Table 11.
Summary of treatment‐related AEs.
Number (%) of patients | ||||||
---|---|---|---|---|---|---|
Prophylactic use (n = 11) | Spontaneous use (n = 59) | Overall (n = 70) | ||||
No. (%) of patients reporting AEs | No. of events | No. (%) of patients reporting AEs | No. of events | No. (%) of patients reporting AEs | No. of events | |
Total no. | 1 (9%) | 5 | 6 (10%) | 17 | 7 (10%) | 22 |
Type of AEs | ||||||
Headache | 1 (9%) | 2 | 2 (3%) | 5 | 3 (4%) | 7 |
Vertigo | 0 (0%) | 0 | 2 (3%) | 4 | 2 (3%) | 4 |
Musculoskeletal stiffness | 1 (9%) | 3 | 0 (0%) | 0 | 1 (1%) | 3 |
Infusion site erythema | 0 (0%) | 0 | 2 (3%) | 2 | 2 (3%) | 2 |
Oedema peripheral | 0 (0%) | 0 | 1 (2%) | 1 | 1 (1%) | 1 |
Pyrexia | 0 (0%) | 0 | 1 (2%) | 1 | 1 (1%) | 1 |
Rigors | 0 (0%) | 0 | 1 (2%) | 1 | 1 (1%) | 1 |
Somnolence | 0 (0%) | 0 | 1 (2%) | 1 | 1 (1%) | 1 |
Contusion | 0 (0%) | 0 | 1 (2%) | 1 | 1 (1%) | 1 |
Pruritus generalized | 0 (0%) | 0 | 1 (2%) | 1 | 1 (1%) | 1 |
AE, adverse events.