Clinical outcomes by treatment group
| Study outcome, n (%) . | Rivaroxaban, n = 90 . | Standard anticoagulation, n = 36 . | Absolute risk difference (95% CI), % . |
|---|---|---|---|
| Recurrent VTE | 0 | 0 | 0 (−11 to 4.2) |
| Other clinically relevant venous thrombosis | 1 (1.1) | 1 (2.8) | −1.7 (−14 to 3.6) |
| Major bleeding | 0 | 0 | 0 (−11 to 4.2) |
| Clinically relevant nonmajor bleeding | 3 (3.3) | 0 | 3.3 (−6.4 to 9.7) |
| Blood in nasogastric tube | 1 | ||
| Hematemesis | 1 | ||
| Hematoma at catheter puncture site* | 1 | ||
| CVC-related infection | 7 (7.8) | 3 (8.3) | −0.6 (−10 to 11) |
| Repeat imaging | |||
| Normalized | 42 (47) | 15 (42) | |
| Improved | 26 (29) | 12 (33) | |
| Unchanged | 2 (2.2) | 5 (14) | |
| Deteriorated | 1 (1.1) | 0 | |
| Uncertain | 19 (21) | 4 (11) |
| Study outcome, n (%) . | Rivaroxaban, n = 90 . | Standard anticoagulation, n = 36 . | Absolute risk difference (95% CI), % . |
|---|---|---|---|
| Recurrent VTE | 0 | 0 | 0 (−11 to 4.2) |
| Other clinically relevant venous thrombosis | 1 (1.1) | 1 (2.8) | −1.7 (−14 to 3.6) |
| Major bleeding | 0 | 0 | 0 (−11 to 4.2) |
| Clinically relevant nonmajor bleeding | 3 (3.3) | 0 | 3.3 (−6.4 to 9.7) |
| Blood in nasogastric tube | 1 | ||
| Hematemesis | 1 | ||
| Hematoma at catheter puncture site* | 1 | ||
| CVC-related infection | 7 (7.8) | 3 (8.3) | −0.6 (−10 to 11) |
| Repeat imaging | |||
| Normalized | 42 (47) | 15 (42) | |
| Improved | 26 (29) | 12 (33) | |
| Unchanged | 2 (2.2) | 5 (14) | |
| Deteriorated | 1 (1.1) | 0 | |
| Uncertain | 19 (21) | 4 (11) |
Twenty-three children had a repeat imaging outcome classified as uncertain because the imaging was not performed or it was not evaluable (n = 4), study medication was continued for >7 days after repeat imaging (n = 8), or repeat imaging was done >7 days after stop study medication (n = 11). Of these children, 19 had a repeat imaging that was normalized (n = 12), improved (n = 6), or unchanged (n = 1).
Bleeding occurred during initial heparinization.