INTRODUCTION: @entity1211 ( @entity1211 ) are a significant cause of @entity204 in @entity1 with @entity5 . The incidence of VTE is not well characterized in early phase clinical trials of novel antineoplastic agents, or in @entity409 studies designed for @entity1 with varying degrees of liver test abnormalities. We compared the incidences of VTE in phase 1 clinical trials (P1CTs) and @entity409 trials (HDCTs) sponsored by the @entity5 Therapy Evaluation Program of the National @entity5 Institute (NCI) of the United States. MATERIALS _ METHODS: We reviewed individual @entity1 records of 1841 subjects for symptomatic VTE diagnosed while on study: 1328 subjects on 42 P1CTs, and 513 subjects on 9 HDCTs. The NCI's Organ Dysfunction Working Group definitions were used to categorize @entity1 . The incidences of @entity1211 between @entity1 were compared by the Chi square test. Confounders were evaluated with the Cochran-Mantel-Haenszel method. RESULTS _ CONCLUSIONS: There were 43 @entity1211 identified among all subjects (2.3%). There were significantly more VTE observed in the subjects on P1CTs (n=38, 2.9%) than in the subjects on HDCTs (n=5, 1.0%; RR 0.341, 95% 0.13-0.86, p=0.015). For @entity1 on HDCTs, those with severe @entity409 had a high incidence of VTE (RR 10.5 (1.12-93.6), p=0.021) that remained significant in a multivariate model. @entity1211 were observed less frequently in @entity1 who were enrolled in HDCT than those who were enrolled in P1CT; however, @entity1 with severe @entity409 were more likely to experience VTE. Severe liver test abnormalities may not be protective against VTE in @entity1 with @entity5 receiving chemotherapy.

Severe XXXX is associated with venous thromboembolic events in phase 1 clinical trials.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity5 :: ('MESH:D009369', 'Disease') :: ['cancer', 'Cancer', 'malignancies'] @entity409 :: ('MESH:D008107', 'Disease') :: ['hepatic dysfunction', 'dysfunction'] @entity1211 :: ('MESH:D054556', 'Disease') :: ['Venous thromboembolic events', 'VTEs'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death']
@entity409 :: (MESH:D008107,Disease) :: ['hepatic dysfunction']
