Adverse Event Clinical Research
1.0.1 - STU1 International flag

This page is part of the Adverse Event Clinical Research (v1.0.1: STU 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, 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-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>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>: completed</p><p><b>actuality</b>: actual</p><p><b>code</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>occurrence</b>: 2020-05-20 --&gt; 2020-06-10</p><p><b>resultingEffect</b>: <span>: Reference to Observation of Alanine aminotransferase (ALT) decreased to 60</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>: 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><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><blockquote><p><b>mitigatingAction</b></p><p><b>item</b>: <a href=\"MedicationAdministration-medication-administration-kadcyla-reduced.html\">MedicationAdministration/medication-administration-kadcyla-reduced</a></p></blockquote><blockquote><p><b>mitigatingAction</b></p><p><b>item</b>: <a href=\"MedicationAdministration-medication-administration-tucatinib-reduced.html\">MedicationAdministration/medication-administration-tucatinib-reduced</a></p></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) decreased to 60</span></td></tr></table><p><b>note</b>: treatment given with reduced dose per protocol guidelines</p></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" : "completed",
  "actuality" : "actual",
  "code" : {
    "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"
  },
  "occurrencePeriod" : {
    "start" : "2020-05-20",
    "end" : "2020-06-10"
  },
  "resultingEffect" : [
    {
      "display" : "Reference to Observation of Alanine aminotransferase (ALT) decreased to 60"
    }
  ],
  "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"
  },
  "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"
            }
          ]
        }
      }
    }
  ],
  "mitigatingAction" : [
    {
      "itemReference" : {
        🔗 "reference" : "MedicationAdministration/medication-administration-kadcyla-reduced"
      }
    },
    {
      "itemReference" : {
        🔗 "reference" : "MedicationAdministration/medication-administration-tucatinib-reduced"
      }
    }
  ],
  "supportingInfo" : [
    {
      "itemReference" : {
        "display" : "Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) decreased to 60"
      }
    }
  ],
  "note" : [
    {
      "text" : "treatment given with reduced dose per protocol guidelines"
    }
  ]
}