Table 1.

Common terminology criteria for adverse events (CTCAE: versions 3 and 4)

•Grade 1–mild: asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated
Example: diet controlled hypertension
•Grade 2–moderate: minimal, local or noninvasive intervention indicated; limiting age appropriate age-appropriate instrumental ADLa
Example: hypertension requiring pharmacologic therapy
•Grade 3–severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; limiting self care ADLb
Examples: congestive heart failure, ovarian failure
•Grade 4–life-threatening or disablingc
Examples: myocardial infarction, organ transplant, second primary cancer (excluding nonmelanoma skin cancer), blindness
•Grade 5–death

Activities of Daily Living (ADL)

  • aInstrumental ADL refer to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.

  • bSelf care ADL refer to bathing, dressing, and undressing, feeding self, using the toilet, taking medications, and not bedridden.

  • NOTES: cIn CTCAEv3 (87), disabling was included with life-threatening as a grade 4 condition. In CTCAEv4 (143), disabling conditions were described as being grade 3 (page 2); however, in the organ-based schema (pages 4–195), the disabling conditions are still scored as grade 4 (as they were in version 3). As an example, blindness was scored as a grade 3 in CTCAEv3 (pages 52–54). Blindness is a disabling but not a life-threatening condition but is scored as a grade 4 condition in the manual.