MII IG Onkologie DE v2025
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
Abweichend zum oBDS können mit dem vorliegenden Profil auch Events der Schweregrade 1 und 2 explizit angegeben werden. Dadurch kann es dazu kommen, dass in den Krebsregisterdaten gar nicht hinterlegt ist, um was für eine Art von Nebenwirkung es sich handelt. In
| Name | Status | Version | Canonical | Basis |
|---|---|---|---|---|
| MII_PR_Onko_Nebenwirkung_Adverse_Event | active | 2025.1.0 | https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event | http://hl7.org/fhir/StructureDefinition/AdverseEvent |
Inhalt
| MII_PR_Onko_Nebenwirkung_Adverse_Event (AdverseEvent) | C | AdverseEvent | |
| id | Σ | 0..1 | string |
| meta | Σ | 0..1 | Meta |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| versionId | Σ | 0..1 | id |
| lastUpdated | Σ | 0..1 | instant |
| source | Σ | 0..1 | uri |
| profile | S Σ | 0..* | canonical(StructureDefinition) |
| security | Σ | 0..* | CodingBinding |
| tag | Σ | 0..* | Coding |
| implicitRules | Σ ?! | 0..1 | uri |
| language | 0..1 | codeBinding | |
| text | 0..1 | Narrative | |
| contained | 0..* | Resource | |
| extension | C | 0..* | Extension |
| modifierExtension | ?! C | 0..* | Extension |
| identifier | Σ | 0..1 | Identifier |
| actuality | Σ ?! | 1..1 | codeBinding |
| category | Σ | 0..* | CodeableConceptBinding |
| event | S Σ | 1..1 | CodeableConcept |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| coding | S Σ | 0..* | Coding |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| system | S Σ | 1..1 | uri |
| version | S Σ | 0..1 | string |
| code | S Σ | 0..1 | codeBinding |
| display | Σ | 0..1 | string |
| userSelected | Σ | 0..1 | boolean |
| text | S Σ | 0..1 | string |
| subject | S Σ C | 1..1 | Reference(Patient) |
| encounter | S Σ C | 0..1 | Reference(Encounter) |
| date | Σ | 0..1 | dateTime |
| detected | Σ | 0..1 | dateTime |
| recordedDate | Σ | 0..1 | dateTime |
| resultingCondition | Σ C | 0..* | Reference(Condition) |
| location | Σ C | 0..1 | Reference(Location) |
| seriousness | S Σ | 1..1 | CodeableConceptBinding |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| coding | S Σ | 0..* | Coding |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| system | S Σ | 1..1 | uri |
| version | Σ | 0..1 | string |
| code | S Σ | 1..1 | code |
| display | Σ | 0..1 | string |
| userSelected | Σ | 0..1 | boolean |
| text | S Σ | 0..1 | string |
| severity | Σ | 0..1 | CodeableConceptBinding |
| outcome | Σ | 0..1 | CodeableConceptBinding |
| recorder | Σ C | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) |
| contributor | Σ C | 0..* | Reference(Device | Practitioner | PractitionerRole) |
| suspectEntity | S Σ | 1..* | BackboneElement |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| modifierExtension | Σ ?! C | 0..* | Extension |
| instance | S Σ C | 1..1 | Reference(MedicationStatement | Procedure) |
| causality | Σ | 0..* | BackboneElement |
| id | 0..1 | string | |
| extension | C | 0..* | Extension |
| modifierExtension | Σ ?! C | 0..* | Extension |
| assessment | Σ | 0..1 | CodeableConcept |
| productRelatedness | Σ | 0..1 | string |
| author | Σ C | 0..1 | Reference(Practitioner | PractitionerRole) |
| method | Σ | 0..1 | CodeableConcept |
| subjectMedicalHistory | Σ C | 0..* | Reference(AllergyIntolerance | Condition | DocumentReference | FamilyMemberHistory | Immunization | Media | Observation | Procedure) |
| referenceDocument | Σ C | 0..* | Reference(DocumentReference) |
| study | Σ C | 0..* | Reference(ResearchStudy) |
Dieses Profil beschreibt die Nebenwirkung von Strahlentherapie und systemische Therapie in der Onkologie. |
| Feldname | Kurzbeschreibung |
|---|---|
| AdverseEvent.meta.profile | |
| AdverseEvent.event | |
| AdverseEvent.event.coding | |
| AdverseEvent.event.coding.system | |
| AdverseEvent.event.coding.version | CTCAE-Version |
| AdverseEvent.event.coding.code | Art der Nebenwirkung |
| AdverseEvent.event.text | |
| AdverseEvent.subject | |
| AdverseEvent.encounter | |
| AdverseEvent.seriousness | |
| AdverseEvent.seriousness.coding | Schweregrad der Nebenwirkung nach CTCAE |
| AdverseEvent.seriousness.coding.system | |
| AdverseEvent.seriousness.coding.code | |
| AdverseEvent.seriousness.text | |
| AdverseEvent.suspectEntity | |
| AdverseEvent.suspectEntity.instance |
<url value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event" />
</telecom>
</contact>
<description value="Dieses Profil beschreibt die Nebenwirkung von Strahlentherapie und systemische Therapie in der Onkologie." />
</mapping>
<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." />
</base>
<human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources" />
</constraint>
<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='#'])]))" />
</constraint>
<human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated" />
<xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))" />
</constraint>
<human value="If a resource is contained in another resource, it SHALL NOT have a security label" />
</constraint>
</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>
</constraint>
</mapping>
</element>
<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." />
</base>
</extension>
</type>
</element>
<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." />
</base>
</type>
</constraint>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</element>
<comment value="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](http.html#read) interaction." />
</base>
</type>
</constraint>
</element>
<definition value="A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](provenance.html#) 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." />
<comment value="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. \n\nThis 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." />
</base>
</type>
</constraint>
</element>
