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Thursday, August 21, 2014

Serious Adverse Experience | Definition

Acronym

  • SAE

Public Health 

  • Serious adverse experience (SAE) is defined as an adverse experience following treatment with a drug that results in any of the  following:
    • death
    • life-threatening condition
    • in-patient hospitalization
    • prolonging of an existing hospitalization
    • persistent or significant disability/ incapacity
    • congenital anomaly
    • cancer
    • overdose
  • World Health Definition

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