Table 2

Efficacy outcomes in the per-protocol population, n = 449

Rivaroxaban
LMWH/VKA n = 101
20 mg, n = 11530 mg, n = 11240 mg, n = 121
Primary efficacy outcome 
    n (%) 7 (6.1) 6 (5.4) 8 (6.6) 10 (9.9) 
    95% CI* 2.5%-12.1% 2.0%-11.3% 2.9%-12.6% 4.9-17.5% 
Symptomatic events, n (%) 3 (2.6) 4 (3.6) 2 (1.7) 7 (6.9) 
    Death (VTE-related) 0 (0.0) 2 (1.8) 1 (0.8) 0 (0.0) 
    PE, nonfatal 1 (0.9) 1 (0.9) 0 (0.0) 1 (1.0) 
    Recurrent DVT 2 (1.7) 1 (0.9) 1 (0.8) 7 (6.9) 
Asymptomatic deterioration on ultrasound and/or perfusion lung scanning, n (%) 4 (3.5) 2 (1.8) 6 (5.0) 3 (3.0) 
Rivaroxaban
LMWH/VKA n = 101
20 mg, n = 11530 mg, n = 11240 mg, n = 121
Primary efficacy outcome 
    n (%) 7 (6.1) 6 (5.4) 8 (6.6) 10 (9.9) 
    95% CI* 2.5%-12.1% 2.0%-11.3% 2.9%-12.6% 4.9-17.5% 
Symptomatic events, n (%) 3 (2.6) 4 (3.6) 2 (1.7) 7 (6.9) 
    Death (VTE-related) 0 (0.0) 2 (1.8) 1 (0.8) 0 (0.0) 
    PE, nonfatal 1 (0.9) 1 (0.9) 0 (0.0) 1 (1.0) 
    Recurrent DVT 2 (1.7) 1 (0.9) 1 (0.8) 7 (6.9) 
Asymptomatic deterioration on ultrasound and/or perfusion lung scanning, n (%) 4 (3.5) 2 (1.8) 6 (5.0) 3 (3.0) 

CI indicates confidence interval; DVT, deep vein thrombosis; PE, pulmonary embolism; and VTE, venous thromboembolism.

*

Two-sided 95% confidence intervals are presented.

One patient presented with both DVT and PE.

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