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Adverse

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

ActionTaken

The action 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.
MedicationChange 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 SpecializedFinding

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 The action 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.
FocalSubjectReference 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, lab test code, 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 required
         |  CodeableConcept should be from http://hl7.org/fhir/ValueSet/substance-code
A set of codes drawn from different coding systems, representing the same concept.
         |  Substance Any matter of defined composition that has discrete existence, whose origin may be biological, mineral or chemical.
         |  Action 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.

NoAdverseEvent [Entry]

Documentation of a situation where no adverse event has been detected or is known. No adverse event (C1963761)

Based On Assertion

Value:  _Value is No adverse event (C1963761)
ValueAbsentReason not used Provides a reason why the value of the observation is missing, if it is expected (some observations are not expected to have a value).
NegationFlag optional A flag that indicates the meaning to be conveyed is the logical opposite of the current assertion. The assertion is negated only when the NegationIndicator is true. If absent or false, the assertion is not negated.
ObservationCode is Assertion (C1301625)
required A code that represents what the finding concerns, for example, the subject's height, blood pressure, disease status, wound dimensions, diabetes risk, etc. Although named ObservationCode, in different contexts the same attribute might be more naturally referred to as a property, observable, or test code. In assertions (observations without an explicit question), the observation code is defaulted to a value representing 'assertion'.
ClinicallyRelevantTime optional The time or time period that the finding addresses. The clinically relevant time is not necessarily when the information is gathered or when a test is carried out, but for example, when a specimen was collected, or the time period referred to by the question. Use a TimePeriod for a measurement or specimen collection continued over a significant period of time (e.g. 24 hour Urine Sodium).
FindingStatus required Indicates whether the finding is preliminary, amended, final, etc..
Category from http://hl7.org/fhir/ValueSet/observation-category
(if covered)
0 or more A class or division of people or things having particular shared characteristics
BodySite optional A location or structure in the body, including tissues, regions, cavities, and spaces, for example, right elbow, or left ventricle of the heart.
ChangeFlag optional Indicator of significant change (delta) from the last or previous measurement.
Details optional An text note containing additional details, explanation, description, comment, or summarization. Details can discuss, support, explain changes to, or dispute information.
Interpretation optional A clinical interpretation of a finding.
ObservationQualifier 0 or more A description of the conditions or context of an observation, for example, under sedation, fasting or post-exercise. Body position and body site are also qualifiers, but handled separately. A qualifier cannot modify the measurement type; for example, a fasting blood sugar is still a blood sugar.
Specimen optional Sample for analysis
Device optional A specific durable physical device used in diagnosis or treatment. The value is the coding for a type of device, for example, a CPAP machine. The same device might be used on multiple patients.
ReferenceRange 0 or more The usual or acceptable range for a test result.
ObservationComponent 0 or more A simplified, non-separable observation consisting of a observation code, value (or value absent reason), reference range, and interpretation. The subject of the observation component is the same as in the parent observation.
Members required Members represent the elements of a group of a related but independent observations. Examples are the measurements that compose a complete blood count (CBC), or the elements of a pathology report. Each member is an independent observation, but the grouping reflects a composite lab order, shared specimen, or a single report author. Typically the Category and Reason are not given for individual findings that are part of the panel, but rather given at the level of the panel itself.
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.
FocalSubjectReference 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, lab test code, or assessment vehicle.
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.

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. C0542243

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 The action 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.
FocalSubjectReference 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, lab test code, 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.