Table 5.

Three-month recurrent VTE, bleeding, and mortality incidences in adult patients in EINSTEIN DVT and EINSTEIN PE [10–12]

	Rivaroxaban n/N (%; 95% CI)	Standard anticoagulation n/N (%; 95% CI)	Absolute risk difference (95% CI)	Hazard ratio (95% CI)
Recurrent VTE	69/4150 (1.7; 1.3–2.1)	82/4131 (2.0; 1.6–2.5)	0.3 (−0.3–0.9)	0.82 (0.60–1.13)
Major bleeding	28/4130 (0.7; 0.5–1.0)	49/4116 (1.2; 0.9–1.6)	0.5 (0.1–0.9)	0.55 (0.35–0.88)
Major and clinically relevant nonmajor bleeding	286/4130 (6.9; 6.2–7.7)	287/4116 (7.0; 6.2–7.8)	0.0 (−1.1–1.1)	0.98 (0.83–1.16)
Mortality	53/4150 (1.3; 1.0–1.7)	61/4131 (1.5; 1.1–1.9)	0.2 (−0.3–0.7)	0.81 (0.56–1.17)

Differences in incidences and their 2-sided 95% CIs were calculated by stratified Mantel–Haenszel method (strata: intended treatment duration and index event)

CI, confidence interval