Table 1.
Summary of demographic and covariate data
| Parameter | Value for study |
|||||
|---|---|---|---|---|---|---|
| 1 (phase II) | 2 (phase III) | 3 (phase III) | 4 (phase III) | 5 (phase III) | All studies | |
| No. and description of subjects with pharmacokinetic data | 57 African children with falciparum malaria | 268 African and Asian children and adults with falciparum malaria | 196 African children and adults with falciparum malaria | 23 Asian children and adults with vivax malaria | 87 African children with falciparum malaria | 631 |
| Median artesunate dose (mg/kg) (interquartile range) | 3.4 (2.8, 3.9) | 3.3 (3.0, 3.6) | 3.3 (2.9, 3.9) | 3.4 (3.0, 3.7) | 3.0 (2.6, 3.3) | 3.3 (2.9, 3.6) |
| Median age of subjects (yr) (interquartile range) | 5 (4, 6) | 24 (19, 35) | 11 (8, 17) | 19 (14, 34) | 5 (3, 7) | 14 (7, 25) |
| Median wt of subjects (kg) (interquartile range) | 16 (14, 20) | 50 (44, 56) | 30 (25, 48) | 47 (35, 53) | 17 (14, 20) | 38 (22, 52) |
| % male subjects | 51 | 77 | 46 | 61 | 48 | 61 |
| Median parasite count (per μl) (interquartile range) | 6,304 (2,051, 14,926) | 12,838 (5,843, 31,168) | 12,607 (3,363, 29,408) | 10,275 (3,757, 15,692) | 10,074 (1,994, 44,068) | 11,462 (3,569, 29,060) |
| No. of patients administered granules | 15 | 0 | 0 | 0 | 87 | 102 |
| No. of patients <12 yr of age | 56 | 23 | 104 | 4 | 87 | 274 |