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Title: Frequency Plot of the Change from Baseline in Alanine Aminotransferase by Visit

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Title Frequency Plot of the Change from Baseline in Alanine Aminotransferase by Visit
Graph_Subgroup Labs Liver
Labs_Liver_Clinical_Question
Gen: Are there graphics which can AID in determining emerging safety signals?
Description This is a frequency line plot comparing the change from baseline in Alanine Aminotransferase between the placebo and active groups at each visit. The x-axis represents the change from baseline in appropriate units (U/L) for the lab parameter and the y-axis represents the frequency or count of observations with the specific change from baseline values. For this graphic, the bin size (how the x-axis values are grouped as it is a continuous variable) is every integer. In other words, all values within the database are rounded to an integer before graphed. The bin size should be adjusted depending on the data. A reference line at zero is included to indicate no change from baseline. The location of this reference line can be altered within the code as needed for alternate lab parameters.

The interpretation of the curve would be dependent upon the lab parameter graphed and the clinical effect(s) expected. However, it should be noted that no difference between active and placebo would be indicated by a curve for active treatment being similar in shape to the placebo curve and seeming to be overlaid on top of the placebo curve. An active curve that is noticeably shifted to the right would indicate a possible larger change from baseline in the active group. Likewise, an active curve that is noticeably shifted to the left would indicate a possible smaller change from baseline as compared to the placebo group.

*Note: The current graph has all data for all subjects at each visit, it is not limited to the maximum value at a specific visit.
Contributor/Email Robert Gordon (rgordon2@its.jnj.com)
Additional_Contributor_Info

Background This graphic was inspired by an original figure created by Christy Chuang-Stein et al as depicted in the article ‘Recent advancements in the analysis and presentation of safety data’, Drug Information Journal, Vol. 35, pp. 377–391, 2001
Keywords Frequency Plot, Line plot, Change, Baseline
References

Datasets CDISC Datasets
CDISC_Data ADLBC
Data_Format

CLASSIFICATIONS

Graph_Type

Variable_Relationship Continuous versus Continuous
Data_Types Continuous
Special_Considerations

Code_Available Yes
Software Program SAS
Software

R-Code - Attachment

R-Code

SAS-Code - Attachment Gordon - Frequency Plot - SAS Code
SAS-Code - v9.2 - Attachment

Stata-Code - Attachment

Stata-Code

Other Code - Attachment

Other Code

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Permission Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions:

The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software.

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Reference Image Gordon_FreqPlot_200.png
Topic revision: r5 - 21 Nov 2013 - 13:31:34 - MaryBanach
 

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