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Serious Adverse Reaction

An adverse drug reaction (ADR) is called serious if at any dose 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 significant disability or incapacity, or
  • is a congenital anomaly or birth defect.

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