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. 2022 Nov 9;64(1):139–151. doi: 10.1111/epi.17431

TABLE 3.

TEAEs occurring in ≥10% of patients during the interim analysis period of the open‐label extension

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.