Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR)

  • results in death
  • requires patient hospitalization
  • results in persistent or significant disability or incapacity
  • is life-threatening
  • or is a congenital anomaly/birth defect.
  • “Severe” describes the intensity of an event (mild, moderate or severe), the event itself may be of minor medical significance (severe headache) and therefore not “serious”
  • “Serious” describes the potential outcome for the patient and is used to define regulatory reporting obligations


Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.


The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.

Found 370 Results
Page 1 of 2



Page 1 of 2