Phase I randomized dose-ascending placebo-controlled trials of ferroquine - a candidate anti-malarial drug - in adults with asymptomatic Plasmodium falciparum infection

Table 3 Frequency of the most common adverse events during the single dose study

System organ class	Preferred term	Single Dose Study
		Placebo	Ferroquine
		(N = 10)	400 mg (N = 6)	800 mg (N = 6)	1200 mg (N = 6)	1400 mg (N = 6)	1600 mg (N = 6)
Any class	Any TEAE	9 (90)	3 (50)	1 (17)	6 (100)	6 (100)	4 (67)
Gastrointestinal disorders	Any TEAE	4 (40)	0	0	3 (50)	4 (67)	4 (67)
	Abdominal pain	3 (30)	0	0	0	3 (50)	2 (33)
	Diarrhoea	0	0	0	1 (17)	2 (33)	0
	Nausea	1 (10)	0	0	1 (17)	1 (17)	2 (33)
	Toothache	1 (10)	0	0	1 (17)	0	0
	Vomiting	0	0	0	1 (17)	1 (17)	2 (33)
Nervous system disorders	Any TEAE	2 (20)	0	0	3 (50)	1 (17)	3 (50)
	Dizziness	1 (10)	0	0	0	1 (17)	2 (33)
	Headache	1 (10)	0	0	3 (50)	1 (17)	1 (17)

NOTE: N (%): count of patients (percentage per group); TEAE: treatment emergent adverse event

ISSN: 1475-2875