Adverse Event Clinical Research
1.0.1 - STU1
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
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{
"resourceType" : "AdverseEvent",
"id" : "adverse-event-compass-ex2",
"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=\"adverse-event-compass-ex2\"> </a><a name=\"hcadverse-event-compass-ex2\"> </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 "adverse-event-compass-ex2" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdverseEvent-clinical-research.html\">Adverse Event Clinical Research</a></p></div><p><b>Adverse Event Grade</b>: Grade 1 Mild Adverse Event <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C41338)</span></p><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</b>: Nausea <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-mdr.html\">Medical Dictionary for Regulatory Activities</a>#10028813)</span></p><p><b>subject</b>: <a href=\"Patient-patient-example-kaitlyn-b.html\">Patient/patient-example-kaitlyn-b</a> " BOUNCE"</p><p><b>occurrence</b>: 2020-05-25 --> 2021-01-21</p><p><b>resultingEffect</b>: <span>: Reference to Condition instance of Nausea that resolved</span></p><p><b>seriousness</b>: Non-serious <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/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/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C49494)</span></p><p><b>recorder</b>: <a href=\"Practitioner-practitioner-oncology-nurse-jane.html\">Practitioner/practitioner-oncology-nurse-jane</a> " NURSE"</p><h3>Participants</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Function</b></td><td><b>Actor</b></td></tr><tr><td style=\"display: none\">*</td><td>authenticator <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-ParticipationType.html\">ParticipationType</a>#AUTHEN)</span></td><td><a href=\"Practitioner-practitioner-owen-oncologist.html\">Practitioner/practitioner-owen-oncologist</a> " ONCOLOGIST"</td></tr></table><p><b>study</b>: <a href=\"ResearchStudy-clinical-trial-example-compass.html\">ResearchStudy/clinical-trial-example-compass</a></p><p><b>expectedInResearchStudy</b>: true</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-medication-administration-kadcyla.html\">MedicationAdministration/medication-administration-kadcyla</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>Possibly Related <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C53258)</span></td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-medication-administration-tucatinib.html\">MedicationAdministration/medication-administration-tucatinib</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>Possibly Related <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C53258)</span></td></tr></table></blockquote><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=\"MedicationRequest-medication-request-example-zofran.html\">MedicationRequest/medication-request-example-zofran</a></td></tr></table><h3>SupportingInfos</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Item[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><span>: Supporting info would have context such as an Reference to Condition instance of Nausea, where Condition.status is resolved.</span></td></tr></table></div>"
},
"extension" : [
{
"url" : "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C41338"
}
],
"text" : "Grade 1 Mild Adverse Event"
}
}
],
"status" : "completed",
"actuality" : "actual",
"code" : {
"coding" : [
{
"system" : "https://www.meddra.org",
"code" : "10028813",
"display" : "Nausea"
}
],
"text" : "Nausea"
},
"subject" : {
🔗 "reference" : "Patient/patient-example-kaitlyn-b"
},
"occurrencePeriod" : {
"start" : "2020-05-25",
"end" : "2021-01-21"
},
"resultingEffect" : [
{
"display" : "Reference to Condition instance of Nausea that resolved"
}
],
"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"
}
]
}
],
"recorder" : {
🔗 "reference" : "Practitioner/practitioner-oncology-nurse-jane"
},
"participant" : [
{
"function" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-ParticipationType",
"code" : "AUTHEN"
}
]
},
"actor" : {
🔗 "reference" : "Practitioner/practitioner-owen-oncologist"
}
}
],
"study" : [
{
🔗 "reference" : "ResearchStudy/clinical-trial-example-compass"
}
],
"expectedInResearchStudy" : true,
"suspectEntity" : [
{
"instanceReference" : {
🔗 "reference" : "MedicationAdministration/medication-administration-kadcyla"
},
"causality" : {
"entityRelatedness" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C53258",
"display" : "Possibly Related"
}
]
}
}
},
{
"instanceReference" : {
🔗 "reference" : "MedicationAdministration/medication-administration-tucatinib"
},
"causality" : {
"entityRelatedness" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C53258",
"display" : "Possibly Related"
}
]
}
}
}
],
"mitigatingAction" : [
{
"itemReference" : {
🔗 "reference" : "MedicationRequest/medication-request-example-zofran"
}
}
],
"supportingInfo" : [
{
"itemReference" : {
"display" : "Supporting info would have context such as an Reference to Condition instance of Nausea, where Condition.status is resolved."
}
}
]
}
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.ae-research-ig#1.0.1 based on FHIR 5.0.0. Generated 2024-04-30
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