Adverse Event Clinical Research R4 Backport
1.0.1 - STU1

Adverse Event Clinical Research R4 Backport, 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-backport-ig/ and changes regularly. See the Directory of published versions

## : adverse-event-compass-ex1b - JSON Representation

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    {
      "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" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: AdverseEvent</b><a name=\"adverse-event-compass-ex1b\"> </a><a name=\"hcadverse-event-compass-ex1b\"> </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 &quot;adverse-event-compass-ex1b&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdverseEvent-clinical-research.html\">Adverse Event Clinical Research</a></p></div><p><b>Resulting Effect</b>: <span>: Reference to Observation of Alanine aminotransferase (ALT) decreased to 60</span></p><blockquote><p><b>Supporting information relevant to the event</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <span>: Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) decreased to 60</span></p></blockquote><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><blockquote><p><b>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/5.5.0/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-practitioner-owen-oncologist.html\">Practitioner/practitioner-owen-oncologist</a> &quot; ONCOLOGIST&quot;</p></blockquote><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href=\"MedicationAdministration-medication-administration-kadcyla.html\">MedicationAdministration/medication-administration-kadcyla</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href=\"MedicationAdministration-medication-administration-tucatinib.html\">MedicationAdministration/medication-administration-tucatinib</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><p><b>Expected In Research Study</b>: true</p><p><b>Adverse Event resolution date</b>: 2020-06-10</p><p><b>Note</b>: treatment given with reduced dose per protocol guidelines</p><blockquote><p><b>Mitigating Action</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href=\"MedicationAdministration-medication-administration-kadcyla-reduced.html\">MedicationAdministration/medication-administration-kadcyla-reduced</a></p></blockquote><blockquote><p><b>Mitigating Action</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href=\"MedicationAdministration-medication-administration-tucatinib-reduced.html\">MedicationAdministration/medication-administration-tucatinib-reduced</a></p></blockquote><blockquote><p><b>modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]</b></p></blockquote><p><b>actuality</b>: actual</p><p><b>event</b>: Alanine aminotransferase (ALT) decreased to 60 <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>#10001551 &quot;Alanine aminotransferase increased&quot;)</span></p><p><b>subject</b>: <a href=\"Patient-patient-example-kaitlyn-b.html\">Patient/patient-example-kaitlyn-b</a> &quot; BOUNCE&quot;</p><p><b>date</b>: 2020-05-20</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>: Recovered/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>#C49498)</span></p><p><b>recorder</b>: <a href=\"Practitioner-practitioner-oncology-nurse-jane.html\">Practitioner/practitioner-oncology-nurse-jane</a> &quot; NURSE&quot;</p><p><b>study</b>: <a href=\"ResearchStudy-clinical-trial-example-compass.html\">ResearchStudy/clinical-trial-example-compass</a></p></div>"
      },
      "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"
        }
      ]
    }