Summary of TEAEs occurring in the blinded study periods (safety analysis set)
| Preferred term . | Overall . | |||
|---|---|---|---|---|
| Caplacizumab (n = 106) . | Placebo (n = 110) . | |||
| n (%) . | No. of events . | n (%) . | No. of events . | |
| At least 1 TEAE | 102 (96.2) | 790 | 105 (95.5) | 897 |
| At least 1 serious TEAE | 31 (29.2) | 44 | 54 (49.1) | 72 |
| Any bleeding TEAE excluding TTP* | 62 (58.5) | 157 | 47 (42.7) | 94 |
| Any serious bleeding TEAE excluding TTP | 12 (11.3) | 15 | 2 (1.8) | 2 |
| Epistaxis | 4 (3.8) | 4 | 0 | 0 |
| Subarachnoid hemorrhage | 2 (1.9) | 2 | 0 | 0 |
| Gingival bleeding | 1 (0.9) | 1 | 0 | 0 |
| Gastric ulcer hemorrhage | 1 (0.9) | 1 | 0 | 0 |
| Hematemesis | 1 (0.9) | 1 | 0 | 0 |
| Upper gastrointestinal hemorrhage | 1 (0.9) | 1 | 0 | 0 |
| Retinal hemorrhage | 1 (0.9) | 1 | 0 | 0 |
| Metrorrhagia | 1 (0.9) | 2 | 0 | 0 |
| Mennorrhagia | 1 (0.9) | 1 | 0 | 0 |
| Hemorrhagic ovarian cyst | 1 (0.9) | 1 | 0 | 0 |
| Cerebral hemorrhage | 0 | 0 | 1 (0.9) | 1 |
| Hemorrhagic transformation Stroke | 0 | 0 | 1 (0.9) | 1 |
| Preferred term . | Overall . | |||
|---|---|---|---|---|
| Caplacizumab (n = 106) . | Placebo (n = 110) . | |||
| n (%) . | No. of events . | n (%) . | No. of events . | |
| At least 1 TEAE | 102 (96.2) | 790 | 105 (95.5) | 897 |
| At least 1 serious TEAE | 31 (29.2) | 44 | 54 (49.1) | 72 |
| Any bleeding TEAE excluding TTP* | 62 (58.5) | 157 | 47 (42.7) | 94 |
| Any serious bleeding TEAE excluding TTP | 12 (11.3) | 15 | 2 (1.8) | 2 |
| Epistaxis | 4 (3.8) | 4 | 0 | 0 |
| Subarachnoid hemorrhage | 2 (1.9) | 2 | 0 | 0 |
| Gingival bleeding | 1 (0.9) | 1 | 0 | 0 |
| Gastric ulcer hemorrhage | 1 (0.9) | 1 | 0 | 0 |
| Hematemesis | 1 (0.9) | 1 | 0 | 0 |
| Upper gastrointestinal hemorrhage | 1 (0.9) | 1 | 0 | 0 |
| Retinal hemorrhage | 1 (0.9) | 1 | 0 | 0 |
| Metrorrhagia | 1 (0.9) | 2 | 0 | 0 |
| Mennorrhagia | 1 (0.9) | 1 | 0 | 0 |
| Hemorrhagic ovarian cyst | 1 (0.9) | 1 | 0 | 0 |
| Cerebral hemorrhage | 0 | 0 | 1 (0.9) | 1 |
| Hemorrhagic transformation Stroke | 0 | 0 | 1 (0.9) | 1 |
Participants may have had more than 1 adverse event (AE) per preferred term. An individual was counted only once if he or she experienced 1 or more AE.
A bleeding TEAE was defined as a Standardized MedDRA Query bleeding TEAE (excluding TTP events), with an onset date on or after the first dose of study medication.