<definition value="A list of profiles (references to [StructureDefinition](structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](structuredefinition-definitions.html#StructureDefinition.url)." />
<comment value="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." />
</base>
</type>
</constraint>
</element>
<definition value="Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure." />
<comment value="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." />
</base>
</type>
</constraint>
</extension>
</extension>
<description value="Security Labels from the Healthcare Privacy and Security Classification System." />
</binding>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</extension>
<description value="Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones"." />
</binding>
</element>
<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." />
</base>
</type>
</constraint>
<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" />
</element>
<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)." />
</base>
</type>
</constraint>
</extension>
</extension>
</extension>
</binding>
</element>
<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." />
</base>
</type>
</constraint>
</mapping>
</element>
<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." />
</base>
</type>
</mapping>
</element>
<definition value="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." />
<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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="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.\n\nModifier 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](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them" />
</mapping>
</element>
<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](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." />
</base>
</type>
</constraint>
</element>
<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." />
</base>
</type>
</constraint>
<isModifierReason value="This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen." />
</extension>
</binding>
</mapping>
</element>
<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" />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</element>
<definition value="This element defines the specific type of event that occurred or that was prevented from occurring." />
</base>
</type>
</constraint>
</extension>
</binding>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<comment value="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." />
<requirements value="Allows for alternative encodings within a code system, and translations to other code systems." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="The identification of the code system that defines the meaning of the symbol in the code." />
<comment value="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." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
</extension>
</extension>
</extension>
</short>
<definition value="Version der für Art der Nebenwirkung verwendeten CTCAE-Klassifikation gemäß 15.3 oBDS 2021.">
</extension>
<valueString value="Version der für Art der Nebenwirkung verwendeten CTCAE-Klassifikation gemäß 15.3 oBDS 2021." />
</extension>
</extension>
</definition>
<comment value="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." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
</extension>
</extension>
</extension>
</short>
<definition value="Art der Nebenwirkung nach CTCAE / MedDRA. Abweichend von 15.2 oBDS 2021 kann dieses Feld leer sein falls eine Nebenwirkung des Schweregrads 1 oder 2 vorliegt und keine spezifische Art der Nebenwirkung dokumentiert wurde">
</extension>
<valueString value="Art der Nebenwirkung nach CTCAE / MedDRA . Abweichend von 15.2 oBDS 2021 kann dieses Feld leer sein falls eine Nebenwirkung des Schweregrads 1 oder 2 vorliegt und keine spezifische Art der Nebenwirkung dokumentiert wurde" />
</extension>
</extension>
</definition>
</base>
</type>
</constraint>
<valueSet value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-art" />
</binding>
</mapping>
</mapping>
</mapping>
</mapping>
</element>
</extension>
<definition value="A representation of the meaning of the code in the system, following the rules of the system." />
<requirements value="Need to be able to carry a human-readable meaning of the code for readers that do not know the system." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays)." />
<comment value="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." />
<requirements value="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." />
</base>
</type>
</constraint>
</mapping>
</mapping>
<map value="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 ]" />
</mapping>
</element>
</extension>
<definition value="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 value="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." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<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." />
</base>
</type>
</constraint>
</mapping>
</element>
<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." />
</base>
</type>
</constraint>
</mapping>
</element>
</base>
</type>
</constraint>
</mapping>
</element>
<definition value="Estimated or actual date the AdverseEvent began, in the opinion of the reporter." />
</base>
</type>
</constraint>
</element>
<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." />
</base>
</type>
</constraint>
</mapping>
</element>
<definition value="Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical)." />
</base>
</type>
</constraint>
</element>
</base>
</type>
</constraint>
</element>
</base>
</type>
</constraint>
</extension>
<valueSet value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-ctcae-grad" />
</binding>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
</extension>
</extension>
</extension>
</short>
</extension>
</extension>
</extension>
</definition>
<comment value="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." />
