NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent C0..*AdverseEventMedical care, research study or other healthcare event causing physical injury
aeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion.
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... research-subject-ref 0..1Reference(ResearchSubject)Research Subject record of subject
URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref
... caused-subject-to-discontinue-study 0..1booleanAdverse event caused subject to discontinue the study
URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study
... seriousness-criteria 0..*(Complex)Criteria reviewed in determining serious adverse event
URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria
... ae-grade 0..1CodeableConceptThe degree of something undesirable, used in oncology trials
URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade
Binding: Adverse Event Clinical Research Grades (preferred)
... expected-in-research-study 0..1booleanConsidered likely or probable or anticipated in the research study
URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study
... note 0..*AnnotationComment on adverse event
URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note
... resolve-date 0..1dateTimeAdverse Event resolution date
URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date
... suspect-entity Σ0..*(Complex)A suspected agent causing the adverse event
URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity
... contributing-factor Σ0..*(Complex)Contributing factors suspected to have increased the probability or severity of the adverse event
URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor
... mitigating-action Σ0..*(Complex)Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm
URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action
... supporting-info Σ0..*(Complex)Subject medical history or document relevant to this adverse event
URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info
... participant 0..*(Complex)Who was involved in the adverse event or the potential adverse event and what they did
URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant
... resultingEffect 0..*Reference(Condition | Observation)Effect on the subject due to this event
URL: http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect
... Slices for modifierExtension 1..*ExtensionExtension
Slice: Unordered, Open by value:url
... modifierExtension:status Σ1..1Statusin-progress | completed | entered-in-error | unknown
Binding: (unbound) (required): Codes identifying the lifecycle stage of an event.

... actuality 1..1codeactual
Required Pattern: actual
... event 1..1CodeableConceptEvent or incident that occurred or was averted
Binding: AdverseEvent Type (example): Detailed type of event.

... resultingCondition 0..0
... seriousness S1..1CodeableConceptInvestigator defined severity of the adverse event, in relation to the subject not the resulting condition
Binding: AdverseEventSeriousness (required)
... outcome S1..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: Adverse Event Clinical Research Outcomes (required)
... suspectEntity 0..0
... subjectMedicalHistory 0..0
... referenceDocument 0..0
... study S1..1Reference(ResearchStudy)AdverseEvent.study

doco Documentation for this format
 <status value="active"/> <date value="2024-04-30T20:04:27+00:00"/> <publisher value="HL7 International / Biomedical Research and Regulation"/> <contact> <name value="Biomedical Research and Regulation WG"/> <telecom> <system value="url"/> <value value="http://www.hl7.org/Special/committees/rcrim"/> </telecom> </contact> <description value="Convenience backport into R4 of FHIR R5 Foundational profile of AdverseEvent for Clinical Research communications."/> <jurisdiction> <coding> <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/> <code value="001"/> </coding> </jurisdiction> <fhirVersion value="4.0.1"/> <mapping> <identity value="w5"/> <uri value="http://hl7.org/fhir/fivews"/> <name value="FiveWs Pattern Mapping"/> </mapping> <mapping> <identity value="rim"/> <uri value="http://hl7.org/v3"/> <name value="RIM Mapping"/> </mapping> <kind value="resource"/> <abstract value="false"/> <type value="AdverseEvent"/> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/AdverseEvent"/> <derivation value="constraint"/> <snapshot> <element id="AdverseEvent"> <path value="AdverseEvent"/> <short value="Medical care, research study or other healthcare event causing physical injury"/> <definition value="Actual or potential/avoided event causing unintended physical injury resulting from or contributed to by medical care, a research study or other healthcare setting factors that requires additional monitoring, treatment, or hospitalization, or that results in death."/> <alias value="AE"/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent"/> <min value="0"/> <max value="*"/> </base> <constraint> <key value="dom-2"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/> <expression value="contained.contained.empty()"/> <xpath value="not(parent::f:contained and f:contained)"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-3"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource"/> <expression value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/> <xpath value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-4"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/> <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/> <xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-5"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a security label"/> <expression value="contained.meta.security.empty()"/> <xpath value="not(exists(f:contained/*/f:meta/f:security))"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice"> <valueBoolean value="true"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation"> <valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/> </extension> <key value="dom-6"/> <severity value="warning"/> <human value="A resource should have narrative for robust management"/> <expression value="text.