TABLE A3.
Venous Thromboembolic Events
| Event | Subcutaneous Group (n = 206), No. (%) | Intravenous Group (n = 210), No. (%) |
|---|---|---|
| Any venous thromboembolic event | 19 (9) | 30 (14) |
| Grade 1 | 1 (0.5) | 7 (3) |
| Grade 2 | 16 (8) | 16 (8) |
| Grade 3 | 2 (1) | 6 (3) |
| Grade 4 | 0 | 1 (0.5) |
| Grade 5 | 0 | 0 |
| Any venous thromboembolic event leading to death | 0 | 0 |
| Any venous thromboembolic event leading to discontinuation of any agent | 0 | 2 (1) |
| Venous thromboembolic eventsa | ||
| Pulmonary embolism | 6 (3) | 9 (4) |
| Deep vein thrombosis | 5 (2) | 11 (5) |
| Embolism venous | 3 (1) | 3 (1) |
| Venous thrombosis limb | 3 (1) | 3 (1) |
| Embolism | 2 (1) | 3 (1) |
| Thrombosis | 2 (1) | 1 (0.5) |
| Subclavian vein thrombosis | 1 (0.5) | 0 |
| Superficial vein thrombosis | 1 (0.5) | 0 |
| Pulmonary infarction | 0 | 1 (0.5) |
| Venous thrombosis | 0 | 3 (1) |
NOTE. The safety population included all patients who were randomly assigned and received at least one dose of any trial treatment.
a
Events in this category are listed according to decreasing incidence in the subcutaneous group.