Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 8:54 AM
Study NCT ID:
NCT00504556
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2007-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation
Sponsor:
Organization:
Raw JSON
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Director', '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': 'DU-176b 30mg qd', 'description': 'DU-176b 30mg tablet once daily (qd)\n\nEdoxaban (DU-176b): 30mg tablet once daily', 'otherNumAtRisk': 235, 'otherNumAffected': 3, 'seriousNumAtRisk': 235, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'DU-176b 30mg Bid', 'description': 'DU-176b 30mg twice daily (bid)\n\nEdoxaban (DU-176b): 30mg tablet twice daily', 'otherNumAtRisk': 244, 'otherNumAffected': 8, 'seriousNumAtRisk': 244, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': 'DU-176b 60mg qd', 'description': 'DU-176b 60mg once daily 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'heamorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 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0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'diabetic vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 244, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 234, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 180, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Incidence of Major Adverse Cardiac Events MACE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}, {'value': '250', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 30mg qd', 'description': 'DU-176b 30mg 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{'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '0.9', 'upperLimit': '5.2'}]}]}, {'title': 'any stroke', 'categories': [{'measurements': [{'value': '.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.3'}, {'value': '.8', 'groupId': 'OG001', 'lowerLimit': '.1', 'upperLimit': '2.9'}, {'value': '.4', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2.4'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '4.0'}, {'value': '1.6', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '4.0'}]}]}, {'title': 'SEE', 'categories': [{'measurements': [{'value': '.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.3'}, {'value': '.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1.6'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '2.0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '1.5'}]}]}, {'title': 'any stroke and/or SEE', 'categories': [{'measurements': [{'value': '.4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.3'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '.3', 'upperLimit': '3.6'}, {'value': '.4', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2.4'}, {'value': '1.1', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '4.0'}, {'value': '1.6', 'groupId': 'OG004', 'lowerLimit': '.4', 'upperLimit': '4.0'}]}]}, {'title': 'MI', 'categories': [{'measurements': [{'value': '.9', 'groupId': 'OG000', 'lowerLimit': '.1', 'upperLimit': '3.0'}, {'value': '.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2.3'}, {'value': '.9', 'groupId': 'OG002', 'lowerLimit': '.1', 'upperLimit': '3.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '2.0'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '1.5'}]}]}, {'title': 'CV death', 'categories': [{'measurements': [{'value': '.9', 'groupId': 'OG000', 'lowerLimit': '.1', 'upperLimit': '3.0'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '.4', 'upperLimit': '4.1'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1.6'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '2.0'}, {'value': '.8', 'groupId': 'OG004', 'lowerLimit': '.1', 'upperLimit': '2.9'}]}]}, {'title': 'hospitalization for any cardiac condition', 'categories': [{'measurements': [{'value': '.9', 'groupId': 'OG000', 'lowerLimit': '.1', 'upperLimit': '3.0'}, {'value': '.8', 'groupId': 'OG001', 'lowerLimit': '.1', 'upperLimit': '2.9'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '6.1'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '2.0'}, {'value': '.4', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '2.