Background incidence of liver chemistry abnormalities in pediatric clinical trials for conditions with and without underlying liver disease.

Background: The FDA provides guidance regarding pre-marketing liver chemistry subject stopping criteria. This study was undertaken to determine the background rates of liver chemistry abnormalities in pediatric clinical trials for conditions with and without underlying liver disease (LD).

Methods: The study included 5410 subjects aged 0-18years in 24 trials for conditions without LD.