MII IG Onkologie DE v2024

Nebenwirkung: AdverseEvent

Dieses Profil beschreibt die Nebenwirkung von Strahlentherapie und systemische Therapie in der Onkologie.

Die Art Nebenwirkung kann entweder als CTCAE-Terminus oder als medDRA-Nummer beschrieben werden. Weitere Hinweise sind der Dokumentationsleitfaden https://plattform65c.atlassian.net/wiki/spaces/Dokumentat/pages/93683749/Nebenwirkungen zu entnehmen. Außerdem stellt die Plattform §65c eine kuratierte Liste mit übersetzten CTCAE-Begriffen und den dazugehörigen medDRA-Nummern bereit. https://plattform65c.atlassian.net/wiki/spaces/UMK/pages/15533115/Nebenwirkungen+CTCAE

Name	Status	Version	Canonical	Basis
MII_PR_Onko_Nebenwirkung_Adverse_Event	draft	2024.0.0-ballot	https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event	http://hl7.org/fhir/StructureDefinition/AdverseEvent

Inhalt

AdverseEvent	I		AdverseEvent	There are no (further) constraints on this element Element id AdverseEvent Short description Medical care, research study or other healthcare event causing physical injury Alternate names AE Definition 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. Data type AdverseEvent Constraints dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources `contained.contained.empty()` dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated `contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()` dom-3: 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 `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()` dom-6: A resource should have narrative for robust management text.`div`.exists() dom-5: If a resource is contained in another resource, it SHALL NOT have a security label `contained.meta.security.empty()` Mappings rim: Entity. Role, or Act
id	Σ	0..1	string	There are no (further) constraints on this element Element id AdverseEvent.id Short description Logical id of this artifact Definition The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. Comments The only time that a resource does not have an id is when it is being submitted to the server using a create operation. Data type string
meta	Σ	0..1	Meta	There are no (further) constraints on this element Element id AdverseEvent.meta Short description Metadata about the resource Definition 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. Data type Meta Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A
id		0..1	string	There are no (further) constraints on this element Element id AdverseEvent.meta.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id AdverseEvent.meta.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
versionId	Σ	0..1	id	There are no (further) constraints on this element Element id AdverseEvent.meta.versionId Short description Version specific identifier Definition The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted. Comments The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes. Data type id Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
lastUpdated	Σ	0..1	instant	There are no (further) constraints on this element Element id AdverseEvent.meta.lastUpdated Short description When the resource version last changed Definition When the resource last changed - e.g. when the version changed. Comments This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction. Data type instant Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
source	Σ	0..1	uri	There are no (further) constraints on this element Element id AdverseEvent.meta.source Short description Identifies where the resource comes from Definition A uri that identifies the source system of the resource. This provides a minimal amount of Provenance information that can be used to track or differentiate the source of information in the resource. The source may identify another FHIR server, document, message, database, etc. Comments In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used. This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
profile	S Σ	0..*	canonical(StructureDefinition)	There are no (further) constraints on this element Element id AdverseEvent.meta.profile Short description Profiles this resource claims to conform to Definition A list of profiles (references to StructureDefinition resources) that this resource claims to conform to. The URL is a reference to StructureDefinition.url. Comments It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set. Data type canonical(StructureDefinition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
security	Σ	0..*	CodingBinding	There are no (further) constraints on this element Element id AdverseEvent.meta.security Short description Security Labels applied to this resource Definition Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure. Comments The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored. Data type Coding Binding Security Labels from the Healthcare Privacy and Security Classification System. All Security Labels (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
tag	Σ	0..*	Coding	There are no (further) constraints on this element Element id AdverseEvent.meta.tag Short description Tags applied to this resource Definition Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource. Comments The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored. Data type Coding Binding Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". CommonTags (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding