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'MACE is defined as the composite of stroke \\[ischemic or hemorrhagic\\], Systemic embolic event (SEE), Myocardial 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60mg tablet once daily'}, {'id': 'OG003', 'title': 'DU-176b 60mg Bid', 'description': 'DU-176b 60mg tablet two times a day\n\nEdoxaban (DU-176b): 60mg tablet two times a day'}, {'id': 'OG004', 'title': 'Warfarin Tablets', 'description': 'warfarin tablets\n\nwarfarin: warfarin tablets'}], 'classes': [{'title': 'All bleeding', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '9.3'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '17.5'}, {'value': '7.3', 'groupId': 'OG002', 'lowerLimit': '4.3', 'upperLimit': '11.4'}, {'value': '18.3', 'groupId': 'OG003', 'lowerLimit': '13.0', 'upperLimit': '24.8'}, {'value': '8.0', 'groupId': 'OG004', 'lowerLimit': '5.0', 'upperLimit': '12.1'}]}]}, {'title': 'Major or clinically relevant non-major bleed', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '6.0'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '4.8', 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'TWO_SIDED', 'groupDescription': 'All bleeds', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.864', 'groupIds': ['OG002', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'All bleeds', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '.002', 'groupIds': ['OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'All bleeds', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Major or Clinically Relevant (CR) non-major bleeding', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.029', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Major or Clinically Relevant (CR) non-major bleeding', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.807', 'groupIds': ['OG002', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Major or Clinically Relevant (CR) non-major bleeding', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.002', 'groupIds': ['OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Major or Clinically Relevant (CR) non-major bleeding', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Major bleeds', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.119', 'groupIds': ['OG001', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Major bleeds', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '1.000', 'groupIds': ['OG002', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Major bleeds', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.023', 'groupIds': ['OG003', 'OG004'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Major bleeds', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Adjudicated Incidence of Bleeding Events during treatment period', 'unitOfMeasure': 'percent of subjects with outcome event', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'safety analysis set'}, {'type': 'SECONDARY', 'title': 'Effects on Biomarker D-dimer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}, {'value': '215', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}, {'value': '230', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 30mg qd', 'description': 'DU-176b 30mg tablet once 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'description': 'Mean (SD) change from baseline in D-dimer', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effects on Biomarker Prothrombin Fragments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '209', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '209', 'groupId': 'OG002'}, {'value': '151', 'groupId': 'OG003'}, {'value': '223', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 30mg qd', 'description': 'DU-176b 30mg tablet once daily (qd)\n\nEdoxaban (DU-176b): 30mg tablet once daily'}, {'id': 'OG001', 'title': 'DU-176b 30mg Bid', 'description': 'DU-176b 30mg twice daily (bid)\n\nEdoxaban (DU-176b): 30mg tablet twice daily'}, {'id': 'OG002', 'title': 'DU-176b 60mg qd', 'description': 'DU-176b 60mg once daily (qd)\n\nEdoxaban (DU-176b): 60mg tablet once daily'}, {'id': 'OG003', 'title': 'DU-176b 60mg Bid', 'description': 'DU-176b 60mg tablet two times 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'234', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 30mg qd', 'description': 'DU-176b 30mg tablet once daily (qd)\n\nEdoxaban (DU-176b): 30mg tablet once daily'}, {'id': 'OG001', 'title': 'DU-176b 30mg Bid', 