Table 2.

Effects of trial treatment on early and later mortality and on permanent disability in Africa (three study sites), Asia (one study site), and all four study sites

	Africa (three study sites)		Asia (one study site)		All four study sites
	Artesunate (N=3041)	Placebo (N=2999)	Artesunate (N=3031)	Placebo (N=2997)	Artesunate (N=6072)	Placebo (N=5996)	Significance
Death by 7–30 day follow-up*
Death in 0–6 h (at a median of 2 h)	42	39	14	12	56	51	NS
Reached clinic in 0–6 h (∼3 h†), died after hour 6	42	47	29	28	71	75	NS
Still not in clinic at 6 h (∼15 h†), died after hour 6	25	47	2	4	27	51	p=0·0039
Alive at 7–30 day follow-up, but with permanent disability‡
CNS HIV or CNS tuberculosis	1	0	0	1	1	1	NS
Sequelae of cerebral malaria	1	12	0	0	1	12	p=0·0020
Overall
Death/permanent disability	111 (3·6%)	145 (4·8%)	45 (1·5%)	45 (1·5%)	156 (2·6%)	190 (3·2%)	p=0·0484

NS=not significant.

^*Seven vs seven of the deaths (all in Africa) could not have been affected by the trial capsule (four vs four patients: capsule expelled intact and not re-inserted, plus three vs three patients: death attributed blindly by endpoint review committee to a disease other than malaria).

^†Median time (for those with an adverse outcome) to arrival at clinic, or prior death (ie, death without arrival at clinic).

^‡One vs one permanent disability could not have been affected by trial capsule (one HIV CNS disease in Africa, one tuberculosis meningitis in Asia; both died after 7–30 day follow-up). All other cases of permanent disability were from CNS malaria in children in Africa, and all were severe; five, all in the placebo group, died after 7–30 day follow-up.