Table 7.

Adverse events potentially related to hypersensitivity reactions occurring in > 1 adult or > 1 child, according to time after start of artemether-lumefantrine treatment (day 0) (safety population) for uncomplicated Plasmodium falciparum malaria

Adverse event	Adults, no. (%)					Children, no. (%)
Days, preferred term	0–3 (n = 647)	4–10 (n = 625)	11–28 (n = 596)	> 28 (n = 224)	Total (n = 647)	1–3 (n = 1,332)	4–10 (n = 1,306)	11–28 (n = 1,280)	> 28 (n = 910)	Total (n = 1,332)
Any event	18 (2.8)	6 (1.0)	2 (0.3)	1 (0.4)	26 (4.0)	14 (1.1)	13 (1.0)	20 (1.6)	11 (1.2)	56 (4.2)
Rash	16 (2.5)	3 (0.5)	2 (0.3)	1 (0.4)	21 (3.2)	11 (0.8)	9 (0.7)	13 (1.0)	6 (0.7)	38 (2.9)
Urticaria	2 (0.3)	2 (0.3)	0	0	4 (0.6)	1 (0.1)	1 (0.1)	0	0	2 (0.2)
Face edema	0	1 (0.2)	0	0	1 (0.2)	0	1 (0.1)	0	0	1 (0.1)
Dermatitis	0	0	0	0	0	0	0	4 (0.3)	2 (0.2)	5 (0.4)
Eczema	0	0	0	0	0	0	1 (0.1)	1 (0.1)	0	2 (0.2)
Pustular rash	0	0	0	0	0	1 (0.1)	0	1 (0.1)	0	2 (0.2)
Allergic conjunctivitis	0	0	0	0	0	0	0	1 (0.1)	0	1 (0.1)
Atopic dermatitis	0	0	0	0	0	0	0	0	1 (0.1)	1 (0.1)
Infected dermatitis	0	0	0	0	0	0	0	0	1 (0.1)	1 (0.1)
Hypersensitivity	0	0	0	0	0	0	0	1 (0.1)	0	1 (0.1)
Oropharyngeal blistering	0	0	0	0	0	0	0	0	1 (0.1)	1 (0.1)
Maculo-papular rash	0	0	0	0	0	0	1 (0.1)	0	0	1 (0.1)
Face swelling	0	0	0	0	0	1 (0.1)	0	0	0	1 (0.1)