Viewing Study NCT00742859

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Ignite Creation Date: 2025-12-24 @ 2:43 PM
Ignite Modification Date: 2026-01-01 @ 2:01 PM
Study NCT ID: NCT00742859
Status: COMPLETED
Last Update Posted: 2023-08-07
First Post: 2008-08-26
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin
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': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543086', 'term': 'betrixaban'}, {'id': 'D014859', 'term': 'Warfarin'}, {'id': 'D000074', 'term': 'Acenocoumarol'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '650-246-7000', 'title': 'Head of Clinical Development', 'organization': 'Portola Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'Due to multiple studies, centers and countries this may vary.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Maximum of 1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Betrixaban 40 mg', 'description': 'Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 61, 'seriousNumAtRisk': 127, 'deathsNumAffected': 61, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Betrixaban 60 mg', 'description': 'Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 68, 'seriousNumAtRisk': 127, 'deathsNumAffected': 68, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'Betrixaban 80 mg', 'description': 'Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 53, 'seriousNumAtRisk': 127, 'deathsNumAffected': 53, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': 'Warfarin', 'description': 'Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 50, 'seriousNumAtRisk': 127, 'deathsNumAffected': 50, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'LIVER FUNCTION TEST ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary Artery Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sick Sinus Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Neoplasm Unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic Lymphocytic Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colon Cancer Recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetes Mellitus Inadequate Control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid Overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Grand Mal Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lumbar Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Hernia Obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ligament Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inappropriate Antidiuretic Hormone Secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Internaional Normalised Ratio Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostatic Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Exposure-adjusted Incidence Rate of Major or Clinically Relevant Non-major Bleeding Episode', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Betrixaban 40 mg', 'description': 'Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months'}, {'id': 'OG001', 'title': 'Betrixaban 60 mg', 'description': 'Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months'}, {'id': 'OG002', 'title': 'Betrixaban 80 mg', 'description': 'Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months'}, {'id': 'OG003', 'title': 'Warfarin', 'description': 'Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months'}], 'classes': [{'categories': [{'measurements': [{'value': '2.02', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '11.3'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '3.28', 'upperLimit': '23.6'}, {'value': '10.5', 'groupId': 'OG002', 'lowerLimit': '3.41', 'upperLimit': '24.5'}, {'value': '14.6', 'groupId': 'OG003', 'lowerLimit': '5.85', 'upperLimit': '30.0'}]}]}], 'analyses': [{'pValue': '0.035', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '0.017', 'ciUpperLimit': '1.14', 'groupDescription': 'Betrixaban 40mg compared to Warfarin', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.546', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.711', 'ciLowerLimit': '0.225', 'ciUpperLimit': '2.24', 'groupDescription': 'Betrixaban 60mg compared to Warfarin', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.712', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.755', 'ciLowerLimit': '0.239', 'ciUpperLimit': '2.39', 'groupDescription': 'Betrixaban 80mg compared to Warfarin', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'A maximum of 1 year', 'description': 'The primary endpoint is the time to the first occurrence of major or clinically relevant non-major bleeding. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution.', 'unitOfMeasure': 'Number of Patients per 100 Patient years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who took at least 1 dose of study medication after randomization.'