The Common Toxicity Criteria (CTC) define adverse events following cancer therapy. It was designed for use in clinical trials of different therapeutic regimens.
Types of adverse biochemical hepatic events:
(1) alkaline phosphatase
(2) bilirubin
(3) GGT
(4) hypoalbuminemia
(5) SGOT (AST)
(6) SGPT (ALT)
Types of adverse clinical hepatic events:
(7) hepatic enlargement
(8) clinical liver dysfunction/failure
(9) portal vein flow
(10) other
Grade 0: normal or no change
|
Parameter |
Finding |
Grade |
|---|---|---|
|
alkaline phosphatase |
<= ULN |
0 |
|
|
> ULN to 2.5 times ULN |
1 |
|
|
> 2.5 to 5.0 times ULN |
2 |
|
|
> 5.0 to 20 times ULN |
3 |
|
|
> 20 times ULN |
4 |
|
bilirubin |
<= ULN |
0 |
|
|
|
1 |
|
|
|
2 |
|
|
|
3 |
|
|
|
4 |
|
bilirubin (for GVHD in BMT) |
< 2 mg/dL |
0 |
|
|
2.0 to 2.99 mg/dL |
1 |
|
|
3.0 to 5.99 mg/dL |
2 |
|
|
6.00 to 14.99 mg/dL |
3 |
|
|
>= 15.0 mg/dL |
4 |
|
GGT |
<= ULN |
0 |
|
|
> ULN to 2.5 times ULN |
1 |
|
|
> 2.5 to 5.0 times ULN |
2 |
|
|
> 5.0 to 20 times ULN |
3 |
|
|
> 20 times ULN |
4 |
|
serum albumin |
>= LLN |
0 |
|
|
< LLN to 3 g/dL |
1 |
|
|
>= 2.00 to 2.99 g/dL |
2 |
|
|
< 2.0 g/dL |
3 |
|
|
|
4 |
|
SGOT (AST) |
<= ULN |
0 |
|
|
> ULN to 2.5 times ULN |
1 |
|
|
> 2.5 to 5.0 times ULN |
2 |
|
|
> 5.0 to 20 times ULN |
3 |
|
|
> 20 times ULN |
4 |
|
SGPT (ALT) |
<= ULN |
0 |
|
|
> ULN to 2.5 times ULN |
1 |
|
|
> 2.5 to 5.0 times ULN |
2 |
|
|
> 5.0 to 20 times ULN |
3 |
|
|
> 20 times ULN |
4 |
where:
• ULN = upper limit of normal reference range
• LLN = lower limit of normal reference range
• GVHD = graft vs host disease
• BMT = bone marrow transplant studies
|
Parameter |
Finding |
Grade |
|---|---|---|
|
hepatomegaly |
none |
0 |
|
|
present |
3 |
|
clinical dysfunction |
none |
0 |
|
|
asterixis |
3 |
|
|
encephalopathy or coma |
4 |
|
portal vein flow |
normal |
0 |
|
|
decreased |
2 |
|
|
reversed or retrograde |
3 |
|
other |
none |
0 |
|
|
mild |
1 |
|
|
moderate |
2 |
|
|
severe |
3 |
|
|
life-threatening or disabling |
4 |
where:
• Hepatic enlargement is graded for treatment-related adverse events including veno-occlusive disease (VOD).
Specialty: Hematology Oncology, Gastroenterology
