Adverse Events Report

Report Results Description

Report Options

Report Option Descriptions

This report generates SAS reports of adverse event counts and percentages by treatment arms , sex, and race.

Report Results Description

Running this report for the Nicardipine study generates a PDF , and/or rtf file summary of the adverse events experienced by the subjects in the trial grouped by treatment, gender and race. The inclusion of an additional table showing counts of each adverse event by severity level can be specified.

The PDF format also contains hyperlinks in their left pane for ease of navigation to specific reports.

Note : Adverse events must meet or exceed the specified threshold occurrence to be included.

Note : For information about how treatment emergent adverse events (TEAEs) are defined in JMP Clinical, please refer to How does JMP Clinical determine whether an Event Is a Treatment Emergent Adverse Event? .

Report Options

Report Option Descriptions

Specific documentation for each of the options can be viewed by clicking on the following links:

General Options

Treatment or Comparison Variable to Use , Treatment or Comparison Variable

Create Counts by Severity , Include serious adverse events only , Event Type

Ignore available treatment emergent flags , Offset for End of Dosing

Subject Filter ¹

Additional Filters

Additional Filter to Include Subjects ²

Merge supplemental domain

Filter to Include Adverse Events

Select the population to include in the analysis

Output

RTF , PDF

Percent Occurrence Threshold

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1

Subject-specific filters must be created using the Create Subject Filter report prior to your analysis.

2

For more information about how to specify a filter using this option, see The SAS WHERE Expression .