implicitRules	Σ ?!	0..1	uri	There are no (further) constraints on this element Element id AdverseEvent.implicitRules Short description A set of rules under which this content was created Definition 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. Comments 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. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
language		0..1	codeBinding	There are no (further) constraints on this element Element id AdverseEvent.language Short description Language of the resource content Definition The base language in which the resource is written. Comments 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). Data type code Binding A human language. CommonLanguages (preferred) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
text		0..1	Narrative	There are no (further) constraints on this element Element id AdverseEvent.text Short description Text summary of the resource, for human interpretation Alternate names narrative, html, xhtml, display Definition 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. Comments 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. Data type Narrative Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a rim: N/A rim: Act.text?
contained		0..*	Resource	There are no (further) constraints on this element Element id AdverseEvent.contained Short description Contained, inline Resources Alternate names inline resources, anonymous resources, contained resources Definition 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. Comments 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. Data type Resource Mappings rim: Entity. Role, or Act rim: N/A
extension	I	0..*	Extension	There are no (further) constraints on this element Element id AdverseEvent.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource. 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	?! I	0..*	Extension	There are no (further) constraints on this element Element id AdverseEvent.modifierExtension Short description Extensions that cannot be ignored Alternate names extensions, user content Definition May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it 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 is allowed to 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). Requirements 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
identifier	Σ	0..1	Identifier	There are no (further) constraints on this element Element id AdverseEvent.identifier Short description 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. Requirements Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers. Comments 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. Data type Identifier Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CX / EI (occasionally, more often EI maps to a resource id or a URL) rim: II - The Identifier class is a little looser than the v3 type II because it allows URIs as well as registered OIDs or GUIDs. Also maps to Role[classCode=IDENT] servd: Identifier
actuality	Σ ?!	1..1	codeBinding	There are no (further) constraints on this element Element id AdverseEvent.actuality Short description actual \| potential Definition 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. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Binding Overall nature of the adverse event, e.g. real or potential. AdverseEventActuality (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.class
category	Σ	0..*	CodeableConceptBinding	There are no (further) constraints on this element Element id AdverseEvent.category Short description 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 The overall type of event, intended for search and filtering purposes. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding Overall categorization of the event, e.g. product-related or situational. AdverseEventCategory (extensible) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD w5: FiveWs.class
event	S Σ	1..1	CodeableConceptBinding	Element id AdverseEvent.event Short description Type of the event itself in relation to the subject Definition This element defines the specific type of event that occurred or that was prevented from occurring. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding Detailed type of event. MII_VS_Onko_Nebenwirkung_Art (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD w5: FiveWs.what[x]
id		0..1	string	There are no (further) constraints on this element Element id AdverseEvent.event.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id AdverseEvent.event.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
coding	S Σ	1..*	Coding	There are no (further) constraints on this element Element id AdverseEvent.event.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id AdverseEvent.event.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id AdverseEvent.event.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
system	S Σ	1..1	uri	There are no (further) constraints on this element Element id AdverseEvent.event.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	S Σ	0..1	string	Element id AdverseEvent.event.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion oBDS: 15.3
code	S Σ	1..1	code	Element id AdverseEvent.event.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code oBDS: 15.2
