Table 2.
Patient demographics and baseline characteristics.1
| Median (range) / N (%) | ||
|---|---|---|
| Model Development Data Set |
Validation Data Set |
|
| Number of Subjects | 90 | 21 |
| Age (years) | 7 (0.1–24) | 2.4 (0.4–13.3) |
| Weight (kg) | 22 (3–101) | 13 (6.6–55.5) |
| Male/Female | 53(59%) / 37(41%) | 17(81%) / 4(19%) |
| Serum creatinine (mg/dL) | 0.3 (0.3–0.95) | 0.3 (0.3–0.55) |
| Creatinine clearance (mL/min/m2)2 | 169 (70–286) | 155 (96–222) |
| Alkaline phosphatase (IU/L) | 159 (46–1760) | 160 (101–289) |
| Aspartate aminotransferase (IU/L) | 30 (10–265) | 26 (17–39) |
| Alanine aminotransferase (IU/L) | 28 (5–525) | 19 (10–44) |
| Total bilirubin (mg/dL) | 0.6 (0.1–3.7) | 0.3 (0.1–0.5) |
1
Laboratory data was collected was just prior to the first dose of busulfan.
2
Creatinine clearance was estimated in children using the Schwartz method and in young adults by the Cockcroft-Gault equation using ideal body weight.