Table 5.
Secondary efficacy endpoints (mITT population) for patients treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria*
| Endpoint | Adults (n = 599) | Children (n = 877) |
|---|---|---|
| Parasite clearance time (hours) | ||
| Median (95% CI)† | 42.3 (41.5–43.2) | 35.3 (31.7–35.7) |
| Mean ± SE† | 47.3 ± 1.6 | 33.2 ± 0.6 |
| ≤ 48 hours, no. (%) | 471 (78.6) | 792 (90.3) |
| > 48 hours, no. (%) | 102 (17.0) | 60 (6.8) |
| Not achieved, no. (%) | 26 (4.3) | 25 (2.9) |
| Fever clearance time (hours) | ||
| Median (95% CI)† | 28.5 (22.3–34.0) | 7.9 (7.9–8.0) |
| Mean ± SE† | 37.4 ± 1.8 | 25.2 ± 1.9 |
| Gametocytes, no. (%) | ||
| Baseline | 58/596 (9.7%) | 45/877 (5.1%) |
| > 0–72 hours | 90/597 (15.1%) | 90/869 (10.4%) |
| > 72 hours–day 7 | 42/543 (7.7%) | 14/828 (1.7%) |
| > Day 7 | 23/554 (4.2%) | 8/846 (0.9%) |
*
mITT = modified intent-to teat; CI = confidence interval. The time at which parasite clearance and fever clearance were assessed varied between studies.
†
Kaplan Meier estimates; if the last observation is censored, the mean is underestimated.