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Concerning Edoxaban & Venous thromboembolism (cancer-associated), the clinical phase III trial NCT02073682 showed that oral edoxaban was noninferior to subcutaneous dalteparin with respect to the composite outcome of recurrent venous thromboembolism or major bleeding. The rate of recurrent Venous Thromboembolism (VTE) was lower, but the rate of major bleeding was higher with edoxaban than with dalteparin.
Edoxaban does not have a specific approval from either the FDA or EMA for a labeled indication that is restricted to "cancer-associated" venous thromboembolism. Instead, its approvals are f…