Common Terminology Criteria for Adverse Events
Adverse Event grades are used to evaluate the severity of an adverse event in kidney cancer patients as well as to ascertain, in a clinical trial, the toxicity of a therapy or combination of therapies.
The Common Terminology Criteria for Adverse Events (CTCAE) displays Grades 1 through 5 with unique clinical descriptions of severity for each Adverse Event (AE) based on this general guideline:
| Grade | Criteria |
|---|---|
| Grade 1 | Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated |
| Grade 2 | Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL* |
| Grade 3 | Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL** |
| Grade 4 | Life-threatening consequences; urgent intervention indicated |
| Grade 5 | Death related to an adverse event |
Note: a semicolon indicates ‘or’ within the description of the Grade. Not all Grades are appropriate for all AEs. Therefore, some AEs are listed with fewer than five options for Grade selection.
Activities of Daily Living (ADL)
*Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.
**Self-Care ADL refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.
For more information, view and download a comprehensive PDF.
November 27, 2017, U.S. Department of Health and Human Services
