Hy’s Law Screening

This analysis visualizes peak values for lab measurements pertaining to Hy’s Law for detecting potential liver toxicity for all subjects across treatment arms . Lab measurements for Bilirubin (BILI), Alanine Aminotransferase ( ALT ), Aspartate Aminotransferase (AST), and Alkaline Phosphatase (ALP) are divided by the upper limit of normal (ULN) and displayed in a scatterplot matrix annotated with Hy's Law reference lines (2*ULN of BILI, 3*ULN of ALT).

Note : As of JMP Clinical 4.1, you can specify that baseline reference values be used for Hy's Law screening instead of the traditional computation of values in reference to the Upper Limit of Normal ( ULN ).

This analysis also creates reports of the distributions of relevant liver test variables , tables of missing tests and categorized liver elevation levels, and displays of the peak liver test values by Study day.

What do I need?

This analysis requires several demographic- and laboratory-related variables. These include:

•

USUBJID ,

•

a treatment variable ( the actual treatment received by each subject ( TRT01A ), or the planned treatment (intent-to-treat) for each subject ( TRT01P ), or the description of the planned treatment arm ( ARM ), and

•

LB variables ( LBTEST, LBTESTCD , LBSTRESN , LBBLFL , LBDTC, LBSTNRHI , and LBSTNRLO ).

Variables can be taken either from the subject level analysis data set ( ADSL ) included in the Analysis Data Model ( ADaM ) folder or from the DM , and LB domains in SDTM .

Data from the Basic Data Structure (BDS) ADaM data sets can also be used for selected JMP Clinical Findings Reports. BDS variables are required and equated with SDTM variables, as follows: PARAMCD = xxTESTCD , AVAL = xxSTRESN , where xx indicates the specific two letter SDTM findings domain ( LB , EG , or VS ). In addition, when BDS is used, AVALC substitutes for xxSTRESC .

Refer to Localization-Specific Value Specification for more information about these data sets.

Note : This analysis can still be run on a blinded study but certain components of the reports are suppressed.

This process requires lab results for bilirubin, alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase. At least one of the standardized short name character strings listed in the following table must be present in the LBTESTCD column for each lab result.


Lab Test ¹ :	Required String:
Bilirubin	Either BILI or TBIL Note : If neither BILI nor TBIL are found, the processes searches for and uses TBILI , TBL , BILT , BILTOT , and BIL (in that order).
Alanine Aminotransferase	Either ALT , ALAT , or SGPT
Aspartate Aminotransferase	Either AST , ASAT , or SGOT
Alkaline Phosphatase	Either ALP or ALKP Note : If neither ALP nor ALKP are found, the process searches for and uses ALK and APH , in that order.

Note : You can specify the correct tests on the Tests tab of the dialog if the relevant tests are not coded using the common strings listed here,

Output/Results

The output generated by this process is summarized by a tabbed report. Refer to the Hy’s Law Screening output documentation for detailed descriptions and guides to interpreting your results.