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Title: Time Course of Lab Test Values, Individual Subject

ClinLFTStatGraphicsForm edit

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Title Time Course of Lab Test Values, Individual Subject
Graph_Subgroup Labs Liver
Labs_Liver_Clinical_Question

Description This graphic depicts line plots of multiple lab parameters for an individual subject over time. Each subject of interest would have an individual graphic. Having study drug administration on the same graph can be especially helpful when study drug is interrupted, stopped, or dose level is changed. The x-axis represents the study day and the negative values are indicative of pre-treatment or screening. Annotations are added for study drug exposure and day of outcome if applicable (outcome can be defined as necessary). The y-axis represents the ‘times upper limit of normal’ for the parameters graphed 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 of 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 (data set variable ‘lbstresn’) in numeric units by the standard high range limit (data set variable ‘lbstnrhi’). Original units can be substituted if needed as the upper limit or normal is normalized (has no units). There are reference lines for the standard values of interest (2xULN and 3xULN for this example). The reference lines should be altered within the code to be appropriate for the specific parameters plotted. The y-axis is in log scale to allow for a wide range of values to be plotted. Note that the annotate function is used extensively to display labels, reference ranges and reference lines. Advanced programming may allow the substitution of macros for most of the annotate function procedures. Additional programming could be used to created a shaded band for the treatment period, if preferred over the arrows on the x-axis.

For the ‘Outcome’ vertical reference line on the graph, various substitutions can be made or footnotes added to describe the outcome (i.e. an efficacy objective could be noted or a specific safety concern could be described).
Contributor/Email Robert Gordon (rgordon2@its.jnj.com)
Background This graphic was created to mimic an image found in a 2008 article, http://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/ucm076777.pdf
Keywords Line plot, liver function, longitudinal, time
References http://www.fda.gov/downloads/Drugs/ScienceResearch/ResearchAreas/ucm076777.pdf
Datasets

CDISC_Data ADLBC
Data_Format

CLASSIFICATIONS

Graph_Type Line Plot
Variable_Relationship Continuous versus Continuous
Data_Types Continuous
Special_Considerations As mentioned previously, the annotate function is used extensively to display labels, reference ranges and reference lines. Advanced programming may allow the substitution of macros for most of the annotate function procedures.

Code_Available Yes
Software Program SAS
Software

R-Code - Attachment

R-Code

SAS-Code - Attachment Gordon - Time Course Lab Values - SAS - Doc
Stata-Code - Attachment

Stata-Code

Other Code - Attachment

Other Code

Disclaimer The views expressed within CTSpedia are those of the author and must not be taken to represent policy or guidance on the behalf of any organization or institution with which the author is affiliated.
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.

THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF ERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT OLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE.
Reference Image Gordon_TimeCourseTest_200.png
Topic revision: r6 - 18 Jun 2012 - 11:32:41 - MaryBanach
 

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