|
Event (MedDRA Preferred Term)1
|
DP n (%)
|
A + M n (%)
|
|---|
|
At least one AE
|
60 (59.4%)
|
33 (67.4%)
|
|
Anaemia
|
6 (5.9%)
|
4 (8.2%)
|
|
Asthenia
|
10 (9.9%)
|
9 (18.4%)
|
|
Pyrexia
|
18 (17.8%)
|
10 (20.4%)
|
|
Malaria2
|
5 (5.0%)
|
7 (14.3%)
|
|
Eosinophil count increased
|
13 (12.9%)
|
2 (4.1%)
|
|
Haematocrit decreased
|
11 (10.9%)
|
5 (10.2%)
|
|
Haemoglobin decreased
|
13 (12.9%)
|
7 (14.3%)
|
|
Red blood cell count decreased
|
11 (10.9%)
|
10 (20.4%)
|
|
At least one SAE
|
5 (5.0%)
|
1 (2.0%)
|
|
At least one drug-related SAE
|
4 (4.0%)
|
1 (2.0%)
|
- AE, adverse event; SAE serious adverse event; DP, dihydroartemisinin-piperaquine; A + M, artesunate-mefloquine.
- 1Shown are Adverse Events with a frequency > 5%.
- 2Reporting of malaria as an adverse event was not complete in this study. Some study centres chose not to report malaria as it was known that to enter the study all patients had to have Plasmodium falciparum infection.
