Table 5.
Summary of TEAEs occurring in ≥5% of children (safety population)
| System organ class preferred terma | Safety population (N = 64) n (%) |
|---|---|
| Any TEAEb | 53 (83) |
| Any treatment-related adverse event | 22 (34) |
| Injection site pain | 20 (31) |
| Nasopharyngitis | 14 (22) |
| Pyrexia | 11 (17) |
| Headache | 10 (16) |
| Cough | 8 (13) |
| Abdominal pain | 6 (9) |
| Injection site erythema | 6 (9) |
| Nausea | 5 (8) |
| Constipation | 4 (6) |
| Vomiting | 4 (6) |
| Upper respiratory tract infection | 4 (6) |
| Bronchospasm | 4 (6) |
| Productive cough | 4 (6) |
| Hot flush | 3 (5) |
Abbreviations: AE, adverse event; TEAE, treatment-emergent adverse event.
a Children with 2 or more adverse events in the same system organ class (or within the same preferred term) were counted only once for that system organ class (or preferred term).
b A TEAE was defined as any AE occurring or worsening on or after the first dose of study drug.