bid Indicates twice daily; and od, once daily.

* Dose adjustment (edoxaban 30 mg, od) in patients with a creatinine clearance of 30-50 mL/min, body weight <60 kg, and in those receiving concomitant treatment with potent P-glycoprotein inhibitors.

† Major bleeding was defined as fatal bleeding, bleeding in a critical area or organ, or bleeding causing a fall in hemoglobin of 2 mg/dL (or 1.24 mmol/L).

‡ Clinically relevant nonmajor bleeding was defined as overt bleeding not meeting the criteria for major bleeding but associated with a medical intervention, an unscheduled contact with a physician, (temporary) cessation of study treatment, or being associated with discomfort for the patient such as pain, or impairment of activities of daily life.