Open-label, randomized, non-inferiority clinical trial of artesunate-amodiaquine versus artemether-lumefantrine fixed-dose combinations in children and adults with uncomplicated falciparum malaria in Côte d'Ivoire

Table 4 Clinical adverse events in the ITT population

Adverse events	AS-AQ			AL			Fisher’s Exact Test
	n	%	95% IC	n	%	95% IC	p value
Asthenia	95	50.5	41.72-59.33	43	22.1	14.75-29.34	<0.0001
Headache	18	9.6	04.39-17.70	22	11.3	05.71-16.84	0.58
Anorexia	40	21.3	14.06-28.47	20	10.3	04.91-15.58	0.003
Abdominal pain	26	13.8	07.74-19.89	13	6.7	02.27-11.04	0.02
Nausea	6	3.2	0.09-06.28	0	0	-	0.01
Vomiting	16	8.5	03.59-13.42	2	1	-	0.001
Drowsiness	5	2.7	-	1	0.5	-	0.09
Dizziness	14	7.4	02.82-12.05	2	1	-	0.002
Rash	0	0	-	1	0.5	-	0.32

Notes: The most commonly reported and possibly drug-related adverse events to both combination therapies were gastrointestinal effects (abdominal pain, anorexia, nausea, abdominal pain, and vomiting); P values were obtained by Fisher’s exact test.
Abbreviations: AL, artemether-lumefantrine; AS-AQ, artesunate-amodiaquine.

ISSN: 1475-2875