Adverse event grade code N

Identifying and definitional attributes

Metadata item type:Value Domain
METeOR identifier:467628
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).

Representational attributes

Representation class:Code
Data type:Number
Format:N
Maximum character length:1
Permissible values:
ValueMeaning
1Grade 1
2Grade 2
3Grade 3
4Grade 4
5Grade 5
Supplementary values:
7Not applicable, no adverse events
8Unknown
9Adverse event, but grade inadequately specified

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

Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc.

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
Reference documents:

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 

Relational attributes

Data elements implementing this value domain:

Health service event—adverse event grade, code N Health, Standard 04/02/2015