Time Lag (in Days) for Classifying Hy’s Law Cases

Use the field or slider to specify a lag time for classifying a subject as a Hy's Law case.

The default value of 0 days indicates that a subject is a Hy’s Law case if Transaminase measurements (ALT or AST) exceed 3 times the upper limit of normal (3*ULN) and Total Bilirubin measurements exceed twice the specified ULN (2*ULN) from tests taken on the same study day. Alternatively, a time lag can be set to x number of days to classify a subject as a Hy's Law Case if Total Bilirubin exceeds 2*ULN within x days after ALT or AST exceeds 3*ULN.

For example, this value can be set to 30 in order to flag subjects as Hy's Law cases if a subject has BILI >= 2*ULN at any time within a month after elevated Transaminase measurements above 3*ULN.

Note: Points on the output scatter plots are colored according to the Hy's Law Case indicator variable generated by this report.

A contingency analysis in the output displays the frequency of Hy's Law occurrence among subjects categorized as Hy's Law Cases by treatment arm (in other words, how many days each subject had elevated liver test measurements as defined by Hy's Law). This analysis can be used to evaluate the possibility of drug induced liver injury (DILI).

Note: If you check the Set custom reference lines for Hy’s Law plots option and specify custom reference lines for Bilirubin and ALT/AST, these lines are used instead to classify Hy's Law logic.

To Specify a Time Lag for Classifying Hy’s Law Cases:

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Either enter the desired value in the text field or use the arrows to change the value.