Table 3.

Hepatic enzyme elevations by prior trial participation on the basis of investigator adverse event reporting, Medical Dictionary for Regulatory Activities preferred term

Hepatic Enzyme ElevationsFrom Replicating Evidence of Preserved Renal Function: An Investigation of Tolvaptan Safety and Efficacy in Autosomal Dominant Polycystic Kidney Disease Tolvaptan, n=505, n (%)From Replicating Evidence of Preserved Renal Function: An Investigation of Tolvaptan Safety and Efficacy in Autosomal Dominant Polycystic Kidney Disease Placebo, n=569, n (%)From Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes 4:4 Tolvaptan, n=717, n (%)Total, n=1800, n (%)aMedian Time to Elevation All Subjects, d (Interquartile Range)
ALT increased10 (2.0)23 (4.0)17 (2.4)51 (2.8)245 (127–460)
 Led to discontinuation1 (0.2)4 (0.7)3 (0.4)8 (0.4)
AST increased3 (0.6)4 (0.7)3 (0.4)10 (0.6)251 (129–460)
 Led to discontinuation0 (0.0)1 (0.2)1 (0.1)2 (0.1)
GGT increased9 (1.8)8 (1.4)2 (0.3)19 (1.1)391 (116–653)
 Led to discontinuation0 (0.0)1 (0.2)0 (0.0)1 (0.1)
  • ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, γ-glutamyltransferase.

  • a The table has no column for subjects who entered the extension directly from the Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes 3:4 or NOCTURNE trials due to the small number of subjects (n=9) from those trials. Data from these subjects were included in the total column and the calculation of median time to elevation.