Table 2.

Treatment course uptake and adverse events

		Artemether–lumefantrine	Multivitamin	p value*
Number of participants		738	742	..
Number of participants participating in courses
	Course 1 (all participants)	738	742	..
	Course 2 (total attended follow-up visit 1 plus total rejoined second follow-up period)	715	721	..
	Course 3 (total attended follow-up visit 2 plus total rejoined third follow-up period)	611	621	..
Number of participants who took more than one dose†		716	721	..
Number of doses taken		18 806	19 132	..
Vomiting within 1 h‡		1 (<0·1%)	0	0·50
Adverse events‡
	Headache	71 (0·4%)	51 (0·3%)	0·070
	Abdominal pain	52 (0·3%)	24 (0·1%)	0·0012
	Dizziness	45 (0·2%)	32 (0·2%)	0·14
	Fatigue	34 (0·2%)	17 (<0·1%)	0·017
	Joint pain	28 (0·1%)	16 (<0·1%)	0·071
	Muscle pain	23 (0·1%)	11 (<0·1%)	0·040
	Diarrhoea	19 (0·1%)	8 (<0·1%)	0·035
	Fever	15 (<0·1%)	7 (<0·1%)	0·092
	Loss of appetite	15 (<0·1%)	4 (<0·1%)	0·012
	Cough	14 (<0·1%)	11 (<0·1%)	0·56
	Sore throat	11 (<0·1%)	8 (<0·1%)	0·50
	Nausea	7 (<0·1%)	4 (<0·1%)	0·39
	Itching	3 (<0·1%)	2 (<0·1%)	0·69
	Vomiting	3 (<0·1%)	1 (<0·1%)	0·37
	Others	15 (<0·1%)	11 (<0·1%)	0·44
	All adverse events	355 (1·9%)	207 (1·1%)	<0·0001
Serious adverse events‡§		2 (<0·1%)	3 (<0·1%)	1·00

Data are n, n/N (%), or n (%).

^*Comparing between groups using Fisher's exact test.

^†All participants (738 in the artemether–lumefantrine group, 742 in the multivitamin group) took the first dose after enrolment; for 22 and 21 participants, respectively, it was not recorded that they took any further doses.

^‡The denominator for the percentages is the total number of doses taken in each group (18 806 in the artemether–lumefantrine group, 19 312 in the multivitamin group).

^§Serious adverse events included one case of dengue fever and one case of hypoglycaemia in the artemether–lumefantrine group, and one suspected hepatocellular carcinoma and two accidents in the multivitamin group.