<requirements value="Allows for alternative encodings within a code system, and translations to other code systems." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
</discriminator>
</slicing>
<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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<definition value="The identification of the code system that defines the meaning of the symbol in the code." />
<comment value="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." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="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." />
<comment value="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." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="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)." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
</extension>
<definition value="A representation of the meaning of the code in the system, following the rules of the system." />
<requirements value="Need to be able to carry a human-readable meaning of the code for readers that do not know the system." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<definition value="Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays)." />
<comment value="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." />
<requirements value="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." />
</base>
</type>
</constraint>
</mapping>
</mapping>
<map value="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 ]" />
</mapping>
</element>
</extension>
<definition value="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 value="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." />
</base>
</type>
</constraint>
</mapping>
</mapping>
</mapping>
</element>
<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." />
</base>
</type>
</constraint>
</extension>
<description value="The severity of the adverse event itself, in direct relation to the subject." />
</binding>
</element>
</base>
</type>
</constraint>
</extension>
</binding>
</element>
<definition value="Information on who recorded the adverse event. May be the patient or a practitioner." />
</base>
</type>
</constraint>
</mapping>
</element>
<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)." />
</base>
</type>
</constraint>
</element>
</base>
</type>
</constraint>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
<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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<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.\n\nModifier 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](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
</mapping>
</element>
<definition value="Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device." />
</base>
</type>
</constraint>
</element>
</base>
</type>
</constraint>
</element>
<definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces." />
</base>
</extension>
</type>
</mapping>
</element>
<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." />
</base>
</type>
</constraint>
</constraint>
</mapping>
</element>
<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.\n\nModifier 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](extensibility.html#modifierExtension)." />
</base>
</type>
</constraint>
</constraint>
<isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them" />
</mapping>
</element>
</base>
</type>
</constraint>
</extension>
</binding>
</element>
</base>
</type>
</constraint>
</element>
</base>
</type>
</constraint>
</element>
</base>
</type>
</constraint>
</extension>
</binding>
</element>
</base>
</type>
</constraint>
</element>
</base>
</type>
</constraint>
</element>
</base>
</type>
</constraint>
</element>
</snapshot>
</element>
</element>
</element>
</element>
</extension>
</extension>
</extension>
</short>
<definition value="Version der für Art der Nebenwirkung verwendeten CTCAE-Klassifikation gemäß 15.3 oBDS 2021.">
</extension>
<valueString value="Version der für Art der Nebenwirkung verwendeten CTCAE-Klassifikation gemäß 15.3 oBDS 2021." />
</extension>
</extension>
</definition>
</mapping>
</element>
</extension>
</extension>
</extension>
</short>
<definition value="Art der Nebenwirkung nach CTCAE / MedDRA. Abweichend von 15.2 oBDS 2021 kann dieses Feld leer sein falls eine Nebenwirkung des Schweregrads 1 oder 2 vorliegt und keine spezifische Art der Nebenwirkung dokumentiert wurde">
</extension>
<valueString value="Art der Nebenwirkung nach CTCAE / MedDRA . Abweichend von 15.2 oBDS 2021 kann dieses Feld leer sein falls eine Nebenwirkung des Schweregrads 1 oder 2 vorliegt und keine spezifische Art der Nebenwirkung dokumentiert wurde" />
</extension>
</extension>
</definition>
<valueSet value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-art" />
</binding>
</mapping>
</element>
</element>
</type>
</element>
</element>
<valueSet value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-ctcae-grad" />
</binding>
</mapping>
</element>
</extension>
</extension>
</extension>
</short>
</extension>
</extension>
</extension>
</definition>
</element>
</element>
</element>
</element>
</element>
</type>
</element>
</differential>
</StructureDefinition>
{
"url": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event",
],
"description": "Dieses Profil beschreibt die Nebenwirkung von Strahlentherapie und systemische Therapie in der Onkologie.",
],
{
"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.",
"AE"
],
},
{
},
{
"human": "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": "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": "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='#'])]))",
},
{
"human": "If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated",
"xpath": "not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))",
},
{
},
{
{
},
{
"valueMarkdown": "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."