}, {'type': 'SECONDARY', 'title': 'Exposure-adjusted Incidence Rate of Any Bleeding (Major, Clinically Relevant Non-major, or Minimal)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Betrixaban 40 mg', 'description': 'Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months'}, {'id': 'OG001', 'title': 'Betrixaban 60 mg', 'description': 'Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months'}, {'id': 'OG002', 'title': 'Betrixaban 80 mg', 'description': 'Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months'}, {'id': 'OG003', 'title': 'Warfarin', 'description': 'Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months'}], 'classes': [{'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000', 'lowerLimit': '31.7', 'upperLimit': '76.5'}, {'value': '77.9', 'groupId': 'OG001', 'lowerLimit': '53.3', 'upperLimit': '110'}, {'value': '56.0', 'groupId': 'OG002', 'lowerLimit': '35.9', 'upperLimit': '83.4'}, {'value': '103', 'groupId': 'OG003', 'lowerLimit': '73.6', 'upperLimit': '140'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.508', 'ciLowerLimit': '0.301', 'ciUpperLimit': '0.856', 'groupDescription': 'Betrixaban 40mg compared to Warfarin', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.308', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.767', 'ciLowerLimit': '0.481', 'ciUpperLimit': '1.22', 'groupDescription': 'Betrixaban 60mg compared to Warfarin', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.022', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.551', 'ciLowerLimit': '0.332', 'ciUpperLimit': '0.914', 'groupDescription': 'Betrixaban 80mg compared to Warfarin', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'A maximum of 1 year', 'description': 'The time to the first occurrence of any bleeding event. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution.', 'unitOfMeasure': 'Number of Patients per 100 Patient years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients who took at least 1 dose of study medication after randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Betrixaban 40 mg', 'description': 'Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months'}, {'id': 'FG001', 'title': 'Betrixaban 60 mg', 'description': 'Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months'}, {'id': 'FG002', 'title': 'Betrixaban 80 mg', 'description': 'Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months'}, {'id': 'FG003', 'title': 'Warfarin', 'description': 'Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '127'}, {'groupId': 'FG003', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '115'}, {'groupId': 'FG002', 'numSubjects': '116'}, {'groupId': 'FG003', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Endpoint', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Amendment 2 patient off study drug >4wks', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Sponsor req visit schedule noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Sponsor request patient out of town', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Site error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Between 31 October 2008 and 05 November 2009, 508 patients were enrolled by 35 study centers in 3 countries (USA, Canada, Germany). Patients were randomized to 1 of 4 treatment groups (1:1:1:1 allocation). The study was open-label for warfarin, while the 3 daily doses of betrixaban (40, 60, or 80 mg) were double-blinded.', 'preAssignmentDetails': '561 patients were screened for study participation. Of these patients, 508 were randomized, all of whom received at least 1 dose of study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}, {'value': '127', 'groupId': 'BG003'}, {'value': '508', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Betrixaban 40 mg', 'description': 'Betrixaban 40 mg once daily for at least 3 months and no longer than approximately 11 months'}, {'id': 'BG001', 'title': 'Betrixaban 60 mg', 'description': 'Betrixaban 60 mg once daily for at least 3 months and no longer than approximately 11 months'}, {'id': 'BG002', 'title': 'Betrixaban 80 mg', 'description': 'Betrixaban 80 mg once daily for at least 3 months and no longer than approximately 11 months'}, {'id': 'BG003', 'title': 'Warfarin', 'description': 'Dose-adjusted warfarin to maintain an INR of 2.0 to 3.0 with INR measured at maximum intervals of 4 weeks. Treatment duration was at least 3 months and no longer than approximately 11 months'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.3', 'spread': '8.50', 'groupId': 'BG000'}, {'value': '73.8', 'spread': '8.35', 'groupId': 'BG001'}, {'value': '72.0', 'spread': '7.65', 'groupId': 'BG002'}, {'value': '72.7', 'spread': '8.75', 'groupId': 'BG003'}, {'value': '73.0', 'spread': '8.32', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<75 years', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '268', 'groupId': 'BG004'}]}]}, {'title': '>=75 years', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '240', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Count of Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '170', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}, {'value': '338', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized patients who took at least 1 dose of study medication after randomization.