A feasibility study of EdoXaban for the Cancer-Associated asymptomatic Venous thromboEmbolism in Japanese gastrointestinal cancer patients receiving chemotherapy. (ExCAVE study)

Interventions: The edoxaban (Lixiana) is orally administered as a once-daily dosing within three days before enrollment. The once-daily starting dose is 60mg.For patients with one or more factors that increase the risk of bleeding, such as renal impairment (CrCl 15-50mL.min), low body weight (under 60 kg), concomitant use of P-gp inhibitors (e.g. cyclosporine, dronedarone, ketoconazole, erythromycin), the dose is reduced by half.
Primary outcome(s): Incidence of major bleeding and clinically relevant non-major bleeding during 3 months after enrollment. Major bleeding events included those that were fatal; occurred in a critical area or organ (eg, intracranial); or caused a fall in hemoglobin of 2 g/dL or more or led to a transfusion of 2 or more units of whole blood or red cells. All non-major bleeding events that required any medical or surgical intervention were classified as clinically relevant non-major bleeding.
Study Design: Single arm Non-randomized