Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-04-19 @ 2:54 AM
Study NCT ID:
NCT02744092
Status:
COMPLETED
Last Update Posted:
2023-10-03
First Post:
2016-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'C522181', 'term': 'apixaban'}, {'id': 'C552171', 'term': 'edoxaban'}, {'id': 'D000069604', 'term': 'Dabigatran'}, {'id': 'D014859', 'term': 'Warfarin'}, {'id': 'D017985', 'term': 'Dalteparin'}, {'id': 'D017984', 'term': 'Enoxaparin'}, {'id': 'D000077425', 'term': 'Fondaparinux'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D009844', 'term': 'Oligosaccharides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jconnors@bwh.harvard.edu', 'phone': '(617) 632-3000', 'title': 'Dr. Jean Connors', 'organization': 'Dana-Farber Cancer Institute'}, 'certainAgreement': {'otherDetails': 'Complete study results are available in JAMA.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study has several limitations. First, participants and physicians were not blinded to treatment assignment. Second, because participants were randomized within 30 days of a new VTE diagnosis, some were treated with different therapy before randomization. Third, in patients with advanced-stage cancer, it was not possible to distinguish VTE from cancer as the cause of death. Fourth, the included population limits generalizability. Fifth, detailed medication diaries were not obtained.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event (AE) data was collected for 6-months.', 'description': 'AEs were reported by physicians. Grade 3+ AEs were severe. Other AEs are grade 1 or 2 . Other AE section reports on events that were experienced in \\>1% of patients, so total # of patients may not match the # of patients experiencing events. We did not report AEs by individual drug arm because we did not randomize drugs; comparisons amongst drugs will be subject to selection bias. Also, the protocol allowed patients to switch drugs, so it would be unclear which AE is affiliated with which drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Randomized Arm 1 (DOACs)', 'description': "Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy.", 'otherNumAtRisk': 330, 'deathsNumAtRisk': 330, 'otherNumAffected': 6, 'seriousNumAtRisk': 330, 'deathsNumAffected': 70, 'seriousNumAffected': 123}, {'id': 'EG001', 'title': 'Randomized Arm 2 (LMWH)', 'description': "Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy.", 'otherNumAtRisk': 308, 'deathsNumAtRisk': 308, 'otherNumAffected': 11, 'seriousNumAtRisk': 308, 'deathsNumAffected': 56, 'seriousNumAffected': 114}, {'id': 'EG002', 'title': 'Preference Cohort 1 (DOACs)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy.', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 3, 'seriousNumAtRisk': 107, 'deathsNumAffected': 18, 'seriousNumAffected': 51}, {'id': 'EG003', 'title': 'Preference Cohort 2 (LMWH)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 2, 'seriousNumAtRisk': 30, 'deathsNumAffected': 9, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Hematoma', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Diarrhea', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Anemia', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Leukocytosis', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Blurred vision', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Constipation', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Dyspepsia', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Nausea', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Vomiting', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Abdominal Pain', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Fever', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Fracture', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hypercalcemia', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hyperkalemia', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Muscle weakness lower limb', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Dizziness', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Seizure', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Stroke', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Confusion', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Acute kidney injury', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Laryngeal hemorrhage', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Thromboembolic event', 'notes': 'Grade 1 or 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}], 'seriousEvents': [{'term': 'Anemia', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Febrile neutropenia', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Leukocytosis', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Atrial fibrillation', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Atrial flutter', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Cardiac arrest', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Chest pain - cardiac', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Heart failure', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Pericardial