`div`.exists()"/> <xpath value="exists(f:text/h:div)"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="aeClinRes-seriousness-1"/> <severity value="error"/> <human value="If seriousness is serious then must have at least one seriousness criterion."/> <expression value="(seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists().not() )"/> <source value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Entity. Role, or Act"/> </mapping> </element> <element id="AdverseEvent.id"> <path value="AdverseEvent.id"/> <short value="Logical id of this artifact"/> <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/> <comment value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="id"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.meta"> <path value="AdverseEvent.meta"/> <short value="Metadata about the resource"/> <definition value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.meta"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Meta"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.implicitRules"> <path value="AdverseEvent.implicitRules"/> <short value="A set of rules under which this content was created"/> <definition value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/> <comment value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.implicitRules"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="true"/> <isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation"/> <isSummary value="true"/> </element> <element id="AdverseEvent.language"> <path value="AdverseEvent.language"/> <short value="Language of the resource content"/> <definition value="The base language in which the resource is written."/> <comment value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.language"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet"> <valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Language"/> </extension> <strength value="preferred"/> <description value="A human language."/> <valueSet value="http://hl7.org/fhir/ValueSet/languages"/> </binding> </element> <element id="AdverseEvent.text"> <path value="AdverseEvent.text"/> <short value="Text summary of the resource, for human interpretation"/> <definition value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/> <comment value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later."/> <alias value="narrative"/> <alias value="html"/> <alias value="xhtml"/> <alias value="display"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.text"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Narrative"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Act.text?"/> </mapping> </element> <element id="AdverseEvent.contained"> <path value="AdverseEvent.contained"/> <short value="Contained, inline Resources"/> <definition value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope."/> <comment value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels."/> <alias value="inline resources"/> <alias value="anonymous resources"/> <alias value="contained resources"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.contained"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Resource"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.extension"> <path value="AdverseEvent.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <ordered value="false"/> <rules value="open"/> </slicing> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="AdverseEvent.extension:research-subject-ref"> <path value="AdverseEvent.extension"/> <sliceName value="research-subject-ref"/> <short value="Research Subject record of subject"/> <definition value="Communicates Research Subject related metadata."/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:caused-subject-to-discontinue-study"> <path value="AdverseEvent.extension"/> <sliceName value="caused-subject-to-discontinue-study"/> <short value="Adverse event caused subject to discontinue the study"/> <definition value="Indicates if the subject discontinued the study due to the adverse event."/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:seriousness-criteria"> <path value="AdverseEvent.extension"/> <sliceName value="seriousness-criteria"/> <short value="Criteria reviewed in determining serious adverse event"/> <definition value="Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events."/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:ae-grade"> <path value="AdverseEvent.extension"/> <sliceName value="ae-grade"/> <short value="The degree of something undesirable, used in oncology trials"/> <definition value="For cancer related trials, severity is represented as a grade. Describes the grade of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity, in oncology related trials this is reported as grade."/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:expected-in-research-study"> <path value="AdverseEvent.extension"/> <sliceName value="expected-in-research-study"/> <short value="Considered likely or probable or anticipated in the research study"/> <definition value="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."/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:note"> <path value="AdverseEvent.extension"/> <sliceName value="note"/> <short value="Comment on adverse event"/> <definition value="Comments made about the adverse event by the performer, subject or other participants."/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:resolve-date"> <path value="AdverseEvent.extension"/> <sliceName value="resolve-date"/> <short value="Adverse Event resolution date"/> <definition value="The date the adverse event was resolved."