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FHIR IG analytics

Packagehl7.fhir.uv.ae-research-backport-ig
Resource TypeAdverseEvent
IdAdverseEvent-adverse-event-compass-ex1b.json
FHIR VersionR4

Resources that use this resource

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Resources that this resource uses

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: AdverseEvent

Resource AdverseEvent "adverse-event-compass-ex1b"

Profile: Adverse Event Clinical Research

Resulting Effect: : Reference to Observation of Alanine aminotransferase (ALT) decreased to 60

Supporting information relevant to the event

url

item

value: : Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) decreased to 60

Adverse Event Grade: Grade 1 Mild Adverse Event (NCI Thesaurus#C41338)

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

Adverse Event resolution date: 2020-06-10

Note: treatment given with reduced dose per protocol guidelines

Mitigating Action

url

item

value: MedicationAdministration/medication-administration-kadcyla-reduced

Mitigating Action

url

item

value: MedicationAdministration/medication-administration-tucatinib-reduced

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

actuality: actual

event: Alanine aminotransferase (ALT) decreased to 60 (Medical Dictionary for Regulatory Activities#10001551 "Alanine aminotransferase increased")

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

date: 2020-05-20

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

outcome: Recovered/Resolved (NCI Thesaurus#C49498)

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

study: ResearchStudy/clinical-trial-example-compass

Source1

{
  "resourceType": "AdverseEvent",
  "id": "adverse-event-compass-ex1b",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect",
      "valueReference": {
        "display": "Reference to Observation of Alanine aminotransferase (ALT) decreased to 60"
      }
    },
    {
      "extension": [
        {
          "url": "item",
          "valueReference": {
            "display": "Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) decreased to 60"
          }
        }
      ],
      "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": "C41338"
          }
        ],
        "text": "Grade 1 Mild 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/resolve-date",
      "valueDateTime": "2020-06-10"
    },
    {
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note",
      "valueAnnotation": {
        "text": "treatment given with reduced dose per protocol guidelines"
      }
    },
    {
      "extension": [
        {
          "url": "item",
          "valueReference": {
            "reference": "MedicationAdministration/medication-administration-kadcyla-reduced"
          }
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"
    },
    {
      "extension": [
        {
          "url": "item",
          "valueReference": {
            "reference": "MedicationAdministration/medication-administration-tucatinib-reduced"
          }
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"
    }
  ],
  "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": "10001551",
        "display": "Alanine aminotransferase increased"
      }
    ],
    "text": "Alanine aminotransferase (ALT) decreased to 60"
  },
  "subject": {
    "reference": "Patient/patient-example-kaitlyn-b"
  },
  "date": "2020-05-20",
  "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"
      }
    ]
  },
  "recorder": {
    "reference": "Practitioner/practitioner-oncology-nurse-jane"
  },
  "study": [
    {
      "reference": "ResearchStudy/clinical-trial-example-compass"
    }
  ]
}