Table V.
Summary of adverse events including local reactions (AT population)
| AE category | Children | Adolescents | Adults |
|---|---|---|---|
| 2–11 years | 12–15 years | 16–64 years | |
| N = 18 | N = 5 | N = 28 | |
| Ni = 678 | Ni = 199 | Ni = 954 | |
| Patients with AEs, n (%) | 18 (100) | 5 (100) | 27 (96.4) |
| Patients with related AEs, n (%) | 7 (38.9) | 2 (40.0) | 22 (78.6) |
| Patients with temporally associated AEs (72 h), n (%) | 17 (94.4) | 5 (100) | 26 (92.9) |
| Patients with related, temporally associated AEs (72 h), n (%) | 7 (38.9) | 2 (40.0) | 20 (71.4) |
| Patients with serious AEs, n (%) | 3 (16.7) | 0 | 2 (7.1) |
| Patients discontinued due to AEs, n (%) | 2 (11.1) | 0 | 4 (14.3) |
| Patients discontinued due to related AEs, n (%) | 0 | 0 | 3 (10.7) |
AT all treated, N number of patients in age group, Ni number of infusions, AEs adverse events