Definitions

Definitions

• Adverse Event (AE)

  An adverse event is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment.

• Adverse Drug Reaction (ADR)

  As established by regional regulations, guidance, and practices, concern noxious and unintended responses to a medicinal product. The phrase “responses to a medicinal product” means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility.

• Serious AE and/or Serious ADR

  Any untoward medical occurrence that at any dose:

  • results in death;
  • is life-threatening: an event/reaction in which the patient was at risk of death at the time of the event/reaction;
  • requires inpatient hospitalization or results in prolongation of existing hospitalization;
  • results in persistent or significant disability;
  • is a congenital anomaly/birth defect.