effusion', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Pericardial tamponade', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Sinus tachycardia', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Cardiac disorders - Other, specify', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hypothyroidism', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Eye disorders - Other, specify', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Ascites', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Colitis', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Colonic obstruction', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 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'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Aspiration', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Bronchopulmonary hemorrhage', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Dyspnea', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Epistaxis', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hypoxia', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Pleural effusion', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Pneumonitis', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other, specify', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Respiratory failure', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Palmar-plantar erythrodysesthesia syndrome', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Skin ulceration', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Skin and subcutaneous tissue disorders - Other, specify', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Surgical and medical procedures - Other, specify', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hematoma', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hypertension', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hypotension', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Thromboembolic event', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Vascular disorders - Other, specify', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Arterial thromboembolism', 'notes': 'Grade 3+', 'stats': [{'groupId': 'EG000', 'numAtRisk': 330, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative Non-Fatal VTE Recurrence at 6 Months (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Arm 1 (DOACs)', 'description': "Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy."}, {'id': 'OG001', 'title': 'Randomized Arm 2 (LMWH)', 'description': "Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy."}, {'id': 'OG002', 'title': 'Preference Cohort 1 (DOACs)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy.'}, {'id': 'OG003', 'title': 'Preference Cohort 2 (LMWH)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}, {'value': '7.5', 'groupId': 'OG002'}, {'value': '4.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'To compare the effectiveness of anticoagulation with a DOAC (intervention) with LMWH/warfarin (comparator) for preventing VTE recurrence in patients with cancer based on cumulative VTE recurrence reported by patients or clinicians at 6 months. Only VTEs that were nonfatal were considered because of the challenges of attributing cause of death in cancer patients to tumor progression vs. VTE.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analyses were performed on the participants who began protocol-directed therapy, the "as treated" population.'}, {'type': 'SECONDARY', 'title': 'Cumulative Rates of Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Arm 1 (DOACs)', 'description': "Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy."}, {'id': 'OG001', 'title': 'Randomized Arm 2 (LMWH)', 'description': "Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy."}, {'id': 'OG002', 'title': 'Preference Cohort 1 (DOACs)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy.'}, {'id': 'OG003', 'title': 'Preference Cohort 2 (LMWH)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}, {'value': '11.5', 'groupId': 'OG002'}, {'value': '7.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'To compare the harms of DOAC vs. LMWH/warfarin therapy for cancer patients with VTE based on the cumulative rate of major bleeding at 6 months. d. Major bleeding was defined as Grade \\>=3 on the Common Terminology Criteria for Adverse Events from the National Cancer Institute (NCI CTCAE) criteria version 5.0 (i.e., severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living).', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analyses were performed on the participants who began protocol-directed therapy, the "as treated" population.'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Arm 1 (DOACs)', 'description': "Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy."}, {'id': 'OG001', 'title': 'Randomized Arm 2 (LMWH)', 'description': "Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy."}, {'id': 'OG002', 'title': 'Preference Cohort 1 (DOACs)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy.'