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Table 5 Three-month recurrent VTE, bleeding, and mortality incidences in adult patients in EINSTEIN DVT and EINSTEIN PE [10,11,12]

From: Rivaroxaban versus standard anticoagulation for acute venous thromboembolism in childhood. Design of the EINSTEIN-Jr phase III study

 

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)

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