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 508}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'dispFirstSubmitDate': '2016-11-30', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2008-08-26', 'dispFirstSubmitQcDate': '2016-11-30', 'resultsFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2008-08-26', 'dispFirstPostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-25', 'studyFirstPostDateStruct': {'date': '2008-08-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exposure-adjusted Incidence Rate of Major or Clinically Relevant Non-major Bleeding Episode', 'timeFrame': 'A maximum of 1 year', 'description': 'The primary endpoint is the time to the first occurrence of major or clinically relevant non-major bleeding. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution.'}], 'secondaryOutcomes': [{'measure': 'Exposure-adjusted Incidence Rate of Any Bleeding (Major, Clinically Relevant Non-major, or Minimal)', 'timeFrame': 'A maximum of 1 year', 'description': 'The time to the first occurrence of any bleeding event. This was presented as the exposure adjusted incidence rate which was calculated as number of subjects experiencing the event divided by total person years across all subjects, where if a patient experiencing the event, year was from first dose date to the first occurrence of the event, and to last study date if not. The confidence interval was calculated via the exact Poisson distribution.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Betrixaban', 'Factor Xa inhibitor', 'Warfarin'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the advantage of not requiring dose adjustments due to international normalized ratios (INRs) outside the target range of 2.0 to 3.0 and a more consistent level of anticoagulation over time.', 'detailedDescription': "To assess the safety and tolerability of betrixaban at doses of 40 mg, 60 mg and 80 mg given orally once a day for at least 3 months compared to dose-adjusted warfarin in patients with non-valvular atrial fibrillation (AF).\n\nThis is a Phase 2, exploratory, randomized, parallel group, multicenter, active comparator, dose finding study of patients with documented non-valvular AF. Patients will be randomized (1:1:1:1) to 1 of 4 treatment groups (approximately 125 patients per group) using an interactive voice response system (IVRS). A dynamic randomization will be used to balance patients by country, concurrent aspirin use (yes or no) and antecedent warfarin (yes or no). The study will be open label for randomization to warfarin versus betrixaban, but the three daily doses of betrixaban, 40 mg, 60 mg or 80 mg, will be double-blind (identical capsules for all three dose levels). The warfarin-treated patients will be managed according to each center's usual clinical routine with INR monitoring and dose-adjustments in order to maintain a target INR of 2.0 to 3.0 at maximum intervals of four weeks. No loading doses or dose titrations will be used for betrixaban. The betrixaban dose should be ingested in the evening (e.g. at bedtime), preferably at least 2 hours after the evening meal. Note: acenocumerol may be substituted for warfarin as indicated by local practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age ≥18 years.\n* If the patient is a woman, she must be without reproductive potential (i.e., postmenopausal for ≥2 years or after hysterectomy).\n* AF at the time of enrollment (randomization) or documented within the last year by Holter, ECG, rhythm strip, pacemaker or other intracardiac recording, resulting in an indication for anticoagulation with warfarin, acenocumerol, phenprocoumon, or other Vitamin K antagonist in the opinion of the treating physician.\n* One or more of the following risk factor(s) for stroke:\n\n 1. Age 75 years or older.\n 2. Prior stroke, TIA or systemic (i.e., central nervous system) embolus at least 30 days remote from the time of screening.\n 3. Symptomatic congestive heart failure within 3 months echocardiography, radionuclide study or contrast angiography.\n 4. Hypertension requiring pharmacological treatment.\n 5. Diabetes.\n 6. Age of 55 years or older and previous coronary artery disease or known peripheral artery disease.\n\nExclusion Criteria:\n\n* Body weight less than 40 kg (88 lbs).\n* Need for either hemodialysis or peritoneal dialysis (or likely to require it within one year).\n* AF due to reversible causes (e.g., thyrotoxicosis, pericarditis, cardiac surgery, pulmonary embolism).\n* Mechanical prosthetic valve (bioprosthetic valve is allowed) or valvular disease likely to be operated on within one year.