Table 3.

Adverse events

Type of adverse event	ASAQ	AL
	n = 123	n = 123	OR	p valuea
Vomiting of study drugs:
at least once	15	11	0.71 (0.31–1.61)	0.408
twice	6	3	0.49 (0.12–1.99)	0.318
	n = 117	n = 120	RR	p valueb
Deaths/hospitalizations	0	0
Anaemiac	82	78	0.90 (0.66–1.23)	0.511
Respiratory symptoms	27	25	0.90 (0.52–1.54)	0.692
Gastrointestinal symptoms	12	10	0.78 (0.34–1.81)	0.565
Dermatological symptoms	3	2	0.63 (0.10–3.76)	0.610
Other symptoms	2	2	0.95 (0.13–6.72)	0.956
Severity of adverse event
	n = 117	n = 120	RR	p valueb
Mild	57	46	0.72 (0.49–1.07)	0.104
Moderate	45	54	1.19 (0.80–1.77)	0.382
Severe	15	22	1.45 (0.75–2.79)	0.268
SAE	2	2	0.96 (0.13–6.80)	0.966

Please note:

Adverse events were classified by means of the Division of Microbiology and Infectious Diseases pediatric toxicity tables [18].

^a Tested by logistic regression.

^b Tested by Cox regression.

^c Defined as Hb concentration <10 g/dl (age <2 years) and <11 g/dl (age >2 years).

ASAQ, artesunate plus amodiaquine; AL, artemether-lumefantrine; OR, odds ratio; RR, relative risk

SAE, serious adverse even