Table 1.

Sequential analytic steps in developing the composite plot, their function and use in review

Steps		Function	Use in review
Step 1: Pretreatment eDISH plot Scatterplot of pretreatment BILI and ALT values in ×ULN. Subjects are represented by colored symbols corresponding to the pretreatment quadrant:		Identifies subjects based on the degree of existing liver injury in an eDISH plot	What are the subjects’ test values before treatment? Identifies extent and relative proportions of abnormal liver tests in the population
Normal & NN	Temple’s Corollary
Cholestasis	Hy’s Law
Step 2: Peak on-treatment eDISH plot Subjects were replotted in an on-treatment eDISH scatterplot showing peak on-treatment BILI and ALT values in ×ULN		Identifies on-treatment migration path between each eDISH quadrant	Which subjects had more extreme ALT and BILI in the population? What is the subject’s origin and destination between different quadrants on eDISH plot? Identifies extent and relative proportions of subjects that migrate between pretreatment and peak on-treatment values
Step 3: Peak on-treatment composite plot (×BLN based) The peak on-treatment BILI and ALT values replotted from ×ULN to ×BLN in each of the eDISH quadrants		Treatment responses of subjects in each eDISH quadrant from Step 2 presented visually as ×BLN, to quickly assess liver tests’ rise or fall from BLN	For subjects within the ×ULN quadrant, how do the peak on-treatment values change compared with their individual pretreatment values? Identifies magnitude of increase or decrease of BILI and ALT values for subjects in each eDISH quadrant compared with their baseline Comparison of proportions of subjects that had liver tests worsen or stabilize/improve on treatment

ALT alanine aminotransferase, BILI total bilirubin, BLN baseline liver test value, eDISH electronic drug-induced serious hepatotoxicity, NN near normal, ULN upper limit of normal