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Serious Adverse Event (SAE)

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Adverse event (AE) means any untoward medical occurrence associated with the use of a drug or pharmaceutical product in humans, whether or not considered drug related.

An adverse reaction (ADR) means any adverse event caused by a drug/ biological product. Adverse reactions are a subset of all suspected adverse reactions for which there is reason to conclude that there is a reasonable possibility the drug caused the event.

Serious Adverse Event

An adverse event can be any unfavorable and unintended sign (eg, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality.

An adverse event can arise from any use of the drug (e.g., off-label use, use in combination with another drug) and from any route of administration, formulation, or dose, including an overdose

An adverse event or suspected adverse reaction is considered “serious” if, in the view of either the investigator or sponsor, it results in any of the following outcomes:

  • Death
  • A life-threatening adverse event
  • Inpatient hospitalization or prolongation of existing hospitalization
  • A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
  • A congenital anomaly/birth defect.

Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment

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