HL7 FHIR Implementation Guide: Common Terminology Criteria (CTC) Adverse Events Release 1 - DRAFT
0.0.1 - DRAFT
HL7 FHIR Implementation Guide: Common Terminology Criteria (CTC) Adverse Events Release 1 - DRAFT, published by HL7 International Clinical Interoperability Council. This guide is not an authorized publication; it is the continuous build for version 0.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/standardhealth/fsh-ae/ and changes regularly. See the Directory of published versions
{
"resourceType" : "AdverseEvent",
"id" : "ctc-adverse-event-example-1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/ctcae/StructureDefinition/ctc-adverse-event"
]
},
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: AdverseEvent</b><a name=\"ctc-adverse-event-example-1\"> </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 "ctc-adverse-event-example-1" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ctc-adverse-event.html\">CTC Adverse Event</a></p></div><p><b>CTC Adverse Event Grade</b>: Moderate Adverse Event <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-ctcae-grade-code-system.html\">CTCAE Grade Code System</a>#2)</span></p><p><b>Adverse Event Expectation</b>: Expected Adverse Event <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C41333)</span></p><p><b>Adverse Event Resolved Date</b>: 2020-05-21</p><blockquote><p><b>Adverse Event Participant</b></p><blockquote><p><b>url</b></p><code>function</code></blockquote><p><b>value</b>: authenticator <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-ParticipationType.html\">ParticipationType</a>#AUTHEN)</span></p><blockquote><p><b>url</b></p><code>actor</code></blockquote><p><b>value</b>: <a href=\"Practitioner-us-core-practitioner-owen-oncologist.html\">Practitioner/us-core-practitioner-owen-oncologist</a> " ONCOLOGIST"</p></blockquote><p><b>actuality</b>: actual</p><p><b>event</b>: DHN IV given <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-MDRAE.html\">MedDRA Am Engl</a>#10012174 "Dehydration")</span></p><p><b>subject</b>: <a href=\"Patient-PatientPersona2.html\">Patient/PatientPersona2</a> " C."</p><p><b>date</b>: 2020-05-20</p><p><b>seriousness</b>: Non-serious Adverse Event <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C41336)</span></p><p><b>outcome</b>: Resolved <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://hl7.org/fhir/R4/codesystem-adverse-event-outcome.html\">AdverseEventOutcome</a>#resolved)</span></p><p><b>recorder</b>: <a href=\"Practitioner-PractitionerExample1.html\">Practitioner/PractitionerExample1</a> " ANYDOC"</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a name=\"medication-example-1\"> </a></p><blockquote><p/><p><a name=\"medication-example-1\"> </a></p><p><b>code</b>: gefitinib 250 MG Oral Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-rxNorm.html\">RxNorm</a>#349472)</span></p></blockquote><h3>Causalities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Assessment</b></td></tr><tr><td style=\"display: none\">*</td><td>Adverse Event Probably Related to Intervention <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C53259)</span></td></tr></table></blockquote><hr/><blockquote><p><b>Generated Narrative: Medication #medication-example-1</b><a name=\"medication-example-1\"> </a></p><p><b>code</b>: gefitinib 250 MG Oral Tablet <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-rxNorm.html\">RxNorm</a>#349472)</span></p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Medication",
"id" : "medication-example-1",
"code" : {
"coding" : [
{
"system" : "http://www.nlm.nih.gov/research/umls/rxnorm",
"code" : "349472",
"display" : "gefitinib 250 MG Oral Tablet"
}
]
}
}
],
"extension" : [
{
"url" : "http://hl7.org/fhir/us/ctcae/StructureDefinition/ctcae-grade",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://hl7.org/fhir/us/ctcae/CodeSystem/ctcae-grade-code-system",
"code" : "2",
"display" : "Moderate Adverse Event"
}
]
}
},
{
"url" : "http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-expectation",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C41333",
"display" : "Expected Adverse Event"
}
]
}
},
{
"url" : "http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-resolved-date",
"valueDateTime" : "2020-05-21"
},
{
"extension" : [
{
"url" : "function",
"valueCodeableConcept" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/v3-ParticipationType",
"code" : "AUTHEN"
}
]
}
},
{
"url" : "actor",
"valueReference" : {
🔗 "reference" : "Practitioner/us-core-practitioner-owen-oncologist"
}
}
],
"url" : "http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-participant"
}
],
"actuality" : "actual",
"event" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/MDRAE",
"code" : "10012174",
"display" : "Dehydration"
}
],
"text" : "DHN IV given"
},
"subject" : {
🔗 "reference" : "Patient/PatientPersona2"
},
"date" : "2020-05-20",
"seriousness" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C41336",
"display" : "Non-serious Adverse Event"
}
]
},
"outcome" : {
"coding" : [
{
"system" : "http://terminology.hl7.org/CodeSystem/adverse-event-outcome",
"code" : "resolved"
}
]
},
"recorder" : {
🔗 "reference" : "Practitioner/PractitionerExample1"
},
"suspectEntity" : [
{
"instance" : {
"reference" : "#medication-example-1"
},
"causality" : [
{
"assessment" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C53259"
}
],
"text" : "Adverse Event Probably Related to Intervention"
}
}
]
}
]
}