TABLE 4.
Shift from baseline to the highest postbaseline value for hepatic enzymes and bilirubina
| Baseline result | Highest postbaseline result | No. of subjects of the following age with the indicated result/total no. of subjects tested (%): |
||||
|---|---|---|---|---|---|---|
| All subjects ages 0 to <2 yr (n = 23) | All subjects ages 2 to <6 yr (n = 17) | All subjects ages 6 to <12 yr (n = 34) | Subjects ages 12 to 17 yr receiving treatment i.v. (n = 10) | All subjects (n = 84) | ||
| ALT concn (U/liter) | ||||||
| Normal (≤ULN) | ≥3×ULN to 10×ULN | 0 | 1/13 (7.7) | 0 | 0 | 1/63 (1.6) |
| Overall | ≥3×ULN to 10×ULN | 0 | 1/16 (6.3) | 0 | 0 | 1/74 (1.4) |
| ≥10×ULN | 1/19 (5.3) | 0 | 0 | 0 | 1/74 (1.4) | |
| AST concn (U/liter) | ||||||
| Normal (≤ULN) | ≥3×ULN to 10×ULN | 0 | 0 | 1/23 (4.3) | 0 | 1/58 (1.7) |
| Overall | ≥3×ULN to 10×ULN | 1/19 (5.3) | 1/16 (6.3) | 1/29 (3.4) | 0 | 3/74 (4.1) |
| ≥10×ULN | 0 | 0 | 0 | 0 | 0 | |
| Bilirubin (total) concn (mg/dl) | ||||||
| Normal (≤ULN) | >ULN to 2×ULN | 1/20 (5.0) | 1/15 (6.7) | 0 | 0 | 2/71 (2.8) |
| Overall | ≥3×ULN to 10×ULN | 0 | 0 | 0 | 0 | 0 |
| ≥10×ULN | 0 | 0 | 0 | 0 | 0 | |
a
ALT, alanine aminotransferase; AST, aspartate aminotransferase; i.v., intravenous; ULN, upper limit of normal.