There were four patients who had concomitant alkaline phosphatase (ALP) >2 × ULN within a 3-day period, whilst the remaining patient showed concomitant ALP <2 × ULN within a 3-day period with a serious AE of immune-mediated hepatitis (meeting the criteria for Hy’s law [ALT or AST >3 × ULN; total bilirubin >2 × ULN; no initial findings of cholestasis [no elevation of ALP to >2 × ULN]; and no other reason for the increase in ALT and bilirubin] [35]). This evidence concerns the gene GPT and cholestasis.