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

## : adverse-event-compass-ex1 - JSON Representation

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    {
      "resourceType" : "AdverseEvent",
      "id" : "adverse-event-compass-ex1",
      "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-ex1\"> </a><a name=\"hcadverse-event-compass-ex1\"> </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-ex1&quot; </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>: in-progress</p><p><b>actuality</b>: actual</p><p><b>code</b>: Alanine aminotransferase (ALT) increased at 50 <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>occurrence</b>: 2020-04-22 --&gt; (ongoing)</p><p><b>resultingEffect</b>: <span>: Reference to Observation of Alanine aminotransferase (ALT) increased at 50</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> &quot; NURSE&quot;</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> &quot; ONCOLOGIST&quot;</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>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 Observation of Alanine aminotransferase (ALT) increased at 50</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" : "in-progress",
      "actuality" : "actual",
      "code" : {
        "coding" : [
          {
            "system" : "https://www.meddra.org",
            "code" : "10001551",
            "display" : "Alanine aminotransferase increased"
          }
        ],
        "text" : "Alanine aminotransferase (ALT) increased at 50"
      },
      "subject" : {
        🔗 "reference" : "Patient/patient-example-kaitlyn-b"
      },
      "occurrencePeriod" : {
        "start" : "2020-04-22"
      },
      "resultingEffect" : [
        {
          "display" : "Reference to Observation of Alanine aminotransferase (ALT) increased at 50"
        }
      ],
      "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"
                }
              ]
            }
          }
        }
      ],
      "supportingInfo" : [
        {
          "itemReference" : {
            "display" : "Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) increased at 50"
          }
        }
      ]
    }