00:10:04 / 00:49:10
cancer. The cancer recurrence is an endpoint, not an AE.
And the last example is a pre-scheduled elective
surgery, such as cataract surgery or a bunion removal
that occurs without any complications. It is important to be
precise when reporting adverse events. At times subjects
and researchers will report and record (in CRF and/or [00:06:14] Adverse Event or Adverse Experience (AE) (2)
medical records) symptoms/signs that are ambiguous. The
[00:06:36] Adverse Event - Examples
[00:08:20] What is Typically Not an Adverse Event?
[00:09:49] Ambiguous AEs
[00:11:34] Serious Adverse Event
[00:11:39] Serious Adverse Event (SAE)