Output Tab Descriptions | Clinical | Hy’s Law Screening

Hy’s Law Screening
The Hy’s Law Screening tab is shown below:
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 log2 transformed (this can be changed to log10 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.
One Data Filter.
Filter the data by Hy’s Law case, elevated AT tests, treatment, sex, or race.