\n* History (including family history) or symptoms of a congenital or acquired bleeding disorder or vascular malformation; or a history of intracranial, retroperitoneal, or intraocular bleeding within the last 6 months; or is felt to be at high risk for bleeding for other reasons including from significant liver disease. This also includes gastrointestinal bleeding within 90 days before randomization or endoscopically verified ulcer disease within 30 days of screening.\n* Conditions other than AF that require chronic anticoagulation (e.g. prosthetic mechanical heart valve).\n* Persistent, uncontrolled hypertension (SBP \\>160 mm Hg on repeated measurements).\n* Active infective endocarditis.\n* Scheduled major surgery.\n* Planned pulmonary vein ablation or surgical procedure for cure of AF or flutter.\n* Recent ischemic stroke, systemic embolic event or acute coronary syndrome within 30 days.\n* Severe co-morbid condition with life expectancy of ≤1 year.\n* Previous known history of genetic coagulopathy (e.g., Factor V Leiden, Protein C Deficiency, Protein S Deficiency, Antiphospholipid Syndrome, etc.).\n* Evidence at Screening of:\n\n 1. Platelet count \\<100,000/mm3.\n 2. Serum alanine aminotransferase (ALT) or aspirate aminotransferase (AST) \\>2 times upper limit of normal (ULN).\n 3. A history (including family history) of "Long QT Syndrome".\n* Aspirin \\>162 mg daily.\n* Use of verapamil (pending the availability of a drug interaction study with betrixaban).\n* Active alcohol or drug abuse, or psychosocial reasons that make study participation impractical.\n* Use of an investigational drug or device within the past 30 days.\n* Inability to comply with INR monitoring or other protocol-related activities.\n* Unable to give written informed consent.'}, 'identificationModule': {'nctId': 'NCT00742859', 'acronym': 'EXPLORE-Xa', 'briefTitle': 'Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2, Randomized, Parallel Group, Dose-Finding, Multicenter, Multinational Study of the Safety, Tolerability and Pilot Efficacy of Three Blinded Doses of the Oral Factor Xa Inhibitor Betrixaban Compared With Open-Label Dose-Adjusted Warfarin in Patients With Non-Valvular Atrial Fibrillation (EXPLORE Xa)', 'orgStudyIdInfo': {'id': '08-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Betrixaban', 'description': 'Betrixaban, 40 mg, orally, once daily for at least 3 months.', 'interventionNames': ['Drug: betrixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Betrixaban', 'description': 'Betrixaban, 60 mg, orally, once daily for at least 3 months', 'interventionNames': ['Drug: betrixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: Betrixaban', 'description': 'Betrixaban, 80 mg, orally, once daily for at least 3 months', 'interventionNames': ['Drug: betrixaban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 4: Warfarin', 'description': 'Warfarin will be prescribed by investigators according to the standard of care.', 'interventionNames': ['Drug: Warfarin']}], 'interventions': [{'name': 'betrixaban', 'type': 'DRUG', 'description': 'orally, once daily for at least 3 months', 'armGroupLabels': ['Arm 1: Betrixaban', 'Arm 2: Betrixaban', 'Arm 3: Betrixaban']}, {'name': 'Warfarin', 'type': 'DRUG', 'otherNames': ['Coumadin', 'Acenocoumarol'], 'description': 'Warfarin will be prescribed by the investigator according to the standard of care.', 'armGroupLabels': ['Arm 4: Warfarin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '32901', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '32501', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '60504', 'city': 'Aurora', 'state': 'Illinois', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 41.76058, 'lon': -88.32007}}, {'zip': '04210', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '21044', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '21804', 'city': 'Salisbury', 'state': 'Maryland', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 38.36067, 'lon': -75.59937}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '97123', 'city': 'Hillsboro', 'state': 'Oregon', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 45.52289, 'lon': -122.98983}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Longueuil', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 45.5152, 'lon': -73.46818}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Portola Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Stuart Connolly, MD, FRCP', 'role': 'STUDY_CHAIR', 'affiliation': 'Population Health Research Institute, McMaster University'}, {'name': 'Rafael Diaz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Instituto Cardiovascular de Rosario, Argentina'}, {'name': 'Paul Dorian, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Toronto, Canada'}, {'name': 'Michael Ezekowitz, MD, PhD,', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lankenau Institute for Medical Research and The Heart Center, United States'}, {'name': 'Stefan H. Hohnloser, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johann Wolgang Goethe University, Frankfurt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Portola Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}