Identifying and definitional attributes
|Metadata item type:||Value Domain|
|Registration status:||Health, Standard 04/02/2015|
|Definition:||A code set representing the grading scale for adverse events (AE) as defined by the American National Institute of Health and National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.0 (CTCAE).|
|Maximum character length:||1|
Collection and usage attributes
|Guide for use:||Grade refers to the severity of the adverse event (AE). The CTCAE displays Grade 1 through to Grade 5 with unique clinical descriptions of severity for each AE based on this general guideline:
CODE 1 Grade 1
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only intervention not indicated.
CODE 2 Grade 2
CODE 3 Grade 3
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Self care ADL refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.
CODE 4 Grade 4
Life-threatening consequences; urgent intervention indicated.
CODE 5 Grade 5
Death related to AE.
The above answer category definitions are for general use. Full definitions for specific AE categories are available at http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf . Where possible specific definitions should be used.
Source and reference attributes
|Submitting organisation:||Cancer Australia|
National Cancer Institute 2009. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Viewed 7/11/2011. http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf
|Data elements implementing this value domain:|
Health service event—adverse event grade, code N Health, Standard 04/02/2015