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

## : AdverseEventFromProcedureNotStudyDrug - JSON Representation

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    {
      "resourceType" : "AdverseEvent",
      "id" : "AdverseEventFromProcedureNotStudyDrug",
      "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=\"AdverseEventFromProcedureNotStudyDrug\"> </a><a name=\"hcAdverseEventFromProcedureNotStudyDrug\"> </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;AdverseEventFromProcedureNotStudyDrug&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 Severity</b>: Moderate <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-adverse-event-severity.html\">AdverseEventSeverity</a>#moderate)</span></p><p><b>Adverse event caused subject to discontinue the study</b>: false</p><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</b>: Moderate hives <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>#10019211 &quot;Hypersensitivity reaction&quot;)</span></p><p><b>subject</b>: <a href=\"Patient-patient-slp.html\">Patient/patient-slp</a> &quot; EXAMPLE&quot;</p><p><b>occurrence</b>: 2021-01-15 --&gt; 2021-01-15</p><p><b>resultingEffect</b>: <a href=\"Condition-AEModeratehives.html\">Condition/AEModeratehives: Moderate hives</a></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>study</b>: <a href=\"ResearchStudy-research-study-acme.html\">ResearchStudy/research-study-acme</a></p><p><b>expectedInResearchStudy</b>: false</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-study-medication-administration-WBY.html\">MedicationAdministration/study-medication-administration-WBY</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>Unlikely 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>#C53257)</span></td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-medication-administration-contrast-dye.html\">MedicationAdministration/medication-administration-contrast-dye</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>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>#C53260)</span></td></tr></table></blockquote><h3>ContributingFactors</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Item[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Procedure-clinical-trial-acme-procedure.html\">Procedure/clinical-trial-acme-procedure</a></td></tr></table><h3>MitigatingActions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Item[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"MedicationAdministration-medication-administration-forhives.html\">MedicationAdministration/medication-administration-forhives</a></td></tr></table><p><b>note</b>: The action taken with the study treatment was the study drug dose not changed</p></div>"
      },
      "extension" : [
        {
          "url" : "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity",
          "valueCodeableConcept" : {
            "coding" : [
              {
                "system" : "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
                "code" : "moderate",
                "display" : "Moderate"
              }
            ]
          }
        },
        {
          "url" : "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/caused-subject-to-discontinue-study",
          "valueBoolean" : false
        }
      ],
      "status" : "completed",
      "actuality" : "actual",
      "code" : {
        "coding" : [
          {
            "system" : "https://www.meddra.org",
            "code" : "10019211",
            "display" : "Hypersensitivity reaction"
          }
        ],
        "text" : "Moderate hives"
      },
      "subject" : {
        🔗 "reference" : "Patient/patient-slp"
      },
      "occurrencePeriod" : {
        "start" : "2021-01-15",
        "end" : "2021-01-15"
      },
      "resultingEffect" : [
        {
          🔗 "reference" : "Condition/AEModeratehives",
          "display" : "Moderate hives"
        }
      ],
      "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"
            }
          ]
        }
      ],
      "study" : [
        {
          🔗 "reference" : "ResearchStudy/research-study-acme"
        }
      ],
      "expectedInResearchStudy" : false,
      "suspectEntity" : [
        {
          "instanceReference" : {
            🔗 "reference" : "MedicationAdministration/study-medication-administration-WBY"
          },
          "causality" : {
            "entityRelatedness" : {
              "coding" : [
                {
                  "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                  "code" : "C53257",
                  "display" : "Unlikely Related"
                }
              ]
            }
          }
        },
        {
          "instanceReference" : {
            🔗 "reference" : "MedicationAdministration/medication-administration-contrast-dye"
          },
          "causality" : {
            "entityRelatedness" : {
              "coding" : [
                {
                  "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                  "code" : "C53260",
                  "display" : "Related"
                }
              ]
            }
          }
        }
      ],
      "contributingFactor" : [
        {
          "itemReference" : {
            🔗 "reference" : "Procedure/clinical-trial-acme-procedure"
          }
        }
      ],
      "mitigatingAction" : [
        {
          "itemReference" : {
            🔗 "reference" : "MedicationAdministration/medication-administration-forhives"
          }
        }
      ],
      "note" : [
        {
          "text" : "The action taken with the study treatment was the study drug dose not changed"
        }
      ]
    }