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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