Table 1.
Characteristics of Patients in the Population Pharmacokinetics (PK) and Outcomes Data Sets
| Parameter | Population PK Data Set (n = 101) | PK Outcomes Data Set (n = 100) |
|---|---|---|
| Malaria episodes, no. | ||
| Overall | 207 | 222 |
| Per child | ||
| 1 | 101 | 100 |
| 2 | 56 | 62 |
| 3 | 34 | 35 |
| 4 | 12 | 19 |
| 5 | 4 | 6 |
| Malaria episodes per child, no., median (range) | 1.9 (1–5) | 2.0 (1–5) |
| Episodes in male children, % | 47.3 | 47.8 |
| Weight, kg, median (range) | 9.1 (6.1–13.0) | 9.0 (6.1–13.3) |
| Total lumefantrine dose per treatment course, mg/kg, median (range) | 81.1 (55.4–118.0) | 80.0 (54.1–118.0) |
| Age, mo, median (range) | 14.4 (6.6–22.2) | 14.9 (6.6–24.2) |
| 6 to <12 | 50 | 49 |
| 12–18 | 120 | 126 |
| >18 to 24 | 37 | 47 |
| Hemoglobin level at diagnosis, g/dL, median (range) | 10.0 (5.6–15.9) | 10.0 (5.6–15.9) |
| Parasite density, parasites, geometric mean no./µL (95% CI) | 15 568 (128–159 393) | 17 603 (13 762–22 516) |
| HIV-infected children | ||
| Overall | 9 | 8 |
| Malaria episodes, no. | 16 | 18 |
| Episodes involving urban-resident children, no. (%) | Not included | 16 (7.2) |
| Episodes involving breast-feeding children, no. (%) | 95 | 101 (46) |
| Children receiving TMP-SMZ prophylaxis | ||
| Overall, no. | 47 | 43 |
| Malaria episodes, no. | 80 | 85 |
| Episodes in underweight children, no. (%) | 26 (12.6)a | 29 (13.1) |
Abbreviations: CI, confidence interval; HIV, human immunodeficiency virus; IQR, interquartile range; TMP-SMZ, trimethoprim-sulfamethoxazole.
a Median z score in the population PK data set was −0.74 (IQR, −3.63–2.08).