Prespecified efficacy and safety outcomes
| . | Rivaroxaban (n = 73) . | Standard anticoagulation (n = 41) . | Absolute difference (95% CI) . |
|---|---|---|---|
| Efficacy population, n (%) | |||
| Symptomatic recurrent VTE | 0 | 1 (2.4)* | 2.4% (−2.6% to 13.5%) |
| Symptomatic recurrent VTE or asymptomatic deterioration on repeat imaging | 0 | 2 (4.9) | 4.9% (−0.4% to 17.1%) |
| Symptomatic recurrent VTE or major bleeding | 0 | 2 (4.9) | 4.9% (−0.4% to 17.1%) |
| Safety population, n (%) | |||
| Major or clinically relevant nonmajor bleeding | 5 (6.8) | 1 (2.4) | 4.4% (−6.7% to 13.4%) |
| Major bleeding | 0 | 1 (2.4)† | |
| Clinically relevant nonmajor bleeding | 5 (6.8)‡ | 0 |
| . | Rivaroxaban (n = 73) . | Standard anticoagulation (n = 41) . | Absolute difference (95% CI) . |
|---|---|---|---|
| Efficacy population, n (%) | |||
| Symptomatic recurrent VTE | 0 | 1 (2.4)* | 2.4% (−2.6% to 13.5%) |
| Symptomatic recurrent VTE or asymptomatic deterioration on repeat imaging | 0 | 2 (4.9) | 4.9% (−0.4% to 17.1%) |
| Symptomatic recurrent VTE or major bleeding | 0 | 2 (4.9) | 4.9% (−0.4% to 17.1%) |
| Safety population, n (%) | |||
| Major or clinically relevant nonmajor bleeding | 5 (6.8) | 1 (2.4) | 4.4% (−6.7% to 13.4%) |
| Major bleeding | 0 | 1 (2.4)† | |
| Clinically relevant nonmajor bleeding | 5 (6.8)‡ | 0 |
Recurrent CVT; occurred in a 6-year-old child with otitis media during the index event. No thrombophilia was reported.
Subdural hematoma; occurred in a 6-month-old child with bacterial meningitis during the index event.
One case each of Mallory-Weiss bleeding in a 15-year-old child with lymphoma, hemorrhoidal bleeding in a 14-year-old child with factor VII deficiency and homocystinuria, and hematuria in a 10-year-old child with lupus nephritis; 2 cases of nasal bleeding (1 in a 4-year-old child with otitis media during the index event and 1 in an 8-year-old child with nephrotic syndrome).