}, {'id': 'OG003', 'title': 'Preference Cohort 2 (LMWH)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '3.0'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '2.0'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '6.3'}, {'value': '-0.3', 'groupId': 'OG003', 'lowerLimit': '-8.7', 'upperLimit': '8.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Change in physical health at 3 months. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The presented scores in this results section indicate the change (difference) in mean scores between the baseline and 3-month follow-up assessment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the 3-month survey assessment'}, {'type': 'SECONDARY', 'title': 'Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Arm 1 (DOACs)', 'description': "Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy."}, {'id': 'OG001', 'title': 'Randomized Arm 2 (LMWH)', 'description': "Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy."}, {'id': 'OG002', 'title': 'Preference Cohort 1 (DOACs)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy.'}, {'id': 'OG003', 'title': 'Preference Cohort 2 (LMWH)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000', 'lowerLimit': '56.1', 'upperLimit': '57.3'}, {'value': '53.3', 'groupId': 'OG001', 'lowerLimit': '52.5', 'upperLimit': '54.2'}, {'value': '55.8', 'groupId': 'OG002', 'lowerLimit': '54.8', 'upperLimit': '56.9'}, {'value': '54.9', 'groupId': 'OG003', 'lowerLimit': '52.4', 'upperLimit': '57.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the 3-month survey assessment'}, {'type': 'SECONDARY', 'title': "Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Arm 1 (DOACs)', 'description': "Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy."}, {'id': 'OG001', 'title': 'Randomized Arm 2 (LMWH)', 'description': "Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy."}, {'id': 'OG002', 'title': 'Preference Cohort 1 (DOACs)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy.'}, {'id': 'OG003', 'title': 'Preference Cohort 2 (LMWH)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000'}, {'value': '18.4', 'groupId': 'OG001'}, {'value': '16.3', 'groupId': 'OG002'}, {'value': '23.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': "To compare the impact of DOAC vs. LMWH/warfarin therapy on mortality in cancer patients with VTE based on survival at 6 months. Mortality was reported by participants' surrogates (via study-specific questionnaire) or clinicians (via study-specific case report form)", 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary analyses were performed on the participants who began protocol-directed therapy, the "as treated" population.'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Arm 1 (DOACs)', 'description': "Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy."}, {'id': 'OG001', 'title': 'Randomized Arm 2 (LMWH)', 'description': "Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy."}, {'id': 'OG002', 'title': 'Preference Cohort 1 (DOACs)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy.'}, {'id': 'OG003', 'title': 'Preference Cohort 2 (LMWH)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '3.8'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '2.2'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '-0.3', 'upperLimit': '4.5'}, {'value': '-2.8', 'groupId': 'OG003', 'lowerLimit': '-10.4', 'upperLimit': '4.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change in physical health at 6 months. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The presented scores in this results section indicate the change (difference) in mean scores between the baseline and 6-month follow-up assessment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the 6-month survey assessment'}, {'type': 'SECONDARY', 'title': 'Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Arm 1 (DOACs)', 'description': "Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy."}, {'id': 'OG001', 'title': 'Randomized Arm 2 (LMWH)', 'description': "Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy."}, {'id': 'OG002', 'title': 'Preference Cohort 1 (DOACs)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy.'}, {'id': 'OG003', 'title': 'Preference Cohort 2 (LMWH)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000', 'lowerLimit': '55.8', 'upperLimit': '57.1'}, {'value': '54.1', 'groupId': 'OG001', 'lowerLimit': '53.2', 'upperLimit': '55.1'}, {'value': '54.9', 'groupId': 'OG002', 'lowerLimit': '53.4', 'upperLimit': '56.4'}, {'value': '53.1', 'groupId': 'OG003', 'lowerLimit': '49.8', 'upperLimit': '56.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the 6-month survey assessment'}, {'type': 'SECONDARY', 'title': 'Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Arm 1 (DOACs)', 'description': "Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy."}, {'id': 'OG001', 'title': 'Randomized Arm 2 (LMWH)', 'description': "Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy."}, {'id': 'OG002', 'title': 'Preference Cohort 1 (DOACs)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy.'