[00:06:14] Adverse Event or Adverse Experience (AE) (2)
[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)
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
medical records) symptoms/signs that are ambiguous. The
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