TABLE 3.
Overview of bleeding/bruising treatment‐emergent adverse events.
| Patient‐level summary |
AT‐E cohort (n = 216) |
AT‐NE cohort (n = 557) |
|---|---|---|
| Bleeding/bruising, n (%) | ||
| Any grade | 97 (44.9) | 181 (32.5) |
| Grade ≥3 | 6 (2.8) | 11 (2.0) |
| Serious bleeding/bruising, n (%) | 6 (2.8) | 10 (1.8) |
| Bleeding/bruising requiring | ||
| Dose interruption, n (%) | 8 (3.7) | 14 (2.5) |
| Dose reduction, n (%) | 0 | 1 (0.2) |
| Dose discontinuation, n (%) | 0 | 0 |
| Hospitalization a , n (%) | 5 (2.3) | 9 (1.6) |
| Median time to first onset of bleeding/bruising, weeks (IQR) | 8.1 (2.6–24.0) | 4.1 (1.3–16.1) |
| Event‐level summary | ||
|---|---|---|
| Total number of bleeding/bruising events | 157 | 296 |
| Recovered/resolved, n (%) | 90 (57.3) | 164 (55.4) |
| With treatment | 10 (6.4) | 17 (5.7) |
| Without treatment | 80 (51.0) | 147 (49.7) |
| Median duration b , weeks (IQR) | 2.1 (0.6–4.3) | 4.0 (1.1–7.9) |
Abbreviations: AT‐E, antithrombotic exposed; AT‐NE, antithrombotic nonexposed; IQR, interquartile range.
a
Including prolonged hospitalization.
b
Duration was calculated for 88 and 159 recovered/resolved adverse events with nonmissing end dates for the AT‐E cohort and AT‐NE cohorts, respectively.