TABLE 4.
Summary of treatment‐emergent bleeding/bruising events. a
| All‐cause | Treatment‐related | |||||||
|---|---|---|---|---|---|---|---|---|
|
AT‐E cohort (n = 216) |
AT‐NE cohort (n = 557) |
AT‐E cohort (n = 216) |
AT‐NE cohort (n = 557) |
|||||
| Events |
All grades n (%) |
Grade ≥3 b n (%) |
All grades n (%) |
Grade ≥3 n (%) |
All grades n (%) |
Grade ≥3 b n (%) |
All grades n (%) |
Grade ≥3 n (%) |
| Bleeding/bruising | 97 (44.9) | 6 (2.8) | 181 (32.5) | 11 (2.0) | 46 (21.3) | 2 (0.9) | 103 (18.5) | 4 (0.7) |
| Hematuria | 12 (5.6) | 0 | 15 (2.7) | 0 | 1 (0.5) | 0 | 3 (0.5) | 0 |
| Epistaxis | 11 (5.1) | 0 | 19 (3.4) | 0 | 1 (0.5) | 0 | 12 (2.2) | 0 |
| Gingival bleeding | 3 (1.4) | 0 | 2 (0.4) | 0 | 1 (0.5) | 0 | 1 (0.2) | 0 |
| Hemoptysis | 3 (1.4) | 0 | 1 (0.2) | 0 | 1 (0.5) | 0 | 0 | 0 |
| Hemarthrosis | 2 (0.9) | 1 (0.5) | 2 (0.4) | 0 | 1 (0.5) | 1 (0.5) | 0 | 0 |
| Hematochezia | 2 (0.9) | 1 (0.5) | 1 (0.2) | 0 | 0 | 0 | 0 | 0 |
| Blood loss anemia | 1 (0.5) | 0 | 1 (0.2) | 1 (0.2) | 0 | 0 | 0 | 0 |
| Bleeding/bruising subcategories | ||||||||
|---|---|---|---|---|---|---|---|---|
| Bruising c | 60 (27.8) | 0 | 123 (22.1) | 0 | 34 (15.7) | 0 | 83 (14.9) | 0 |
| Contusion | 49 (22.7) | 0 | 101 (18.1) | 0 | 31 (14.4) | 0 | 68 (12.2) | 0 |
| Petechiae | 8 (3.7) | 0 | 27 (4.8) | 0 | 3 (1.4) | 0 | 19 (3.4) | 0 |
| Ecchymosis | 4 (1.9) | 0 | 6 (1.1) | 0 | 1 (0.5) | 0 | 2 (0.4) | 0 |
| Increased tendency to bruise | 3 (1.4) | 0 | 4 (0.7) | 0 | 0 | 0 | 3 (0.5) | 0 |
| Hemorrhage/hematoma c | 34 (15.7) | 4 (1.9) | 54 (9.7) | 10 (1.8) | 13 (6.0) | 1 (0.5) | 18 (3.2) | 4 (0.7) |
| Hematoma | 7 (3.2) | 0 | 10 (1.8) | 2 (0.4) | 3 (1.4) | 0 | 5 (0.9) | 2 (0.4) |
| Conjunctival hemorrhage | 4 (1.9) | 0 | 6 (1.1) | 0 | 2 (0.9) | 0 | 2 (0.4) | 0 |
| Upper gastrointestinal hemorrhage | 3 (1.4) | 2 (0.9) | 3 (0.5) | 2 (0.4) | 2 (0.9) | 1 (0.5) | 1 (0.2) | 1 (0.2) |
| Vitreous hemorrhage | 3 (1.4) | 0 | 1 (0.2) | 0 | 2 (0.9) | 0 | 1 (0.2) | 0 |
| Hemorrhage | 1 (0.5) | 0 | 5 (0.9) | 1 (0.2) | 1 (0.5) | 0 | 3 (0.5) | 0 |
| Gastrointestinal hemorrhage | 1 (0.5) | 0 | 2 (0.4) | 2 (0.4) | 0 | 0 | 0 | 0 |
| Postprocedural hemorrhage | 1 (0.5) | 1 (0.5) | 1 (0.2) | 1 (0.2) | 0 | 0 | 0 | 0 |
| Subdural hematoma | 2 (0.9) | 1 (0.5) | 0 | 0 | 0 | 0 | 0 | 0 |
| Pulmonary hemorrhage | 0 | 0 | 1 (0.2) | 1 (0.2) | 0 | 0 | 1 (0.2) | 1 (0.2) |
| Subarachnoid hemorrhage | 0 | 0 | 1 (0.2) | 1 (0.2) | 0 | 0 | 0 | 0 |
Abbreviations: AT‐E, antithrombotic exposed; AT‐NE, antithrombotic nonexposed.
a
Events occurring in ≥3% of patients and events of interest occurring at a lower percentage are presented.
b
No grade 4–5 bleeding/bruising events occurred in patients in the AT‐E cohort.
c
Bruising and hemorrhage/hematoma are subcategories of bleeding/bruising.