display	Σ	0..1	string	There are no (further) constraints on this element Element id AdverseEvent.event.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id AdverseEvent.event.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	S Σ	0..1	string	There are no (further) constraints on this element Element id AdverseEvent.event.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
subject	S Σ I	1..1	Reference(Patient)	Element id AdverseEvent.subject Short description Subject impacted by event Alternate names patient Definition This subject or group impacted by the event. Requirements Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital. Comments If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject. Data type Reference(Patient) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.who
encounter	S Σ I	0..1	Reference(Encounter)	There are no (further) constraints on this element Element id AdverseEvent.encounter Short description Encounter created as part of Definition The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated. Comments 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. Data type Reference(Encounter) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.context
date	Σ	0..1	dateTime	There are no (further) constraints on this element Element id AdverseEvent.date Short description When the event occurred Definition The date (and perhaps time) when the adverse event occurred. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.init
detected	Σ	0..1	dateTime	There are no (further) constraints on this element Element id AdverseEvent.detected Short description When the event was detected Definition Estimated or actual date the AdverseEvent began, in the opinion of the reporter. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
recordedDate	Σ	0..1	dateTime	There are no (further) constraints on this element Element id AdverseEvent.recordedDate Short description When the event was recorded Definition The date on which the existence of the AdverseEvent was first recorded. Comments 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. Data type dateTime Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a w5: FiveWs.recorded
resultingCondition	Σ I	0..*	Reference(Condition)	There are no (further) constraints on this element Element id AdverseEvent.resultingCondition Short description Effect on the subject due to this event Definition Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical). Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Condition) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
location	Σ I	0..1	Reference(Location)	There are no (further) constraints on this element Element id AdverseEvent.location Short description Location where adverse event occurred Definition The information about where the adverse event occurred. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Location) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
seriousness	Σ	0..1	CodeableConcept	There are no (further) constraints on this element Element id AdverseEvent.seriousness Short description Seriousness of the event Definition Assessment whether this event was of real importance. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding Overall seriousness of this event for the patient. AdverseEventSeriousness (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
severity	S Σ	1..1	CodeableConceptBinding	Element id AdverseEvent.severity Short description mild \| moderate \| severe Definition 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. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding The severity of the adverse event itself, in direct relation to the subject. MII_VS_Onko_Nebenwirkung_CTCAE_Grad (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD oBDS: 15.1
id		0..1	string	There are no (further) constraints on this element Element id AdverseEvent.severity.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id AdverseEvent.severity.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
coding	S Σ	0..*	Coding	There are no (further) constraints on this element Element id AdverseEvent.severity.coding Short description Code defined by a terminology system Definition A reference to a code defined by a terminology system. Requirements Allows for alternative encodings within a code system, and translations to other code systems. Comments Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true. Data type Coding Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE subset one of the sets of component 1-3 or 4-6 rim: CV orim: fhir:Coding rdfs:subClassOf dt:CDCoding v2: CE.1-8, CE.10-22 rim: union(., ./translation) orim: fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
id		0..1	string	There are no (further) constraints on this element Element id AdverseEvent.severity.coding.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id AdverseEvent.severity.coding.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
system	S Σ	1..1	uri	There are no (further) constraints on this element Element id AdverseEvent.severity.coding.system Short description Identity of the terminology system Definition The identification of the code system that defines the meaning of the symbol in the code. Requirements Need to be unambiguous about the source of the definition of the symbol. Comments The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously. Data type uri Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.3 rim:* ./codeSystem orim: fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
