Adverse Event Clinical Research
1.0.1 - STU1

Adverse Event Clinical Research, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-ig/ and changes regularly. 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:

- Use this Extension: Adverse Event Clinical Research
- Examples for this Extension: AdverseEvent/adverse-event-compass-ex1, AdverseEvent/adverse-event-compass-ex1a, AdverseEvent/adverse-event-compass-ex1b, AdverseEvent/adverse-event-compass-ex2 and AdverseEvent/adverse-event-device-death

### Formal Views of Extension Content

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

- Text Summary
- Differential Table
- Snapshot Table
- All

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

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
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)
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
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"
value[x] |  | 0..1 | CodeableConcept | Value of extension Binding: Adverse Event Clinical Research Grades (preferred)
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

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
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)
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints
--- | --- | --- | --- | ---
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"
value[x] |  | 0..1 | CodeableConcept | Value of extension Binding: Adverse Event Clinical Research Grades (preferred)
Documentation for this format

Other representations of profile: CSV, Excel, Schematron

#### Terminology Bindings

Path | Conformance | ValueSet | URI
Extension.value[x] | preferred | AdverseEventClinicalResearchGrades `http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-grades`

#### Constraints

Id | Grade | Path(s) | Details | Requirements
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |