JMP Clinical Basics | Distribution Reports | Distribution Report Results

Distribution Report Results
The distribution reports are designed to enable you to customize the specific view according to your individual needs. While there are too many options to fully describe, the several examples presented below highlight the variety of reports that can be generated.
In general, an AE/events/interventions report contain the following key components.
Distributions of the event/intervention, descriptive variables about the event/intervention (for example, for AEs this could include Body System , Seriousness, Severity, Causality, Outcome, Action Taken, and so on), and demographic distributions of subjects experiencing the event/intervention
Column Switchers : Choose the grouping variable used as the demographic comparison for the counts plot and table and a stacking variable to categorize events/interventions (especially useful with adverse events).
Profile Subjects : Generates Patient Profiles for subjects experiencing selected events.
Show Subjects : Subsets and opens ADSL (or DM , if ADSL is unavailable) for subjects experiencing selected events. A Table of USUBJIDs is also presented.
Cluster Subjects : Clusters subjects experiencing selected events based on available covariates .
Create Subject Filter : Creates a data set of USUBJIDs for subjects experiencing selected events, which subsets all subsequently run processes to those selected individuals. The currently available filter data set can be applied by selecting the Subject Filter data set in any process dialog on the Filters tab.
Related CM (AE/Events Distribution only): For subjects experiencing selected events, this drill-down launches Interventions Distribution to summarize the distribution of concomitant medications ( CM ).
Demographic Counts : For subjects experiencing selected events, this drill-down generates a stacked Histogram to show subjects across study sites by Trial Time Windows .
Related Labs : For subjects experiencing selected events, this drill-down launches Findings Time Trends to summarize laboratory results ( LB ) across time.
Related Vitals : For subjects experiencing selected events, this drill-down launches Findings Time Trends to summarize vitals signs ( VS ) across time.
Related ECG : For subjects experiencing selected events, this drill-down launches Findings Time Trends to summarize ECG measurements ( EG ) across time.
Related AE (Interventions Distribution only): For subjects taking selected medications, this drill-down launches AE Distribution to summarize the distribution of adverse events ( AE ).
The AE Distribution report described in this example is shown below:
Example 1: AE Distribution Treatment Emergent Adverse Events That Occur in at Least 5% of Subjects in a Safety Population
Open AE Distribution .
Note : The most significant change made in this example is that the Percent Occurrence Threshold has been adjusted from 0 to 5 (circled above).
Click Run .
The results of this analysis are based on summarizing adverse events by Dictionary-Derived Term ( AEDECOD ) with group organization as Body System or Organ Class ( AEBODSYS ). Variations of options for this are dependent on the available terms in the domain data set.
The counts ( Y -axis) represent the count of subjects that experienced the given event term ( X -axis); the counts are categorized as stacked bar charts for levels of Severity/Intensity ( AESEV ). This categorization is a result of choosing that variable from the AE Stacking drill-down.
When a unique occurrence is counted only for each subject/event, the percent of subjects experiencing an event within any of the available demographic grouping variables is calculated interactively by the report. The plot below was generated by clicking Show Percents (circled above).
The counts table (shown below) reflects the same counts/percentages as shown in the counts plot in tabular form. The Grouping and Stacking column from the drill down panel drive the format and detail in this table. This flexibility enables you to create several tables for summarizing events from one report.
The output STUDY_aed_xx.sas7bdat data set used to generate these plots and tables contains a row for each subject experiencing each event (optionally by treatment period in a cross-over scenario).
Rows that do not meet the Percent Occurrence Threshold specified on the dialog (5% in this example) are hidden and excluded from analysis. This filter can be interactively changed using the Data Filter option for Percent Occurrence (circled below) .