This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions 
: ClinicalResearchAdverseEventUseCase16 - JSON Representation
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{
"resourceType" : "AdverseEvent",
"id" : "ClinicalResearchAdverseEventUseCase16",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: AdverseEvent</b><a name=\"ClinicalResearchAdverseEventUseCase16\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource AdverseEvent "ClinicalResearchAdverseEventUseCase16" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdverseEvent-clinical-research.html\">Adverse Event Clinical Research</a></p></div><p><b>Severity Or Grade</b>: Mild <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-adverse-event-severity-or-grade-cs.html\">AdverseEvent Severity or Grade Codes</a>#1)</span></p><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href=\"MedicationAdministration-study-medication-administration-MMD.html\">MedicationAdministration/study-medication-administration-MMD</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><blockquote><p><b>Mitigating Action</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href=\"MedicationAdministration-medication-administration-tylenol.html\">MedicationAdministration/medication-administration-tylenol</a></p></blockquote><p><b>Adverse event caused subject to discontinue the study</b>: false</p><p><b>Expected In Research Study</b>: true</p><p><b>Note</b>: Headaches are mild, occur once a week and resolved with Tylenol, but still ongoing. Action taken with the study is dose not chnaged.</p><blockquote><p><b>modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]</b></p></blockquote><p><b>actuality</b>: actual</p><p><b>event</b>: Headache <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (www.meddra.org#10019211)</span></p><p><b>subject</b>: <a href=\"Patient-patient-moumic.html\">Patient/patient-moumic</a> " EXAMPLE"</p><p><b>date</b>: 2022-02-01</p><p><b>seriousness</b>: Non-serious <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-adverse-event-seriousness.html\">AdverseEventSeriousness</a>#non-serious)</span></p><p><b>outcome</b>: Not recovering/not resolved <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C49494)</span></p><p><b>study</b>: <a href=\"ResearchStudy-research-study-DISNEY.html\">ResearchStudy/research-study-DISNEY</a></p></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/severity-or-grade",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/ae-research-backport-ig/CodeSystem/adverse-event-severity-or-grade-cs",
"code" : "1",
"display" : "Mild"
}
]
}
},
{
"extension" : [
{
"url" : "instance",
"valueReference" : {
"reference" : "MedicationAdministration/study-medication-administration-MMD"
}
},
{
"extension" : [
{
"url" : "entityRelatedness",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C53257",
"display" : "Unlikely Related"
}
]
}
}
],
"url" : "causality"
}
],
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"
},
{
"extension" : [
{
"url" : "item",
"valueReference" : {
"reference" : "MedicationAdministration/medication-administration-tylenol"
}
}
],
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"
},
{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study",
"valueBoolean" : false
},
{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study",
"valueBoolean" : true
},
{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note",
"valueAnnotation" : {
"text" : "Headaches are mild, occur once a week and resolved with Tylenol, but still ongoing. Action taken with the study is dose not chnaged."
}
}
],
"modifierExtension" : [
{
"url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status",
"valueCode" : "completed"
}
],
"actuality" : "actual",
"event" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10019211",
"display" : "Headache"
}
]
},
"subject" : {
"reference" : "Patient/patient-moumic"
},
"date" : "2022-02-01",
"seriousness" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
"code" : "non-serious",
"display" : "Non-serious"
}
]
},
"outcome" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C49494",
"display" : "Not recovering/not resolved"
}
]
},
"study" : [
{
"reference" : "ResearchStudy/research-study-DISNEY"
}
]
}
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