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    Class AdverseEvent

    AdverseEvent Class

    An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.

    FHIR Specification

    • Short: An event that may be related to unintended effects on a patient or research participant
    • Definition: An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.
    • FHIR Version: 5.0.0

    FHIR AdverseEvent

    Hierarchy (View Summary)

    Implements

    Index

    Constructors

    constructor

    Properties

    identifier? eventStatusEnum status adverseEventActualityEnum actuality category? code? subject encounter? occurrence? detected? recordedDate? resultingEffect? location? seriousness? outcome? recorder? participant? study? expectedInResearchStudy? suspectEntity? contributingFactor? preventiveAction? mitigatingAction? supportingInfo? note?

    Methods

    parse getIdentifier setIdentifier addIdentifier hasIdentifier getStatusEnumType setStatusEnumType hasStatusEnumType getStatusElement setStatusElement hasStatusElement getStatus setStatus hasStatus getActualityEnumType setActualityEnumType hasActualityEnumType getActualityElement setActualityElement hasActualityElement getActuality setActuality hasActuality getCategory setCategory addCategory hasCategory getCode setCode hasCode getSubject setSubject hasSubject getEncounter setEncounter hasEncounter getOccurrence setOccurrence hasOccurrence getOccurrenceDateTimeType hasOccurrenceDateTimeType getOccurrencePeriod hasOccurrencePeriod getOccurrenceTiming hasOccurrenceTiming getDetectedElement setDetectedElement hasDetectedElement getDetected setDetected hasDetected getRecordedDateElement setRecordedDateElement hasRecordedDateElement getRecordedDate setRecordedDate hasRecordedDate getResultingEffect setResultingEffect addResultingEffect hasResultingEffect getLocation setLocation hasLocation getSeriousness setSeriousness hasSeriousness getOutcome setOutcome addOutcome hasOutcome getRecorder setRecorder hasRecorder getParticipant setParticipant addParticipant hasParticipant getStudy setStudy addStudy hasStudy getExpectedInResearchStudyElement setExpectedInResearchStudyElement hasExpectedInResearchStudyElement getExpectedInResearchStudy setExpectedInResearchStudy hasExpectedInResearchStudy getSuspectEntity setSuspectEntity addSuspectEntity hasSuspectEntity getContributingFactor setContributingFactor addContributingFactor hasContributingFactor getPreventiveAction setPreventiveAction addPreventiveAction hasPreventiveAction getMitigatingAction setMitigatingAction addMitigatingAction hasMitigatingAction getSupportingInfo setSupportingInfo addSupportingInfo hasSupportingInfo getNote setNote addNote hasNote fhirType isEmpty isRequiredFieldsEmpty copy toJSON getText setText hasText getContained setContained addContained hasContained getExtension setExtension hasExtension getExtensionByUrl addExtension removeExtension getModifierExtension setModifierExtension hasModifierExtension getModifierExtensionByUrl addModifierExtension removeModifierExtension resourceType getIdElement setIdElement hasIdElement getId setId hasId getMeta setMeta hasMeta getImplicitRulesElement setImplicitRulesElement hasImplicitRulesElement getImplicitRules setImplicitRules hasImplicitRules getLanguageElement setLanguageElement hasLanguageElement getLanguage setLanguage hasLanguage isResource isDataType isComplexDataType isPrimitive isBooleanPrimitive isStringPrimitive isNumberPrimitive isBigIntPrimitive isDateTimePrimitive copyValues initIdentifier initCategory initResultingEffect initOutcome initParticipant initStudy initSuspectEntity initContributingFactor initPreventiveAction initMitigatingAction initSupportingInfo initNote

    Constructors

    Properties

    identifier?: Identifier[]

    AdverseEvent.identifier Element

    FHIR Specification

    • Short: Business identifier for the event
    • Definition: Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server.
    • Comment: This is a business identifier, not a resource identifier (see discussion). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number.
    • Requirements: Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.
    • FHIR Type: Identifier
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    eventStatusEnum: EventStatusEnum

    FHIR CodeSystem: EventStatus

    EventStatusEnum

    status: null | EnumCodeType

    AdverseEvent.status Element

    FHIR Specification

    • Short: in-progress | completed | entered-in-error | unknown
    • Definition: The current state of the adverse event or potential adverse event.
    • Comment: This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.
    • FHIR Type: code
    • Cardinality: 1..1
    • isModifier: true
    • isModifierReason: This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
    • isSummary: true

