Appendix M. Common terminology criteria for adverse events (CTCAE)

The Common Terminology Criteria for Adverse Events (CTCAE) is descriptive terminology used for reporting an adverse event (AE) in a concise and standardized manner. It is supported by the U.S. Department of Health and Human Services, National Institutes of Health, and National Cancer Institute. An AE term is a unique representation of a specific event that can be used for medical documentation and scientific analyses. Along with cancer medications, other drugs may use the CTCAE system for dose and treatment modifications.

CTCAE terms are grouped by system organ classes, such as Blood/Lymphatic, GI, Nervous, Renal, and Respiratory disorders. Within each system organ class, AEs are listed and accompanied by a brief description. A grading scale is then provided for each AE term, and each grade refers to a specific severity.

The CTCAE grading scale displays grades 1–5 with particular descriptions and/or recommendations. The severity for each AE is based on the following generalized guidelines: Grade 1: 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 activity of daily living (ADL). Grade 3: Severe or medically significant but not immediately life threatening; hospitalization or prolonged hospitalization indicated; disabling; limiting self-care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.

CTCAE EXAMPLES

	Grade
Adverse Event	1	2	3	4	5
Blood/Lymphatic Anemia	Hgb < lower limit of normal–10 g/dL	Hgb 8–10 g/dL	Hgb <8 g/dL; transfusion indicated	Life-threatening consequences Urgent intervention indicated	Death
Gastrointestinal Diarrhea	Increase of <4 stools/day over baseline Mild ostomy output	Increase of 4–6 stools/day over baseline Moderate ostomy output	Increase of 7 stools/day over baseline Severe ostomy output Hospitalization required	Life-threatening consequences Urgent intervention indicated	Death
General Fever	38–39˚C (100.4–102.2˚F)	>39–40˚C (102.3–104˚ F)	>40˚C (>104˚ F) for less than 24 hrs	>40˚C (>104˚F) for more than 24 hrs	Death
Infections UTI	N/A	Localized; local intervention indicated (topical, antifungal, antiviral)	IV antibiotic, antifungal, antiviral intervention indicated. Radiologic or surgical intervention indicated	Life-threatening consequences Urgent intervention indicated	Death
Investigations Lipase increased	>ULN–1.5 times ULN	>1.5–2 times ULN	>2–5 times ULN	>5 times ULN	N/A
Metabolism/ Nutrition Hyperkalemia	>ULN–5.5 mmol/L	>5.5–6 mmol/L	>6–7 mmol/L	>7 mmol/L; life-threatening consequences	Death

ULN, Upper limit of normal.