Generated Narrative: AdverseEvent

Criteria reviewed in determining serious adverse event

url

criterionPresent

value: false

url

criterionCode

value: Results In Persistent Or Significant Disability (NCI Thesaurus#C11338)

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

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)

Resulting Effect: Condition/janetReported-condition

Suspect Entity

url

instance

value: Medication/bresentrik

url

causality

Supporting information relevant to the event

url

item

value: MedicationAdministration/medicationAdministration-for-bresentrik

Suspect Entity

url

instance

value: ResearchStudy/BreastCancerTrial

url

causality

Supporting information relevant to the event

url

item

value: Observation/weight-janet

Supporting information relevant to the event

url

item

value: Observation/blood-pressure-janet

Supporting information relevant to the event

url

item

value: MedicationStatement/example001

Supporting information relevant to the event

url

item

value: MedicationStatement/example007

Supporting information relevant to the event

url

item

value: MedicationStatement/example003

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

actuality: actual

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

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

date: 2023-04-10

seriousness: Serious (AdverseEventSeriousness#serious)

outcome: Recovered/Resolved (NCI Thesaurus#C49498)

recorder: Patient/JanetPatient " CLINICAL TRIAL PATIENT"

study: ResearchStudy/BreastCancerTrial