}, {'id': 'OG003', 'title': 'Preference Cohort 2 (LMWH)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '11.6'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '11.2'}, {'value': '10.3', 'groupId': 'OG002', 'lowerLimit': '9.6', 'upperLimit': '11.0'}, {'value': '10.5', 'groupId': 'OG003', 'lowerLimit': '8.9', 'upperLimit': '12.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-months', 'description': 'To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the 3-month survey assessment'}, {'type': 'SECONDARY', 'title': 'Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Arm 1 (DOACs)', 'description': "Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy."}, {'id': 'OG001', 'title': 'Randomized Arm 2 (LMWH)', 'description': "Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy."}, {'id': 'OG002', 'title': 'Preference Cohort 1 (DOACs)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy.'}, {'id': 'OG003', 'title': 'Preference Cohort 2 (LMWH)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '12.1'}, {'value': '11.3', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '11.8'}, {'value': '11.5', 'groupId': 'OG002', 'lowerLimit': '10.8', 'upperLimit': '12.1'}, {'value': '10.1', 'groupId': 'OG003', 'lowerLimit': '8.6', 'upperLimit': '11.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-months', 'description': 'To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the 6-moth survey assessment'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 3-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Arm 1 (DOACs)', 'description': "Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy."}, {'id': 'OG001', 'title': 'Randomized Arm 2 (LMWH)', 'description': "Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy."}, {'id': 'OG002', 'title': 'Preference Cohort 1 (DOACs)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy.'}, {'id': 'OG003', 'title': 'Preference Cohort 2 (LMWH)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-1.8', 'upperLimit': '1.1'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '2.1'}, {'value': '0.3', 'groupId': 'OG002', 'lowerLimit': '-2.1', 'upperLimit': '2.6'}, {'value': '0.4', 'groupId': 'OG003', 'lowerLimit': '-4.5', 'upperLimit': '5.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-months', 'description': 'Change in mental health at 3 months from baseline. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The scores indicate change in score from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the 3-month survey assessment'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 6-months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Arm 1 (DOACs)', 'description': "Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy."}, {'id': 'OG001', 'title': 'Randomized Arm 2 (LMWH)', 'description': "Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy."}, {'id': 'OG002', 'title': 'Preference Cohort 1 (DOACs)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy.'}, {'id': 'OG003', 'title': 'Preference Cohort 2 (LMWH)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.\n\nWarfarin: Anticoagulation therapy.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '1.7'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '-0.5', 'upperLimit': '2.3'}, {'value': '1.1', 'groupId': 'OG002', 'lowerLimit': '-1.1', 'upperLimit': '3.3'}, {'value': '-1.9', 'groupId': 'OG003', 'lowerLimit': '-7.0', 'upperLimit': '3.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6-months', 'description': 'Change in mental health at 6 months from baseline. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The scores indicate change in score from baseline.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the 6-month survey assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Randomized Arm 1 (DOACs)', 'description': "Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy."}, {'id': 'FG001', 'title': 'Randomized Arm 2 (LMWH)', 'description': "Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy."}, {'id': 'FG002', 'title': 'Preference Cohort 1 (DOACs)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy.'}, {'id': 'FG003', 'title': 'Preference Cohort 2 (LMWH)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy.'}], 'periods': [{'title': 'Enrolled & Received Selected Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '335'}, {'groupId': 'FG001', 'numSubjects': '336'}, {'groupId': 'FG002', 'numSubjects': '108'}, {'groupId': 'FG003', 'numSubjects': '32'}]}, {'type': 'Received Assigned Treatment (Apixaban)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '57'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Received Assigned Treatment (Rivaroxaban)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Received Assigned Treatment (Dabigatran)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Received Assigned Treatment (Edoxaban)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Received Assigned Treatment (Enoxaparin)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '277'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '24'}]}, {'type': 'Received