Serious adverse event (serious adverse drug reaction)

Serious adverse event (SAE) is a subtype of adverse event, which may occur during clinical trial, and that might be significant enough to lead to important changes in the way the medicinal product is developed. This is particularly true for events (or reactions ) that threaten life or body function of a patient . Such events (reactions) should be reported to regulators promptly.

Definitions

ICH E6(R2)

1.50 Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR):

Any untoward medical occurrence that at any dose:

• results in death,
• is life-threatening ,
• requires inpatient hospitalization or prolongation of existing hospitalization,
• results in persistent or significant disability/incapacity, or
• is a congenital anomaly/birth defect .

“Important medical events” as an additional criterion

Medical and scientific judgment should be applied to decide if other medical events, which do not initially meet the definitions above, might still jeopardize the patient or require intervention to prevent serious outcomes. Such events might be considered important and reported accordingly.

“Serious” vs “severe” condition

Terms “serious” and “severe” are not synonymous. Term “severity” refers to the strength or intensity of symptoms, while “seriousness” is based on the event outcome or administrative actions and is associated with a threat to a patient's life or functioning.

Expedited reporting

Specific medical or administrative criteria of seriousness exist to justify expedited reporting, which is a procedure of accelerated submission of information about adverse events or reactions to regulatory authorities and ethics committees.

See also

Another relevant pages

• Adverse Drug Reaction
• Adverse Event

Links to this page

• Abbreviations ‎ (← links)
• SAE (redirect page) ‎ (← links)
  • Regulation (EU) No 536/2014 ‎ (← links)