Table 3.
Toxicity grading scale for determining the severity of laboratory adverse events
| Parameter | Normal Range# | Grade for Abnormal Results (Value or Change from Reference) | |||
| (Grade 0) | Mild (Grade 1) | Moderate (Grade 2) | Severe (Grade 3)* | Severe (Grade 4)* | |
| ALT (GPT) | 5 – 40 U/L | >ULN – 2.5 × ULN | >2.5 – 5.0 × ULN | >5.0 – 20.0 × ULN | >20.0 × ULN |
| AST (GOT) | 6 – 35 U/L | >ULN – 2.5 × ULN | >2.5 – 5.0 × ULN | >5.0 – 20.0 × ULN | >20.0 × ULN |
| Creatinine | 0.7 – 1.5 mg/L | >ULN – 1.5 × ULN | >1.5 – 3.0 × ULN | >3.0 – 6.0 × ULN | >6.0 × ULN |
| Pancreatic Amylase | <120 U/L | >ULN – 1.5 × ULN | >1.5 – 2.0 × ULN | >2.0 – 5.0 × ULN | >5.0 × ULN |
# Normal lab ranges may vary from time to time depending on the reagent/kit used at local lab. Every time the normal ranges change, the laboratory will fax a copy of the "normal ranges" for that date to the Investigators. To respect confidentiality, the subject's name will be covered.
* Grade 3 or 4 lab value: Suspend treatment.
ULN: Upper limit of normal range
Ref: Toxicity Grading based on CTCAE v3.0 DCTD, NCI, NIH, DHHS December 12, 2003 http://ctep.cancer.gov.