This report generates SAS reports of adverse event counts and percentages by treatment
arms, sex, and race, and are organized by body system. All tables are consistent with the
ICH E3 guidelines on the structure and contents of clinical reports
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.
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 a variable other than the ARM or
TRTxxP (planned treatment) or
ACTARM or
TRTxxA (actual treatment) from the CDISC models as a surrogate variable to serve as a comparator. Finally you can select
None to plot the data without segregating it by a treatment variable.
By default, this report generates several tables reporting the percent occurrence of adverse effects by treatment arm. No information about the severity of these effects is provided in these tables. The Create Counts by Severity option enables you to generate an additional table listing the adverse events and indicating the numbers (counts) of subjects in each arm experiencing mild, moderate, or severe events.
Analysis can consider all events or only those that emerge at specific times before, during, or after the trial period. For example, selecting On treatment events as the
Event Type includes only those events that occur on or after the first dose of study drug and at or before the last dose of drug (+ the offset for end of dosing).
If you choose to Ignore available treatment emergent flags, the analysis includes all adverse events that occur on or after day 1 of the study.
By default, post-treatment monitoring begins after the patient receives the last treatment. However, you might want to specify an Offset for End of Dosing, increasing the time between the end of dosing and post-treatment monitoring for treatments having an extended half-life.
When the end of treatment date is not known, check the Treatment end date is equivalent to the start date box to use the treatment start date to impute treatment end date, implying all treatment doses start and end the same day.
Use the Include events with overall percent occurrence greater than option to specify a threshold for reporting adverse events. Only events that occur above the entered threshold (in terms of overall percent of occurrence) are displayed in the reports. This value is set to 2 by default.
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.