'description': 'DU-176b 30mg twice daily (bid)\n\nEdoxaban (DU-176b): 30mg tablet twice daily'}, {'id': 'OG002', 'title': 'DU-176b 60mg qd', 'description': 'DU-176b 60mg once daily (qd)\n\nEdoxaban (DU-176b): 60mg tablet once daily'}, {'id': 'OG003', 'title': 'DU-176b 60mg Bid', 'description': 'DU-176b 60mg tablet two times a day\n\nEdoxaban (DU-176b): 60mg tablet two times a day'}], 'classes': [{'title': 'Cmin,ss (ng/mL)', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '33.8'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '53.1'}, {'value': '39.6', 'groupId': 'OG002', 'lowerLimit': '15.4', 'upperLimit': '71.6'}, {'value': '75.7', 'groupId': 'OG003', 'lowerLimit': '40.7', 'upperLimit': '144.8'}]}]}, {'title': 'Cmax,ss (ng/mL)', 'categories': [{'measurements': [{'value': '84.9', 'groupId': 'OG000', 'lowerLimit': '48.9', 'upperLimit': '178.8'}, {'value': '173.0', 'groupId': 'OG001', 'lowerLimit': '106.7', 'upperLimit': '338.5'}, {'value': '115.0', 'groupId': 'OG002', 'lowerLimit': '72.9', 'upperLimit': '240.0'}, {'value': '221.4', 'groupId': 'OG003', 'lowerLimit': '162.9', 'upperLimit': '400.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'Median (min, max) values of Cmin,ss; Cmax,ss', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}, {'value': '250', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 30mg qd', 'description': 'DU-176b 30mg tablet once daily (qd)\n\nEdoxaban (DU-176b): 30mg tablet once daily'}, {'id': 'OG001', 'title': 'DU-176b 30mg Bid', 'description': 'DU-176b 30mg twice daily (bid)\n\nEdoxaban (DU-176b): 30mg tablet twice daily'}, {'id': 'OG002', 'title': 'DU-176b 60mg qd', 'description': 'DU-176b 60mg once daily (qd)\n\nEdoxaban (DU-176b): 60mg tablet once daily'}, {'id': 'OG003', 'title': 'DU-176b 60mg Bid', 'description': 'DU-176b 60mg tablet two times a day\n\nEdoxaban (DU-176b): 60mg tablet two times a day'}, {'id': 'OG004', 'title': 'Warfarin Tablets', 'description': 'warfarin tablets\n\nwarfarin: warfarin tablets'}], 'classes': [{'title': 'ALT, total >= 3x ULN', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '3.8'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '.01', 'upperLimit': '3.0'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '5.6'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '5.0'}, {'value': '1.2', 'groupId': 'OG004', 'lowerLimit': '0.3', 'upperLimit': '3.5'}]}]}, {'title': 'AST, total >= 3x ULN', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '3.1'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.0'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '3.8'}, {'value': '1.2', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '4.1'}, {'value': '0.8', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '2.9'}]}]}, {'title': 'total bilirubin, total >= 2x ULN', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '3.1'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '3.7'}, {'value': '0.4', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '2.4'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '6.7'}, {'value': '1.6', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '4.1'}]}]}, {'title': 'ALT or AST >=3 x ULN', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '3.8'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.0'}, {'value': '3.1', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '6.2'}, {'value': '1.7', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '5.0'}, {'value': '1.6', 'groupId': 'OG004', 'lowerLimit': '0.4', 'upperLimit': '4.1'}]}]}, {'title': 'ALT or AST >=3 x ULN and TBL >=2 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.6'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2.3'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1.6'}, {'value': '0.6', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '3.2'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '1.