Table 3.
Summary of Adverse Events Reported in Pediatric Switch Patients up to 2 Years (Safety Analysis Set)
| Pediatric Switch Patients (N=10) |
||
|---|---|---|
| n (%) | Events | |
| Patients with any AE | 10 (100%) | 91 |
| AE severity | ||
| Grade 1 | 8 (80%) | 30 |
| Grade 2 | 8 (80%) | 55 |
| Grade 3 | 1 (10%) | 6 |
| Grade 4 | 0 (0%) | 0 |
| Grade 5 | 0 (0%) | 0 |
| Patients with any SAE | 1 (10%) | 5 |
| Patients with any treatment-related AE | 2 (20%) | 4 |
| Study discontinuation because of AE | 0 (0%) | 0 |
| Death because of AE | 0 (0%) | 0 |
| Meningococcal infections | 0 (0%) | 0 |
Abbreviations: AE, adverse event; SAE, serious adverse event.