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Title: Scatter Plot of Maximum Transaminase versus Maximum Total Bilirubin

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Title Scatter Plot of Maximum Transaminase versus Maximum Total Bilirubin
Graph_Subgroup Labs Liver
Labs_Liver_Clinical_Question

Description This graphic is based upon the eDISH (evaluation of Drug Induced Serious Hepatotoxicity) plot of Watkins et al in a 2008 publication from Hepatology. Maximum total bilirubin values (TBL) are plotted versus maximum alanine transaminase (ALT) values. Maximum values are defined as the maximum post-baseline value at any time during the entire length of the observation period. Both axes are in log scale to control for the dispersion of the data. The values are plotted in ‘times upper limit of normal’ where a value of 1 would mean that the result was normal. Any value above or below 1 would be considered above the upper limit or normal or below the upper limit of normal respectively. For instance, a value of 3 would be read as ‘3 times the upper limit of normal’. Upper limit of normal is calculated by dividing the standard result (variable ‘lbstresn’ within dataset) in numeric units by the standard high range limit (variable ‘lbstnrhi’ within dataset). Original units can be substituted if needed as the upper limit of normal is normalized (has no units). Reference lines are included to determine various states, based upon clinical interpretation of the values and includes the following:
• Hyperbilirubinemia TBL at least 2 xULN and ALT less than 3 xULN
• Normal Range TBL <= 1 xULN and ALT <= 1xULN
• Temple’s Corollary TBL <= 1 xULN and ALT at least 3 xULN
• Possible Hy’s Law TBL at least 2 xULN and ALT at least 3 xULN

This plot could easily be adjusted for other lab parameters and reference ranges as needed. Consultation with a clinical expert to determine which associations would be clinically meaningful and how to interpret those associations is recommended. No diagnosis is made on the basis of this graphic (peak values). Medical evaluation and introspection is required to investigate those peak values, including a detailed look into the narratives of the case(s). Note that if grayscale is used, adjustment to the symbols used would be necessary. A simple approach is to create a subset of data which includes all subjects of interest and their maximum lab test values.
Contributor/Email Robert Gordon (rgordon2@its.jnj.com)
Additional_Contributor_Info

Background Additional background information on the graphic
Keywords Hy's Law, eDISH, Scatter Plot, Liver, Hepatic
References Watkins P, Seligman P, Pears J, Avigan M, Senior J. Using controlled clinical trials to learn more about acute drug-induced liver injury, Hepatology 2008; Vol 8, No.5
Datasets

CDISC_Data ADLBC
Data_Format

CLASSIFICATIONS

Graph_Type Scatterplot
Variable_Relationship Continuous versus Continuous
Data_Types Continuous
Special_Considerations This example used the maximum ALT and maximum bilirubin values at any time during the study period and the maximum values need not be concurrent. Clinical input would be recommended at the planning stage to determine if values should be concurrent or not before programming. Proper interpretation depends on the understanding of the programming rules. The footnote on the graphic should be adjusted accordingly. Some examples of different constraints on the maximum values are as follows:
• Maximum values are those maximum values that occur post-baseline (no time constraints and not necessarily concurrent events)
• Maximum values are chosen by determining the maximum post-baseline TBL value and including the corresponding ALT value for that visit. In addition, the maximum post-baseline ALT value is determined and the corresponding TBL value for that visit is included. This brings about 2 pairs of values for a subject.
• Maximum value is considered the maximum TBL within 30 days after the maximum post-baseline ALT.
Code_Available Yes
Software Program SAS
Software SAS version 9.2 utilized for this program, although the program should run in SAS version 9.1 as well
R-Code - Attachment

R-Code

SAS-Code - Attachment Gordon - Scatter Peak ALT - SAS - Doc
SAS-Code - v9.2 - Attachment

Stata-Code - Attachment

Stata-Code

Other Code - Attachment

Other Code

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Reference Image MaxBilirubin_200.png
Topic revision: r13 - 28 Nov 2012 - 11:22:23 - MaryBanach
 

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