Adverse Events & Toxicities Grading

2–3 minutes

June 7, 2026

Common Terminology Criteria for Adverse Events (CTCAE) v6.0 (MedDRA 28.0)
Published on July 22, 2025 Link

Liver Function

Alkaline phosphatase increased (ALP)

Grade 1	Grade 2	Grade 3	Grade 4
>Baseline and ULN	–	–	–

Definition: A finding based on laboratory test results that indicate an increase in the level of alkaline phosphatase (ALP) in a blood specimen.

Alanine aminotransferase (ALT)

Grade 1	Grade 2	Grade 3	Grade 4
>ULN – 3.0 x ULN if baseline was normal or less than normal; 1.0 – 1.5 x baseline if baseline was >ULN	>3.0 – 5.0 x ULN if baseline was normal or less than normal; >1.5 – 2.0 x baseline if baseline was >ULN	>5.0 – 20.0 x ULN if baseline was normal or less than normal; >2.0 – 4.0 x baseline if baseline was >ULN up to 5 x ULN	>20.0 x ULN if baseline was normal or less than normal; 4.0 x baseline if baseline was >ULN

Definition: A finding based on laboratory test results that indicate an increase in the level of alanine aminotransferase (ALT or SGPT) in the blood specimen.
Navigational Note: Consider Hepatobiliary disorders: Hepatic failure. R

Aspartate aminotransferase (AST)

Grade 1	Grade 2	Grade 3	Grade 4
>ULN – 3.0 x ULN if baseline was normal or less than normal; 1.0 – 1.5 x baseline if baseline was >ULN	>3.0 – 5.0 x ULN if baseline was normal or less than normal; >1.5 – 2.0 x baseline if baseline was >ULN	>5.0 – 20.0 x ULN if baseline was normal or less than normal; >2.0 – 4.0 x baseline if baseline was >ULN up to 5 x ULN	>20.0 x ULN if baseline was normal or less than normal; 4.0 x baseline if baseline was >ULN

Definition: A finding based on laboratory test results that indicate an increase in the level of aspartate aminotransferase (AST or SGOT) in a blood specimen.
Navigational Note: Consider Hepatobiliary disorders: Hepatic failure.

Blood bilirubin increased

Grade 1	Grade 2	Grade 3	Grade 4
>ULN – 1.5 x ULN if baseline was normal or less than normal; 1.0 – 1.5 x baseline if baseline was >ULN	>1.5 – 3.0 x ULN if baseline was normal or less than normal; >1.5 – 2.5 x baseline if baseline was >ULN	>3.0 – 10.0 x ULN if baseline was normal or less than normal; >2.5 – 10.0 x baseline if baseline was >ULN	>10.0 x ULN if baseline was normal or less than normal; 10.0 x baseline if baseline was >ULN

Definition: A finding based on laboratory test results that indicate an abnormally high level of total bilirubin in the blood. Excess bilirubin
is associated with jaundice.
Navigational Note: Consider Hepatobiliary disorders: Hepatic failure.

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