Table 2 |
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|
Risk (%) of adverse events (of moderate or greater severity) associated with study treatment within the first 14 days of treatment |
|||
| AQ+SP (n = 396) |
AS+AQ (n = 362) |
AL (n = 362) |
|
|
|
|||
| Signs and symptoms |
|||
|
|
|||
| 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** |
|||
|
|
|||
| 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 |
|
|
|||
|
* Anorexia: AQ+SP vs. AL, p = 0.004 † Weakness: AQ+SP vs. AL, p < 0.001 ‡ Subjective Fever: AQ+SP vs. AS+AQ, p = 0.010; AQ+SP vs AL, p = 0.017 γ Elevated Temperature: AL vs. AS+AQ, p = 0.007 ** Laboratory data not available on all participants |
|||
|
Maiteki-Sebuguzi et al. Malaria Journal 2008 7:106 doi:10.1186/1475-2875-7-106 |
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