Table 3 |
||||
|
Adverse events |
||||
|
Type of adverse event |
ASAQ |
AL |
||
|
|
||||
|
n = 123 |
n = 123 |
OR |
p valuea |
|
|
Vomiting of study drugs: |
||||
|
at least once |
15 |
11 |
0.71 (0.31–1.61) |
0.408 |
|
twice |
6 |
3 |
0.49 (0.12–1.99) |
0.318 |
|
|
||||
|
n = 117 |
n = 120 |
RR |
p valueb |
|
|
Deaths/hospitalizations |
0 |
0 |
||
|
Anaemiac |
82 |
78 |
0.90 (0.66–1.23) |
0.511 |
|
Respiratory symptoms |
27 |
25 |
0.90 (0.52–1.54) |
0.692 |
|
Gastrointestinal symptoms |
12 |
10 |
0.78 (0.34–1.81) |
0.565 |
|
Dermatological symptoms |
3 |
2 |
0.63 (0.10–3.76) |
0.610 |
|
Other symptoms |
2 |
2 |
0.95 (0.13–6.72) |
0.956 |
|
|
||||
|
Severity of adverse event |
||||
|
|
||||
|
n = 117 |
n = 120 |
RR |
p valueb |
|
|
Mild |
57 |
46 |
0.72 (0.49–1.07) |
0.104 |
|
Moderate |
45 |
54 |
1.19 (0.80–1.77) |
0.382 |
|
Severe |
15 |
22 |
1.45 (0.75–2.79) |
0.268 |
|
SAE |
2 |
2 |
0.96 (0.13–6.80) |
0.966 |
|
|
||||
|
Please note: Adverse events were classified by means of the Division of Microbiology and Infectious Diseases pediatric toxicity tables [18]. a Tested by logistic regression. b Tested by Cox regression. c Defined as Hb concentration <10 g/dl (age <2 years) and <11 g/dl (age >2 years). ASAQ, artesunate plus amodiaquine; AL, artemether-lumefantrine; OR, odds ratio; RR, relative risk SAE, serious adverse even |
||||
|
Kobbe et al. Malaria Journal 2008 7:261 doi:10.1186/1475-2875-7-261 |
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