Assigned Treatment (Fondaparinux)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Received Assigned Treatment (Dalteparin)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Did Not Receive Assigned/Selected Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '330'}, {'groupId': 'FG001', 'numSubjects': '308'}, {'groupId': 'FG002', 'numSubjects': '107'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}, {'title': '6-Month Clinical Outcomes(Chart Review)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '330'}, {'groupId': 'FG001', 'numSubjects': '308'}, {'groupId': 'FG002', 'numSubjects': '107'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '330'}, {'groupId': 'FG001', 'numSubjects': '308'}, {'groupId': 'FG002', 'numSubjects': '107'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': '3-Month Patient-Reported Outcomes Survey', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '330'}, {'groupId': 'FG001', 'numSubjects': '308'}, {'groupId': 'FG002', 'numSubjects': '107'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'Approached for 3-month Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '280'}, {'groupId': 'FG002', 'numSubjects': '99'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '212'}, {'groupId': 'FG001', 'numSubjects': '197'}, {'groupId': 'FG002', 'numSubjects': '77'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '111'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '14'}]}]}, {'title': '6-Month Patient-Reported Outcomes Survey', 'milestones': [{'type': 'STARTED', 'comment': 'All patients were eligible to be included in the 6-month survey, regardless of whether or not they completed the 3-month survey.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '330'}, {'groupId': 'FG001', 'numSubjects': '308'}, {'groupId': 'FG002', 'numSubjects': '107'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'Approached for 6-month Survey', 'achievements': [{'groupId': 'FG000', 'numSubjects': '262'}, {'groupId': 'FG001', 'numSubjects': '253'}, {'groupId': 'FG002', 'numSubjects': '89'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '191'}, {'groupId': 'FG001', 'numSubjects': '177'}, {'groupId': 'FG002', 'numSubjects': '75'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}, {'groupId': 'FG001', 'numSubjects': '131'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '18'}]}]}], 'recruitmentDetails': 'Patients were recruited from 67 US-based healthcare institutions between December 2016 and April 2020.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'BG000'}, {'value': '308', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '775', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Randomized Arm 1 (DOACs)', 'description': "Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy."}, {'id': 'BG001', 'title': 'Randomized Arm 2 (LMWH)', 'description': "Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy."}, {'id': 'BG002', 'title': 'Preference Cohort 1 (DOACs)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).\n\nRivaroxaban: Anticoagulation therapy.\n\nApixaban: Anticoagulation therapy.\n\nEdoxaban: Anticoagulation therapy.\n\nDabigatran: Anticoagulation therapy.'}, {'id': 'BG003', 'title': 'Preference Cohort 2 (LMWH)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.\n\nDalteparin: Anticoagulation therapy.\n\nEnoxaparin: Anticoagulation therapy.\n\nFondaparinux: Anticoagulation therapy.'}, {'id': 'BG004', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '428', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '347', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age, median (q1, q3)', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '56', 'upperLimit': '70'}, {'value': '62', 'groupId': 'BG001', 'lowerLimit': '54', 'upperLimit': '68'}, {'value': '66', 'groupId': 'BG002', 'lowerLimit': '58', 'upperLimit': '72'}, {'value': '67', 'groupId': 'BG003', 'lowerLimit': '61', 'upperLimit': '72'}, {'value': '64', 'groupId': 'BG004', 'lowerLimit': '55', 'upperLimit': '70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '172', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '422', 'groupId': 'BG004'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '353', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '306', 'groupId': 'BG000'}, {'value': '287', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '722', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '277', 'groupId': 'BG000'}, {'value': '255', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '645', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-25', 'size': 1369739, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-04T14:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 811}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2016-04-11', 'resultsFirstSubmitDate': '2023-02-10', 'studyFirstSubmitQcDate': '2016-04-15', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-08', 'studyFirstPostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Non-Fatal VTE Recurrence at 6 Months (%)', 'timeFrame': '6 months', 'description': 'To compare the effectiveness of anticoagulation with a DOAC (intervention) with LMWH/warfarin (comparator) for preventing VTE recurrence in patients with cancer based on cumulative VTE recurrence reported by patients or clinicians at 6 months. Only VTEs that were nonfatal were considered because of the challenges of attributing cause of death in cancer patients to tumor progression vs. VTE.'