Table 1.
Baseline characteristics of patients in three distinct clinical trials included in the population pharmacokinetic analysis
| Parameter | Value for study groupa |
||
|---|---|---|---|
| Pediatric Indian (n = 53) | Adult Indian (n = 26) | Adult European (n = 17) | |
| Indication | VL | VL | CL |
| Ethnicity | Indian | Indian | Caucasian |
| No. of patients [no. male/no. female] | 39 [23/16] | 40 [30/10] | 31 [30/1] |
| Age (yr) | 7 (3–11) | 18.5 (12–50) | 24 (19–49) |
| Height (cm) | 108 (80–135) | 152.5 (108–180) | 184 (175–200) |
| Body wt (kg) | 15 (9–23) | 35.5 (16–58) | 85 (70–113) |
| Fat-free mass (kg)b | 13.9 (8.58–22.6) | 31.6 (15.4–49.3) | 64.6 (52.9–81.2) |
| Body mass index (kg m−2) | 12.8 (9.57–15.7) | 15.2 (11.0–23.2) | 25.1 (20.0–28.8) |
| No. of PK measurementsc | 4 (4–4) | 18 (16–19) | 11 (8–19) |
a
All values are median values (range) unless stated otherwise. CL, cutaneous leishmaniasis; VL, visceral leishmaniasis; PK, pharmacokinetic.
b
Fat-free mass was calculated by the formula of Janmahasatian et al. (25).
c
Data represent measurements after start of treatment, per patient.