TABLE 1.
Clinical datae
| Characteristica | Values | No. (%) subjects with data available |
|---|---|---|
| Median (range) value for: | ||
| GA (wk)b | 38 (32–39) | 10 (7)b |
| PNA (yr) | 7.9 (0.1–20.2) | 153 (100) |
| WT (kg) | 30.8 (2.4–147.9) | 153 (100) |
| SCR (mg/dl) | 0.5 (0.1–5.9) | 117 (77) |
| AST (U/liter) | 31 (12–291) | 56 (37) |
| ALT (U/liter) | 42 (9–282) | 57 (37) |
| TBIL (mg/dl) | 0.5 (0.1–11.1) | 54 (35) |
| DBIL (mg/dl) | 0.2 (0–8.5) | 19 (12) |
| ALB (g/dl) | 3.4 (1.7–4.8) | 78 (51) |
| No. (%) of male subjects | 82 (54) | 153 (100) |
| No. (%) of subjects by race | 153 (100) | |
| White | 109 (71) | |
| Black | 29 (19) | |
| Unknown | 3 (2) | |
| Others | 12 (8) | |
| No. (%) of subjects by ethnicity | 153 (100) | |
| Hispanic | 26 (17) | |
| Not Hispanic | 123 (80) | |
| Unknown | 4 (3) | |
| No. (%) of obese subjectsc | 53 (35) | 153 (100) |
| No. (%) of subjects receiving the following drug formulation: | 153 (100) | |
| Oral suspension | 78 (51) | |
| Tablets | 75 (49) | |
| No. (%) of subjects receiving drug by the following route: | 153 (100) | |
| Oral | 125 (82) | |
| Gastrostomy | 17 (11) | |
| Othersd | 11 (7) |
a
Descriptive statistics are calculated on the basis of the values at the time of first recorded dose. GA, gestational age; PNA, postnatal age; WT, total body weight; SCR, serum creatinine concentration; AST, aspartate aminotransferase concentration; ALT, alanine aminotransferase concentration; TBIL, total bilirubin concentration; DBIL, direct bilirubin concentration; ALB, serum albumin concentration.
b
For infants of <120 days postnatal age (n = 10).
c
Body mass index, ≥95th percentile. The body mass index was not assessed for subjects <2 years of age.
d
Others include the nasogastric, orogastric, or nasojejunal route or administration by jejunostomy.
e
Data are for 153 subjects.