PURPOSE: @entity1211 ( @entity1211 ) is common in @entity5 @entity1 . Evidence has suggested that low molecular weight heparin (LMWH) might improve survival in @entity1 with @entity5 by preventing both @entity1211 and the progression of @entity3 . No trial in a single @entity5 type has been powered to demonstrate a clinically significant survival difference. The aim of this trial was to investigate this question in @entity1 with @entity2 . @entity1 AND METHODS: We conducted a multicenter, open-label, randomized trial to evaluate the addition of a primary prophylactic dose of LMWH for 24 weeks to standard treatment in @entity1 with newly diagnosed @entity2 of any stage and histology. The primary outcome was 1-year survival. Secondary outcomes included @entity3 -free survival, @entity1211 -free survival, @entity137 , and quality of life. RESULTS: For this trial, 2,202 @entity1 were randomly assigned to the two treatment arms over 4 years. The trial did not reach its intended number of events for the primary analysis (2,047 @entity204 ), and data were analyzed after 2,013 @entity204 after discussion with the independent data monitoring committee. There was no evidence of a difference in overall or @entity3 -free survival between the two arms (hazard ratio [HR], 1.01; 95% CI, 0.93 to 1.10; P = .814; and HR, 0.99; 95% CI, 0.91 to 1.08; P = .864, respectively). There was a reduction in the risk of @entity1211 from 9.7% to 5.5% (HR, 0.57; 95% CI, 0.42 to 0.79; P = .001) in the LMWH arm and no difference in major @entity548 events but evidence of an increase in the composite of major and clinically relevant nonmajor @entity548 in the LMWH arm. CONCLUSION: LMWH did not improve overall survival in the @entity1 with @entity2 in this trial. A significant reduction in @entity1211 is associated with an increase in clinically relevant nonmajor @entity548 . Strategies to target those at greatest risk of @entity1211 are warranted.

Randomized Phase III Trial of Standard Therapy Plus Low Molecular Weight Heparin in XXXX With @entity2 : FRAGMATIC Trial.

@entity1 :: ('9606', 'Species') :: ['patients', 'PATIENTS'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity548 :: ('MESH:D006470', 'Disease') :: ['bleeding'] @entity5 :: ('MESH:D009369', 'Disease') :: ['cancer'] @entity2 :: ('MESH:D008175', 'Disease') :: ['lung cancer'] @entity3 :: ('MESH:D009362', 'Disease') :: ['metastasis', 'metastases'] @entity1211 :: ('MESH:D054556', 'Disease') :: ['Venous thromboembolism', 'VTE'] @entity204 :: ('MESH:D003643', 'Disease') :: ['deaths']
@entity1 :: (9606,Species) :: ['Patients']