}], 'secondaryOutcomes': [{'measure': 'Cumulative Rates of Major Bleeding', 'timeFrame': '6 months', 'description': 'To compare the harms of DOAC vs. LMWH/warfarin therapy for cancer patients with VTE based on the cumulative rate of major bleeding at 6 months. d. Major bleeding was defined as Grade \\>=3 on the Common Terminology Criteria for Adverse Events from the National Cancer Institute (NCI CTCAE) criteria version 5.0 (i.e., severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living).'}, {'measure': 'Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire', 'timeFrame': '3 months', 'description': 'Change in physical health at 3 months. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The presented scores in this results section indicate the change (difference) in mean scores between the baseline and 3-month follow-up assessment.'}, {'measure': 'Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire', 'timeFrame': '3 months', 'description': 'To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden).'}, {'measure': "Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form)", 'timeFrame': '6 months', 'description': "To compare the impact of DOAC vs. LMWH/warfarin therapy on mortality in cancer patients with VTE based on survival at 6 months. Mortality was reported by participants' surrogates (via study-specific questionnaire) or clinicians (via study-specific case report form)"}, {'measure': 'Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire', 'timeFrame': '6 months', 'description': 'Change in physical health at 6 months. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The presented scores in this results section indicate the change (difference) in mean scores between the baseline and 6-month follow-up assessment.'}, {'measure': 'Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire', 'timeFrame': '6 months', 'description': 'To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden).'}, {'measure': 'Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire', 'timeFrame': '3-months', 'description': 'To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits).'}, {'measure': 'Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire', 'timeFrame': '6-months', 'description': 'To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits).'}, {'measure': 'Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 3-months', 'timeFrame': '3-months', 'description': 'Change in mental health at 3 months from baseline. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The scores indicate change in score from baseline.'}, {'measure': 'Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 6-months', 'timeFrame': '6-months', 'description': 'Change in mental health at 6 months from baseline. Health-related quality of life was measured using the 12-Item Short Form Health Survey (SF-12) sub-scales for physical and mental health (score range, 0-100; higher scores indicate better physical and mental health functioning). Survey content included minor verbiage changes for clarity. The scores indicate change in score from baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rivaroxaban (Xarelto)', 'Apixaban (Eliquis)', 'Edoxaban (Savaysa)', 'Dabigatran (Pradaxa)', 'Warfarin (Coumadin)', 'Low molecular weight heparin (LMWH)'], 'conditions': ['Cancer', 'Venous Thromboembolism', 'Deep Vein Thrombosis (DVT)', 'Pulmonary Embolism (PE)', 'Blood Clot']}, 'referencesModule': {'availIpds': [{'id': 'AFT-28', 'url': 'https://www.allianceforclinicaltrialsinoncology.org/main/public/standard.xhtml?path=%2FPublic%2FAFT', 'type': 'Study Protocol', 'comment': 'Email the study team at CANVAS@AllianceFoundationTrials.org.'}], 'references': [{'pmid': '37266947', 'type': 'DERIVED', 'citation': 'Schrag D, Uno H, Rosovsky R, Rutherford C, Sanfilippo K, Villano JL, Drescher M, Jayaram N, Holmes C, Feldman L, Zattra O, Farrar-Muir H, Cronin C, Basch E, Weiss A, Connors JM; CANVAS Investigators. Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin and Recurrent VTE in Patients With Cancer: A Randomized Clinical Trial. JAMA. 2023 Jun 13;329(22):1924-1933. doi: 10.1001/jama.2023.7843.'}, {'pmid': '34172290', 'type': 'DERIVED', 'citation': 'Riaz IB, Fuentes HE, Naqvi SAA, He H, Sipra QR, Tafur AJ, Padranos L, Wysokinski WE, Marshall AL, Vandvik PO, Montori V, Bryce AH, Liu H, Badgett RG, Murad MH, McBane RD 2nd. Direct Oral Anticoagulants Compared With Dalteparin for Treatment of Cancer-Associated Thrombosis: A Living, Interactive Systematic Review and Network Meta-analysis. Mayo Clin Proc. 2022 Feb;97(2):308-324. doi: 10.1016/j.mayocp.2020.10.041. Epub 2021 Jun 22.'