Evaluation of two novel tablet formulations of artemether-lumefantrine (Coartem®) for bioequivalence in a randomized, open-label, two-period study

Table 4 Subjects with adverse events by body system and preferred term

		80/480 mg tablet	Four standard tablets	Total*	60/360 mg tablet	Three standard tablets	Total**
Body system	Preferred term	N = 58	N = 60	N = 60	N = 57	N = 60	N = 60
Body system	Preferred term	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
Any body system	Total	1 (1.7)	3 (5.0)	4 (6.7)	1 (1.8)	4 (6.7)	5 (8.3)
Gastrointestinal disorders	Vomiting	0 (0.0)	1 (1.7)	1 (1.7)	0 (0.0)	1 (1.7)	1 (1.7)
General disorders and administrative site conditions	Pyrexia	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (1.7)	1 (1.7)
Injury, poisoning and procedural complications	Excoriation	0 (0.0)	0 (0.0)	0 (0.0)	1 (1.8)	0 (0.0)	1 (1.7)
	Radius fracture	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)	1 (1.7)	1 (1.7)
	Navicular bone fracture	0 (0.0)	1 (1.7)	1 (1.7)	0 (0.0)	0 (0.0)	0 (0.0)
Investigations	Blood creatine phosphokinase increased	0 (0.0)	1 (1.7)	1 (1.7)	0 (0.0)	1 (1.7)	1 (1.7)
Investigations	Blood lactate dehydrogenase increased	1 (1.7)	1 (1.7)	2 (3.3)	0 (0.0)	0 (0.0)	0 (0.0)

*An overall summary for all subjects treated with 80/480 mg tablet or four standard tablets.
**An overall summary for all subjects treated with 60/360 mg tablet or three standard tablets.
A subject with multiple adverse events within a system organ class is counted only once in the total row.

ISSN: 1475-2875