Table 2 Risk (%) of adverse events (of moderate or greater severity) associated with study treatment within the first 14 days of treatment
| Â | AQ+SP (n = 396) | AS+AQ (n = 362) | AL (n = 362) |
|---|---|---|---|
Signs and symptoms | Â | Â | Â |
Coryza | 18 (4.6%) | 29 (8.0%) | 21 (5.8%) |
Cough | 30 (7.6%) | 45 (12.4%) | 37 (10.2%) |
Anorexia* | 39 (9.9%) | 24 (6.6%) | 15 (4.1%) |
Weakness†| 37 (9.3%) | 20 (5.5%) | 9 (2.5%) |
Abdominal pain | 11 (2.8%) | 8 (2.2%) | 6 (1.7%) |
Vomiting | 15 (3.8%) | 5 (1.4%) | 7 (1.9%) |
Subjective fever‡ | 59 (14.9%) | 31 (8.6%) | 33 (9.1%) |
Headache | 2 (0.5%) | 5 (1.38%) | 4 (1.1%) |
Rash | 15 (3.8%) | 10 (2.8%) | 11 (3.0%) |
Generalized pruritus | 21 (5.3%) | 19 (5.3%) | 16 (4.4%) |
Diarrhoea | 0 | 4 (1.1%) | 5 (1.4%) |
Elevated temperatureγ | 14 (3.5%) | 8 (2.2%) | 23 (6.4%) |
Nausea | 4 (1.0%) | 1 (0.3%) | 1 (0.3%) |
Hepatosplenomegaly | 1 (0.3%) | 1 (0.3%) | 1 (0.3%) |
Laboratory abnormalities** | Â | Â | Â |
Neutropaenia | 1/381(0.3%) | 2/345 (0.6%) | 0/343 |
Anaemia | 4/393 (1.0%) | 5/356 (1.4%) | 1/357 (0.3%) |
Elevated ALT | 0/392 | 0/358 | 1/357 (0.3%) |
Thrombocytopaenia | 1/389 (0.3%) | 0/350 | 0/351 |