Table 1 Risk (%) of adverse events associated with study treatment within the first 14 days of treatment, including events of any severity grade
| Â | AQ+SP (n = 396) | AS+AQ (n = 362) | AL (n = 362) |
|---|---|---|---|
Signs and symptoms | Â | Â | Â |
Coryza | 115 (29.0%) | 125 (34.5%) | 118 (32.6%) |
Cough | 119 (30.1%) | 108 (29.8%) | 117 (32.3%) |
Anorexia* | 115 (29.0%) | 89 (24.6%) | 67 (18.5%) |
Weakness†| 93 (23.5%) | 58 (16.0%) | 47 (13.0%) |
Abdominal pain | 77 (19.4%) | 56 (15.5%) | 63 (17.4%) |
Vomiting | 64 (16.2%) | 49 (13.5%) | 41 (11.3%) |
Subjective fever‡ | 59 (14.9%) | 31 (8.6%) | 33 (9.1%) |
Headache | 45 (11.3%) | 38 (10.5%) | 50 (13.8%) |
Rash | 38 (9.6%) | 43 (11.9%) | 46 (12.7%) |
Generalized pruritus | 34 (8.6%) | 39 (10.8%) | 30 (8.3%) |
Diarrhoea | 34 (8.6%) | 29 (8.0%) | 31 (8.6%) |
Elevated temperatureγ | 20 (5.1%) | 14 (3.9%) | 31 (8.6%) |
Nausea | 12 (3.0%) | 14 (3.9%) | 13 (3.6%) |
Hepatosplenomegaly | 6 (1.5%) | 9 (2.5%) | 4 (1.1%) |
Laboratory abnormalities** | Â | Â | Â |
Neutropaenia | 27/381 (7.1%) | 18/345 (5.2%) | 13/343 (3.8%) |
Anaemia | 9/393 (2.3%) | 20/356 (5.6%) | 11/357 (3.1%) |
Elevated ALT | 2/392 (0.5%) | 1/358 (0.3%) | 2/357 (0.6%) |
Thrombocytopaenia | 1/389 (0.3%) | 0/350 | 0/351 |
Serious adverse events | 7 (1.8%) | 4 (1.1%) | 4 (1.1%) |