Table 3.
Caplacizumab-related adverse events
| Adverse event | Number of adverse events | Description |
|---|---|---|
| Major bleeding | 2 | One with hemorrhagic shock with lower digestive bleeding |
| One with abundant menorrhagia with a decrease in hemoglobin level of 2.5 g/dL | ||
| Clinically relevant nonmajor bleeding | 11 | Three with macroscopic gastrointestinal hemorrhage |
| Seven with epistaxis | ||
| One with subcutaneous hematoma larger than 25 cm2 | ||
| Non–clinically relevant nonmajor bleeding | 17 | Nine with ecchymosis or small hematoma |
| Six with gingival bleedings | ||
| Two with catheter site hemorrhage | ||
| Inflammatory reaction | 6 | Inflammatory swelling at the injection site, especially at the end of the treatment course |
| Thrombocytosis | 19 | Platelet count (×103/mm3) |
| >450-600: 11 cases | ||
| >600-900: 7 cases | ||
| >900: 1 case |