This page is part of the Adverse Event Clinical Research (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR v5.0.0. . For a full list of available versions, see the Directory of published versions 
: ClinicalResearchAdverseEventUseCase17 - JSON Representation
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{
"resourceType" : "AdverseEvent",
"id" : "ClinicalResearchAdverseEventUseCase17",
"meta" : {
"profile" : [
"http://hl7.org/fhir/uv/ae-research-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=\"ClinicalResearchAdverseEventUseCase17\"> </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 "ClinicalResearchAdverseEventUseCase17" </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>: Moderate <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>#2)</span></p><p><b>Adverse event caused subject to discontinue the study</b>: false</p><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</b>: Moderate hives <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>#C57954 "Grade 2 - Urticaria")</span></p><p><b>subject</b>: <a href=\"Patient-patient-slp.html\">Patient/patient-slp</a> " EXAMPLE"</p><p><b>occurrence</b>: 2021-01-15 --> 2021-01-15</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>: Recovered/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>#C49498)</span></p><p><b>study</b>: <a href=\"ResearchStudy-research-study-acme.html\">ResearchStudy/research-study-acme</a></p><p><b>expectedInResearchStudy</b>: false</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-study-medication-administration-WBY.html\">MedicationAdministration/study-medication-administration-WBY</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>EntityRelatedness</b></td></tr><tr><td style=\"display: none\">*</td><td>Unlikely Related <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>#C53257)</span></td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-medication-administration-contrast-dye.html\">MedicationAdministration/medication-administration-contrast-dye</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>EntityRelatedness</b></td></tr><tr><td style=\"display: none\">*</td><td>Related <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>#C53260)</span></td></tr></table></blockquote><h3>ContributingFactors</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Item[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Procedure-clinical-trial-acme-procedure.html\">Procedure/clinical-trial-acme-procedure</a></td></tr></table><h3>MitigatingActions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Item[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"MedicationAdministration-medication-administration-forhives.html\">MedicationAdministration/medication-administration-forhives</a></td></tr></table><p><b>note</b>: The action taken with the study treatment was the study drug dose not changed</p></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/severity-or-grade",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/uv/ae-research-ig/CodeSystem/adverse-event-severity-or-grade-cs",
"code" : "2",
"display" : "Moderate"
}
]
}
},
{
"url" : "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/caused-subject-to-discontinue-study",
"valueBoolean" : false
}
],
"status" : "completed",
"actuality" : "actual",
"code" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C57954",
"display" : "Grade 2 - Urticaria"
}
],
"text" : "Moderate hives"
},
"subject" : {
"reference" : "Patient/patient-slp"
},
"occurrencePeriod" : {
"start" : "2021-01-15",
"end" : "2021-01-15"
},
"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" : "C49498",
"display" : "Recovered/Resolved"
}
]
}
],
"study" : [
{
"reference" : "ResearchStudy/research-study-acme"
}
],
"expectedInResearchStudy" : false,
"suspectEntity" : [
{
"instanceReference" : {
"reference" : "MedicationAdministration/study-medication-administration-WBY"
},
"causality" : {
"entityRelatedness" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C53257",
"display" : "Unlikely Related"
}
]
}
}
},
{
"instanceReference" : {
"reference" : "MedicationAdministration/medication-administration-contrast-dye"
},
"causality" : {
"entityRelatedness" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C53260",
"display" : "Related"
}
]
}
}
}
],
"contributingFactor" : [
{
"itemReference" : {
"reference" : "Procedure/clinical-trial-acme-procedure"
}
}
],
"mitigatingAction" : [
{
"itemReference" : {
"reference" : "MedicationAdministration/medication-administration-forhives"
}
}
],
"note" : [
{
"text" : "The action taken with the study treatment was the study drug dose not changed"
}
]
}
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