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00:12:04 / 00:49:10 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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