/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:suspect-entity"> <path value="AdverseEvent.extension"/> <sliceName value="suspect-entity"/> <short value="A suspected agent causing the adverse event"/> <definition value="Describes an entity that is suspected to have caused the adverse event."/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:contributing-factor"> <path value="AdverseEvent.extension"/> <sliceName value="contributing-factor"/> <short value="Contributing factors suspected to have increased the probability or severity of the adverse event"/> <definition value="A contributing factors suspected to have increased the probability or severity of the adverse event."/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:mitigating-action"> <path value="AdverseEvent.extension"/> <sliceName value="mitigating-action"/> <short value="Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm"/> <definition value="The ameliorating action taken after the adverse event occurred in order to reduce the extent of harm."/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:supporting-info"> <path value="AdverseEvent.extension"/> <sliceName value="supporting-info"/> <short value="Subject medical history or document relevant to this adverse event"/> <definition value="Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action."/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:participant"> <path value="AdverseEvent.extension"/> <sliceName value="participant"/> <short value="Who was involved in the adverse event or the potential adverse event and what they did"/> <definition value="Indicates who or what participated in the adverse event and how they were involved."/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:resultingEffect"> <path value="AdverseEvent.extension"/> <sliceName value="resultingEffect"/> <short value="Effect on the subject due to this event"/> <definition value="Information about the condition that occurred as a result of the adverse event."/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.modifierExtension"> <path value="AdverseEvent.modifierExtension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <ordered value="false"/> <rules value="open"/> </slicing> <short value="Extension"/> <definition value="An Extension"/> <min value="1"/> <max value="*"/> <base> <path value="DomainResource.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/> <isSummary value="false"/> </element> <element id="AdverseEvent.modifierExtension:status"> <path value="AdverseEvent.modifierExtension"/> <sliceName value="status"/> <short value="in-progress | completed | entered-in-error | unknown"/> <definition value="The current state of the adverse event or potential adverse event."/> <comment value="This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition."/> <min value="1"/> <max value="1"/> <base> <path value="DomainResource.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="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 value="true"/> </element> <element id="AdverseEvent.identifier"> <path value="AdverseEvent.identifier"/> <short value="Business identifier for the event"/> <definition value="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 value="This is a business identifier, not a resource identifier (see [discussion](http://hl7.org/fhir/R4/resource.html#identifiers)). 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 value="Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.identifier"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Identifier"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.actuality"> <path value="AdverseEvent.actuality"/> <short value="actual"/> <definition value="Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely."/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.actuality"/> <min value="1"/> <max value="1"/> </base> <type> <code value="code"/> </type> <patternCode value="actual"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="true"/> <isModifierReason value="This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen."/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventActuality"/> </extension> <strength value="required"/> <description value="Overall nature of the adverse event, e.g. real or potential."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.class"/> </mapping> </element> <element id="AdverseEvent.category"> <path value="AdverseEvent.category"/> <short value="product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment"/> <definition value="The overall type of event, intended for search and filtering purposes."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.category"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventCategory"/> </extension> <strength value="extensible"/> <description value="Overall categorization of the event, e.g. product-related or situational."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-category"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.class"/> </mapping> </element> <element id="AdverseEvent.event"> <path value="AdverseEvent.event"/> <short value="Event or incident that occurred or was averted"/> <definition value="Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused."/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.event"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventType"/> </extension> <strength value="example"/> <description value="Detailed type of event."/> <valueSet value="http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> </element> <element id="AdverseEvent.subject"> <path value="AdverseEvent.subject"/> <short value="Subject impacted by event"/> <definition value="This subject or group impacted by the event."/> <comment value="If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject."