Therapeutic efficacy and safety of dihydroartemisinin-piperaquine versus artesunate-mefloquine in uncomplicated Plasmodium falciparum malaria in India

Table 6 Proportions of adverse events by treatment group

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.