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Adverse Event Grading

Adverse events are graded based on severity from 1 to 5. The common terminology criteria for adverse events (CTCAE) from the US Department of Health and Human Services provides descriptions for specific adverse events.

These criteria are based on standardized guidance for the grading:

  • Grade 1: Mild. Mild symptoms or asymptomatic. Only appropriate clinical and diagnostic observations indicated. No interventions indicated. No limitations in ADLs.
  • Grade 2: Moderate Some interference with age-appropriate instrumental ADLs such as preparing food, shopping, and managing money. Minimal, local, or noninvasive intervention is needed.
  • Grade 3: Severe, but not immediately life-threatening. Disabling with limiting of self-care ADLs such as bathing, dressing, and feeding oneself. Hospitalization or prolongation of hospitalization is indicated.
  • Grade 4: Life threatening with urgent need for intervention.
  • Grade 5 Death related to adverse event.

Source: U.S. Department of Health and Human Services, National Institute of Health, & National Cancer Institute. (2017, November). Common Terminology Criteria for Adverse Events (CTCAE) (No. 5). U.S. Department of Health and Human Services. https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_8.5×11.pdf