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Table 3 Toxicity grading scale for determining the severity of laboratory adverse events

From: Double blind, randomized controlled trial, to evaluate the effectiveness of a controlled nitric oxide releasing patch versus meglumine antimoniate in the treatment of cutaneous leishmaniasis [NCT00317629]

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

  1. # 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.
  2. * Grade 3 or 4 lab value: Suspend treatment.
  3. ULN: Upper limit of normal range
  4. Ref: Toxicity Grading based on CTCAE v3.0 DCTD, NCI, NIH, DHHS December 12, 2003 http://ctep.cancer.gov.