version	Σ	0..1	string	There are no (further) constraints on this element Element id AdverseEvent.severity.coding.version Short description Version of the system - if relevant Definition The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged. Comments Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.7 rim:* ./codeSystemVersion orim: fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
code	S Σ	1..1	code	There are no (further) constraints on this element Element id AdverseEvent.severity.coding.code Short description Symbol in syntax defined by the system Definition A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination). Requirements Need to refer to a particular code in the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type code Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.1 rim:* ./code orim: fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
display	Σ	0..1	string	There are no (further) constraints on this element Element id AdverseEvent.severity.coding.display Short description Representation defined by the system Definition A representation of the meaning of the code in the system, following the rules of the system. Requirements Need to be able to carry a human-readable meaning of the code for readers that do not know the system. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.2 - but note this is not well followed rim:* CV.displayName orim: fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
userSelected	Σ	0..1	boolean	There are no (further) constraints on this element Element id AdverseEvent.severity.coding.userSelected Short description If this coding was chosen directly by the user Definition Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays). Requirements This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing. Comments Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely. Data type boolean Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: Sometimes implied by being first rim: CD.codingRationale orim: fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
text	S Σ	0..1	string	There are no (further) constraints on this element Element id AdverseEvent.severity.text Short description Plain text representation of the concept Definition A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user. Requirements The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source. Comments Very often the text is the same as a displayName of one of the codings. Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE.9. But note many systems use CE.2 for this rim: ./originalText[mediaType/code="text/plain"]/data orim: fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
outcome	Σ	0..1	CodeableConceptBinding	There are no (further) constraints on this element Element id AdverseEvent.outcome Short description resolved \| recovering \| ongoing \| resolvedWithSequelae \| fatal \| unknown Definition Describes the type of outcome from the adverse event. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding TODO (and should this be required?). AdverseEventOutcome (required) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
recorder	Σ I	0..1	Reference(Patient \| Practitioner \| PractitionerRole \| RelatedPerson)	There are no (further) constraints on this element Element id AdverseEvent.recorder Short description Who recorded the adverse event Definition Information on who recorded the adverse event. May be the patient or a practitioner. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Patient \| Practitioner \| PractitionerRole \| RelatedPerson) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity) w5: FiveWs.author
contributor	Σ I	0..*	Reference(Practitioner \| PractitionerRole \| Device)	There are no (further) constraints on this element Element id AdverseEvent.contributor Short description Who was involved in the adverse event or the potential adverse event Definition 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). Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Practitioner \| PractitionerRole \| Device) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
suspectEntity	S Σ	1..*	BackboneElement	There are no (further) constraints on this element Element id AdverseEvent.suspectEntity Short description The suspected agent causing the adverse event Definition Describes the entity that is suspected to have caused the adverse event. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id AdverseEvent.suspectEntity.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id AdverseEvent.suspectEntity.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id AdverseEvent.suspectEntity.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition 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). Requirements 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. Comments 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. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
instance	S Σ I	1..1	Reference(Procedure \| MedicationStatement)	Element id AdverseEvent.suspectEntity.instance Short description Refers to the specific entity that caused the adverse event Alternate names Substance or Medication or Device Definition Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Procedure \| MedicationStatement) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