}
],
}
],
]
},
{
"definition": "The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.",
"comment": "The only time that a resource does not have an id is when it is being submitted to the server using a create operation.",
},
{
{
}
],
}
],
},
{
"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.",
},
],
{
}
],
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"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.",
"comment": "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.",
},
],
{
}
],
},
{
"comment": "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](http.html#read) interaction.",
},
],
{
}
],
},
{
"definition": "A uri that identifies the source system of the resource. This provides a minimal amount of [Provenance](provenance.html#) 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.",
"comment": "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. \n\nThis 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.",
},
],
{
}
],
},
{
"definition": "A list of profiles (references to [StructureDefinition](structuredefinition.html#) resources) that this resource claims to conform to. The URL is a reference to [StructureDefinition.url](structuredefinition-definitions.html#StructureDefinition.url).",
"comment": "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.",
},
{
"http://hl7.org/fhir/StructureDefinition/StructureDefinition"
]
}
],
{
}
],
},
{
"definition": "Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.",
"comment": "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.",
},
],
{
}
],
{
},
{
}
],
}
},
{
"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.",
"comment": "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.",
},
],
{
}
],
{
}
],
"description": "Codes that represent various types of tags, commonly workflow-related; e.g. \"Needs review by Dr. Jones\".",
}
},
{
"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.",
"comment": "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.",
},
],
{
}
],
"isModifierReason": "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",
},
{
"comment": "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).",
},
],
{
}
],
{
},
{
},
{
}
],
}
},
{
"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.",
"comment": "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.",
"narrative",
"html",
"xhtml",
"display"
],
},
],
{
}
],
]
},
{
"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.",
"comment": "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.",
"inline resources",
"anonymous resources",
"contained resources"
],
},
],
]
},
{
"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.",
"comment": "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.",
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "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": "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](extensibility.html#modifierExtension).",
"extensions",
"user content"
],
},
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them",
]
},
{
"definition": "Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server.",
"comment": "This is a business identifier, not a resource identifier (see [discussion](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": "Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.",
},
],
{
}
],
},
{
"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.",
},
],
{
}
],
"isModifierReason": "This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.",
{
}
],
},
]
},
{
"short": "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": "This element defines the specific type of event that occurred or that was prevented from occurring.",
},
],
{
}
],
{
}
],
},
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"comment": "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.",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
},
],
{
}
],
{
},
{
},
{
}
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"definition": "The identification of the code system that defines the meaning of the symbol in the code.",
"comment": "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.",
},
],
{
}
],
{
},
{
},
{
}
]
},
{
{
],
}
]
},
"definition": "Version der für Art der Nebenwirkung verwendeten CTCAE-Klassifikation gemäß 15.3 oBDS 2021.",
{
{
},
{
"valueString": "Version der für Art der Nebenwirkung verwendeten CTCAE-Klassifikation gemäß 15.3 oBDS 2021."
