FHIRsmith: AdverseEvent/AdverseEvent-SeriousAdverseEventResearchStudy.json

FHIR IG analytics

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

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Resources that this resource uses

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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

Adverse Event Severity: Severe (AdverseEventSeverity#severe)

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 caused subject to discontinue the study: true

status: completed

actuality: actual

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

subject: Patient/SCHJO ""

occurrence: 2021-12-02 --> 2021-12-09

resultingEffect: Condition/GIBleed

seriousness: Serious (AdverseEventSeriousness#serious)

outcome: Recovered/Resolved (NCI Thesaurus#C49498)

study: ResearchStudy/research-study-XYZ

expectedInResearchStudy: false

suspectEntity
instance: MedicationAdministration/study-medication-administration-ABC
Causalities
- EntityRelatedness
* Possibly Related (NCI Thesaurus#C53258)

mitigatingAction
item: Procedure/procedure-upper-endoscopy

mitigatingAction
item: study drug withdrawn (NCI Thesaurus#C49502 "DRUG WITHDRAWN")

mitigatingAction
item: MedicationRequest/medicationrequest-for-study-medication-administration-ABC: Medication Request where study drug prescription was discontinued

SupportingInfos

Item[x]

: 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.

Source1

{
  "resourceType": "AdverseEvent",
  "id": "SeriousAdverseEventResearchStudy",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "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": "severe",
            "display": "Severe"
          }
        ]
      }
    },
    {
      "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/caused-subject-to-discontinue-study",
      "valueBoolean": true
    }
  ],
  "status": "completed",
  "actuality": "actual",
  "code": {
    "coding": [
      {
        "system": "https://www.meddra.org",
        "code": "10017955",
        "display": "Gastrointestinal haemorrhage"
      }
    ]
  },
  "subject": {
    "reference": "Patient/SCHJO"
  },
  "occurrencePeriod": {
    "start": "2021-12-02",
    "end": "2021-12-09"
  },
  "resultingEffect": [
    {
      "reference": "Condition/GIBleed"
    }
  ],
  "seriousness": {
    "coding": [
      {
        "system": "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness",
        "code": "serious",
        "display": "Serious"
      }
    ]
  },
  "outcome": [
    {
      "coding": [
        {
          "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code": "C49498",
          "display": "Recovered/Resolved"
        }
      ]
    }
  ],
  "study": [
    {
      "reference": "ResearchStudy/research-study-XYZ"
    }
  ],
  "expectedInResearchStudy": false,
  "suspectEntity": [
    {
      "instanceReference": {
        "reference": "MedicationAdministration/study-medication-administration-ABC"
      },
      "causality": {
        "entityRelatedness": {
          "coding": [
            {
              "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code": "C53258",
              "display": "Possibly Related"
            }
          ]
        }
      }
    }
  ],
  "mitigatingAction": [
    {
      "itemReference": {
        "reference": "Procedure/procedure-upper-endoscopy"
      }
    },
    {
      "itemCodeableConcept": {
        "coding": [
          {
            "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code": "C49502",
            "display": "DRUG WITHDRAWN"
          }
        ],
        "text": "study drug withdrawn"
      }
    },
    {
      "itemReference": {
        "reference": "MedicationRequest/medicationrequest-for-study-medication-administration-ABC",
        "display": "Medication Request where study drug prescription was discontinued"
      }
    }
  ],
  "supportingInfo": [
    {
      "itemReference": {
        "display": "Supporting info would have context such as an Observation on the drop in hemoglobin"
      }
    }
  ],
  "note": [
    {
      "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."
    }
  ]
}