    CodeSystem Enumeration: EventStatusEnum

    adverseEventActualityEnum: AdverseEventActualityEnum

    FHIR CodeSystem: AdverseEventActuality

    AdverseEventActualityEnum

    actuality: null | EnumCodeType

    AdverseEvent.actuality Element

    FHIR Specification

    • Short: actual | potential
    • Definition: Whether the event actually happened or was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely.
    • Comment: AllergyIntolerance should be used for the initial capture or recording of the individual's propensity to an adverse reaction to a substance. If an AllergyIntolerance does not exist, then an adverse reaction should be recorded as an AllergyIntolerance. If an AllergyIntolerance does exist and the substance was given, then an adverse reaction should be recorded as an AdverseEvent due to the aberrant workflow.
    • FHIR Type: code
    • Cardinality: 1..1
    • isModifier: true
    • isModifierReason: This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
    • isSummary: true

    CodeSystem Enumeration: AdverseEventActualityEnum

    category?: CodeableConcept[]

    AdverseEvent.category Element

    FHIR Specification

    • Short: wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
    • Definition: The overall type of event, intended for search and filtering purposes.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    code?: CodeableConcept

    AdverseEvent.code Element

    FHIR Specification

    • Short: Event or incident that occurred or was averted
    • Definition: Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    subject: null | Reference

    AdverseEvent.subject Element

    FHIR Specification

    encounter?: Reference

    AdverseEvent.encounter Element

    FHIR Specification

    • Short: The Encounter associated with the start of the AdverseEvent
    • Definition: The Encounter associated with the start of the AdverseEvent.
    • Comment: This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the associated encounter. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the associated encounter.
    • FHIR Type: Reference
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    occurrence?: IDataType

    AdverseEvent.occurrence[x] Element

    @ChoiceDataTypesMeta('AdverseEvent.occurrence[x]', ['dateTime','Period','Timing',]

    FHIR Specification

    • Short: When the event occurred
    • Definition: The date (and perhaps time) when the adverse event occurred.
    • FHIR Types: 'dateTime', 'Period', 'Timing',
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    detected?: DateTimeType

    AdverseEvent.detected Element

    FHIR Specification

    • Short: When the event was detected
    • Definition: Estimated or actual date the AdverseEvent began, in the opinion of the reporter.
    • FHIR Type: dateTime
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    recordedDate?: DateTimeType

    AdverseEvent.recordedDate Element

    FHIR Specification

    • Short: When the event was recorded
    • Definition: The date on which the existence of the AdverseEvent was first recorded.
    • Comment: The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata.
    • FHIR Type: dateTime
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    resultingEffect?: Reference[]

    AdverseEvent.resultingEffect Element

    FHIR Specification

    location?: Reference

    AdverseEvent.location Element

    FHIR Specification

    • Short: Location where adverse event occurred
    • Definition: The information about where the adverse event occurred.
    • FHIR Type: Reference
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    seriousness?: CodeableConcept

    AdverseEvent.seriousness Element

    FHIR Specification

    • Short: Seriousness or gravity of the event
    • Definition: Assessment whether this event, or averted event, was of clinical importance.
    • Comment: Using an example, a rash can have an AdverseEvent.resultingEffect.severity = severe, yet an AdverseEvent.seriousness = non-serious. Alternatively, a medication given with the wrong dose (chemotherapy given with too low of a dose) can have an AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious. Another example would be a beta blocker clinical trial where patients with asthma should be excluded, yet a patient with asthma was included and had an asthmatic episode where AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: true
    outcome?: CodeableConcept[]

    AdverseEvent.outcome Element

    FHIR Specification

    • Short: Type of outcome from the adverse event
    • Definition: Describes the type of outcome from the adverse event, such as resolved, recovering, ongoing, resolved-with-sequelae, or fatal.
    • FHIR Type: CodeableConcept
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    recorder?: Reference

    AdverseEvent.recorder Element

    FHIR Specification

    participant?: AdverseEventParticipantComponent[]

    AdverseEvent.participant Element

    FHIR Specification

    • Short: Who was involved in the adverse event or the potential adverse event and what they did
    • Definition: Indicates who or what participated in the adverse event and how they were involved.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    study?: Reference[]

    AdverseEvent.study Element

    FHIR Specification

    • Short: Research study that the subject is enrolled in
    • Definition: The research study that the subject is enrolled in.
    • FHIR Type: Reference
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    expectedInResearchStudy?: BooleanType

    AdverseEvent.expectedInResearchStudy Element

    FHIR Specification

    • Short: Considered likely or probable or anticipated in the research study
    • Definition: Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.
    • FHIR Type: boolean
    • Cardinality: 0..1
    • isModifier: false
    • isSummary: false
    suspectEntity?: AdverseEventSuspectEntityComponent[]

    AdverseEvent.suspectEntity Element

    FHIR Specification

    • Short: The suspected agent causing the adverse event
    • Definition: Describes the entity that is suspected to have caused the adverse event.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    contributingFactor?: AdverseEventContributingFactorComponent[]

    AdverseEvent.contributingFactor Element

    FHIR Specification

    • Short: Contributing factors suspected to have increased the probability or severity of the adverse event
    • Definition: The contributing factors suspected to have increased the probability or severity of the adverse event.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    preventiveAction?: AdverseEventPreventiveActionComponent[]

