Impact of clinical trial design and execution-related factors on incidence of thromboembolic events in cancer patients: a systematic review and meta-analysis

Abstract

Objective: The objective of this study was to quantify the incidence of thromboembolic events (specifically, deep vein thromboses [DVT] and pulmonary embolism [PE]) in patients with cancer, and to examine the effects of a major clinical trial design and execution factors on those incidence rates.Research design and methods: The study included a systematic review of Medline, Current Contents, and accepted study bibliographies, as well as an analysis of studies. Studies included both longitudinal studies (prospective and retrospective) published in the English language between January 1990 and October 2005. Studies of patients with cancer that reported the incidence of thromboembolic events (DVT, PE, and total venous thromboembolic events [VTE]) were eligible for inclusion. Incidence of these events was calculated by study design, surveillance type (active or passive), length of follow-up, and other treatment risk factors. Incidence rates were estimated by random effects Poisson meta-regression mode...