Table 5.
Adverse events (occurring after baseline but before recurrence of parasitaemia in > 2% of children) suspected by investigators to be related to study medication by body weight group
| Adverse Events | n (%) | |||
|
BWG1 5-<10 kg (N = 50) |
BWG2 10-<15 kg (N = 37) |
BWG3 15-<25 kg (N = 16) |
Total 5-<25 kg (N = 103) |
|
| At least one adverse event | 30 (60.0) | 16 (43.2) | 6 (37.5) | 52 (50.5) |
| Anaemia | 7 (14.0) | 6 (16.2) | 1 (6.3) | 14 (13.6) |
| Diarrhoea | 5 (10.0) | 5 (13.5) | 1 (6.3) | 11 (10.7) |
| Clonus | 7 (14.0) | 5 (13.5) | 1 (6.3) | 13 (12.6) |
| Vomiting | 7 (14.0) | 0 (-) | 4 (25.0) | 11 (10.7) |
| Rashes | 4 (8.0) | 3 (8.1) | 0 (-) | 7 (6.8) |
| Hyperreflexia | 1 (2.0) | 2 (5.4) | 1 (6.3) | 4 (3.9) |
| Cough | 2 (4.0) | 1 (2.7) | 0 (-) | 3 (2.9) |