Baseline characteristic | Model-building dataset (n = 48) | MQ validation dataset (n = 378) | MQ pharmacokinetic–pharmacodynamic analysis dataset (n = 451) | |||
---|---|---|---|---|---|---|
Value | % or range | Value | % or range | Value | % or range | |
Demographic characteristics | ||||||
Sex (male/female) (no.) | 19/29 | 40/60 | 183/195 | 48/52 | 219/232 | 49/51 |
Median age (year) | 2.6 | 0.6–5.0 | 2.3 | 0.5–5.0 | 2.4 | 0.5–5.0 |
Median body weight (kg) | 12 | 7–17 | 11 | 5–18 | 11 | 5–19 |
Median height/length (cm) | 89 | 66–114 | 85 | 62–114 | 86 | 60–114 |
Physiological characteristics | ||||||
Total bilirubin (μmol/L) | 10 | 1–77 | 10 | 0.4–74 | 17 | 0.5–163 |
Serum creatinine (μmol/L) | 42 | 3–119 | 36 | 2–86 | 40 | 3–120 |
Haematocrit (%) | 31 | 17–49 | 30 | 16–59 | 30 | 17–62 |
Haemoglobin (g/dL) | 10 | 5–15 | 9 | 5–18 | 9 | 5–19 |
AST (IU) | 39 | 5–302 | 34 | 7–576 | 39 | 5–680 |
ALT (IU) | 19 | 7–449 | 16 | 4–378 | 18 | 3–814 |
Baseline parasite counts (no/μL) | ||||||
Median at day 0 | 58,131 | 3322–190,896 | – | – | – | – |
Median at day 1 | 280 | 0–13,816 | – | – | – | – |
Median at day 2 | 0 | 0–100 | – | – | – | – |
Co-administered drugs | ||||||
CYP3A4 inducers (at least for one drug measurement/never) (no.) | 7/41 | 15/85 | – | – | – | – |