    AdverseEvent.preventiveAction Element

    FHIR Specification

    • Short: Preventive actions that contributed to avoiding the adverse event
    • Definition: Preventive actions that contributed to avoiding the adverse event.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    mitigatingAction?: AdverseEventMitigatingActionComponent[]

    AdverseEvent.mitigatingAction Element

    FHIR Specification

    • Short: Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
    • Definition: The ameliorating action taken after the adverse event occured in order to reduce the extent of harm.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    supportingInfo?: AdverseEventSupportingInfoComponent[]

    AdverseEvent.supportingInfo Element

    FHIR Specification

    • Short: Supporting information relevant to the event
    • Definition: Supporting information relevant to the event.
    • FHIR Type: BackboneElement
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true
    note?: Annotation[]

    AdverseEvent.note Element

    FHIR Specification

    • Short: Comment on adverse event
    • Definition: Comments made about the adverse event by the performer, subject or other participants.
    • FHIR Type: Annotation
    • Cardinality: 0..*
    • isModifier: false
    • isSummary: true

    Methods

    • Parse the provided AdverseEvent JSON to instantiate the AdverseEvent data model.

      Parameters

      • sourceJson: Value

        JSON representing FHIR AdverseEvent

      • OptionaloptSourceField: string

        Optional data source field (e.g. <complexTypeName>.<complexTypeFieldName>); defaults to AdverseEvent

      Returns undefined | AdverseEvent

      AdverseEvent data model or undefined for AdverseEvent

      JsonError if the provided JSON is not a valid JSON object

    • Assigns the provided Subject object value to the subject property.

      Parameters

      • value: undefined | null | Reference

        the subject object value

      Returns this

      this

      @ReferenceTargets('AdverseEvent.subject', ['Patient','Group','Practitioner','RelatedPerson','ResearchSubject',])

      InvalidTypeError for invalid data type or reference value

    • Assigns the provided Recorder object value to the recorder property.

      Parameters

      • value: undefined | Reference

        the recorder object value

      Returns this

      this

      @ReferenceTargets('AdverseEvent.recorder', ['Patient','Practitioner','PractitionerRole','RelatedPerson','ResearchSubject',])

      InvalidTypeError for invalid data type or reference value

    • Assigns the provided value to the text property.

      Parameters

      Returns this

      this

    • Returns boolean

      true if the text property exists and has a value; false otherwise

    • Assigns the provided Resource array value to the contained property.

      Parameters

      • value: undefined | IResource[]

        the contained array value

      Returns this

      this

    • Returns boolean

      true if the contained property exists and has a value; false otherwise

    • Assigns the provided array of Extension values to the extension property.

      Parameters

      • extension: undefined | IExtension[]

        array of Extensions

      Returns this

      this

    • Determines if the extension property exists.

      Parameters

      • Optionalurl: string

        the url that identifies a specific Extension

      Returns boolean

      true if an Extension has the provided url; false otherwise

      If the url is provided, determines if an Extension having the provided url exists. If the url is not provided, determines if the extension property exists and has any values.

      AssertionError for invalid url

    • Adds the provided Extension to the extension property array.

      Parameters

      • extension: undefined | IExtension

        the Extension value to add to the extension property array

      Returns this

      this

    • Removes the Extension having the provided url from the extension property array.

      Parameters

      • url: string

        the url that identifies a specific Extension to remove

      Returns void

      AssertionError for invalid url

    • Determines if the modifierExtension property exists.

      Parameters

      • Optionalurl: string

        the url that identifies a specific Extension

      Returns boolean

      true if an Extension has the provided url

      If the url is provided, determines if an Extension having the provided url exists. If the url is not provided, determines if the modifierExtension property exists and has any values.

      AssertionError for invalid url

    • Assigns the provided PrimitiveType value to the id property.

      Parameters

      • element: undefined | IdType

        the id value

      Returns this

      this

    • Returns undefined | string

      the id property value as a primitive value

    • Assigns the provided primitive value to the id property.

      Parameters

      • value: undefined | string

        the id value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns boolean

      true if the id property exists and has a value; false otherwise

    • Assigns the provided value to the meta property.

      Parameters

      • value: undefined | Meta

        the meta value

      Returns this

      this

    • Returns boolean

      true if the meta property exists and has a value; false otherwise

    • Assigns the provided primitive value to the implicitRules property.

      Parameters

      • value: undefined | string

        the implicitRules value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns undefined | string

      the language property value as a primitive value

    • Assigns the provided primitive value to the language property.

      Parameters

      • value: undefined | string

        the language value

      Returns this

      this

      PrimitiveTypeError for invalid primitive types

    • Returns boolean

      true if the language property exists and has a value; false otherwise

    • Returns boolean

      true if the instance is a FHIR complex or primitive datatype; false otherwise

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