Adverse Event Clinical Research
1.0.1 - STU1 International flag

This page is part of the Adverse Event Clinical Research (v1.0.1: STU 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Extension: Adverse Event Grade

Official URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade Version: 1.0.1
Standards status: Trial-use Maturity Level: 2 Computable Name: AdverseEventGrade

For cancer related trials, severity is represented as a grade. Describes the grade of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity, in oncology related trials this is reported as grade.

Context of Use

This extension may be used on the following element(s):

  • Element ID AdverseEvent

Usage info

Usage:

Formal Views of Extension Content

Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.

This structure is derived from Extension

Summary

Simple Extension of type CodeableConcept: For cancer related trials, severity is represented as a grade. Describes the grade of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity, in oncology related trials this is reported as grade.

Maturity: 2

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Adverse Event Grade
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade"
... value[x] 0..1 CodeableConcept Value of extension
Binding: Adverse Event Clinical Research Grades (preferred)

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Adverse Event Grade
... id 0..1 id Unique id for inter-element referencing
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade"

doco Documentation for this format

This structure is derived from Extension

Summary

Simple Extension of type CodeableConcept: For cancer related trials, severity is represented as a grade. Describes the grade of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity, in oncology related trials this is reported as grade.

Maturity: 2

Differential View

This structure is derived from Extension

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Adverse Event Grade
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade"
... value[x] 0..1 CodeableConcept Value of extension
Binding: Adverse Event Clinical Research Grades (preferred)

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..* Extension Adverse Event Grade
... id 0..1 id Unique id for inter-element referencing
... extension 0..0
... url 1..1 uri "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade"

doco Documentation for this format

 

Other representations of profile: CSV, Excel, Schematron

Terminology Bindings

PathConformanceValueSetURI
Extension.value[x]preferredAdverseEventClinicalResearchGrades
http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-grades

Constraints

IdGradePath(s)DetailsRequirements
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()