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

## Example AdverseEvent: ClinicalTrialSignificantAdverseEvent

Page standards status: Informative

Generated Narrative: AdverseEvent

Resource AdverseEvent "ClinicalTrialSignificantAdverseEvent"

Profile: Adverse Event Clinical Research

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

> value: Results In Persistent Or Significant Disability (NCI Thesaurus#C11338)

> > url

> > `criterionPresent`

> value: false

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

> value: Requires Inpatient Hospitalization (NCI Thesaurus#C83052)

> > url

> > `criterionPresent`

> value: true

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

> value: Death Related to Adverse Event (NCI Thesaurus#C48275)

> > url

> > `criterionPresent`

> value: false

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

> value: Is Life Threatening (NCI Thesaurus#C84266)

> > url

> > `criterionPresent`

> value: true

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

> value: Congenital Anomaly or Birth Defect (NCI Thesaurus#C83117)

> > url

> > `criterionPresent`

> value: false

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

> value: Other Medically Important Condition (NCI Thesaurus#C82521)

> > url

> > `criterionPresent`

> value: false

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

> value: Required Intervention to Prevent Permanent Impairment/damage (NCI Thesaurus#C201939)

> > url

> > `criterionPresent`

> value: true

Adverse Event Severity: Severe (AdverseEventSeverity#severe)

status: completed

actuality: actual

code: Serious reportable event associated with product or device (SNOMED CT#370901008)

subject: Patient/ClinicalTrialSubject5 " CLINICAL TRIAL"

detected: 1905-08-23

recordedDate: 1905-08-24

resultingEffect:

- Condition/AEHepaticFailure
- Condition/AEHepaticFailurecomplication

seriousness: Serious (AdverseEventSeriousness#serious)

outcome: Recovering/Resolving (NCI Thesaurus#C49496)

recorder: : Clinical Research Associate

study: : NCT1010101

> suspectEntity

> instance: MedicationAdministration/medadmin0301: Study Medication

> ### Causalities

> - | EntityRelatedness
> * | Related (NCI Thesaurus#C53260)

### MitigatingActions

- | Item[x]
* | MedicationRequest/medicationrequest0301-discontinue: Medication Request where study drug prescription was discontinued