Processes | Clinical | Exposure Summary

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:
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.