/> <requirements value="Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital."/> <alias value="patient"/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.subject"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.who"/> </mapping> </element> <element id="AdverseEvent.encounter"> <path value="AdverseEvent.encounter"/> <short value="Encounter created as part of"/> <definition value="The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated."/> <comment value="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 context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.encounter"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Encounter"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.context"/> </mapping> </element> <element id="AdverseEvent.date"> <path value="AdverseEvent.date"/> <short value="When the event occurred"/> <definition value="The date (and perhaps time) when the adverse event occurred."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.date"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.init"/> </mapping> </element> <element id="AdverseEvent.detected"> <path value="AdverseEvent.detected"/> <short value="When the event was detected"/> <definition value="Estimated or actual date the AdverseEvent began, in the opinion of the reporter."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.detected"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.recordedDate"> <path value="AdverseEvent.recordedDate"/> <short value="When the event was recorded"/> <definition value="The date on which the existence of the AdverseEvent was first recorded."/> <comment value="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."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.recordedDate"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.recorded"/> </mapping> </element> <element id="AdverseEvent.resultingCondition"> <path value="AdverseEvent.resultingCondition"/> <short value="Effect on the subject due to this event"/> <definition value="Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical)."/> <min value="0"/> <max value="0"/> <base> <path value="AdverseEvent.resultingCondition"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Condition"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.location"> <path value="AdverseEvent.location"/> <short value="Location where adverse event occurred"/> <definition value="The information about where the adverse event occurred."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.location"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.seriousness"> <path value="AdverseEvent.seriousness"/> <short value="Investigator defined severity of the adverse event, in relation to the subject not the resulting condition"/> <definition value="Assessment whether this event was of real importance."/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.seriousness"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <strength value="required"/> <valueSet value="http://terminology.hl7.org/ValueSet/adverse-event-seriousness"/> </binding> </element> <element id="AdverseEvent.severity"> <path value="AdverseEvent.severity"/> <short value="mild | moderate | severe"/> <definition value="Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.severity"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventSeverity"/> </extension> <strength value="required"/> <description value="The severity of the adverse event itself, in direct relation to the subject."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1"/> </binding> </element> <element id="AdverseEvent.outcome"> <path value="AdverseEvent.outcome"/> <short value="resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown"/> <definition value="Describes the type of outcome from the adverse event."/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.outcome"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <strength value="required"/> <valueSet value="http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes"/> </binding> </element> <element id="AdverseEvent.recorder"> <path value="AdverseEvent.recorder"/> <short value="Who recorded the adverse event"/> <definition value="Information on who recorded the adverse event. May be the patient or a practitioner."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.recorder"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.author"/> </mapping> </element> <element id="AdverseEvent.contributor"> <path value="AdverseEvent.contributor"/> <short value="Who was involved in the adverse event or the potential adverse event"/> <definition value="Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness)."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.contributor"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity"> <path value="AdverseEvent.suspectEntity"/> <short value="The suspected agent causing the adverse event"/> <definition value="Describes the entity that is suspected to have caused the adverse event."/> <min value="0"/> <max value="0"/> <base> <path value="AdverseEvent.suspectEntity"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.id"> <path value="AdverseEvent.suspectEntity.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.extension"> <path value="AdverseEvent.suspectEntity.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.modifierExtension"> <path value="AdverseEvent.suspectEntity.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.instance"> <path value="AdverseEvent.suspectEntity.instance"/> <short value="Refers to the specific entity that caused the adverse event"/> <definition value="Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device."