Standard Safety Reports

Report Results Description

Report Options

Special Case: Modifying the Reports

Running this report generates selected standard safety reports on the population meeting the specified filter criteria, in the format(s) specified ( RTF , PDF , HTML , or text file).

This report calls a number of SAS programs that are included with JMP Clinical. By default, these program files are located C:\Program Files\SASHome\JMPClinical\12\Clinical\StandardReports .

Report Results Description

The selected standard safety reports are generated in the specified format ( RTF , PDF , html , or plain text).

The PDF and HTML formats also contain hyperlinks in their left pane for ease of navigation to specific reports.

This report creates various standard safety tabular reports in rtf , PDF , html , or plain text format.

Report Options

Setting Up Report Option Descriptions

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

General

Treatment or Comparison Variable to Use , Treatment Variable

Additional Filters

Select the population to include in the analysis

Demographics

Include demographic reports , Patient Population by Age , Patient Population by Race , Patient Population by Sex ’ Patient Population by Treatment

Disposition

Include disposition reports , Death Age Analysis , Death Age Group , Death Days , Death Gender , Death Listing , Death Race , Dropout Group and Reason , Mortality Treatment Group

Adverse Events

Include adverse event reports , Body System Sorted by p-Value , Body System Sorted Alphabetically , By Age Group , By Race , By Sex , Cardiovascular , Dropout Listing , Drug Body System , Listing , SAE Listing , Percent Body System , Percent Drug Body System , Relationship to Drug , Severity , Summary Report , Totals

Labs

Include lab reports , Hepatotoxicity Patient Listing , Mean Change from Baseline , Mean Chemistry Values for Visit , Visit Number to Compare to Visit 1 , Mean Values Baseline Worst , Patient Visit Count , Significant Changes

Medical History

Include medical history reports , Conditions Summary

Output

Output as RTF , Output as PDF

Special Case: Modifying the Reports

The standard reports produced by this report should be sufficient for most purposes. However, your circumstances might require one or more specialized reports. To modify one or more of the reports that are produced by this report, you must modify the corresponding SAS programs that generate them.

Caution : You should not attempt to modify these SAS programs unless you are an experienced SAS programmer.

To modify one or more programs, complete the following steps:

•

Copy all of the program files located in the C:\Program Files\SASHome\JMPClinical\102\StandardReports directory and paste the copies in a new directory. All of the program files, even those that are unmodified, must be located in the same folder. Generating a complete second set of files in a new directory satisfies this requirement and ensures that you do not overwrite the standard program files.

•	Modify only those files in the new directory.

•	Make your changes to the desired program files. Save the changes.

Caution : You must not change the names of the SAS program files.

Specify the new directory when you run the Standard Safety Reports report.