How are organ specific toxicities caused by immunotherapies graded?
The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) is a descriptive terminology used for adverse event (AE) reporting. A grade refers to the severity of an AE and a general guideline is used to grade AEs on a scale of 1 through 5. Grade 1 AEs are defined as mild or no symptoms and can be clinically monitored without intervention. Grade 2 AEs are moderate and limit age-appropriate activities of daily living (ADLs); minimal, local, or noninvasive intervention is indicated. Grade 3 AEs are severe, but not immediately life-threatening; they limit self-care ADLs, and hospitalization is generally needed. Grade 4 AEs have life-threatening consequences, and urgent intervention is needed. A Grade 5 AE is one that leads to a patient’s death.