Standardized MedDRA Queries Distribution

This report compares distributions of SMQs across treatment arms .

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:

The following sections are generated by this process:

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Distribution Details (SMQ Distribution) : Provides Bar Chart s 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.

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 report:

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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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Create Subject Filter : Select subjects and click

to create a data set of USUBJID s for subjects experiencing selected events, which subsets all subsequently run processes to those selected subjects. The currently available filter data set can be applied by selecting Apply Subject Filter in any process 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 .

General

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Click