Table 3.
Serious adverse events and related non-serious adverse events
| Preferred term | On-demand (N = 19) |
Prophylaxis (N = 17) |
All (N = 36) | ||
|---|---|---|---|---|---|
| Number of AEs | N (%)* | Number of AEs | N (%)* | N (%)† | |
| Serious adverse events | |||||
| Abdominal wall haematoma | 0 | 0 (0.0) | 1 | 1 (5.9) | 1 (2.8) |
| Cholecystitis acute | 1 | 1 (5.3) | 0 | 0 (0.0) | 1 (2.8) |
| Haematoma infection | 1 | 1 (5.3) | 0 | 0 (0.0) | 1 (2.8) |
| Femoral neck fracture | 1 | 1 (5.3) | 0 | 0 (0.0) | 1 (2.8) |
| HBsAb positive | 1‡ | 1 (5.3) | 4§ | 4 (23.5) | 5 (13.9) |
| Arthropathy | 1 | 1 (5.3) | 0 | 0 (0.0) | 1 (2.8) |
| Haemarthrosis | 3 | 1 (5.3) | 8 | 2 (11.8) | 3 (8.3) |
| Muscle haemorrhage | 0 | 0 (0.0) | 1 | 1 (5.9) | 1 (2.8) |
| Haematuria | 1 | 1 (5.3) | 0 | 0 (0.0) | 1 (2.8) |
| Epistaxis | 1 | 1 (5.3) | 0 | 0 (0.0) | 1 (2.8) |
| Catheter removal | 1 | 1 (5.3) | 0 | 0 (0.0) | 1 (2.8) |
| Arteriosclerosis | 1 | 1 (5.3) | 0 | 0 (0.0) | 1 (2.8) |
| Haematoma | 0 | 0 (0.0) | 2 | 1 (5.9) | 1 (2.8) |
| Haemorrhage | 1 | 1 (5.3) | 0 | 0 (0.0) | 1 (2.8) |
| Hypertensive crisis | 1 | 1 (5.3) | 0 | 0 (0.0) | 1 (2.8) |
| Related non-serious adverse events | |||||
| Headache | 20 | 1 (5.3) | 0 | 0 (0.0) | 1 (2.8) |
| Dizziness | 1 | 1 (5.3) | 0 | 0 (0.0) | 1 (2.8) |
| Hypersensitivity | 0 | 0 (0.0) | 1 | 1 (5.9) | 1 (2.8) |
| Hypotension | 0 | 0 (0.0) | 1 | 1 (5.9) | 1 (2.8) |
| Rash | 0 | 0 (0.0) | 1 | 1 (5.9) | 1 (2.8) |
AE, adverse event; N (%), number of subjects (% of subjects); HBsAb, hepatitis B surface antibody.
*
Per cent relative to total number of subjects exposed to FEIBA NF within each arm.
†
Per cent relative to total number of subjects exposed to FEIBA NF.
‡
This SAE was considered related to administration of FEIBA NF.
§
Three of these four SAEs were considered related to administration of FEIBA NF (two by investigators and one by sponsor).