TABLE 6.

Clinically significant elevations in serum bilirubin, hepatic transaminases, ALKP, and serum creatinine

Biochemical parameterCriterion for elevation (ULN)No. of patients receiving loading dose followed by 3 mg/kg (n/N)aNo. of patients receiving 4 mg/kg (n/N)
Bilirubin>1.51/275/27
ALT>32/273/27
AST>31/271/27
ALKP>30/250/26
Creatinine>1.30/260/27
  • a n, number of patients with abnormal values; N, number of patients studied and for whom serial laboratory values were recorded.