What is the clinical impact of bleeding in people taking anticoagulants for venous thromboembolism? Systematic review with meta-analysis. Thirty-three studies met inclusion criteria (29 randomised controlled trials, 4 prospective cohort studies; 10,757 people). Major bleeding occurred in 27610,757 (2.6%) of people receiving anticoagulant therapy for venous thromboembolism (see Table 1). Intracranial bleeding accounted for 24276 (8.7%) of all major bleeding episodes with fatalities occurring in 1124 (45.8%) of these episodes.Table 1 Clinical impact of bleeding in people receiving anticoagulant therapy for venous thromboembolism.Absolute risk (%)Absolute risk for fatal episodes (%)Rate of bleeding per 100 patient-years (95% CI)Entire anticoagulation periodMajor bleeding episodes276/10,757 (2.6%)37/276 (13.4%)7.22 (7.19 to 7.24)Intracranial bleeding episodes24/8717 (0.3%)11/24 (45.8%)1.15 (1.14 to 1.16) Major bleeding associated with anticoagulant therapy has considerable clinical consequences that will need to be weighed against therapeutic benefits in people with venous thromboembolism.