/> <alias value="Substance or Medication or Device"/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.instance"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Immunization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Substance"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Medication"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationAdministration"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationStatement"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.causality"> <path value="AdverseEvent.suspectEntity.causality"/> <short value="Information on the possible cause of the event"/> <definition value="Information on the possible cause of the event."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.suspectEntity.causality"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.causality.id"> <path value="AdverseEvent.suspectEntity.causality.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.causality.extension"> <path value="AdverseEvent.suspectEntity.causality.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.causality.modifierExtension"> <path value="AdverseEvent.suspectEntity.causality.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.causality.assessment"> <path value="AdverseEvent.suspectEntity.causality.assessment"/> <short value="Assessment of if the entity caused the event"/> <definition value="Assessment of if the entity caused the event."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causality.assessment"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventCausalityAssessment"/> </extension> <strength value="example"/> <description value="Codes for the assessment of whether the entity caused the event."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-causality-assess"/> </binding> </element> <element id="AdverseEvent.suspectEntity.causality.productRelatedness"> <path value="AdverseEvent.suspectEntity.causality.productRelatedness"/> <short value="AdverseEvent.suspectEntity.causalityProductRelatedness"/> <definition value="AdverseEvent.suspectEntity.causalityProductRelatedness."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causality.productRelatedness"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.causality.author"> <path value="AdverseEvent.suspectEntity.causality.author"/> <short value="AdverseEvent.suspectEntity.causalityAuthor"/> <definition value="AdverseEvent.suspectEntity.causalityAuthor."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causality.author"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.causality.method"> <path value="AdverseEvent.suspectEntity.causality.method"/> <short value="ProbabilityScale | Bayesian | Checklist"/> <definition value="ProbabilityScale | Bayesian | Checklist."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causality.method"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventCausalityMethod"/> </extension> <strength value="example"/> <description value="TODO."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-causality-method"/> </binding> </element> <element id="AdverseEvent.subjectMedicalHistory"> <path value="AdverseEvent.subjectMedicalHistory"/> <short value="AdverseEvent.subjectMedicalHistory"/> <definition value="AdverseEvent.subjectMedicalHistory."/> <min value="0"/> <max value="0"/> <base> <path value="AdverseEvent.subjectMedicalHistory"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Condition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Observation"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/AllergyIntolerance"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/FamilyMemberHistory"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Immunization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Media"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.referenceDocument"> <path value="AdverseEvent.referenceDocument"/> <short value="AdverseEvent.referenceDocument"/> <definition value="AdverseEvent.referenceDocument."/> <min value="0"/> <max value="0"/> <base> <path value="AdverseEvent.referenceDocument"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.study"> <path value="AdverseEvent.study"/> <short value="AdverseEvent.study"/> <definition value="AdverseEvent.study."/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.study"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="true"/> <isModifier value="false"/> <isSummary value="true"/> </element> </snapshot> <differential> <element id="AdverseEvent"> <path value="AdverseEvent"/> <constraint> <key value="aeClinRes-seriousness-1"/> <severity value="error"/> <human value="If seriousness is serious then must have at least one seriousness criterion."/> <expression value="(seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria').exists().not() )"/> <source value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"/> </constraint> </element> <element id="AdverseEvent.extension"> <path value="AdverseEvent.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <ordered value="false"/> <rules value="open"/> </slicing> </element> <element id="AdverseEvent.extension:research-subject-ref"> <path value="AdverseEvent.extension"/> <sliceName value="research-subject-ref"/> <short value="Research Subject record of subject"/> <min value="0"/> <max value="1"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/research-subject-ref"/> </type> </element> <element id="AdverseEvent.extension:caused-subject-to-discontinue-study"> <path value="AdverseEvent.extension"/> <sliceName value="caused-subject-to-discontinue-study"/> <min value="0"/> <max value="1"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study"/> </type> </element> <element id="AdverseEvent.extension:seriousness-criteria"> <path value="AdverseEvent.extension"/> <sliceName value="seriousness-criteria"/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"/> </type> </element> <element id="AdverseEvent.extension:ae-grade"> <path value="AdverseEvent.extension"/> <sliceName value="ae-grade"/> <short value="The degree of