causality	Σ	0..*	BackboneElement	There are no (further) constraints on this element Element id AdverseEvent.suspectEntity.causality Short description Information on the possible cause of the event Definition Information on the possible cause of the event. Data type BackboneElement Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
id		0..1	string	There are no (further) constraints on this element Element id AdverseEvent.suspectEntity.causality.id Short description Unique id for inter-element referencing Definition Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. Data type string Mappings rim: n/a
extension	I	0..*	Extension	There are no (further) constraints on this element Element id AdverseEvent.suspectEntity.causality.extension Short description Additional content defined by implementations Alternate names extensions, user content Definition 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. Comments 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. Data type Extension Sliced: Unordered, Open, by url(Value) Extensions are always sliced by (at least) url Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
modifierExtension	Σ ?! I	0..*	Extension	There are no (further) constraints on this element Element id AdverseEvent.suspectEntity.causality.modifierExtension Short description Extensions that cannot be ignored even if unrecognized Alternate names extensions, user content, modifiers Definition 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). Requirements 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. Comments 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. Data type Extension Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ext-1: Must have either extensions or value[x], not both `extension.exists() != value.exists()` Mappings rim: n/a rim: N/A
assessment	Σ	0..1	CodeableConcept	There are no (further) constraints on this element Element id AdverseEvent.suspectEntity.causality.assessment Short description Assessment of if the entity caused the event Definition Assessment of if the entity caused the event. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding Codes for the assessment of whether the entity caused the event. AdverseEventCausalityAssessment (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
productRelatedness	Σ	0..1	string	There are no (further) constraints on this element Element id AdverseEvent.suspectEntity.causality.productRelatedness Short description AdverseEvent.suspectEntity.causalityProductRelatedness Definition AdverseEvent.suspectEntity.causalityProductRelatedness. Comments Note that FHIR strings SHALL NOT exceed 1MB in size Data type string Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a
author	Σ I	0..1	Reference(Practitioner \| PractitionerRole)	There are no (further) constraints on this element Element id AdverseEvent.suspectEntity.causality.author Short description AdverseEvent.suspectEntity.causalityAuthor Definition AdverseEvent.suspectEntity.causalityAuthor. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Practitioner \| PractitionerRole) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
method	Σ	0..1	CodeableConcept	There are no (further) constraints on this element Element id AdverseEvent.suspectEntity.causality.method Short description ProbabilityScale \| Bayesian \| Checklist Definition ProbabilityScale \| Bayesian \| Checklist. Comments Not all terminology uses fit this general pattern. In some cases, models should not use CodeableConcept and use Coding directly and provide their own structure for managing text, codings, translations and the relationship between elements and pre- and post-coordination. Data type CodeableConcept Binding TODO. AdverseEventCausalityMethod (example) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` Mappings rim: n/a v2: CE/CNE/CWE rim: CD orim: fhir:CodeableConcept rdfs:subClassOf dt:CD
subjectMedicalHistory	Σ I	0..*	Reference(Condition \| Observation \| AllergyIntolerance \| FamilyMemberHistory \| Immunization \| Procedure \| Media \| DocumentReference)	There are no (further) constraints on this element Element id AdverseEvent.subjectMedicalHistory Short description AdverseEvent.subjectMedicalHistory Definition AdverseEvent.subjectMedicalHistory. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(Condition \| Observation \| AllergyIntolerance \| FamilyMemberHistory \| Immunization \| Procedure \| Media \| DocumentReference) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
referenceDocument	Σ I	0..*	Reference(DocumentReference)	There are no (further) constraints on this element Element id AdverseEvent.referenceDocument Short description AdverseEvent.referenceDocument Definition AdverseEvent.referenceDocument. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(DocumentReference) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)
study	Σ I	0..*	Reference(ResearchStudy)	There are no (further) constraints on this element Element id AdverseEvent.study Short description AdverseEvent.study Definition AdverseEvent.study. Comments References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Data type Reference(ResearchStudy) Constraints ele-1: All FHIR elements must have a @value or children `hasValue() or (children().count() > id.count())` ref-1: SHALL have a contained resource if a local reference is provided `reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))` Mappings rim: n/a rim: The target of a resource reference is a RIM entry point (Act, Role, or Entity)

