TABLE 1.
Demographic and clinical characteristics stratified by age groupd
| Characteristic | Value(s) for subjects in the following age groups: |
||||
|---|---|---|---|---|---|
| 0 to <2 yr | 2 to <6 yr | 6 to <12 yr | 12 to 17 yr | Total | |
| No. of subjects | 22 | 17 | 34 | 23 | 96 |
| Median (range) wt (kg) | 8.05 (3.8–14.6) | 14.5 (11.0–25.4) | 27.85 (11.3–105.0) | 63.0 (28.6–84.0) | 23.0 (3.8–105.0) |
| Median (range) postnatal age (yr) | 0.6 (0.0–1.8) | 3.1 (2.0–5.0) | 7.5 (6.0–11.0) | 15.0 (12.0–17.0) | 7.0 (0.0–17.0) |
| Median (range) PMA (wk)a | 71.6 (39.6–144.3) | 234 (147.0–344.4) | 473.6 (356.0–653.0) | 865 (666.1–972.1) | 411.0 (39.6–972.1) |
| No. (%) of female subjects | 10 (45) | 8 (47) | 17 (50) | 18 (78) | 53 (55) |
| No. (%) of white subjects | 20 (91) | 13 (76) | 28 (82) | 20 (87) | 81 (84) |
| No. (%) of non-Hispanic subjects | 18 (82) | 16 (94) | 25 (74) | 18 (78) | 77 (80) |
| Median (range) serum creatinine concn (mg/dl) | 0.30 (0.10–0.77) | 0.30 (0.12–0.61) | 0.39 (0.20–0.88) | 0.60 (0.32–1.2) | 0.39 (0.10–1.2) |
| Median (range) AST concn (U/liter) | 36.0 (18.0–97.0) | 27.0 (11.0–84.0) | 27.0 (14.0–93.0) | 24.0 (13.0–96.0) | 28.0 (11.0–97.0) |
| Median (range) ALT concn (U/liter) | 22.0 (9.0–115) | 14.0 (5.0–84.0) | 24.0 (6.0–73.0)b | 27.0 (6.0–205.0) | 23.0 (5.0–205.0)c |
| Median (range) albumin concn (g/dl) | 3.5 (2.3–4.6) | 3.2 (1.4–4.5) | 3.6 (1.5–4.9) | 3.7 (2.3–4.8) | 3.6 (1.4–4.9) |
a
Postmenstrual age (PMA) was calculated as postnatal age (PNA; in weeks) + gestational age (GA; in weeks), calculated using the value at the time of the first study dose. Missing GA was imputed as 40 weeks for the calculation of PMA.
b
Data for this variable were available for 33 subjects.
c
Data for this variable were available for 95 subjects.
d
Descriptive statistics were calculated on the basis of the value at the time of the first dose. AST, aspartate aminotransferase; ALT, alanine aminotransferase.