FHIRsmith: AdverseEvent/AdverseEvent-SeriousAdverseEventResearchStudy.json

FHIR IG analytics

Package	hl7.fhir.uv.ae-research-backport-ig
Resource Type	AdverseEvent
Id	AdverseEvent-SeriousAdverseEventResearchStudy.json
FHIR Version	R4

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Narrative

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

Generated Narrative: AdverseEvent

Resource AdverseEvent "SeriousAdverseEventResearchStudy"

Profile: Adverse Event Clinical Research

Resulting Effect: Condition/GIBleed

Suspect Entity
url
instance
value: MedicationAdministration/study-medication-administration-ABC
url
causality

Adverse Event resolution date: 2021-12-09

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

Mitigating Action
url
item
value: Procedure/procedure-upper-endoscopy

Mitigating Action
url
item
value: study drug withdrawn (NCI Thesaurus#C49502 "DRUG WITHDRAWN")

Mitigating Action
url
item
value: MedicationRequest/medicationrequest-for-study-medication-administration-ABC: Medication Request where study drug prescription was discontinued

Adverse event caused subject to discontinue the study: true

Expected In Research Study: false

Supporting information relevant to the event
url
item
value: : Supporting info would have context such as an Observation on the drop in hemoglobin

Note: The patient’s hemoglobin dropped to 6.5 g/dL and received 2 units of PRBCs. The patient had an upper endoscopy that showed a moderate amount of bleeding from the esophagus. The site was cauterized, and the patient had no further bleeding after the procedure. The GI bleed resolved within one week after discontinuation of study drug and the patient was discharged on 9-Dec-2021 in good condition.

modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]

actuality: actual

event: Gastrointestinal haemorrhage (Medical Dictionary for Regulatory Activities#10017955)

subject: Patient/SCHJO ""

date: 2021-12-02

seriousness: Serious (AdverseEventSeriousness#serious)

severity: Severe (AdverseEventSeverity#severe)

outcome: Recovered/Resolved (NCI Thesaurus#C49498)

study: ResearchStudy/research-study-XYZ

Source1

{
  "resourceType": "AdverseEvent",
  "id": "SeriousAdverseEventResearchStudy",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect",
      "valueReference": {
        "reference": "Condition/GIBleed"
      }
    },
    {
      "extension": [
        {
          "url": "instance",
          "valueReference": {
            "reference": "MedicationAdministration/study-medication-administration-ABC"
          }
        },
        {
          "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/resolve-date",
      "valueDateTime": "2021-12-09"
    },
    {
      "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-backport-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-backport-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-backport-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-backport-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-backport-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-backport-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-backport-ig/StructureDefinition/seriousness-criteria"
    },
    {
      "extension": [
        {
          "url": "item",
          "valueReference": {
            "reference": "Procedure/procedure-upper-endoscopy"
          }
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"
    },
    {
      "extension": [
        {
          "url": "item",
          "valueCodeableConcept": {
            "coding": [
              {
                "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
                "code": "C49502",
                "display": "DRUG WITHDRAWN"
              }
            ],
            "text": "study drug withdrawn"
          }
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"
    },
    {
      "extension": [
        {
          "url": "item",
          "valueReference": {
            "reference": "MedicationRequest/medicationrequest-for-study-medication-administration-ABC",
            "display": "Medication Request where study drug prescription was discontinued"
          }
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"
    },
    {
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study",
      "valueBoolean": true
    },
    {
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study",
      "valueBoolean": false
    },
    {
      "extension": [
        {
          "url": "item",
          "valueReference": {
            "display": "Supporting info would have context such as an Observation on the drop in hemoglobin"
          }
        }
      ],
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info"
    },
    {
      "url": "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note",
      "valueAnnotation": {
        "text": "The patient’s hemoglobin dropped to 6.5 g/dL and received 2 units of PRBCs. The patient had an upper endoscopy that showed a moderate amount of bleeding from the esophagus. The site was cauterized, and the patient had no further bleeding after the procedure. The GI bleed resolved within one week after discontinuation of study drug and the patient was discharged on 9-Dec-2021 in good condition."
      }
    }
  ],
  "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": "10017955",
        "display": "Gastrointestinal haemorrhage"
      }
    ]
  },
  "subject": {
    "reference": "Patient/SCHJO"
  },
  "date": "2021-12-02",
  "seriousness": {
    "coding": [
      {
        "system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
        "code": "serious",
        "display": "Serious"
      }
    ]
  },
  "severity": {
    "coding": [
      {
        "system": "http://terminology.hl7.org/CodeSystem/adverse-event-severity",
        "code": "severe",
        "display": "Severe"
      }
    ]
  },
  "outcome": {
    "coding": [
      {
        "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "code": "C49498",
        "display": "Recovered/Resolved"
      }
    ]
  },
  "study": [
    {
      "reference": "ResearchStudy/research-study-XYZ"
    }
  ]
}