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Adverse

The SHR Adverse domain contains definitions for describing adverse events and adverse reactions.

ActionTaken

ActionTopic taken as a result of the adverse reaction. May include changing or discontinuing medication, reducing dose, etc.

Details required An text note containing additional details, explanation, description, comment, or summarization. Details can discuss, support, explain changes to, or dispute information.
MedicationChangeTopic optional Description of a modification or change of a medication or dosage.

AdverseEvent [Entry]

Any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. EXAMPLE(S): back pain, headache, pulmonary embolism, death. The AdverseEvent may also document a causal relationship to an intervention is at least a reasonable possibility i.e., the relationship cannot be ruled out. C0877248

Based On Finding

Value:  CodeableConcept must be from MedDRAVS A set of codes drawn from different coding systems, representing the same concept.
Details optional An text note containing additional details, explanation, description, comment, or summarization. Details can discuss, support, explain changes to, or dispute information.
OccurrenceTime optional The point in time in which something happens.
AdverseEventGrade required A coded value specifying the level of injury suffered by the subject for whom the event is reported, using the CTCAE coding system.
SeriousAdverseEvent optional Clinical significance of adverse event usually associated with events that pose a threat to a patient's life or functioning. Seriousness of adverse event serves as a primary guide for defining regulatory reporting obligations and changes in medicinal product development and usage.
PatternOfEvent (TBD) optional Description TBD
Outcome must be from http://hl7.org/fhir/ValueSet/adverse-event-outcome optional The result of performing an action or behavior, for example, an adverse reaction or new finding.
AssociatedStudy optional The clinical trial or other formal study related to this procedure.
CauseCategory required Whether the adverse event is attributed to a treatment, course of the disease, unrelated to either, or unknown.
AdverseEventAttribution 0 or more A possible cause of an observed adverse event, known or theorized. There can be more than one possible cause.
ActionTaken 0 or more ActionTopic taken as a result of the adverse reaction. May include changing or discontinuing medication, reducing dose, etc.
Subject optional The person or thing that this entry relates to, usually the Person of Record. However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, finding, condition, or intervention.
FocalSubject optional For use when FHIR's subject does not allow the desired type of Subject in the Finding.Subject field.
FindingMethod optional The technique used to create the finding, for example, the specific imaging technical or assessment vehicle.
FindingStatus optional Indicates whether the finding is preliminary, amended, final, etc..
Evidence 0 or more A symptom, observation, or other item, for example, a radiology report, that serves as evidence for the current assessment.
RelatedEncounter optional If content was generated during a patient encounter, related encounter is the encounter where the information was gained.
Author optional The person or organization who created the entry and is responsible for (and may certify) the content.
Informant optional The person or entity that provided the information in the entry, as distinct from who created the entry, e.g. the subject (patient), medical professional, family member, device or software program.

AdverseEventAttribution

A possible cause of an observed adverse event, known or theorized. There can be more than one possible cause. Adverse Event Attribution to Product or ProcedurePerformed (C1510821)

Value:  Choice
         |  CodeableConcept should be from http://hl7.org/fhir/ValueSet/substance-code required A set of codes drawn from different coding systems, representing the same concept.
         |  Substance required Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical.
         |  ActionTopic required An entry related to an action or intervention, whether potential or actual, past or future. An intervention is an action addressing a undesired health state, behavior, risk, or goal.
Certainty required The degree of confidence in a conclusion or assertion.
RouteIntoBody optional The way a substance enters an organism after contact, particularly, the route of drug administration.

AdverseEventGrade

A coded value specifying the level of injury suffered by the subject for whom the event is reported, using the CTCAE coding system. C2985911

Value:  CodeableConcept must be from AdverseEventGradeVS A set of codes drawn from different coding systems, representing the same concept.

CauseCategory

Whether the adverse event is attributed to a treatment, course of the disease, unrelated to either, or unknown.

Value:  CodeableConcept must be from AttributionCategoryVS A set of codes drawn from different coding systems, representing the same concept.

SeriousAdverseEvent

Clinical significance of adverse event usually associated with events that pose a threat to a patient's life or functioning. Seriousness of adverse event serves as a primary guide for defining regulatory reporting obligations and changes in medicinal product development and usage. C1710056

Value:  CodeableConcept must be from YesNoUnknownVS A set of codes drawn from different coding systems, representing the same concept.

ToxicReaction [Entry]

A grade 3 or 4 adverse reaction to medication, radiation treatment, or other therapy.

Based On AdverseEvent

Value:  CodeableConcept must be from MedDRAVS A set of codes drawn from different coding systems, representing the same concept.
AdverseEventGrade must be from ToxicReactionVS required A coded value specifying the level of injury suffered by the subject for whom the event is reported, using the CTCAE coding system.
CauseCategory is treatment required Whether the adverse event is attributed to a treatment, course of the disease, unrelated to either, or unknown.
Details optional An text note containing additional details, explanation, description, comment, or summarization. Details can discuss, support, explain changes to, or dispute information.
OccurrenceTime optional The point in time in which something happens.
SeriousAdverseEvent optional Clinical significance of adverse event usually associated with events that pose a threat to a patient's life or functioning. Seriousness of adverse event serves as a primary guide for defining regulatory reporting obligations and changes in medicinal product development and usage.
PatternOfEvent (TBD) optional Description TBD
Outcome must be from http://hl7.org/fhir/ValueSet/adverse-event-outcome optional The result of performing an action or behavior, for example, an adverse reaction or new finding.
AssociatedStudy optional The clinical trial or other formal study related to this procedure.
AdverseEventAttribution 0 or more A possible cause of an observed adverse event, known or theorized. There can be more than one possible cause.
ActionTaken 0 or more ActionTopic taken as a result of the adverse reaction. May include changing or discontinuing medication, reducing dose, etc.
Subject optional The person or thing that this entry relates to, usually the Person of Record. However, not all entries have health information specifically about the patient, but in different contexts, could refer to a fetus, family member (living or dead), device, location, organization, finding, condition, or intervention.
FocalSubject optional For use when FHIR's subject does not allow the desired type of Subject in the Finding.Subject field.
FindingMethod optional The technique used to create the finding, for example, the specific imaging technical or assessment vehicle.
FindingStatus optional Indicates whether the finding is preliminary, amended, final, etc..
Evidence 0 or more A symptom, observation, or other item, for example, a radiology report, that serves as evidence for the current assessment.
RelatedEncounter optional If content was generated during a patient encounter, related encounter is the encounter where the information was gained.
Author optional The person or organization who created the entry and is responsible for (and may certify) the content.
Informant optional The person or entity that provided the information in the entry, as distinct from who created the entry, e.g. the subject (patient), medical professional, family member, device or software program.