Table 3.

Time to First Occurrence of Major Bleeding Event, On-Treatment (Safety Analysis Set)

Endpoint	Rivaroxaban 10 mg	Placebo	Rivaroxaban 10 mg vs. Placebo
			HR (95% CI)∗	p Value†
ISTH major bleeding	13/4,890 (0.27)	9/4,890 (0.18)	1.44 (0.62–3.37)	0.398
Fall in hemoglobin of ≥2 g/dl	11/4,890 (0.22)	6/4,890 (0.12)	1.83 (0.68–4.95)	—
Transfusion of ≥2 U of packed red blood cells or whole blood	8/4,890 (0.16)	3/4,890 (0.06)	2.66 (0.71–10.04)	—
Critical site	2/4,890 (0.04)	2/4,890 (0.04)	1.00 (0.14–7.10)	—
Fatal outcome	2/4,890 (0.04)	0/4,890	NA	NA

Values are n/N (%) unless otherwise indicated. All adjudicated by the clinical event committee. Safety analysis set: all intention-to-treat patients who take at least 1 dose of study drug.

ISTH = International Society on Thrombosis and Haemostasis; NA = not applicable; other abbreviations as in Table 2.

^∗HRs (95% CIs) are from Cox proportional hazards model with treatment as the only covariate.

^†p value (2-sided) for superiority of rivaroxaban vs. placebo from Cox proportional hazards model.