something undesirable, used in oncology trials"/> <min value="0"/> <max value="1"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade"/> </type> </element> <element id="AdverseEvent.extension:expected-in-research-study"> <path value="AdverseEvent.extension"/> <sliceName value="expected-in-research-study"/> <short value="Considered likely or probable or anticipated in the research study"/> <min value="0"/> <max value="1"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study"/> </type> </element> <element id="AdverseEvent.extension:note"> <path value="AdverseEvent.extension"/> <sliceName value="note"/> <short value="Comment on adverse event"/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note"/> </type> </element> <element id="AdverseEvent.extension:resolve-date"> <path value="AdverseEvent.extension"/> <sliceName value="resolve-date"/> <short value="Adverse Event resolution date"/> <min value="0"/> <max value="1"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date"/> </type> </element> <element id="AdverseEvent.extension:suspect-entity"> <path value="AdverseEvent.extension"/> <sliceName value="suspect-entity"/> <short value="A suspected agent causing the adverse event"/> <definition value="Describes an entity that is suspected to have caused the adverse event."/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:contributing-factor"> <path value="AdverseEvent.extension"/> <sliceName value="contributing-factor"/> <short value="Contributing factors suspected to have increased the probability or severity of the adverse event"/> <definition value="A contributing factors suspected to have increased the probability or severity of the adverse event."/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:mitigating-action"> <path value="AdverseEvent.extension"/> <sliceName value="mitigating-action"/> <short value="Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm"/> <definition value="The ameliorating action taken after the adverse event occurred in order to reduce the extent of harm."/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:supporting-info"> <path value="AdverseEvent.extension"/> <sliceName value="supporting-info"/> <short value="Subject medical history or document relevant to this adverse event"/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:participant"> <path value="AdverseEvent.extension"/> <sliceName value="participant"/> <short value="Who was involved in the adverse event or the potential adverse event and what they did"/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant"/> </type> </element> <element id="AdverseEvent.extension:resultingEffect"> <path value="AdverseEvent.extension"/> <sliceName value="resultingEffect"/> <short value="Effect on the subject due to this event"/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect"/> </type> </element> <element id="AdverseEvent.modifierExtension"> <path value="AdverseEvent.modifierExtension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <ordered value="false"/> <rules value="open"/> </slicing> <min value="1"/> </element> <element id="AdverseEvent.modifierExtension:status"> <path value="AdverseEvent.modifierExtension"/> <sliceName value="status"/> <short value="in-progress | completed | entered-in-error | unknown"/> <definition value="The current state of the adverse event or potential adverse event."/> <comment value="This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition."/> <min value="1"/> <max value="1"/> <type> <code value="Extension"/> <profile value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status"/> </type> <isModifierReason value="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 value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventStatus"/> </extension> <strength value="required"/> <description value="Codes identifying the lifecycle stage of an event."/> </binding> </element> <element id="AdverseEvent.actuality"> <path value="AdverseEvent.actuality"/> <short value="actual"/> <patternCode value="actual"/> </element> <element id="AdverseEvent.event"> <path value="AdverseEvent.event"/> <short value="Event or incident that occurred or was averted"/> <definition value="Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused."/> <min value="1"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventType"/> </extension> <strength value="example"/> <description value="Detailed type of event."/> <valueSet value="http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs"/> </binding> </element> <element id="AdverseEvent.resultingCondition"> <path value="AdverseEvent.resultingCondition"/> <max value="0"/> </element> <element id="AdverseEvent.seriousness"> <path value="AdverseEvent.seriousness"/> <short value="Investigator defined severity of the adverse event, in relation to the subject not the resulting condition"/> <min value="1"/> <mustSupport value="true"/> <binding> <strength value="required"/> <valueSet value="http://terminology.hl7.org/ValueSet/adverse-event-seriousness"/> </binding> </element> <element id="AdverseEvent.outcome"> <path value="AdverseEvent.outcome"/> <min value="1"/> <mustSupport value="true"/> <binding> <strength value="required"/> <valueSet value="http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes"/> </binding> </element> <element id="AdverseEvent.suspectEntity"> <path value="AdverseEvent.suspectEntity"/> <max value="0"/> </element> <element id="AdverseEvent.subjectMedicalHistory"> <path value="AdverseEvent.subjectMedicalHistory"/> <max value="0"/> </element> <element id="AdverseEvent.referenceDocument"> <path value="AdverseEvent.referenceDocument"/> <max value="0"/> </element> <element id="AdverseEvent.study"> <path value="AdverseEvent.study"/> <min value="1"/> <max value="1"/> <mustSupport value="true"/> </element> </differential> </StructureDefinition>