FHIRsmith: AdverseEvent/AdverseEvent-ClinicalTrialSignificantAdverseEvent.json

FHIR IG analytics

Package	hl7.fhir.uv.ae-research-ig
Resource Type	AdverseEvent
Id	AdverseEvent-ClinicalTrialSignificantAdverseEvent.json
FHIR Version	R5

Resources that use this resource

No resources found

Resources that this resource uses

No resources found

Narrative

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

Generated Narrative: AdverseEvent

Resource AdverseEvent "ClinicalTrialSignificantAdverseEvent"

Profile: Adverse Event Clinical Research

Criteria reviewed in determining serious adverse event
url
criterionCode
value: Results In Persistent Or Significant Disability (NCI Thesaurus#C11338)
url
criterionPresent
value: false

Criteria reviewed in determining serious adverse event
url
criterionCode
value: Requires Inpatient Hospitalization (NCI Thesaurus#C83052)
url
criterionPresent
value: true

Criteria reviewed in determining serious adverse event
url
criterionCode
value: Death Related to Adverse Event (NCI Thesaurus#C48275)
url
criterionPresent
value: false

Criteria reviewed in determining serious adverse event
url
criterionCode
value: Is Life Threatening (NCI Thesaurus#C84266)
url
criterionPresent
value: true

Criteria reviewed in determining serious adverse event
url
criterionCode
value: Congenital Anomaly or Birth Defect (NCI Thesaurus#C83117)
url
criterionPresent
value: false

Criteria reviewed in determining serious adverse event
url
criterionCode
value: Other Medically Important Condition (NCI Thesaurus#C82521)
url
criterionPresent
value: false

Criteria reviewed in determining serious adverse event
url
criterionCode
value: Required Intervention to Prevent Permanent Impairment/damage (NCI Thesaurus#C201939)
url
criterionPresent
value: true

Adverse Event Severity: Severe (AdverseEventSeverity#severe)

status: completed

actuality: actual

code: Serious reportable event associated with product or device (SNOMED CT#370901008)

subject: Patient/ClinicalTrialSubject5 " CLINICAL TRIAL"

detected: 1905-08-23

recordedDate: 1905-08-24

resultingEffect:

seriousness: Serious (AdverseEventSeriousness#serious)

outcome: Recovering/Resolving (NCI Thesaurus#C49496)

recorder: : Clinical Research Associate

study: : NCT1010101

suspectEntity
instance: MedicationAdministration/medadmin0301: Study Medication
Causalities
- EntityRelatedness
* Related (NCI Thesaurus#C53260)

MitigatingActions

Item[x]

MedicationRequest/medicationrequest0301-discontinue: Medication Request where study drug prescription was discontinued

Source1

{
  "resourceType": "AdverseEvent",
  "id": "ClinicalTrialSignificantAdverseEvent",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "extension": [
        {
          "url": "criterionCode",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C11338",
                "display": "Results In Persistent Or Significant Disability"
              }
            ]
          }
        },
        {
          "url": "criterionPresent",
          "valueBoolean": false
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"
    },
    {
      "extension": [
        {
          "url": "criterionCode",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C83052",
                "display": "Requires Inpatient Hospitalization"
              }
            ]
          }
        },
        {
          "url": "criterionPresent",
          "valueBoolean": true
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"
    },
    {
      "extension": [
        {
          "url": "criterionCode",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C48275",
                "display": "Death Related to Adverse Event"
              }
            ]
          }
        },
        {
          "url": "criterionPresent",
          "valueBoolean": false
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"
    },
    {
      "extension": [
        {
          "url": "criterionCode",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C84266",
                "display": "Is Life Threatening"
              }
            ]
          }
        },
        {
          "url": "criterionPresent",
          "valueBoolean": true
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"
    },
    {
      "extension": [
        {
          "url": "criterionCode",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C83117",
                "display": "Congenital Anomaly or Birth Defect"
              }
            ]
          }
        },
        {
          "url": "criterionPresent",
          "valueBoolean": false
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"
    },
    {
      "extension": [
        {
          "url": "criterionCode",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C82521",
                "display": "Other Medically Important Condition"
              }
            ]
          }
        },
        {
          "url": "criterionPresent",
          "valueBoolean": false
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"
    },
    {
      "extension": [
        {
          "url": "criterionCode",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C201939",
                "display": "Required Intervention to Prevent Permanent Impairment/damage"
              }
            ]
          }
        },
        {
          "url": "criterionPresent",
          "valueBoolean": true
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"
    },
    {
      "url": "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity",
      "valueCodeableConcept": {
        "coding": [
          {
            "system": "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
            "code": "severe",
            "display": "Severe"
          }
        ]
      }
    }
  ],
  "status": "completed",
  "actuality": "actual",
  "code": {
    "coding": [
      {
        "system": "http://snomed.info/sct",
        "code": "370901008",
        "display": "Serious reportable event associated with product or device"
      }
    ]
  },
  "subject": {
    "reference": "Patient/ClinicalTrialSubject5"
  },
  "detected": "1905-08-23",
  "recordedDate": "1905-08-24",
  "resultingEffect": [
    {
      "reference": "Condition/AEHepaticFailure"
    },
    {
      "reference": "Condition/AEHepaticFailurecomplication"
    }
  ],
  "seriousness": {
    "coding": [
      {
        "system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
        "code": "serious"
      }
    ]
  },
  "outcome": [
    {
      "coding": [
        {
          "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code": "C49496",
          "display": "Recovering/Resolving"
        }
      ]
    }
  ],
  "recorder": {
    "display": "Clinical Research Associate"
  },
  "study": [
    {
      "display": "NCT1010101"
    }
  ],
  "suspectEntity": [
    {
      "instanceReference": {
        "reference": "MedicationAdministration/medadmin0301",
        "display": "Study Medication"
      },
      "causality": {
        "entityRelatedness": {
          "coding": [
            {
              "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code": "C53260",
              "display": "Related"
            }
          ]
        }
      }
    }
  ],
  "mitigatingAction": [
    {
      "itemReference": {
        "reference": "MedicationRequest/medicationrequest0301-discontinue",
        "display": "Medication Request where study drug prescription was discontinued"
      }
    }
  ]
}