|
Risk (%) of adverse events associated with study treatment within the first 14 days of treatment, including events of any severity grade |
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| AQ+SP (n = 396) |
AS+AQ (n = 362) |
AL (n = 362) |
|
|
|
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| Signs and symptoms |
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|
|
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| 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%) |
|
|
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| Laboratory abnormalities** |
|||
|
|
|||
| 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 |
|
|
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| Serious adverse events |
7 (1.8%) |
4 (1.1%) |
4 (1.1%) |
|
* Anorexia: AQ+SP vs. AL, p = 0.001 † Weakness: AQ+SP vs. AS+AQ, p = 0.015; 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 = 0.013 ** 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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