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that is fatal, an immediately life threatening adverse
experience, for example, an anaphylactic reaction an event
which results in an inpatient hospitalization or prolongation
of an existing hospitalization disability, meaning a
substantial disruption of a person's ability to conduct
normal life functions. For example, a stroke with residual        [00:08:20] What is Typically Not an Adverse Event?
paralysis a congenital anomaly/birth defect, or important
                                                                  [00:09:49] Ambiguous AEs
medical events that may not
                                                                  [00:11:34] Serious Adverse Event
                                                                  [00:11:39] Serious Adverse Event (SAE)
                                                                  [00:13:00] Adverse Event - Seriousness
                                                                  [00:13:42] Remember...

				
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posted:4/26/2010
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