JMP Clinical Basics | Distribution Reports | Distribution Workflow Summary

Distribution Workflow Summary
The following diagram outlines the analysis performed to summarize adverse events count and percent calculations for the AE Distribution report.
Distribution Workflow Steps
Apply Domain Filters
Three parameters, Include serious adverse events only , Event Type and Offset for End of Dosing , are used to specify a domain filter.
Available options are described in the following table:
Event Type options rely on the available Date/Time start and end variables referenced above. Options include:
AESDTC before RFXSTDC , for example
Use the optional Offset for End of Dosing for specifying end of dosing (to account for drug half-life, for example).
Use the optional Offset for End of Dosing for specifying end of dosing (to account for drug half-life, for example).
You can also use the Include the following adverse events: and Filter to Include Adverse Events options based on user-customized condition and/or on new/modified/stable records (when JMP Clinical snapshot comparison is being used)
Apply Subject Filters
These options filter the available subjects to use for the analysis and impact both the counts of adverse events (relevant events are considered only for subject in the analysis population) as well as for computing denominators to perform subject percent calculation.
Three parameters, Subject Filter , Additional Filter to Include Subjects and Select the population to include in the analysis , are used to specify a domain filter.
Available options are described in the following table:
Data set containing USUBJID values of subject to include in analysis. These data sets can be created from most of the JMP Clinical reports.
General user-customized condition (enter Sex = "F" to only include females in the analysis, for example).
Detect Crossover Study
If an ADSL table is defined and contains multiple treatment periods ( TRTxxP for example) and treatment period start/stop dates, ADSL is merged in and the corresponding treatment and period is assigned based on comparison with AESDTC .
Calculate Demographic Group Denominators
Fixed adverse event frequency/percent values are not computed and output in the results data set. Instead, the subject counts for all relevant treatment and demography variables are computed, in order to support interactive computation of AE subject percent calculations based on user filtering and selection of treatment or demographic group categories.
Note : If you want to output static AE percent tables only, the Adverse Event Report menu command should be run.
The subject counts for each value of relevant demographic variables ( Treatment , SEX , RACE , COUNTRY , SITEID , STUDYID (if not constant) are computed and then the reciprocal of the subject count is recorded in the DM or ADSL data set for merging into AE. This value can be used as a frequency weight for each subject that has a specific event to calculate the percent of subjects for that given demographic group that experience the AE.
The following example uses the Nicardipine data included with JMP Clinical.
In this example:
These reciprocal or frequency variables based on the demographic variable counts for each subject are computed and used when merged into the AE records table to compute percentages.
These columns are used in the distribution results dashboard to dynamically calculate percentages. Further examples are given when describing the dashboard results.
Note : If cross-over is detected, these demographic counts represent the total subjects for EACH treatment period.
Merge AE and DM/ADSL
The (filtered) AE data and the (filtered) DM or ADSL table (with computed demographic frequencies) are merged by USUBJID (and treatment period if cross-over is detected)
Optional Count Multiple Event Occurrence
The dialog contains an option to count multiple occurrences of events.
This option is turned OFF by default.
Percent calculations are performed only if this option is UNCHECKED so that when a unique event is counted only once per subject, you can interpret the frequency of AE counts as the percentage of subjects experiencing the event. The representative adverse event is chosen based on Seriousness ( AESER if exists), Severity ( AESEV ), and computed study day ( AESTDY or based on AESDTC )
Note : JMP Clinical assumes accordance with controlled terminology: "Y" to represent severe events, and "MILD", "MODERATE", "SEVERE" to select the serious, most severe event as representative.
For other events/interventions, the representative unique occurrence is chosen based on the first occurrence. The following help documentation for the Count multiple occurrences of an event per subject check box option describes the result of this option.
Each subject contributes only one time to the occurrence count of an intervention, regardless of how many times that specific intervention might have been applied to the subject.
Note : Representative intervention occurrence per subject is selected by sorting the data and taking the first intervention occurring to a subject based on Study Day.
Overall Subject Percent Occurrence for Each Event
This step is performed only when a unique occurrence of an event is counted (based on above check box option). This is total percent of subjects experiencing an event, calculated for each event.
For example, in the Nicardipine data , 560 of the 902 subjects in the safety population experienced vasoconstriction.
After all of these steps have been completed, the STUDY_ae_xx.sas7bdat results table is used for the JMP results dashboard report.