NCI CTCAE v5.0 hepatobiliary toxicity

Adverse event	Grade 1	Grade 2	Grade 3	Grade 4	Grade 5
Alkaline phosphatase increased	>ULN to 2.5 x ULN if baseline was normal; 2 to 2.5 x baseline if baseline was abnormal	>2.5 to 5 x ULN if baseline was normal; >2.5 to 5 x baseline if baseline was abnormal	>5 to 20 x ULN if baseline was normal; >5 to 20 x baseline if baseline was abnormal	>20 x ULN if baseline was normal; >20 x baseline if baseline was abnormal
Alanine aminotransferase increased	>ULN to 3 x ULN if baseline was normal; 1.5 to 3 x baseline if baseline was abnormal	>3 to 5 x ULN if baseline was normal; >3 to 5 x baseline if baseline was abnormal	>5 to 20 x ULN if baseline was normal; >5 to 20 x baseline if baseline was abnormal	>20 x ULN if baseline was normal; >20 x baseline if baseline was abnormal
Aspartate aminotransferase increased	>ULN to 3 x ULN if baseline was normal; 1.5 to 3 x baseline if baseline was abnormal	>3 to 5 x ULN if baseline was normal; >3 to 5 x baseline if baseline was abnormal	>5 to 20 x ULN if baseline was normal; >5 to 20 x baseline if baseline was abnormal	>20 x ULN if baseline was normal; >20 x baseline if baseline was abnormal
Blood bilirubin increased	>ULN to 1.5 x ULN if baseline was normal; >1 to 1.5 x baseline if baseline was abnormal	>1.5 to 3 x ULN if baseline was normal; >1.5 to 3 x baseline if baseline was abnormal	>3 to 10 x ULN if baseline was normal; >3 to 10 x baseline if baseline was abnormal	>10 x ULN if baseline was normal; >10 x baseline if baseline was abnormal
GGT increased	>ULN to 2.5 x ULN if baseline was normal; 2 to 2.5 x baseline if baseline was abnormal	>2.5 to 5 x ULN if baseline was normal; >2.5 to 5 x baseline if baseline was abnormal	>5 to 20 x ULN if baseline was normal; >5 to 20 x baseline if baseline was abnormal	>20 x ULN if baseline was normal; >20 x baseline if baseline was abnormal
Hepatic failure			Asterixis; mild encephalopathy; drug-induced liver injury (DILI); limiting self-care ADL*	Life-threatening consequences; moderate to severe encephalopathy; coma	Death
Portal hypertension		Decreased portal vein flow	Reversal/retrograde portal vein flow associated with varices and/or ascites	Life-threatening consequences; urgent intervention needed	Death

The laboratory findings (ie, increased alkaline phosphatase, bilirubin, GGT, aspartate aminotransferase [also called AST or SGOT], and alanine aminotransferase [also called ALT or SGPT]) are graded separately under "Investigations" in the source document. Hepatic failure, characterized by the inability of the liver to metabolize chemicals in the body, and portal hypertension, characterized by an increase in blood pressure in the portal venous system, are graded under hepatobiliary disorders.

NCI CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Events; ULN: upper limit of normal; GGT: gamma-glutamyl transpeptidase (also called gamma-glutamyl transferase); DILI: drug-induced liver injury; ADL: activities of daily living.
* DILI is defined by Hy's law; refer to text for details. Self-care ADLs include bathing, dressing/undressing, using the toilet, taking medications, and not bedridden.

Reproduced from: Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0, November 2017, National Institutes of Health, National Cancer Institute. Available at: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf (Accessed March 27, 2018).

Graphic 77533 Version 12.0

خرید پکیج

NCI CTCAE v5.0 hepatobiliary toxicity