Running Standardized MedDRA Queries Distribution for the Nicardipine study using MedDRA Version 16.0 files generates the Report window shown below. Refer to the Standardized MedDRA Queries Distribution requirements description for more information.
Note: Your output might vary depending on which version of MedDRA you provide (in terms of the location of the *.asc files).
The Report contains the following elements:
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Distribution Details (SMQ Distribution): Provides Bar Charts to summarize the frequency or percentage of major classes of SMQs by treatment.
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Hierarchical SMQ’s: Summarizes hierarchical SMQs graphically and provides observed and cumulative sample sizes and percentages of SMQs.
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Profile Subjects: Select subjects and click
 to generate the patient profiles for subjects experiencing selected events. See Profile Subjects for additional information. |
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Demographic Counts: Select subjects and click
 to create a data set of USUBJIDs for subjects experiencing selected events, 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. |
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Show SMQs: Select SMQs from the plots and click
 to open and subset the underlying data table to the selected SMQs. |
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Show Events Leading to SMQs: Select SMQs from the plots and click
 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. |
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Click
 to view the associated data tables. Refer to View Data for more information. |
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Click
 to generate a standardized pdf- or rtf-formatted report containing the plots and charts of selected sections. |
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Click
 to take notes, and store them in a central location. Refer to Add Notes for more information. |
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Click
 to read user-generated notes. Refer to View Notes for more information. |
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Click the arrow to reopen the completed report dialog used to generate this output.
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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.
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