{ "resourceType" : "AdverseEvent", "id" : "adverse-event-compass-ex1a", "meta" : { "profile" : ["http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"] }, "text" : { "status" : "extensions", "div" : "

Generated Narrative: AdverseEvent

Resource AdverseEvent "adverse-event-compass-ex1a"

Profile: Adverse Event Clinical Research

Resulting Effect: : Reference to Observation of Alanine aminotransferase (ALT) increased at 200

Supporting information relevant to the event

url

item

value: : Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) increased at 200

Adverse Event Grade: Grade 3 Severe Adverse Event (NCI Thesaurus#C41340)

Participant

url

function

value: authenticator (ParticipationType#AUTHEN)

url

actor

value: Practitioner/practitioner-owen-oncologist " ONCOLOGIST"

Suspect Entity

url

instance

value: MedicationAdministration/medication-administration-kadcyla

url

causality

Suspect Entity

url

instance

value: MedicationAdministration/medication-administration-tucatinib

url

causality

Expected In Research Study: true

Note: treatment held today per protocol guidelines and the patient was scheduled to return in one week for repeat lab work

modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]

actuality: actual

event: Alanine aminotransferase (ALT) increased to 200 (Medical Dictionary for Regulatory Activities#10001551 "Alanine aminotransferase increased")

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

date: 2020-05-13

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

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

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

study: ResearchStudy/clinical-trial-example-compass

" }, "extension" : [{ "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect", "valueReference" : { "display" : "Reference to Observation of Alanine aminotransferase (ALT) increased at 200" } }, { "extension" : [{ "url" : "item", "valueReference" : { "display" : "Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) increased at 200" } }], "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info" }, { "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade", "valueCodeableConcept" : { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C41340" }], "text" : "Grade 3 Severe Adverse Event" } }, { "extension" : [{ "url" : "function", "valueCodeableConcept" : { "coding" : [{ "system" : "http://terminology.hl7.org/CodeSystem/v3-ParticipationType", "code" : "AUTHEN" }] } }, { "url" : "actor", "valueReference" : { "reference" : "Practitioner/practitioner-owen-oncologist" } }], "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant" }, { "extension" : [{ "url" : "instance", "valueReference" : { "reference" : "MedicationAdministration/medication-administration-kadcyla" } }, { "extension" : [{ "url" : "entityRelatedness", "valueCodeableConcept" : { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C53258", "display" : "Possibly Related" }] } }], "url" : "causality" }], "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity" }, { "extension" : [{ "url" : "instance", "valueReference" : { "reference" : "MedicationAdministration/medication-administration-tucatinib" } }, { "extension" : [{ "url" : "entityRelatedness", "valueCodeableConcept" : { "coding" : [{ "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl", "code" : "C53258", "display" : "Possibly Related" }] } }], "url" : "causality" }], "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity" }, { "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" : "treatment held today per protocol guidelines and the patient was scheduled to return in one week for repeat lab work" } }], "modifierExtension" : [{ "url" : "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status", "valueCode" : "in-progress" }], "actuality" : "actual", "event" : { "coding" : [{ "system" : "https://www.meddra.org", "code" : "10001551", "display" : "Alanine aminotransferase increased" }], "text" : "Alanine aminotransferase (ALT) increased to 200" }, "subject" : { "reference" : "Patient/patient-example-kaitlyn-b" }, "date" : "2020-05-13", "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" }, "study" : [{ "reference" : "ResearchStudy/clinical-trial-example-compass" }] }