}], 'seeAlsoLinks': [{'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202439s001lbl.pdf', 'label': 'FDA Package Insert for Rivaroxaban (Xarelto)'}, {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202155s000lbl.pdf', 'label': 'FDA Package Insert for Apixaban (Eliquis)'}, {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206316lbl.pdf', 'label': 'FDA Package Insert for Edoxaban (Savaysa)'}, {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022512s007lbl.pdf', 'label': 'FDA Package Insert for Dabigatran (Pradaxa)'}, {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020287s050lbl.pdf', 'label': 'FDA Package Insert for Dalteparin (Fragmin)'}, {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020164s083lbl.pdf', 'label': 'FDA Package Insert for Enoxaparin (Lovenox)'}, {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021345s023lbl.pdf', 'label': 'FDA Package Insert for Fondaparinux (Arixtra)'}, {'url': 'http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009218s107lbl.pdf', 'label': 'FDA Package Insert for Warfarin (Coumadin)'}]}, 'descriptionModule': {'briefSummary': 'The overarching objective of the study is to determine the effectiveness of LMWH/ warfarin vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The intervention strategy is Direct Oral AntiCoagulants (DOAC) therapy with edoxaban, apixaban, rivaroxaban, or dabigatran. The comparator is low molecular weight heparin (LMWH) alone or with warfarin. The information gained will empower cancer patients and physicians to make more informed choices about anticoagulation strategies to manage VTE.', 'detailedDescription': "Venous blood clots affect nearly a million Americans each year. Venous clots in the legs are called deep venous thrombosis (DVT) and are dangerous because they travel to the lungs where they cause blockages known as pulmonary emboli (PE). DVT and PE are called venous thromboemboli (VTE). Cancer is a risk factor with nearly 200,000 VTEs in cancer patients each year. The purpose of VTE treatment is to prevent the initial clot from spreading and to prevent new clots from forming. This is accomplished by thinning the blood, or anticoagulation. Without anticoagulation, VTEs recur and are often fatal.\n\nRecently, the FDA has approved 4 new Direct Oral AntiCoagulants (DOACs) for preventing VTE recurrence. Few cancer patients were included in the efficacy trials, and practice guidelines fall silent on whether switching to DOAC therapy is advisable. To fill this knowledge gap, the Alliance Foundation Trials LLC, a research network of academic and community practices across the US, is conducting a pragmatic randomized effectiveness trial.\n\nThe overarching objective of the study is to determine the effectiveness of LMWH/ warfarin vs. DOAC anticoagulation for preventing recurrent VTE in cancer patients. The investigators will conduct a trial of 811 cancer patients followed for 6 months. The intervention strategy is DOAC therapy with edoxaban, apixaban, rivaroxaban, or dabigatran. The comparator is LMWH alone or with warfarin. Within each arm, patients can choose the agent they prefer based on side effects, drug interactions, and practical issues such as co-pays. The trial compares these two strategies in terms of treatment: 1) benefits based on VTE recurrence; 2) harms based on bleeding rates; 3) burdens based on patients' reports of their experiences; and 4) mortality rates.\n\nThe investigators hypothesize that the benefits, harms and burdens of DOAC treatment will be non-inferior to, or better than, usual care with LMWH/ warfarin among cancer patients. The information gained will empower cancer patients and physicians to make more informed choices about anticoagulation strategies to manage VTE."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of advanced solid tumor cancer, lymphoma, or myeloma (no time restrictions or limitations) -OR- diagnosis of early stage solid tumor cancer, lymphoma, or myeloma \\<= 12 months prior to study enrollment\n* Diagnosis of VTE \\<= 30 days prior to study enrollment for which potential benefits of anticoagulation therapy to prevent recurrence of VTE are felt by the treating physician to exceed the potential harms\n\n * Any anticoagulation drug/strategy may be used to treat the index VTE; protocol treatment will begin \\<= 30days after the index VTE diagnosis date\n* Treating physician intends to put participant on anticoagulation therapy for at least three months.\n* Age \\>= 18 years\n* Platelet count is \\>= 50,000/mm\\^3 (\\<= 7 days prior to enrollment)\n* CrCl (Creatinine Clearance) is \\>= 15 ml/min (\\<= 7 days prior to enrollment)\n\nExclusion Criteria:\n\n* Diagnosis of acute leukemia\n* Has ever received or is scheduled to receive an Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)\n\n * Patients who have ever received an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) ARE eligible.