Liver injury / hepatotoxicity incidence

Method

Proportion of participants with an adjudicated hepatic injury event, defined by the trial as transaminase or bilirubin elevation above a stated protocol threshold (commonly three or five times the upper limit of normal) with or without symptoms, pooled as a risk ratio.

The method is part of the endpoint identity. Studies measuring the same quantity by a different method are held as separate endpoints.

Notes

A dichotomised, adjudicated event. Its near-miss is the continuous serum aminotransferase nodes, alanine and aspartate aminotransferase, drawn from the same assays: in PMID 18054420 aspartate aminotransferase rose moderately with maca while no hepatic adverse event was declared. A shift in a group mean and a count of participants crossing a clinical threshold are different questions, and a mean can move with no individual crossing the line. Distinct also from gamma-glutamyl transferase, which is a cholestatic rather than hepatocellular marker.