TABLE 3.
Adverse event | 2 to <18 years, n = 174, n (%) | 18–36 years, n = 73, n (%) | Overall, n = 247, n (%) |
---|---|---|---|
Any TEAE | 138 (79.3%) | 65 (89.0%) | 203 (82.2%) |
Any SAE | 29 (16.7%) | 11 (15.1%) | 40 (16.2%) |
Decreased appetite | 28 (16.1%) | 12 (16.4%) | 40 (16.2%) |
Fatigue | 23 (13.2%) | 10 (13.7%) | 33 (13.4%) |
Nasopharyngitis | 23 (13.2%) | 8 (11.0%) | 31 (12.6%) |
Seizure | 16 (9.2%) | 11 (15.1%) | 27 (10.9%) |
Note: Age groups are by entry into the core study.
Abbreviations: SAE, serious adverse event; TEAE, treatment‐emergent adverse event.