FHIRsmith: AdverseEvent/AdverseEvent-clinical-research-ae-example-medwatch-patient-report.json

FHIR IG analytics

Package	hl7.fhir.uv.ae-research-ig
Resource Type	AdverseEvent
Id	AdverseEvent-clinical-research-ae-example-medwatch-patient-report.json
FHIR Version	R5

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Narrative

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

Generated Narrative: AdverseEvent

Resource AdverseEvent "clinical-research-ae-example-medwatch-patient-report"

Profile: Adverse Event Clinical Research

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

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: false

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: false

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

status: completed

actuality: actual

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

subject: Patient/JanetPatient: Janet " CLINICAL TRIAL PATIENT"

detected: 2023-04-10

resultingEffect: Condition/janetReported-condition

seriousness: Serious (AdverseEventSeriousness#serious)

outcome: Recovered/Resolved (NCI Thesaurus#C49498)

recorder: Patient/JanetPatient " CLINICAL TRIAL PATIENT"

study: ResearchStudy/BreastCancerTrial

suspectEntity
instance: Medication/bresentrik
Causalities
- EntityRelatedness Author
* Possibly Related (NCI Thesaurus#C53258) Patient/JanetPatient: Janet " CLINICAL TRIAL PATIENT"

suspectEntity
instance: ResearchStudy/BreastCancerTrial
Causalities
- EntityRelatedness Author
* Possibly Related (NCI Thesaurus#C53258) Patient/JanetPatient: Janet " CLINICAL TRIAL PATIENT"

supportingInfo
item: MedicationAdministration/medicationAdministration-for-bresentrik

supportingInfo
item: Observation/weight-janet

supportingInfo
item: Observation/blood-pressure-janet

supportingInfo
item: MedicationStatement/example001

supportingInfo
item: MedicationStatement/example007

supportingInfo
item: MedicationStatement/example003

note: A 64-year-old woman (Janet) is participating in a breast cancer clinical trial and taking an investigational drug. As part of her participation in the study, she was instructed to use a patient reported outcomes (ePRO) application to report an adverse event that resulted in any of the following: hospitalization, required help to prevent permanent harm, disability or health problem, birth defect, life-threatening, death, other serious/important medical incident (this list identifies the event as being serious events). The application is designed to capture data elements found on the 3500A Form. The Clinical Investigator (CI) receives a notification that Janet has an adverse event and reviews the event in Janet’s EHR system. The adverse event form is pre-populated from EHR data for the clinical investigator. The CI assesses causality for Janet’s adverse event and submits the serious adverse event to the sponsor. The sponsor reviews the received adverse event and performs its own causality assessment. Since this event is a Suspected Unexpected Serious Adverse Reaction (SUSAR) within FDA’s regulation. If the Suspected Unexpected Serious Adverse Reaction (SUSAR) was life threatening or death, it is submitted within 7 calendar days. Any other types of seriousness are submitted within 15 calendar days. (By Patient/JanetPatient @2023-04-12)

Source1

{
  "resourceType": "AdverseEvent",
  "id": "clinical-research-ae-example-medwatch-patient-report",
  "meta": {
    "profile": [
      "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"
    ]
  },
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
  "extension": [
    {
      "extension": [
        {
          "url": "criterionPresent",
          "valueBoolean": true
        },
        {
          "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": "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": "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": 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": "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": 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": "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"
    }
  ],
  "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/JanetPatient",
    "display": "Janet"
  },
  "detected": "2023-04-10",
  "resultingEffect": [
    {
      "reference": "Condition/janetReported-condition"
    }
  ],
  "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": "C49498",
          "display": "Recovered/Resolved"
        }
      ]
    }
  ],
  "recorder": {
    "reference": "Patient/JanetPatient"
  },
  "study": [
    {
      "reference": "ResearchStudy/BreastCancerTrial"
    }
  ],
  "suspectEntity": [
    {
      "instanceReference": {
        "reference": "Medication/bresentrik"
      },
      "causality": {
        "entityRelatedness": {
          "coding": [
            {
              "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code": "C53258",
              "display": "Possibly Related"
            }
          ]
        },
        "author": {
          "reference": "Patient/JanetPatient",
          "display": "Janet"
        }
      }
    },
    {
      "instanceReference": {
        "reference": "ResearchStudy/BreastCancerTrial"
      },
      "causality": {
        "entityRelatedness": {
          "coding": [
            {
              "system": "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
              "code": "C53258",
              "display": "Possibly Related"
            }
          ]
        },
        "author": {
          "reference": "Patient/JanetPatient",
          "display": "Janet"
        }
      }
    }
  ],
  "supportingInfo": [
    {
      "itemReference": {
        "reference": "MedicationAdministration/medicationAdministration-for-bresentrik"
      }
    },
    {
      "itemReference": {
        "reference": "Observation/weight-janet"
      }
    },
    {
      "itemReference": {
        "reference": "Observation/blood-pressure-janet"
      }
    },
    {
      "itemReference": {
        "reference": "MedicationStatement/example001"
      }
    },
    {
      "itemReference": {
        "reference": "MedicationStatement/example007"
      }
    },
    {
      "itemReference": {
        "reference": "MedicationStatement/example003"
      }
    }
  ],
  "note": [
    {
      "authorReference": {
        "reference": "Patient/JanetPatient"
      },
      "time": "2023-04-12",
      "text": "A 64-year-old woman (Janet) is participating in a breast cancer clinical trial and taking an investigational drug. As part of her participation in the study, she was instructed to use a patient reported outcomes (ePRO) application to report an adverse event that resulted in any of the following: hospitalization, required help to prevent permanent harm, disability or health problem, birth defect, life-threatening, death, other serious/important medical incident (this list identifies the event as being serious events). The application is designed to capture data elements found on the 3500A Form. \n\nThe Clinical Investigator (CI) receives a notification that Janet has an adverse event and reviews the event in Janet’s EHR system. The adverse event form is pre-populated from EHR data for the clinical investigator. The CI assesses causality for Janet’s adverse event and submits the serious adverse event to the sponsor. The sponsor reviews the received adverse event and performs its own causality assessment. Since this event is a Suspected Unexpected Serious Adverse Reaction (SUSAR) within FDA’s regulation. If the Suspected Unexpected Serious Adverse Reaction (SUSAR) was life threatening or death, it is submitted within 7 calendar days.\n\nAny other types of seriousness are submitted within 15 calendar days."
    }
  ]
}