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Eliquis® safety profile vs. warfarin
*Major bleeding was the primary safety endpoint of the ARISTOTLE trial. Intracranial bleeding and major bleeding at other locations including GI bleeding were components of the primary safety endpoint. The comparison of the primary safety outcome of bleeding according to the ISTH criteria is in the hierarchical sequence preserving a type I error.2
†Fatal bleeding (including haemorrhagic stroke): The rate of death from noncardiovascular causes includes fatal bleeding other than that from haemorrhagic stroke.2
No statistical analysis for HR/RRR is available on this endpoint.3
‡Eliquis® was studied in a randomised, double-blind, double-dummy, non-inferiority trial in 18,201 patients.2 Stroke/ systemic embolism was the primary efficacy endpoint and
major bleeding was the primary safety endpoint.2 Intracranial bleeding and major bleeding at other locations including GI bleeding were components of the primary safety endpoint.2 The endpoints presented were selected due to their frequency and severity: Intracranial bleeding, the most feared complication of anticoagulation therapy due to its high risk of death and disability4; and GI bleeding, whose incidence was increased with OACs like dabigatran 150mg and rivaroxaban.4
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