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'liver enzyme (ALT and/or AST) and/or bilirubin (TBL) abnormalities', 'unitOfMeasure': 'percent subjects with liver related MA', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'safety analysis set'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 30mg qd', 'description': 'DU-176b 30mg tablet once daily (qd)\n\nEdoxaban (DU-176b): 30mg tablet once daily'}, {'id': 'OG001', 'title': 'DU-176b 30mg Bid', 'description': 'DU-176b 30mg twice daily (bid)\n\nEdoxaban (DU-176b): 30mg tablet twice daily'}, {'id': 'OG002', 'title': 'DU-176b 60mg qd', 'description': 'DU-176b 60mg once daily (qd)\n\nEdoxaban (DU-176b): 60mg tablet once daily'}, {'id': 'OG003', 'title': 'DU-176b 60mg Bid', 'description': 'DU-176b 60mg tablet two times a day\n\nEdoxaban (DU-176b): 60mg tablet two times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '825', 'groupId': 'OG000', 'lowerLimit': '600', 'upperLimit': '1862'}, {'value': '1729', 'groupId': 'OG001', 'lowerLimit': '1176', 'upperLimit': '3103'}, {'value': '1728', 'groupId': 'OG002', 'lowerLimit': '1096', 'upperLimit': '3125'}, {'value': '3301', 'groupId': 'OG003', 'lowerLimit': '2485', 'upperLimit': '5859'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'Median (min, max) values of AUCss', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '184', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 30mg qd', 'description': 'DU-176b 30mg tablet once daily (qd)\n\nEdoxaban (DU-176b): 30mg tablet once daily'}, {'id': 'OG001', 'title': 'DU-176b 30mg Bid', 'description': 'DU-176b 30mg twice daily (bid)\n\nEdoxaban (DU-176b): 30mg tablet twice daily'}, {'id': 'OG002', 'title': 'DU-176b 60mg qd', 'description': 'DU-176b 60mg once daily (qd)\n\nEdoxaban (DU-176b): 60mg tablet once daily'}, {'id': 'OG003', 'title': 'DU-176b 60mg Bid', 'description': 'DU-176b 60mg tablet two times a day\n\nEdoxaban (DU-176b): 60mg tablet two times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '1.46', 'spread': '.96', 'groupId': 'OG000'}, {'value': '1.91', 'spread': '.97', 'groupId': 'OG001'}, {'value': '2.42', 'spread': '1.63', 'groupId': 'OG002'}, {'value': '3.28', 'spread': '1.46', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Mean (SD) change from baseline in biomarker anti-Factor Xa \\[FXa\\] activity on Day 28, 1-3 hours post dose.', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}, {'value': '190', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 30mg qd', 'description': 'DU-176b 30mg tablet once daily (qd)\n\nEdoxaban (DU-176b): 30mg tablet once daily'}, {'id': 'OG001', 'title': 'DU-176b 30mg Bid', 'description': 'DU-176b 30mg twice daily (bid)\n\nEdoxaban (DU-176b): 30mg tablet twice daily'}, {'id': 'OG002', 'title': 'DU-176b 60mg qd', 'description': 'DU-176b 60mg once daily (qd)\n\nEdoxaban (DU-176b): 60mg tablet once daily'}, {'id': 'OG003', 'title': 'DU-176b 60mg Bid', 'description': 'DU-176b 60mg tablet two times a day\n\nEdoxaban (DU-176b): 60mg tablet two times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '-40.3', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '-40.2', 'spread': '25.5', 'groupId': 'OG001'}, {'value': '-44.4', 'spread': '25.7', 'groupId': 'OG002'}, {'value': '-45.2', 'spread': '26.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Mean (SD) change from baseline in biomarker endogenous FX activity on Day 28, 1-3 hours post dose.', 'unitOfMeasure': 'percent change of Endogenous FX activity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 30mg qd', 'description': 'DU-176b 30mg tablet once daily (qd)\n\nEdoxaban (DU-176b): 30mg tablet once daily'}, {'id': 'OG001', 'title': 'DU-176b 30mg Bid', 'description': 'DU-176b 30mg twice daily (bid)\n\nEdoxaban (DU-176b): 30mg tablet twice daily'}, {'id': 'OG002', 'title': 'DU-176b 60mg qd', 'description': 'DU-176b 60mg once daily (qd)\n\nEdoxaban (DU-176b): 60mg tablet once daily'}, {'id': 'OG003', 'title': 'DU-176b 60mg Bid', 'description': 'DU-176b 60mg tablet two times a day\n\nEdoxaban (DU-176b): 60mg tablet two times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '14.0', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '18.3', 'spread': '11.9', 'groupId': 'OG002'}, {'value': '19.6', 'spread': '6.4', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Mean (SD) change from baseline in biomarker prothrombinase induced clotting time \\[PICT\\] on Day 28, 1-3 hours post dose.\n\nPICT was determined by PICT aasay which is a plasma based functional assay to determine the anticoagulant activity on FXa and FIIa inhibition.