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: adverse-event-compass-ex1

Page standards status: Informative

Generated Narrative: AdverseEvent

Resource AdverseEvent "adverse-event-compass-ex1"

Profile: Adverse Event Clinical Research

Adverse Event Grade: Grade 1 Mild Adverse Event (NCI Thesaurus#C41338)

status: in-progress

actuality: actual

code: Alanine aminotransferase (ALT) increased at 50 (Medical Dictionary for Regulatory Activities#10001551 "Alanine aminotransferase increased")

subject: Patient/patient-example-kaitlyn-b " BOUNCE"

occurrence: 2020-04-22 --> (ongoing)

resultingEffect: : Reference to Observation of Alanine aminotransferase (ALT) increased at 50

seriousness: Non-serious (AdverseEventSeriousness#non-serious)

outcome: Not recovering/not resolved (NCI Thesaurus#C49494)

recorder: Practitioner/practitioner-oncology-nurse-jane " NURSE"

### Participants

- | Function | Actor
* | authenticator (ParticipationType#AUTHEN) | Practitioner/practitioner-owen-oncologist " ONCOLOGIST"

study: ResearchStudy/clinical-trial-example-compass

expectedInResearchStudy: true

> suspectEntity

> instance: MedicationAdministration/medication-administration-kadcyla

> ### Causalities

> - | EntityRelatedness
> * | Possibly Related (NCI Thesaurus#C53258)

> suspectEntity

> instance: MedicationAdministration/medication-administration-tucatinib

> ### Causalities

> - | EntityRelatedness
> * | Possibly Related (NCI Thesaurus#C53258)

### SupportingInfos

- | Item[x]
* | : Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) increased at 50