Dieses Profil beschreibt die Nebenwirkung von Strahlentherapie und systemische Therapie in der Onkologie.

Feldname
AdverseEvent.meta.profile
AdverseEvent.event
AdverseEvent.event.coding
AdverseEvent.event.coding.system
AdverseEvent.event.coding.version
AdverseEvent.event.coding.code
AdverseEvent.event.text
AdverseEvent.subject
AdverseEvent.encounter
AdverseEvent.severity
AdverseEvent.severity.coding
AdverseEvent.severity.coding.system
AdverseEvent.severity.coding.code
AdverseEvent.severity.text
AdverseEvent.suspectEntity
AdverseEvent.suspectEntity.instance

<StructureDefinition xmlns="http://hl7.org/fhir">
    <id value="mii-pr-onko-nebenwirkung-adverse-event" />
    <url value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event" />
    <version value="2024.0.0-ballot" />
    <name value="MII_PR_Onko_Nebenwirkung_Adverse_Event" />
    <title value="MII PR Onkologie Nebenwirkung von Strahlentherapie und systemische Therapie" />
    <status value="draft" />
    <publisher value="Medizininformatik Initiative" />
    <contact>
        <telecom>
            <system value="url" />
            <value value="https://www.medizininformatik-initiative.de" />
        </telecom>
    </contact>
    <description value="Dieses Profil beschreibt die Nebenwirkung von Strahlentherapie und systemische Therapie in der Onkologie." />
    <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>
    <mapping>
        <identity value="oBDS" />
        <name value="Mapping FHIR zu oBDS" />
    </mapping>
    <kind value="resource" />
    <abstract value="false" />
    <type value="AdverseEvent" />
    <baseDefinition value="http://hl7.org/fhir/StructureDefinition/AdverseEvent" />
    <derivation value="constraint" />
    <differential>
        <element id="AdverseEvent.meta.profile">
            <path value="AdverseEvent.meta.profile" />
            <mustSupport value="true" />
        </element>
        <element id="AdverseEvent.event">
            <path value="AdverseEvent.event" />
            <min value="1" />
            <mustSupport value="true" />
            <binding>
                <strength value="required" />
                <valueSet value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-art" />
            </binding>
        </element>
        <element id="AdverseEvent.event.coding">
            <path value="AdverseEvent.event.coding" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="AdverseEvent.event.coding.system">
            <path value="AdverseEvent.event.coding.system" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="AdverseEvent.event.coding.version">
            <path value="AdverseEvent.event.coding.version" />
            <mustSupport value="true" />
            <mapping>
                <identity value="oBDS" />
                <map value="15.3" />
                <comment value="Nebenwirkungen nach CTCAE Version" />
            </mapping>
        </element>
        <element id="AdverseEvent.event.coding.code">
            <path value="AdverseEvent.event.coding.code" />
            <min value="1" />
            <mustSupport value="true" />
            <mapping>
                <identity value="oBDS" />
                <map value="15.2" />
                <comment value="Nebenwirkungen nach CTCAE Art" />
            </mapping>
        </element>
        <element id="AdverseEvent.event.text">
            <path value="AdverseEvent.event.text" />
            <mustSupport value="true" />
        </element>
        <element id="AdverseEvent.subject">
            <path value="AdverseEvent.subject" />
            <type>
                <code value="Reference" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient" />
            </type>
            <mustSupport value="true" />
        </element>
        <element id="AdverseEvent.encounter">
            <path value="AdverseEvent.encounter" />
            <mustSupport value="true" />
        </element>
        <element id="AdverseEvent.severity">
            <path value="AdverseEvent.severity" />
            <min value="1" />
            <mustSupport value="true" />
            <binding>
                <strength value="required" />
                <valueSet value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-ctcae-grad" />
            </binding>
            <mapping>
                <identity value="oBDS" />
                <map value="15.1" />
                <comment value="Nebenwirkungen nach CTCAE-Grad" />
            </mapping>
        </element>
        <element id="AdverseEvent.severity.coding">
            <path value="AdverseEvent.severity.coding" />
            <mustSupport value="true" />
        </element>
        <element id="AdverseEvent.severity.coding.system">
            <path value="AdverseEvent.severity.coding.system" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="AdverseEvent.severity.coding.code">
            <path value="AdverseEvent.severity.coding.code" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="AdverseEvent.severity.text">
            <path value="AdverseEvent.severity.text" />
            <mustSupport value="true" />
        </element>
        <element id="AdverseEvent.suspectEntity">
            <path value="AdverseEvent.suspectEntity" />
            <min value="1" />
            <mustSupport value="true" />
        </element>
        <element id="AdverseEvent.suspectEntity.instance">
            <path value="AdverseEvent.suspectEntity.instance" />
            <type>
                <code value="Reference" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure" />
                <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationStatement" />
            </type>
            <mustSupport value="true" />
        </element>
    </differential>
</StructureDefinition>