}
],
}
]
},
"comment": "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.",
},
],
{
}
],
{
},
{
},
{
},
{
}
]
},
{
{
{
},
{
}
],
}
]
},
"definition": "Art der Nebenwirkung nach CTCAE / MedDRA. Abweichend von 15.2 oBDS 2021 kann dieses Feld leer sein falls eine Nebenwirkung des Schweregrads 1 oder 2 vorliegt und keine spezifische Art der Nebenwirkung dokumentiert wurde",
{
{
},
{
"valueString": "Art der Nebenwirkung nach CTCAE / MedDRA . Abweichend von 15.2 oBDS 2021 kann dieses Feld leer sein falls eine Nebenwirkung des Schweregrads 1 oder 2 vorliegt und keine spezifische Art der Nebenwirkung dokumentiert wurde"
}
],
}
]
},
},
],
{
}
],
"valueSet": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-art"
},
{
},
{
},
{
},
{
}
]
},
{
{
}
],
"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.",
},
],
{
}
],
{
},
{
},
{
}
]
},
{
"definition": "Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).",
"comment": "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.",
"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.",
},
],
{
}
],
{
},
{
},
{
"map": "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 ]"
}
]
},
{
{
}
],
"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.",
},
],
{
}
],
{
},
{
},
{
}
]
},
{
"comment": "If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.",
"requirements": "Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.",
"patient"
],
},
],
{
}
],
]
},
{
"definition": "The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.",
"comment": "This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context.",
},
],
{
}
],
]
},
{
},
],
{
}
],
]
},
{
},
],
{
}
],
},
{
"comment": "The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata.",
},
],
{
}
],
]
},
{
"definition": "Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).",
},
],
{
}
],
},
{
},
],
{
}
],
},
{
},
],
{
}
],
{
}
],
"valueSet": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-ctcae-grad"
},
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
{
{
},
{
}
],
}
]
},
{
{
},
{
}
],
}
]
},
"comment": "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.",
"requirements": "Allows for alternative encodings within a code system, and translations to other code systems.",
},
],
{
}
],
{
},
{
},
{
}
]
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
],
},
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"definition": "The identification of the code system that defines the meaning of the symbol in the code.",
"comment": "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.",
},
],
{
}
],
{
},
{
},
{
}
]
},
{
"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.",
"comment": "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.",
},
],
{
}
],
{
},
{
},
{
}
]
},
{
"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).",
},
],
{
}
],
{
},
{
},
{
}
]
},
{
{
}
],
"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.",
},
],
{
}
],
{
},
{
},
{
}
]
},
{
"definition": "Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).",
"comment": "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.",
"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.",
},
],
{
}
],
{
},
{
},
{
"map": "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 ]"
}
]
},
{
{
}
],
"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.",
},
],
{
}
],
{
},
{
},
{
}
]
},
{
"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.",
},
],
{
}
],
{
}
],
}
},
{
},
],
{
}
],
{
}
],
}
},
{
"definition": "Information on who recorded the adverse event. May be the patient or a practitioner.",
},
{
"http://hl7.org/fhir/StructureDefinition/Patient",
"http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole",
"http://hl7.org/fhir/StructureDefinition/RelatedPerson"
]
}
],
{
}
],
]
},
{
"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).",
},
{
"http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole",
"http://hl7.org/fhir/StructureDefinition/Device"
]
}
],
{
}
],
},
{
},
],
{
}
],
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "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": "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](extensibility.html#modifierExtension).",
"extensions",
"user content",
"modifiers"
],
},
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
]
},
{
"definition": "Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.",
"Substance or Medication or Device"
],
},
{
"http://hl7.org/fhir/StructureDefinition/Procedure",
"http://hl7.org/fhir/StructureDefinition/MedicationStatement"
]
}
],
{
}
],
},
{
},
],
{
}
],
},
{
"xmlAttr"
],
"definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
},
{
{
}
],
}
],
]
},
{
"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.",
"comment": "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.",
"extensions",
"user content"
],
},
],
{
},
{
}
],
]
},
{
"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.\n\nModifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).",
"comment": "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": "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](extensibility.html#modifierExtension).",
"extensions",
"user content",
"modifiers"
],
},
],
{
},
{
}
],
"isModifierReason": "Modifier extensions are expected to modify the meaning or interpretation of the element that contains them",
]
},
{
},
],
{
}
],
{
}
],
}
},
{
},
],
{
}
],
},
{
},
{
"http://hl7.org/fhir/StructureDefinition/Practitioner",
"http://hl7.org/fhir/StructureDefinition/PractitionerRole"
]
}
],
{
}
],
},
{
},
],
{
}
],
{
}
],
}
},
{
},
{
"http://hl7.org/fhir/StructureDefinition/Condition",
"http://hl7.org/fhir/StructureDefinition/Observation",
"http://hl7.org/fhir/StructureDefinition/AllergyIntolerance",
"http://hl7.org/fhir/StructureDefinition/FamilyMemberHistory",
"http://hl7.org/fhir/StructureDefinition/Immunization",
"http://hl7.org/fhir/StructureDefinition/Procedure",
"http://hl7.org/fhir/StructureDefinition/Media",
"http://hl7.org/fhir/StructureDefinition/DocumentReference"
]
}
],
{
}
],
},
{
},
{
"http://hl7.org/fhir/StructureDefinition/DocumentReference"
]
}
],
{
}
],
},
{
},
{
}
],
{
}
],
}
]
},
{
},
{
},
{
},
{
},
{
{
],
}
]
},
"definition": "Version der für Art der Nebenwirkung verwendeten CTCAE-Klassifikation gemäß 15.3 oBDS 2021.",
{
{
},
{
"valueString": "Version der für Art der Nebenwirkung verwendeten CTCAE-Klassifikation gemäß 15.3 oBDS 2021."
