Comment Report

This report generates either a PDF or RTF document listing all the comments for selected subjects recorded in the CO domain.

Report Results Description

An example of the generated PDF or RTF document that provides the comments for a given subject is shown below.

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Report Options

Treatment or Comparison Variable:

When specifying a treatment or comparison variable, a distribution of the selected variable is shown in the output and the demographic tables are categorized by the values of the variable.

Available variables include Planned, which is selected when the treatments patients received exactly match what was planned and Actual, which is selected when treatment deviates from what was planned. You can also specify any demographic variable from DM and/or ADSL as a surrogate for the treatment variables. Finally you can select None to plot the data without segregating it by a treatment variable.

See Treatment or Comparison Variable to Use, Treatment or Comparison Variable for more information.

Filtering the Data:

Filters enable you to restrict the analysis to a specific subset of subjects and/or adverse events, based on values within variables. You can also filter based on population flags (Safety is selected by default) within the study data.

If there is a supplemental domain (SUPPAE) associated with your study, you can opt to merge the non-standard data contained therein into your data.

See Select the analysis population, Select saved subject filter1 Subject-specific filters must be created using the Create Subject Filter report prior to your analysis. , Merge supplemental domain, and Additional Filter to Include Subjects for more information.

Output

You can use the output options to specify the format (RTF or PDF) of the final report.