Output Tab Descriptions | Clinical | Hy’s Law Screening

Hy’s Law Screening
The Hy’s Law Screening tab consists of the following elements:
One Overlay Plot of Hy's Law Lab Tests.
This plot shows maximum laboratory values for the Alanine Aminotransferase ( ALT ), Aspartate Aminotransferase ( AST ), Total Bilirubin ( BILI ), and Alkaline Phosphatase ( ALP ) laboratory tests. The values are log 2 transformed (this can be changed to log 10 or no transformation in the process dialog ) and normalized by the Upper Limit of Normal ( LBSTNRHI ). Reference lines are drawn by default at 3* ULN for ALT and AST and 2* ULN for BILI and ALP . These reference limits can be customized on the dialog.
These limits are also used to create the Hy's Law indicator flag. Subjects with a test value exceeding 3* ULN for ALT or AST (signs of hepatocellular injury) accompanied or followed by elevation of 2* ULN or greater for the BILI test will have a "Yes" value for the Hys Law Case variable created. A note defining the Hy's Law flag is located above the scatterplot matrix. For example, with the default settings the note is as follows: " Hys Law Cases are flagged if ALT or AST >= 3*ULN and BILI >= 2*ULN within 0 Days of ALT/AST peak. " You can change the number of days following ALT / AST elevation for which to look for BILI elevation to flag possible Hy's Law cases on the process dialog. Subjects in the plot are colored by the Hy's Law criteria ( red for "Yes", blue for "No") and marked by their treatment arm . You can choose to label the quadrants of Hy's Law (Cholestasis, Hy's Law, and Temple's Corollary) in the bottom left scatterplot through a check box option on the dialog.