Output Overview Descriptions | Clinical | Standardized MedDRA Queries Distribution

Standardized MedDRA Queries Distribution
Running this process for the Nicardipine study using MedDRA Version 16.0 files generates the tabbed Results window shown below. Refer to the Standardized MedDRA Queries Distribution process description for more information. Your output might vary depending on which version of MedDRA you provide (in terms of the location of the *.asc files). Output from the process is organized into tabs. Each tab contains one or more plots, data panels, data filters, and so on that facilitate your analysis.
The Results window contains the following panes:
Tab Viewer
This pane provides you with a space to view individual tabs within the Results window. Use the tabs to access and view the output plots and associated data sets.
The following tabs are generated by this process:
Distribution Details (SMQ Distribution): Provides Bar Charts to summarize the frequency or percentage of major classes of SMQs by treatment.
Hierarchical SMQ’s: Summarizes hierarchical SMQs graphically and provides observed and cumulative sample sizes and percentages of SMQs.
Drill Down Buttons
Drill down buttons provide you with an easy way to drill down into your data. The following drill down buttons are generated by this process:
Profile Subjects: Select subjects and click Profile Subjects to generate the patient profiles. See Profile Subjects for additional information.
Create Subject Filter: Select subjects and click Create Subject Filter to create a subject filter. Follow-up analyses are subset to these subjects if the Subject Filter is applied in the dialog.
Show SMQs: Select SMQs and click Show SMQs to open and subset the underlying data table to the selected SMQs.
Show Events Leading to SMQs: Select SMQs and click Show Events Leading to SMQs to open a set of distributions of the preferred or lower level terms (if available in the AE domain) that contribute to SMQs that are currently selected from one or more box plots.
Click View Data to view the associated data table. Refer to View Data for more information.
Click Reopen Dialog to reopen the completed process dialog used to generate this output.
Click Create Report to generate a standardized pdf- or rtf-formatted report containing the plots and charts of selected tabs.
Click Add Notes to take notes, and store them in a central location. Refer to Add Notes for more information.
Click View Notes to read user-generated notes. Refer to View Notes for more information.
Click Close All to close all graphics windows and underlying data sets associated with the output.