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 30mg qd', 'description': 'DU-176b 30mg tablet once daily (qd)\n\nEdoxaban (DU-176b): 30mg tablet once daily'}, {'id': 'OG001', 'title': 'DU-176b 30mg Bid', 'description': 'DU-176b 30mg twice daily (bid)\n\nEdoxaban (DU-176b): 30mg tablet twice daily'}, {'id': 'OG002', 'title': 'DU-176b 60mg qd', 'description': 'DU-176b 60mg once daily (qd)\n\nEdoxaban (DU-176b): 60mg tablet once daily'}, {'id': 'OG003', 'title': 'DU-176b 60mg Bid', 'description': 'DU-176b 60mg tablet two times a day\n\nEdoxaban (DU-176b): 60mg tablet two times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '6.6', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '6.6', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '11.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Mean (SD) change from baseline in biomarker prothrombin time (PT) on Day 28, 1-3 hours post dose.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '165', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'DU-176b 30mg qd', 'description': 'DU-176b 30mg tablet once daily (qd)\n\nEdoxaban (DU-176b): 30mg tablet once daily'}, {'id': 'OG001', 'title': 'DU-176b 30mg Bid', 'description': 'DU-176b 30mg twice daily (bid)\n\nEdoxaban (DU-176b): 30mg tablet twice daily'}, {'id': 'OG002', 'title': 'DU-176b 60mg qd', 'description': 'DU-176b 60mg once daily (qd)\n\nEdoxaban (DU-176b): 60mg tablet once daily'}, {'id': 'OG003', 'title': 'DU-176b 60mg Bid', 'description': 'DU-176b 60mg tablet two times a day\n\nEdoxaban (DU-176b): 60mg tablet two times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '.51', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '.62', 'groupId': 'OG001'}, {'value': '0.17', 'spread': '.61', 'groupId': 'OG002'}, {'value': '0.26', 'spread': '.61', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 28', 'description': 'Mean (SD) change from baseline in biomarker International Normalized Ratio (INR) on Day 28, 1-3 hours post dose.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DU-176b 30mg qd', 'description': 'DU-176b 30mg tablet once daily (qd)\n\nEdoxaban (DU-176b): 30mg tablet once daily'}, {'id': 'FG001', 'title': 'DU-176b 30mg Bid', 'description': 'DU-176b 30mg twice daily (bid)\n\nEdoxaban (DU-176b): 30mg tablet twice daily'}, {'id': 'FG002', 'title': 'DU-176b 60mg qd', 'description': 'DU-176b 60mg once daily (qd)\n\nEdoxaban (DU-176b): 60mg tablet once daily'}, {'id': 'FG003', 'title': 'DU-176b 60mg Bid', 'description': 'DU-176b 60mg tablets two times a day\n\nEdoxaban (DU-176b): 60mg tablet two times a day'}, {'id': 'FG004', 'title': 'Warfarin Tablets', 'description': 'warfarin tablets\n\nwarfarin: warfarin tablets'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '245'}, {'groupId': 'FG002', 'numSubjects': '235'}, {'groupId': 'FG003', 'numSubjects': '180'}, {'groupId': 'FG004', 'numSubjects': '251'}]}, {'type': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '244'}, {'groupId': 'FG002', 'numSubjects': '234'}, {'groupId': 'FG003', 'numSubjects': '180'}, {'groupId': 'FG004', 'numSubjects': '250'}]}, {'type': 'Per Protocol Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '243'}, {'groupId': 'FG002', 'numSubjects': '234'}, {'groupId': 'FG003', 'numSubjects': '180'}, {'groupId': 'FG004', 'numSubjects': '250'}]}, {'type': 'Pharmacodynamic Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '236'}, {'groupId': 'FG002', 'numSubjects': '228'}, {'groupId': 'FG003', 'numSubjects': '170'}, {'groupId': 'FG004', 'numSubjects': '244'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '207'}, {'groupId': 'FG002', 'numSubjects': '204'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '226'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '128'}, {'groupId': 'FG004', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '12'}]}, {'type': 'administrative reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'did not meet entry criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'data monitor committee decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '100'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'not in safety analysis set', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '180', 'groupId': 'BG003'}, {'value': '250', 'groupId': 'BG004'}, {'value': '1143', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'DU-176b 30mg qd', 'description': 'DU-176b 30mg tablet