Table 4.
Adverse events | Total n (%) | Children n (%) | Adults n (%) |
---|---|---|---|
At least one AE | 25 (71.4) | 16 (84.2) | 9 (56.3) |
Somnolence | 14 (40) | 11(57.9) | 3 (18.8) |
Diarrhea | 12 (34.3) | 7 (38.8) | 5 (31.3) |
Weight gain >5% | 8 (22.9) | 8 (42.1) | 0 (0) |
Loss of appetite | 7 (20) | 5 (26.3) | 2 (12.5) |
Irritability | 7 (20) | 6 (31.6) | 1 (6.3) |
Increased appetite | 5 (14.3) | 4 (21.1) | 1 (6.3) |
Weight loss >5% | 4 (11.4) | 2 (10.5) | 2 (12.5) |
Others* | 4 (11.4) | 4 (21.1) | 0 (0) |
drowsiness (n = 3), extrapyramidal symptoms (n = 1).
AE, adverse event.