Efficacy and safety of fixed dose combination of arterolane maleate and piperaquine phosphate dispersible tablets in paediatric patients with acute uncomplicated Plasmodium falciparum malaria: a phase II, multicentric, open-label study

Table 7 Adverse events

	Age group 1 (6 months to <2 years)	Age group 2 (2 to <6 years)	Age group 3 (6 to ≤ 12years)	Total (n = 141)
No. of patients with at least one adverse event	22 (100 %)	49 (100 %)	68 (97.1 %)	139 (98.6 %)
Clinical adverse events
Vomiting	9 (40.9 %)	21 (42.9 %)	5 (7.1 %)	35 (24.8 %)
Anaemia	1 (4.5 %)	7 (14.3 %)	13 (18.6 %)	21 (14.9 %)
Cough	2 (9.1 %)	4 (8.2 %)	2 (2.9 %)	8 (5.7 %)
Pyrexia	0 (0.0 %)	2 (4.1 %)	2 (2.9 %)	4 (2.8 %)
Diarrhoea	1 (4.5 %)	1 (2.0 %)	0 (0.0 %)	2 (1.4 %)
Otitis media	1 (4.5 %)	0 (0.0 %)	1 (1.4 %)	2 (1.4 %)
Headache	0 (0.0 %)	0 (0.0 %)	2 (2.9 %)	2 (1.4 %)
Hyperhidrosis	0 (0.0 %)	2 (4.1 %)	0 (0.0 %)	2 (1.4 %)
Abdominal pain	0 (0.0 %)	1 (2.0 %)	0 (0.0 %)	1 (0.7 %)
Nausea	0 (0.0 %)	1 (2.0 %)	0 (0.0 %)	1 (0.7 %)
Asthenia	0 (0.0 %)	1 (2.0 %)	0 (0.0 %)	1 (0.7 %)
Rhinitis	0 (0.0 %)	1 (2.0 %)	0 (0.0 %)	1 (0.7 %)
Varicella	0 (0.0 %)	1 (2.0 %)	0 (0.0 %)	1 (0.7 %)
Productive cough	1 (4.5 %)	0 (0.0 %)	0 (0.0 %)	1 (0.7 %)
Decreased appetite	0 (0.0 %)	1 (2.0 %)	0 (0.0 %)	1 (0.7 %)

ISSN: 1475-2875