Reports | Exposure Summary

Exposure Summary
This report 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 s list on the Exposure Duration tab. The exposure plot is generated for all subjects across any time of exposure.
Report Results Description
Running Exposure Summary for Nicardipine using default settings generates the Report shown below.
The Report contains the following elements:
Exposure Summary
Displays three plots showing the percent of subjects who remain on the study medication by Day of Study, the distribution of doses by arm , and a list of dose descriptive statistics by ARM along with a Box Plot of doses.
It contains the following elements:
The first shows the percentage of subjects remaining in each arm (plotted on the Y axis) on each assayed day of the study (plotted on the X axis). The percentages in each arm are calculated by using the number of remaining subjects assigned to that arm as the numerator and the total count of subjects who have been assigned to the arm as the denominator.
The second plot shows the distribution of doses among each arm's subjects in terms of a percentage of the maximum total number of doses received throughout the study in each treatment arm.
Box Plot s and a table of descriptive statistics of the cumulative number of doses taken by treatment value.
Duration Distribution
Presents a Histogram for the total duration of exposure in terms of the number of days exposed to treatment.
It contains the following elements:
Presents a histogram for the total duration of exposure in terms of the number of days exposed to treatment. A second histogram summarizes the distribution of the treatment variable .
See Distribution for more information.
One Data Filter .
This enables you to subset subjects based on treatment, demographics, and study site. Refer to Data Filter for more information.
Note : You can toggle between viewing percentage or number of subjects by clicking Display Number/Percentage of Subjects Remaining on Study Medication .
Action Buttons
Action buttons, provide you with an easy way to drill down into your data. The following action buttons are generated by this report:
Profile Subjects : Select subjects and click to generate the patient profiles. See Profile Subjects for additional information.
Show Subjects : Select subjects and click to open the ADSL (or DM if ADSL is unavailable) of selected subjects.
Cluster Subjects : Select subjects and click to cluster them using data from available covariates . See Cluster Subjects for additional information.
Demographic Counts : Select subjects and click to create a data set of USUBJID s, which subsets all subsequently run reports to those selected subjects. The currently available filter data set can be applied by selecting Apply Subject Filter in any report dialog .
Click to generate a standardized pdf - or rtf -formatted report containing the plots and charts of selected sections.
Click the Options arrow to reopen the completed dialog used to generate this output.
Click the gray border to the left of the Options tab to open a dynamic report navigator that lists all of the reports in the review. Refer to Report Navigator for more information.
An Exposure Summary Report is also generated. Click the Open Exposure Summary link to view this report. It summarizes the dosing in terms of Subject Years, presents summary statistics of subjects’ exposure to treatment, the frequency of subjects within exposure categories (number and range determined by Number of Duration Time Windows and Duration Time Windows in the dialog), and the cumulative frequency within exposure categories. If Exposure Duration ( EXDUR ) is missing and end date/time of treatment ( EXENDT ) is incomplete or missing for a subject(s), the subject(s) are excluded from the min/max duration times in the report.
Two additional tables are included in this report:
The second Table (shown below) lists the changes in dosage each subject received over the course of the study. JMP Clinical uses data from USUBJID , EXTRT , EXDOSE , and EXDOSU to generate the list of subjects with dosage changes reported in the table (as shown in the diagram below).
The original dose and the changed dose are calculated using combined data from EXTRT / EXDOSE / EXDOSU. The date and reason the dosage was changed are provided by EXENDTC and EXADJ . The default response of Not Given is shown whenever EXADJ is either empty or non-existent.
Report Options
Report Option Descriptions
Specific documentation for each of the options can be viewed by clicking on the following links:
General Options
Treatment or Comparison Variable to Use , Treatment or Comparison Variable , Number of Bins for Dose Group
Subject Filter 1
Additional Filters
Additional Filter to Include Subjects 2 , Merge supplemental domain , Select the population to include in the analysis , By Variables
Exposure Duration
Duration Time Scale , Duration Time Window Method , Number of Duration Time Windows , Duration Time Windows

Subject-specific filters must be created using the Create Subject Filter report prior to your analysis.

For more information about how to specify a filter using this option, see The SAS WHERE Expression .