Serious Adverse Event

An adverse event (AE) is called serious if it:

  • results in death,
  • is life-threatening (at risk of death at the time of the adverse event, not an event which could™ hypothetically have caused death if it were more severe),
  • requires hospitalisation or extension of existing inpatients™ hospitalisation,
  • results in a persistent or significate disability or incapacity, or
  • is a congenital anomaly or birth defect.

Other events such as those requiring emergency intervention to prevent one of the serious outcomes described above might also be reported as a serious adverse event.

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