}
],
}
]
},
]
},
{
{
{
},
{
}
],
}
]
},
"definition": "Art der Nebenwirkung nach CTCAE / MedDRA. Abweichend von 15.2 oBDS 2021 kann dieses Feld leer sein falls eine Nebenwirkung des Schweregrads 1 oder 2 vorliegt und keine spezifische Art der Nebenwirkung dokumentiert wurde",
{
{
},
{
"valueString": "Art der Nebenwirkung nach CTCAE / MedDRA . Abweichend von 15.2 oBDS 2021 kann dieses Feld leer sein falls eine Nebenwirkung des Schweregrads 1 oder 2 vorliegt und keine spezifische Art der Nebenwirkung dokumentiert wurde"
}
],
}
]
},
"valueSet": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-art"
},
]
},
{
},
{
],
},
{
},
{
"valueSet": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-ctcae-grad"
},
]
},
{
{
{
},
{
}
],
}
]
},
{
{
},
{
}
],
}
]
},
},
{
},
{
},
{
},
{
},
{
{
"http://hl7.org/fhir/StructureDefinition/Procedure",
"http://hl7.org/fhir/StructureDefinition/MedicationStatement"
]
}
],
}
]
}
}
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.seriousness.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.seriousness |
Suchparameter
Folgende Suchparameter sind für das Modul Onkologie relevant, auch in Kombination:
Der Suchparameter
_idMUSS unterstützt werden:Beispiele:
GET [base]/AdverseEvent?_id=1234Anwendungshinweise: Weitere Informationen zur Suche nach "_id" finden sich in der FHIR-Basisspezifikation - Abschnitt "Parameters for all resources".
Der Suchparameter
_profileMUSS unterstützt werden:Beispiele:
GET [base]/AdverseEvent?_profile=https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-eventAnwendungshinweise: Weitere Informationen zur Suche nach "_profile" finden sich in der FHIR-Basisspezifikation - Abschnitt "token".
Der Suchparameter
eventMUSS unterstützt werden: Beispiele:GET [base]/AdverseEvent?event=https://www.meddra.org|10016256Anwendungshinweise: Weitere Informationen zur Suche nach "event" finden sich in der FHIR-Basisspezifikation - Abschnitt "token".
Der Suchparameter
seriousnessMUSS unterstützt werden:Beispiele:
GET [base]/AdverseEvent?seriousness=https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-nebenwirkung-ctcae-grad|4Anwendungshinweise: Weitere Informationen zur Suche nach "seriousness" finden sich in der FHIR-Basisspezifikation - Abschnitt "token".
Der Suchparameter
suspectEntity.instanceMUSS unterstützt werden:Beispiele:
GET [base]/AdverseEvent?suspectEntity.instance=Patient/exampleAnwendungshinweise: Weitere Informationen zur Suche nach "severity" finden sich in der FHIR-Basisspezifikation - Abschnitt "reference".
Beispiele
{
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event"
]
},
{
}
]
},
},
{
"system": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-nebenwirkung-ctcae-grad",
}
]
},
]
}
Nebenwirkung ohne MedDRA-Codierung:
{
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event"
]
},
},
},
{
"system": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-nebenwirkung-ctcae-grad",
}
]
},
]
}