The safety outcome
occurred in 349 patients (8.5%) in the edoxaban group and 423 patients (10.3%) in
the warfarin group (hazard ratio, 0.81; 95% CI, 0.71 to 0.94; P = 0.004 for superiority).
The rates of other adverse events were similar in the two groups. A total of 938 patients
with pulmonary embolism had right ventricular dysfunction, as assessed by
measurement of N-terminal pro–brain natriuretic peptide levels; the rate of recurrent
venous thromboembolism in this subgroup was 3.3% in the edoxaban group
and 6.2% in the warfarin group (hazard ratio, 0.52; 95% CI, 0.28 to 0.98).