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) |