{
    "resourceType": "StructureDefinition",
    "id": "mii-pr-onko-nebenwirkung-adverse-event",
    "url": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event",
    "version": "2024.0.0-ballot",
    "name": "MII_PR_Onko_Nebenwirkung_Adverse_Event",
    "title": "MII PR Onkologie Nebenwirkung von Strahlentherapie und systemische Therapie",
    "status": "draft",
    "publisher": "Medizininformatik Initiative",
    "contact":  [
        {
            "telecom":  [
                {
                    "system": "url",
                    "value": "https://www.medizininformatik-initiative.de"
                }
            ]
        }
    ],
    "description": "Dieses Profil beschreibt die Nebenwirkung von Strahlentherapie und systemische Therapie in der Onkologie.",
    "fhirVersion": "4.0.1",
    "mapping":  [
        {
            "identity": "w5",
            "uri": "http://hl7.org/fhir/fivews",
            "name": "FiveWs Pattern Mapping"
        },
        {
            "identity": "rim",
            "uri": "http://hl7.org/v3",
            "name": "RIM Mapping"
        },
        {
            "identity": "oBDS",
            "name": "Mapping FHIR zu oBDS"
        }
    ],
    "kind": "resource",
    "abstract": false,
    "type": "AdverseEvent",
    "baseDefinition": "http://hl7.org/fhir/StructureDefinition/AdverseEvent",
    "derivation": "constraint",
    "differential": {
        "element":  [
            {
                "id": "AdverseEvent.meta.profile",
                "path": "AdverseEvent.meta.profile",
                "mustSupport": true
            },
            {
                "id": "AdverseEvent.event",
                "path": "AdverseEvent.event",
                "min": 1,
                "mustSupport": true,
                "binding": {
                    "strength": "required",
                    "valueSet": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-art"
                }
            },
            {
                "id": "AdverseEvent.event.coding",
                "path": "AdverseEvent.event.coding",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "AdverseEvent.event.coding.system",
                "path": "AdverseEvent.event.coding.system",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "AdverseEvent.event.coding.version",
                "path": "AdverseEvent.event.coding.version",
                "mustSupport": true,
                "mapping":  [
                    {
                        "identity": "oBDS",
                        "map": "15.3",
                        "comment": "Nebenwirkungen nach CTCAE Version"
                    }
                ]
            },
            {
                "id": "AdverseEvent.event.coding.code",
                "path": "AdverseEvent.event.coding.code",
                "min": 1,
                "mustSupport": true,
                "mapping":  [
                    {
                        "identity": "oBDS",
                        "map": "15.2",
                        "comment": "Nebenwirkungen nach CTCAE Art"
                    }
                ]
            },
            {
                "id": "AdverseEvent.event.text",
                "path": "AdverseEvent.event.text",
                "mustSupport": true
            },
            {
                "id": "AdverseEvent.subject",
                "path": "AdverseEvent.subject",
                "type":  [
                    {
                        "code": "Reference",
                        "targetProfile":  [
                            "http://hl7.org/fhir/StructureDefinition/Patient"
                        ]
                    }
                ],
                "mustSupport": true
            },
            {
                "id": "AdverseEvent.encounter",
                "path": "AdverseEvent.encounter",
                "mustSupport": true
            },
            {
                "id": "AdverseEvent.severity",
                "path": "AdverseEvent.severity",
                "min": 1,
                "mustSupport": true,
                "binding": {
                    "strength": "required",
                    "valueSet": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-ctcae-grad"
                },
                "mapping":  [
                    {
                        "identity": "oBDS",
                        "map": "15.1",
                        "comment": "Nebenwirkungen nach CTCAE-Grad"
                    }
                ]
            },
            {
                "id": "AdverseEvent.severity.coding",
                "path": "AdverseEvent.severity.coding",
                "mustSupport": true
            },
            {
                "id": "AdverseEvent.severity.coding.system",
                "path": "AdverseEvent.severity.coding.system",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "AdverseEvent.severity.coding.code",
                "path": "AdverseEvent.severity.coding.code",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "AdverseEvent.severity.text",
                "path": "AdverseEvent.severity.text",
                "mustSupport": true
            },
            {
                "id": "AdverseEvent.suspectEntity",
                "path": "AdverseEvent.suspectEntity",
                "min": 1,
                "mustSupport": true
            },
            {
                "id": "AdverseEvent.suspectEntity.instance",
                "path": "AdverseEvent.suspectEntity.instance",
                "type":  [
                    {
                        "code": "Reference",
                        "targetProfile":  [
                            "http://hl7.org/fhir/StructureDefinition/Procedure",
                            "http://hl7.org/fhir/StructureDefinition/MedicationStatement"
                        ]
                    }
                ],
                "mustSupport": true
            }
        ]
    }
}

