This process generates SAS reports of
adverse events
counts and percentages by treatment
arm
, sex, and race.
Running this process 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
Determining If an Event Is a Treatment Emergent Adverse Event
.