity to publish results of the study, provided Daiichi Sankyo has had the opportunity to review and comment on the study site's proposed publication prior to being submitted for publication with the advice of patent council and need for subject protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '15mg BID', 'description': '15mg edoxaban administered twice daily (BID)', 'otherNumAtRisk': 85, 'otherNumAffected': 24, 'seriousNumAtRisk': 85, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': '30mg QD', 'description': '30mg edoxaban administered once daily (QD)', 'otherNumAtRisk': 75, 'otherNumAffected': 19, 'seriousNumAtRisk': 75, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': '30mg BID', 'description': '30mg edoxaban administered twice daily (BID)', 'otherNumAtRisk': 129, 'otherNumAffected': 65, 'seriousNumAtRisk': 129, 'seriousNumAffected': 9}, {'id': 'EG003', 'title': '60mg QD', 'description': '60mg edoxaban administered once daily (QD)', 'otherNumAtRisk': 99, 'otherNumAffected': 56, 'seriousNumAtRisk': 99, 'seriousNumAffected': 10}, {'id': 'EG004', 'title': '60mg BID', 'description': '60mg edoxaban administered twice daily (BID)', 'otherNumAtRisk': 115, 'otherNumAffected': 66, 'seriousNumAtRisk': 115, 'seriousNumAffected': 10}, {'id': 'EG005', 'title': '120mg QD', 'description': '120mg edoxaban administered once daily (QD)', 'otherNumAtRisk': 103, 'otherNumAffected': 34, 'seriousNumAtRisk': 103, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 129, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 115, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 129, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 115, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 129, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 115, 'numAffected': 23}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 129, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 115, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 129, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 115, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 129, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 115, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 115, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'prothrombin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 115, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 115, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 115, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 129, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 115, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'anaemia post-operative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 75, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 99, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 115, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}], 'seriousEvents': [{'term': 'obstructive inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'dislocation of joint prosthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'blood alkaline phosphatase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'alanine aminotransferase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'blood bilirubin abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'aspartate amniotransferase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'hepatic enzyme increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'sciatic nerve palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'snake bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'contrast media reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'wound haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'postprocedural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'anemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'lymphadentis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'alanine aminotransferase increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'blood alkaline phosphatase increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 75, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 115, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevention of Venous Thromboembolism (VTE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '84', 'groupId': 'OG004'}, {'value': '80', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '15mg BID', 'description': '15mg edoxaban administered twice daily (BID)'}, {'id': 'OG001', 'title': '30mg QD', 'description': '30mg edoxaban administered once daily (QD)'}, {'id': 'OG002', 'title': '30mg BID', 'description': '30mg edoxaban administered twice daily (BID)'}, {'id': 'OG003', 'title': '60mg QD', 'description': '60mg edoxaban administered once daily (QD)'}, {'id': 'OG004', 'title': '60mg BID', 'description': '60mg edoxaban administered twice daily (BID)'}, {'id': 'OG005', 'title': '120mg QD', 'description': '120mg edoxaban administered once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '28.7'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '29.9'}, {'value': '10', 'groupId': 'OG002', 'lowerLimit': '5.7', 'upperLimit': '16.9'}, {'value': '13', 'groupId': 'OG003', 'lowerLimit': '10.9', 'upperLimit': '26.8'}, {'value': '16', 'groupId': 'OG004', 'lowerLimit': '12.3', 'upperLimit': '27.5'}, {'value': '17', 'groupId': 'OG005', 'lowerLimit': '14.0', 'upperLimit': '30.2'}]}]}], 'analyses': [{'pValue': '0.238', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], '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 (approximately 2 weeks post surgery).