MII PR Onkologie Nebenwirkung von Strahlentherapie und systemische Therapie

Mapping Datensatz zu FHIR

Datensatz	Erklaerung	FHIR
Nebenwirkungen	Nebenwirkungen
Nebenwirkungen nach CTCAE-Grad	Gibt an, zu welchem Schweregrad von Nebenwirkungen es bei der Bestrahlung oder der systemischen Therapie gekommen ist.	AdverseEvent.severity.coding.code
Nebenwirkungen nach CTCAE Art	Gibt an, zu welcher Nebenwirkung es bei der Bestrahlung oder der systemischen Therapie gekommen ist. Bei der Bestrahlung sind sogenannte akute Nebenwirkungen bis zum 90. Tag nach Bestrahlungsbeginn gemeint.	AdverseEvent.event.coding.code
Nebenwirkungen nach CTCAE Version	Für den medizinischen Katalog gültige Versionsbezeichnungen.	AdverseEvent.event.coding.version

Mapping Einheitlicher onkologischer Basisdatensatz (oBDS) zu FHIR

oBDS	Definition	FHIR
15.3	Nebenwirkungen nach CTCAE Version	AdverseEvent.event.coding.version
15.2	Nebenwirkungen nach CTCAE Art	AdverseEvent.event.coding.code
15.1	Nebenwirkungen nach CTCAE-Grad	AdverseEvent.severity

Suchparameter

Folgende Suchparameter sind für das Modul Onkologie relevant, auch in Kombination:

Der Suchparameter _id MUSS unterstützt werden:

Beispiele:

GET [base]/AdverseEvent?_id=1234

Anwendungshinweise: Weitere Informationen zur Suche nach "_id" finden sich in der FHIR-Basisspezifikation - Abschnitt "Parameters for all resources".
Der Suchparameter _profile MUSS unterstützt werden:

Beispiele:

GET [base]/AdverseEvent?_profile=https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event

Anwendungshinweise: Weitere Informationen zur Suche nach "_profile" finden sich in der FHIR-Basisspezifikation - Abschnitt "token".
Der Suchparameter event MUSS unterstützt werden: Beispiele:

GET [base]/AdverseEvent?event=https://www.meddra.org|10016256

Anwendungshinweise: Weitere Informationen zur Suche nach "event" finden sich in der FHIR-Basisspezifikation - Abschnitt "token".
Der Suchparameter serverity MUSS unterstützt werden:

Beispiele:

GET [base]/AdverseEvent?severity=https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-vs-onko-nebenwirkung-ctcae-grad|4

Anwendungshinweise: Weitere Informationen zur Suche nach "severity" finden sich in der FHIR-Basisspezifikation - Abschnitt "token".
Der Suchparameter suspectEntity.instance MUSS unterstützt werden:

Beispiele:

GET [base]/AdverseEvent?suspectEntity.instance=Patient/example

Anwendungshinweise: Weitere Informationen zur Suche nach "severity" finden sich in der FHIR-Basisspezifikation - Abschnitt "reference".

Beispiele

{
    "resourceType": "AdverseEvent",
    "id": "mii-pr-onko-nebenwirkung-0",
    "meta": {
        "profile":  [
            "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event"
        ]
    },
    "actuality": "actual",
    "event": {
        "coding":  [
            {
                "code": "10016256",
                "system": "https://www.meddra.org",
                "display": "Fatigue",
                "version": "Version 4"
            }
        ]
    },
    "subject": {
        "reference": "Patient/example"
    },
    "severity": {
        "coding":  [
            {
                "code": "4",
                "system": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-vs-onko-nebenwirkung-ctcae-grad",
                "display": "Lebensbedrohlich"
            }
        ]
    },
    "suspectEntity":  [
        {
            "instance": {
                "reference": "Procedure/Strahlentherapie"
            }
        }
    ]
}