once daily (qd)\n\nEdoxaban (DU-176b): 30mg tablet once daily'}, {'id': 'BG001', 'title': 'DU-176b 30mg Bid', 'description': 'DU-176b 30mg twice daily (bid)\n\nEdoxaban (DU-176b): 30mg tablet twice daily'}, {'id': 'BG002', 'title': 'DU-176b 60mg qd', 'description': 'DU-176b 60mg once daily (qd)\n\nEdoxaban (DU-176b): 60mg tablet once daily'}, {'id': 'BG003', 'title': 'DU-176b 60mg Bid', 'description': 'DU-176b 60mg tablet two times a day\n\nEdoxaban (DU-176b): 60mg tablet two times a day'}, {'id': 'BG004', 'title': 'Warfarin Tablets', 'description': 'warfarin tablets\n\nwarfarin: warfarin tablets'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '119', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}, {'value': '97', 'groupId': 'BG004'}, {'value': '513', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}, {'value': '153', 'groupId': 'BG004'}, {'value': '630', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.2', 'spread': '8.34', 'groupId': 'BG000'}, {'value': '64.8', 'spread': '8.83', 'groupId': 'BG001'}, {'value': '64.9', 'spread': '8.81', 'groupId': 'BG002'}, {'value': '64.7', 'spread': '8.96', 'groupId': 'BG003'}, {'value': '66.0', 'spread': '8.49', 'groupId': 'BG004'}, {'value': '64.9', 'spread': '8.71', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '99', 'groupId': 'BG004'}, {'value': '433', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}, {'value': '151', 'groupId': 'BG004'}, {'value': '710', 'groupId': 'BG005'}]}]}], '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': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}, {'value': '176', 'groupId': 'BG003'}, {'value': '243', 'groupId': 'BG004'}, {'value': '1116', 'groupId': 'BG005'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belarus', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '64', 'groupId': 'BG005'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}, {'value': '391', 'groupId': 'BG005'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '97', 'groupId': 'BG004'}, {'value': '432', 'groupId': 'BG005'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}]}]}, {'title': 'Latvia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}]}]}, {'title': 'Moldova, Republic of', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '57', 'groupId': 'BG005'}]}]}, {'title': 'Bosnia and Herzegovina', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '55', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'dispFirstSubmitDate': '2010-08-25', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-08', 'studyFirstSubmitDate': '2007-07-18', 'dispFirstSubmitQcDate': '2010-08-25', 'resultsFirstSubmitDate': '2015-02-05', 'studyFirstSubmitQcDate': '2007-07-18', 'dispFirstPostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-03-12', 'studyFirstPostDateStruct': {'date': '2007-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjudicated Incidence of Bleeding Events', 'timeFrame': '3 months', 'description': 'Adjudicated Incidence of Bleeding Events during treatment period'}, {'measure': 'Percent of Subjects With Liver-related Laboratory Marked Abnormalities (MA)', 'timeFrame': '3 months', 'description': 'liver enzyme (ALT and/or AST) and/or bilirubin (TBL) abnormalities'}], 'secondaryOutcomes': [{'measure': 'Incidence of Major Adverse Cardiac Events MACE)', 'timeFrame': '3 months', 'description': 'MACE is defined as the composite of stroke \\[ischemic or hemorrhagic\\], Systemic embolic event (SEE), Myocardial Infarction (MI), Cardiovascular (CV) death, and hospitalization for any cardiac condition'}, {'measure': 'Effects on Biomarker D-dimer', 'timeFrame': '3 months', 'description': 'Mean (SD) change from baseline in D-dimer'}, {'measure': 'Effects on Biomarker Prothrombin Fragments', 'timeFrame': '3 months', 'description': 'Mean (SD) change from baseline in Prothrombin Fragments 1 and 2 (F1 and F2)'}, {'measure': 'Pharmacokinetics (Cmin, Cmax) of DU-176b in Subjects Receiving DU-176b', 'timeFrame': '3 months', 'description': 'Median (min, max) values of Cmin,ss; Cmax,ss'}, {'measure': 'Pharmacokinetics (AUC) of DU-176b in Subjects Receiving DU-176b', 'timeFrame': '3 months', 'description': 'Median (min, max) values of AUCss'}, {'measure': 'Effects on Pharmacodynamic Biomarker Anti-Factor Xa Activity in Subjects Receiving DU-176b', 'timeFrame': 'Day 28', 'description': 'Mean (SD) change from baseline in biomarker anti-Factor Xa \\[FXa\\] activity on Day 28, 1-3 hours post dose.'