Publication Build: This will be filled in by the publication tooling
Extension: Fujitsu Adverse Event Grade
| Official URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-ae-grade | Version: 1.1.28 | |||
| Active as of 2025-07-09 | Computable Name: FujitsuAdverseEventGrade | |||
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.
がん関連の試験では、重症度はグレードで表される。有害事象のグレードは、結果として生じた状態ではなく、被験者との関係で記述される。臨床研究の文脈では、治験責任医師による重症度の評価であり、がん関連試験ではグレードとして報告される。
Context of Use
This extension may be used on the following element(s):
- Element ID AdverseEvent
Usage info
Usage:
- Use this Extension: Fujitsu 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.
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.
がん関連の試験では、重症度はグレードで表される。有害事象のグレードは、結果として生じた状態ではなく、被験者との関係で記述される。臨床研究の文脈では、治験責任医師による重症度の評価であり、がん関連試験ではグレードとして報告される。
This structure is derived from Extension
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  Extension |
0..* | Extension | Adverse Event Grade (有害事象グレード) | |
  extension |
0..0 | |||
| url |
1..1 | uri | "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-ae-grade" | |
  value[x] |
0..1 | CodeableConcept | Value of extension (グレード) Binding: Adverse Event Clinical Research Grades (preferred) | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Extension |
0..* | Extension | Adverse Event Grade (有害事象グレード) | |
 id |
0..1 | string | Unique id for inter-element referencing | |
| extension |
0..0 | |||
| url |
1..1 | uri | "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-ae-grade" | |
| value[x] |
0..1 | CodeableConcept | Value of extension (グレード) 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.
がん関連の試験では、重症度はグレードで表される。有害事象のグレードは、結果として生じた状態ではなく、被験者との関係で記述される。臨床研究の文脈では、治験責任医師による重症度の評価であり、がん関連試験ではグレードとして報告される。
Differential View
This structure is derived from Extension
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| Extension |
0..* | Extension | Adverse Event Grade (有害事象グレード) | |
| extension |
0..0 | |||
| url |
1..1 | uri | "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-ae-grade" | |
| value[x] |
0..1 | CodeableConcept | Value of extension (グレード) 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 (有害事象グレード) | |
| id |
0..1 | string | Unique id for inter-element referencing | |
| extension |
0..0 | |||
| url |
1..1 | uri | "http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-ae-grade" | |
| value[x] |
0..1 | CodeableConcept | Value of extension (グレード) 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 | AdverseEventClinicalResearchGradeshttp://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() |