\n\nConfirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography', 'unitOfMeasure': 'percentage of patients with event', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'modified ITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for Prothrombin Time (PT) Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}, {'value': '95', 'groupId': 'OG004'}, {'value': '91', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '15mg BID', 'description': '15mg edoxaban administered twice daily (BID)'}, {'id': 'OG001', 'title': '30mg QD', 'description': '30mg edoxaban administered once daily (QD)'}, {'id': 'OG002', 'title': '30mg BID', 'description': '30mg edoxaban administered twice daily (BID)'}, {'id': 'OG003', 'title': '60mg QD', 'description': '60mg edoxaban administered once daily (QD)'}, {'id': 'OG004', 'title': '60mg BID', 'description': '60mg edoxaban administered twice daily (BID)'}, {'id': 'OG005', 'title': '120mg QD', 'description': '120mg edoxaban administered once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '-.2', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-.1', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '.7', 'spread': '1.3', 'groupId': 'OG002'}, {'value': '.8', 'spread': '2.0', 'groupId': 'OG003'}, {'value': '1.1', 'spread': '1.9', 'groupId': 'OG004'}, {'value': '1.8', 'spread': '4.3', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'end of treatment', 'description': 'Intent to Treat (ITT) population', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for International Normalized Ratio (INR) Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}, {'value': '95', 'groupId': 'OG004'}, {'value': '91', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '15mg BID', 'description': '15mg edoxaban administered twice daily (BID)'}, {'id': 'OG001', 'title': '30mg QD', 'description': '30mg edoxaban administered once daily (QD)'}, {'id': 'OG002', 'title': '30mg BID', 'description': '30mg edoxaban administered twice daily (BID)'}, {'id': 'OG003', 'title': '60mg QD', 'description': '60mg edoxaban administered once daily (QD)'}, {'id': 'OG004', 'title': '60mg BID', 'description': '60mg edoxaban administered twice daily (BID)'}, {'id': 'OG005', 'title': '120mg QD', 'description': '120mg edoxaban administered once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '.2', 'groupId': 'OG000'}, {'value': '0', 'spread': '.3', 'groupId': 'OG001'}, {'value': '.1', 'spread': '.1', 'groupId': 'OG002'}, {'value': '.1', 'spread': '.2', 'groupId': 'OG003'}, {'value': '.1', 'spread': '.2', 'groupId': 'OG004'}, {'value': '.2', 'spread': '.4', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'end of treatment', 'description': 'Intent to Treat (ITT) population', 'unitOfMeasure': 'INR ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG002'}, {'value': '84', 'groupId': 'OG003'}, {'value': '94', 'groupId': 'OG004'}, {'value': '91', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '15mg BID', 'description': '15mg edoxaban administered twice daily (BID)'}, {'id': 'OG001', 'title': '30mg QD', 'description': '30mg edoxaban administered once daily (QD)'}, {'id': 'OG002', 'title': '30mg BID', 'description': '30mg edoxaban administered twice daily (BID)'}, {'id': 'OG003', 'title': '60mg QD', 'description': '60mg edoxaban administered once daily (QD)'}, {'id': 'OG004', 'title': '60mg BID', 'description': '60mg edoxaban administered twice daily (BID)'}, {'id': 'OG005', 'title': '120mg QD', 'description': '120mg edoxaban administered once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.1', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '25.3', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '9.8', 'groupId': 'OG002'}, {'value': '4.1', 'spread': '17.0', 'groupId': 'OG003'}, {'value': '5.8', 'spread': '16.1', 'groupId': 'OG004'}, {'value': '11.3', 'spread': '23.1', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'end of treatment', 'description': 'Intent to Treat (ITT) population', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '15mg BID', 'description': '15mg edoxaban administered twice daily (BID)'}, {'id': 'FG001', 'title': '30mg QD', 'description': '30mg edoxaban administered once daily (QD)'}, {'id': 'FG002', 'title': '30mg BID', 'description': '30mg edoxaban administered twice daily (BID)'}, {'id': 'FG003', 'title': '60mg QD', 'description': '60mg edoxaban administered once daily (QD)'}, {'id': 'FG004', 'title': '60mg BID', 'description': '60mg edoxaban administered twice daily (BID)'}, {'id': 'FG005', 'title': '120mg QD', 'description': '120mg edoxaban administered once daily (QD)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '129'}, {'groupId': 'FG003', 'numSubjects': '99'}, {'groupId': 'FG004', 'numSubjects': '115'}, {'groupId': 'FG005', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '104'}, {'groupId': 'FG003', 'numSubjects': '87'}, {'groupId': 'FG004', 'numSubjects': '94'}, {'groupId': 'FG005', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Administrative Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}, {'value': '115', 'groupId': 'BG004'}, {'value': '103', 'groupId': 'BG005'}, {'value': '606', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': '15mg BID', 'description': '15mg edoxaban administered twice daily (BID)'}, {'id': 