Table 3.
On-treatment VTEs, PTS, bleeding events, and fatal events at 12 months by age strata (treated set)
| Dabigatran | Total, N = 203 | |||
|---|---|---|---|---|
| 12 to <18 y, n = 153 | 2 to <12 y, n = 42 | 0 to <2 y, n = 8 | ||
| Recurrent VTE event, n (%) | 2 (1.3) | 0 | 0 | 2 (1.0) |
| Subgroup analysis,* n/N (%) | ||||
| Sex | ||||
| Male | 0/87 (0.0) | 0/21 (0.0) | 0/5 (0.0) | 0/113 (0.0) |
| Female | 2/66 (3.0) | 0/21 (0.0) | 0/3 (0.0) | 2/90 (2.2) |
| PTS,† n (%) | 2/128 (1.6) | 0/27 (0.0) | 0/7 (0.0) | 2/162 (1.2) |
| Subgroup analysis,* n/N (%) | ||||
| Sex | ||||
| Male | 2/80 (2.5) | 0/12 (0.0) | 0/5 (0.0) | 2/97 (2.1) |
| Female | 0/48 (0.0) | 0/15 (0.0) | 0/2 (0.0) | 0/65 (0.0) |
| Bleeding events, n (%) | 37 (24.2) | 2 (4.8) | 1 (12.5) | 40 (19.7) |
| Major | 3 (2.0) | 0 | 0 | 3 (1.5) |
| Clinically relevant non-major | 1 (0.7) | 1 (2.4) | 0 | 2 (1.0) |
| Minor | 34 (22.2) | 2 (4.8) | 1 (12.5) | 37 (18.2) |
| All-cause death, n (%) | 0 | 0 | 0 | 0 |
*
Missing data for 1 adolescent.
†
Calculated over the number of patients with deep vein thrombosis (other than central-line and cerebral venous thrombosis) or central-line thrombosis.