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.

Note : JMP Clinical employs a special protocol for data including non-unique Findings test names. Refer to How does JMP Clinical handle non-unique Findings test names? for more information.

Refer to the Hy’s Law Screening requirements description for more information.

Running this process with the Nicardipine sample setting generates the report shown below.

The Report contains the following elements:

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Hy’s Law Screening : This tab displays an overall scatterplot of peak ALT , AST , BILI , and ALP measurements across the study, with color used to flag subjects meeting Hy's Law criteria.

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Scatterplots : This tab displays scatterplots of peak ALT , AST , BILI , and ALP measurements across the study, with color used to flag subjects meeting Hy's Law criteria. Two contingency analyses show duration of Hy's Law and incidence of ALT or AST elevation by treatment.

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Distributions (Hy’s Law Screening) : This tab displays a set of histograms and summary statistics for the Hy's Law case counts, first day of Hy's Law events, AT test counts and first day of elevation along with demographics.

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Tables : This tab contains tables corresponding to AT Test Elevation and Potential Hy’s Law Cases, as well as counts and percentages for elevation categories for each liver test.

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Tests by Study Day : This tab contains a scatterplot matrix of four liver tests, plotting their peak values for each study day for each subject.

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Missing Lab Test Summary : This tab contains a table showing counts of subjects for which the relevant Hy's Law lab tests were not measured.

Drill down buttons, provide you with an easy way to drill down into your data. The following drill down buttons are generated by this process:

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Profile Subjects : Select subjects and click

to generate the patient profiles. See Profile Subjects for additional information.

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Show Subjects : Select subjects and click

to open the ADSL (or DM if ADSL is unavailable) of selected subjects.

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Cluster Subjects : Select subjects and click

to cluster them using data from available covariates . See Cluster Subjects for additional information.

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Create Subject Filter : Select subjects and click

to create a data set of USUBJID s, which subsets all subsequently run processes to those selected subjects.

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Graph Time Profiles : Select subjects and click

to view a window of Hy’s Law Time Course Plot s for each.

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Liver Lab Shift Plots : Click

to launch and run liver labs ( ALT , AST , ALP , BILI , or the LBTESTCD values that correspond to these tests) Shift Plot s (and shift tables) via the Findings Shift Plots report on the data. This analysis currently runs using all subjects.

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Click

to generate a standardized pdf - or rtf -formatted report containing the plots and charts of selected sections.

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Click the Options arrow to reopen the completed process dialog used to generate this output.