}, {'measure': 'Effects on Pharmacodynamic Biomarker (Endogenous FX Activity) in Subjects Receiving DU-176b', 'timeFrame': 'Day 28', 'description': 'Mean (SD) change from baseline in biomarker endogenous FX activity on Day 28, 1-3 hours post dose.'}, {'measure': 'Effects on Pharmacodynamic Biomarker PICT Activity in Subjects Receiving DU-176b', 'timeFrame': 'Day 28', 'description': 'Mean (SD) change from baseline in biomarker prothrombinase induced clotting time \\[PICT\\] on Day 28, 1-3 hours post dose.\n\nPICT was determined by PICT aasay which is a plasma based functional assay to determine the anticoagulant activity on FXa and FIIa inhibition.'}, {'measure': 'Effects on Pharmacodynamic Biomarker PT in Subjects Receiving DU-176b', 'timeFrame': 'Day 28', 'description': 'Mean (SD) change from baseline in biomarker prothrombin time (PT) on Day 28, 1-3 hours post dose.'}, {'measure': 'Effects on Pharmacodynamic Biomarker INR in Subjects Receiving DU-176b', 'timeFrame': 'Day 28', 'description': 'Mean (SD) change from baseline in biomarker International Normalized Ratio (INR) on Day 28, 1-3 hours post dose.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anti-coagulant', 'Non-valvular', 'Venous Thromboembolism', 'Prevention of Blood Clots', 'Atrial Fibrillation', 'Non-valvular atrial fibrillation'], 'conditions': ['Atrial Fibrillation', 'Thromboembolism']}, 'descriptionModule': {'briefSummary': 'This study is to assess the safety of a potential new drug DU-176b for the prevention of stroke/systemic embolic event (SEE) in individuals with non-valvular atrial fibrillation (AF). The duration is 3 months of treatment and a 30 day follow-up visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, 18 to 80 years old.\n2. Able to provide written informed consent.\n3. Persistent non-valvular AF supported by abnormal electrocardiogram (ECG)\n4. A congestive heart failure, hypertension, age ≥ 75 years, diabetes, and prior stroke (CHADS2) index score of at least 2\n\nExclusion Criteria:\n\n1. Subjects with mitral valve disease or previous valvular heart surgery\n2. Known contraindication to any anticoagulant including vitamin K antagonists such as warfarin\n3. Known or suspected hereditary or acquired bleeding or coagulation disorder'}, 'identificationModule': {'nctId': 'NCT00504556', 'briefTitle': 'A Study to Assess the Safety of a Potential New Drug in Comparison to the Standard Practice of Dosing With Warfarin for Non-valvular Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Phase 2, Randomized, Parallel Group, Multi Center, Multi National Study for the Evaluation of Safety of Four Fixed Dose Regimens of DU-176b in Subjects With Non- Valvular Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'DU176b-PRT018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'DU-176b 30mg tablet once daily', 'interventionNames': ['Drug: Edoxaban (DU-176b)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'DU-176b 60mg once daily', 'interventionNames': ['Drug: Edoxaban (DU-176b)']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'DU-176b 30mg b.i.d.', 'interventionNames': ['Drug: Edoxaban (DU-176b)']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'DU-176b 60mg tablets two times a day', 'interventionNames': ['Drug: Edoxaban (DU-176b)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5', 'description': 'warfarin tablets', 'interventionNames': ['Drug: warfarin']}], 'interventions': [{'name': 'Edoxaban (DU-176b)', 'type': 'DRUG', 'description': '30mg tablet once daily', 'armGroupLabels': ['1']}, {'name': 'Edoxaban (DU-176b)', 'type': 'DRUG', 'description': '60mg tablet once daily', 'armGroupLabels': ['2']}, {'name': 'Edoxaban (DU-176b)', 'type': 'DRUG', 'description': '30mg tablet two times a day', 'armGroupLabels': ['3']}, {'name': 'Edoxaban (DU-176b)', 'type': 'DRUG', 'description': '60mg tablet two times a day', 'armGroupLabels': ['4']}, {'name': 'warfarin', 'type': 'DRUG', 'description': 'warfarin tablets', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huntsville', 'state': 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