Tolerability and safety of artesunate-amodiaquine and artemether-lumefantrine fixed dose combinations for the treatment of uncomplicated Plasmodium falciparum malaria: two open-label, randomized trials in Nimba County, Liberia

Table 4 Patients with at least one AE of specific interest, safety population, Study-T (>5 years)

Patients N (%)	ASAQ	AL	p-value
Patients N (%)	N = 496	N = 502	p-value
AEs “possibly related to study drug”	382 (77.0)	348 (69.3)	0.006
AEs ≥ grade 3	17 (3.4)	8 (1.6)	0.064
Fatigue (pooled) **	200 (39.8)	81 (16.3)	<0.001
Abdominal pain	29 (5.8)	18 (3.6)	0.091
Diarrhoea	20 (4.0)	14 (2.8)	0.279
Vomiting	35 (7.1)	8 (1.6)	<0.001
Vomiting after drug intake	2 (0.4)	0	0.247*
Nausea	16 (3.2)	5 (1.0)	0.015*
Hepatotoxicity ***	23 (4.6)	31 (6.3)	0.283
Rash	4 (0.8)	0	0.061*
Itching	0	0	-
Abnormal movements (Dystonia)	0	0	-
Neutropaenia	94 (19.0)	110 (21.9)	0.246
Anaemia	74 (14.9)	49 (9.8)	0.013
Thrombocytopaenia	4 (0.8)	0	0.061*

AE adverse event; * Fisher exact test; ** Frequencies of reported PTs “weakness”, “fatigue” and “asthenia” were pooled; *** defined as any or combination of the following AEs: hepatitis, hepatomegaly, AST and/or ALT increased, jaundice.

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