Table 3.
Effects of trial treatment (artesunate or placebo) on death or permanent disability, subdivided by study site and time taken to reach clinic
|
Risk of death in 0–6 h (median 2 h) for all patients |
Risk of later death/disability (if survived >6 h)*Reached clinic in 0–6 h? |
|||||
|---|---|---|---|---|---|---|
| Artesunate | Placebo |
Yes (∼3 h†) |
No (∼15 h‡) |
|||
| Artesunate | Placebo | Artesunate | Placebo | |||
| Africa (age 6–72 months) | ||||||
| Handeni, Tanzania | 22/726 | 21/737 | 15/286 | 17/292 | 17/418 | 33/424 |
| Kilosa, Tanzania | 11/1170 | 6/1169 | 8/542 | 11/539 | 8/617 | 14/624 |
| Navrongo, Ghana | 9/1145 | 12/1093 | 19/816 | 26/798 | 2/320 | 5/283 |
| All in Africa | 42/3041 (1·4%) | 39/2999 (1·3%) | 42/1644 (2·6%) | 54/1629 (3·3%) | 27/1355 (2·0%) | 52/1331 (3·9%) |
| Chittagong, Asia (by age) | ||||||
| 6–72 months | 5/1022 | 7/988 | 7/947 | 19/918 | 2/70 | 5/63 |
| Older child/adult | 9/2009 | 5/2009 | 22/1859 | 9/1879 | 0/141 | 0/125 |
| All in Asia | 14/3031 (0·5%) | 12/2997 (0·4%) | 29/2806 (1·0%) | 28/2797 (1·0%) | 2/211 (0·9%) | 5/188 (2·7%) |
| Total | ||||||
| Africa and Asia | 56/6072 (0·94%) | 51/5996 (0·85%) | 71/4450 (1·6%) | 82/4426 (1·9%) | 29/1566 (1·9%) | 57/1519 (3·8%) |
| Relative risk (95% CI) | 1·10 (0·75–1·61) | 0·86(0·63–1·18) | 0·49(0·32–0·77) | |||
| p value§ | 0·61 | 0·35 | 0·0013 | |||
Denominators=numbers surviving more than 6 h after entry, subdivided by whether patient reached clinic in 0–6 h. Time to clinic was recorded in all who died or had neurological damage; otherwise, it was recorded routinely only in Kilosa and Navrongo. For those who did not die in Handeni and Chittagong, it was recorded whether they reached a clinic. For this table it is assumed that, if they did die, the proportions doing so in 0-6 h were 50% in Handeni and 95% in Chittagong.
For those who reached clinic in 0–6 h and then died after hour 6, median time to arrival was 2 h in Chittagong and 4 h in Africa.
For those still not in clinic after more than 6 h who died, the median time to reach clinic (or to death without reaching clinic) was 15 h.
Relative risk (95% CI) and p value for artesunate versus placebo.