Table 3.
Proportion of Patients with Liver Function Test Elevations
| Parameter | Patients [n (%)] (N = 57)* |
|---|---|
| ALT or AST | |
| >3× ULN | 11 (19.3) |
| >5× ULN | 5 (8.8) |
| >8× ULN | 3 (5.3) |
| Alkaline phosphatase | |
| >1.5× ULN | 1 (1.8) |
| Total bilirubin | |
| >1.5× ULN | 0 |
Definition of abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal.
Patients with multiple events were counted once in the worst applicable cutoff category.
*
Number of subjects with at least one nonmissing measurement during the period from initiation of study drug to 28 days following last dose.