Exposure Summary

This process generates an exposure plot for all subjects in a study for an investigational product by dose and exposure time for the safety population by treatment. Summaries of exposure duration for subjects are also produced along with a static report of counts of total duration periods for subjects. The duration report and summary can be produced for specific duration times only through use of a duration time windows list on the Exposure Duration tab. The exposure plot is generated for all subjects across any time of exposure.

What do I need?

This process requires several demographic- and exposure-related variables . These include:

•

USUBJID ,

•	a treatment variable ( the actual treatment received by each subject ( TRT01A ) ) ,

•	the planned treatment (intent-to-treat) for each subject ( TRT01P ), or the description of the planned treatment arm ( ARM ),

•	AGE , SEX , RACE, SITEID , EXDOSE , VISITNUM , EXSTDTC , and EXENDTC .

Variables can be taken either from the subject level analysis data set ( ADSL ) included in the Analysis Data Model ( ADaM ) folder or from the DM and EX domains in SDTM . Refer to Localization-Specific Value Specification for more information about these data sets.

Output/Results

The output generated by this process is summarized by a tabbed report. Refer to the Exposure Summary output documentation for detailed descriptions and guides to interpreting your results.