Table 4.
Adverse events of the safety set
| Variables | Treatment group (n = 35) |
|---|---|
| Total TEAEs | 34 (97.1) |
| TEAEs in ≥ 10% of subjects | |
| Upper respiratory tract infection | 19 (54.3) |
| Fever | 18 (51.4) |
| Pneumonia | 8 (22.9) |
| Febrile infection | 5 (14.3) |
| Diarrhea | 5 (14.3) |
| Adenoidal hypertrophy | 5 (14.3) |
| Hypoglycemia | 5 (14.3) |
| Sleep apnea syndrome | 4 (11.4) |
| Total TRAEs | 6 (17.1) |
| Elevated serum alkaline phosphatase | 3 (8.6) |
| Sleep apnea syndrome | 3 (8.6) |
| Adenoidal hypertrophy | 3 (8.6) |
| Elevated serum thyroid stimulating hormone | 1 (2.9) |
| Hypothyroidism | 1 (2.9) |
| Hypertension | 1 (2.9) |
| SAEs | 7 (20.0) |
| Pneumonia | 4 (11.4) |
| Sepsis | 1 (2.9) |
| Hypoglycemia | 1 (2.9) |
| Seizure | 1 (2.9) |
| Respiratory failure | 1 (2.9) |
| Treatment withdrawal due to TEAEs | 5 (14.3) |
| Treatment withdrawal due to TRAEs | 1 (2.9) |
| Sleep apnea syndrome | 1 (2.9) |
| Death due to TEAEs | 1 (2.9) |
Data are presented as n (%). TEAEs treatment-emergent adverse events, TRAEs treatment-related adverse events, SAEs serious adverse events