\n * Patients who are scheduled to receive an Autologous Hematopoietic Stem Cell Transplantation (autoHSCT) are NOT eligible\n* Ongoing, clinically significant bleeding (CTCAE grade 3 or 4)\n* Ongoing therapy with a P-gp inhibitor (e.g., nelfinavir, indinavir, or saquinavir-protease inhibitors for HIV) as these drugs interact with the factor Xa inhibitors\n* Therapy with any azole antifungals (e.g., itraconazole, ketaconazole, voriconazole) at the time of enrollment'}, 'identificationModule': {'nctId': 'NCT02744092', 'acronym': 'CANVAS', 'briefTitle': 'Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance Foundation Trials, LLC.'}, 'officialTitle': 'Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial)', 'orgStudyIdInfo': {'id': 'AFT-28'}, 'secondaryIdInfos': [{'id': 'CER-1503-29805', 'type': 'OTHER_GRANT', 'domain': 'Patient-Centered Outcomes Research Institute (PCORI)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Randomized Arm 1 (DOACs)', 'description': "Randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC). There are four FDA-approved DOAC drugs that may be used for this study: Rivaroxaban, Apixaban, Edoxaban, or Dabigatran. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.", 'interventionNames': ['Drug: Rivaroxaban', 'Drug: Apixaban', 'Drug: Edoxaban', 'Drug: Dabigatran']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Randomized Arm 2 (LMWH)', 'description': "Randomized Arm 2 will get anticoagulation therapy with low molecular weight heparin (LMWH) with or without a transition to warfarin. There are three FDA-approved LMWH drugs that may be used for this study: Dalteparin, Enoxaparin, or Fondaparinux. The treatment (including dosage form, dosage, frequency and duration) should be administered in accordance with the drug's FDA package insert, and all modifications are at the discretion of the treating investigator.", 'interventionNames': ['Drug: Warfarin', 'Drug: Dalteparin', 'Drug: Enoxaparin', 'Drug: Fondaparinux']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Preference Cohort 1 (DOACs)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 1 will get anticoagulation therapy with a Direct Oral AntiCoagulant (DOAC).', 'interventionNames': ['Drug: Rivaroxaban', 'Drug: Apixaban', 'Drug: Edoxaban', 'Drug: Dabigatran']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Preference Cohort 2 (LMWH)', 'description': 'If an eligible participant is offered randomization and declines randomization, then a limited number of participants (up to N=190) will be allowed to enroll in the Preference Cohort. In this case, the treating physician and patient choose Arm 1 or Arm 2 (non-randomized).\n\nPreference cohort: Non-randomized Arm 2 will get anticoagulation therapy with Low Molecular Weight Heparin (LMWH) with or without a transition to warfarin.', 'interventionNames': ['Drug: Warfarin', 'Drug: Dalteparin', 'Drug: Enoxaparin', 'Drug: Fondaparinux']}], 'interventions': [{'name': 'Rivaroxaban', 'type': 'DRUG', 'otherNames': ['Xarelto'], 'description': 'Anticoagulation therapy.', 'armGroupLabels': ['Preference Cohort 1 (DOACs)', 'Randomized Arm 1 (DOACs)']}, {'name': 'Apixaban', 'type': 'DRUG', 'otherNames': ['Eliquis'], 'description': 'Anticoagulation therapy.', 'armGroupLabels': ['Preference Cohort 1 (DOACs)', 'Randomized Arm 1 (DOACs)']}, {'name': 'Edoxaban', 'type': 'DRUG', 'otherNames': ['Savaysa'], 'description': 'Anticoagulation therapy.', 'armGroupLabels': ['Preference Cohort 1 (DOACs)', 'Randomized Arm 1 (DOACs)']}, {'name': 'Dabigatran', 'type': 'DRUG', 'otherNames': ['Pradaxa'], 'description': 'Anticoagulation therapy.', 'armGroupLabels': ['Preference Cohort 1 (DOACs)', 'Randomized Arm 1 (DOACs)']}, {'name': 'Warfarin', 'type': 'DRUG', 'otherNames': ['Coumadin'], 'description': 'Anticoagulation therapy.', 'armGroupLabels': ['Preference Cohort 2 (LMWH)', 'Randomized Arm 2 (LMWH)']}, {'name': 'Dalteparin', 'type': 'DRUG', 'otherNames': ['Fragmin'], 'description': 'Anticoagulation therapy.', 'armGroupLabels': ['Preference Cohort 2 (LMWH)', 'Randomized Arm 2 (LMWH)']}, {'name': 'Enoxaparin', 'type': 'DRUG', 'otherNames': ['Lovenox'], 'description': 'Anticoagulation therapy.', 'armGroupLabels': ['Preference Cohort 2 (LMWH)', 'Randomized Arm 2 (LMWH)']}, {'name': 'Fondaparinux', 'type': 'DRUG', 'otherNames': ['Arixtra'], 'description': 'Anticoagulation therapy.', 'armGroupLabels': ['Preference Cohort 2 (LMWH)', 'Randomized Arm 2 (LMWH)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'South County Hematology', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '91913', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Rees-Stealy', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Washington Hospital Healthcare System', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Washington Hospital', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '93073', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'VA Central California Fresno Medical Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Cancer Center Oncology Medical Group', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Oncology Associates- San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Rees-Stealy', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Medical Center - 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