'BG001', 'title': '30mg QD', 'description': '30mg edoxaban administered once daily (QD)'}, {'id': 'BG002', 'title': '30mg BID', 'description': '30mg edoxaban administered twice daily (BID)'}, {'id': 'BG003', 'title': '60mg QD', 'description': '60mg edoxaban administered once daily (QD)'}, {'id': 'BG004', 'title': '60mg BID', 'description': '60mg edoxaban administered twice daily (BID)'}, {'id': 'BG005', 'title': '120mg QD', 'description': '120mg edoxaban administered once daily (QD)'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '10.71', 'groupId': 'BG000'}, {'value': '59.0', 'spread': '11.06', 'groupId': 'BG001'}, {'value': '60.1', 'spread': '13.09', 'groupId': 'BG002'}, {'value': '58.6', 'spread': '11.90', 'groupId': 'BG003'}, {'value': '58.8', 'spread': '12.80', 'groupId': 'BG004'}, {'value': '56.5', 'spread': '12.83', 'groupId': 'BG005'}, {'value': '58.5', 'spread': '12.25', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}, {'value': '72', 'groupId': 'BG005'}, {'value': '396', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '210', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}, {'value': '350', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}, {'value': '256', 'groupId': 'BG006'}]}]}], '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'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}, {'value': '108', 'groupId': 'BG004'}, {'value': '99', 'groupId': 'BG005'}, {'value': '578', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}, {'value': '194', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}, {'value': '76', 'groupId': 'BG005'}, {'value': '400', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}, {'value': '206', 'groupId': 'BG006'}]}]}, {'title': 'Europe', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}, {'value': '76', 'groupId': 'BG005'}, {'value': '400', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 606}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-08', 'studyFirstSubmitDate': '2005-04-11', 'resultsFirstSubmitDate': '2015-02-05', 'studyFirstSubmitQcDate': '2005-04-11', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-02-26', 'studyFirstPostDateStruct': {'date': '2005-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevention of Venous Thromboembolism (VTE)', '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 (approximately 2 weeks post surgery).\n\nConfirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline for Prothrombin Time (PT) Results', 'timeFrame': 'end of treatment', 'description': 'Intent to Treat (ITT) population'}, {'measure': 'Change From Baseline for International Normalized Ratio (INR) Results', 'timeFrame': 'end of treatment', 'description': 'Intent to Treat (ITT) population'}, {'measure': 'Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results', 'timeFrame': 'end of treatment', 'description': 'Intent to Treat (ITT) population'}]}, 'conditionsModule': {'keywords': ['Deep Vein Thrombosis,', 'Anticoagulant,', 'Venous thromboembolic'], 'conditions': ['Arthroplasty, Replacement, Hip', 'Thrombosis']}, 'descriptionModule': {'briefSummary': 'Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery.', 'detailedDescription': 'The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral hip replacement\n\nExclusion Criteria:\n\n* Patients scheduled for bilateral hip replacement in same procedure\n* Patients with increased risk of bleeding\n* Uncontrolled hypertension (BP greater than 180/100 mmHg)\n* Patients less than 111 lbs or more than 243 lbs\n* Patients on long-term anticoagulants\n* Patients with contraindications to venography\n* Patients with medical history of venous thromboembolism\n* Patients with impaired hepatic function\n* Known to be pregnant\n* Lactating women'}, 'identificationModule': {'nctId': 'NCT00107900', 'briefTitle': 'Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Phase IIa, Multi-center, Multi-national, Open Label, Dose Ranging Study of the Efficacy, Safety, and Tolerability of Oral DU-176b Administered Once or Twice Daily in the Treatment of Adult Patients Undergoing Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': 'DU176b-PRT007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '15mg BID', 'description': '15mg edoxaban administered twice daily (BID)', 'interventionNames': ['Drug: DU-176b']}, {'type': 'EXPERIMENTAL', 'label': '30mg QD', 'description': '30mg edoxaban administered once daily (QD)', 'interventionNames': ['Drug: DU-176b']}, {'type': 'EXPERIMENTAL', 'label': '30mg BID', 'description': '30mg edoxaban administered twice daily (BID)', 'interventionNames': ['Drug: DU-176b']}, {'type': 'EXPERIMENTAL', 'label': '60mg QD', 'description': '60mg edoxaban administered once daily (QD)', 'interventionNames': ['Drug: DU-176b']}, {'type': 'EXPERIMENTAL', 'label': '60mg BID', 'description': '60mg edoxaban administered twice daily (BID)', 'interventionNames': ['Drug: DU-176b']}, {'type': 'EXPERIMENTAL', 'label': '120mg QD', 'description': '120mg edoxaban administered once daily (QD)', 'interventionNames': ['Drug: DU-176b']}], 'interventions': [{'name': 'DU-176b', 'type': 'DRUG', 'armGroupLabels': ['120mg QD', '15mg BID', '30mg BID', '30mg QD', '60mg BID', '60mg QD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}]}, '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', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Anne MacDonald', 'oldOrganization': 'Daiichi Sankyo'}}}}