IDEA4RC FHIR Implementation Guide
0.1.0 - CI Build 150

IDEA4RC FHIR Implementation Guide, published by IDEA4RC Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/idea4rc/ and changes regularly. See the Directory of published versions

Logical Model: AdverseEventI4rc - Detailed Descriptions

Draft as of 2024-11-12

Definitions for the AdverseEvent logical model.

Guidance on how to interpret the contents of this table can be found here

0. AdverseEvent
Definition

Adverse Event

ShortAdverse Event
Logical ModelInstances of this logical model are not marked to be the target of a Reference
2. AdverseEvent.episodeEvent
Definition

EpisodeEvent element containing the data regarding the patient's cancer

ShortEpisode Event reference
Control1..1
Typehttp://hl7.eu/fhir/ig/idea4rc/StructureDefinition/EpisodeEvent
Obligations
    ObligationsActor
    SHALL:handle
    4. AdverseEvent.type
    Definition

    the Common Terminology Criteria for Adverse Events (CTCAE) is used to identify the adverse events. It includes details of the adverse event type and grade

    ShortAdverse event type (CTCAE Term)
    Control1..1
    TypeCodeableConcept
    Obligations
      ObligationsActor
      SHALL:handle
      6. AdverseEvent.eventStartingDate
      Definition

      specifies when adverse events begins

      ShortAdverse event starting date �
      Control1..1
      Typedate
      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
      Obligations
        ObligationsActor
        SHALL:handle
        8. AdverseEvent.eventDuration
        Definition

        specifies the duration of the adverse event

        ShortAdverse event duration
        Comments

        Less than one week; More than one week but less than a month; More than a month but less than 3 months; More than 3 months; Unknown. Custom

        Control1..1
        TypeCodeableConcept
        Obligations
          ObligationsActor
          SHALL:handle

          Guidance on how to interpret the contents of this table can be found here

          0. AdverseEvent
          Definition

          Adverse Event

          ShortAdverse Event
          Control0..*
          Is Modifierfalse
          Logical ModelInstances of this logical model are not marked to be the target of a Reference
          2. AdverseEvent.episodeEvent
          Definition

          EpisodeEvent element containing the data regarding the patient's cancer

          ShortEpisode Event reference
          Control1..1
          Typehttp://hl7.eu/fhir/ig/idea4rc/StructureDefinition/EpisodeEvent
          Obligations
            ObligationsActor
            SHALL:handle
            4. AdverseEvent.type
            Definition

            the Common Terminology Criteria for Adverse Events (CTCAE) is used to identify the adverse events. It includes details of the adverse event type and grade

            ShortAdverse event type (CTCAE Term)
            Control1..1
            TypeCodeableConcept
            Obligations
              ObligationsActor
              SHALL:handle
              6. AdverseEvent.eventStartingDate
              Definition

              specifies when adverse events begins

              ShortAdverse event starting date �
              Control1..1
              Typedate
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Obligations
                ObligationsActor
                SHALL:handle
                8. AdverseEvent.eventDuration
                Definition

                specifies the duration of the adverse event

                ShortAdverse event duration
                Comments

                Less than one week; More than one week but less than a month; More than a month but less than 3 months; More than 3 months; Unknown. Custom

                Control1..1
                TypeCodeableConcept
                Obligations
                  ObligationsActor
                  SHALL:handle

                  Guidance on how to interpret the contents of this table can be found here

                  0. AdverseEvent
                  Definition

                  Adverse Event

                  ShortAdverse Event
                  Control0..*
                  Is Modifierfalse
                  Logical ModelInstances of this logical model are not marked to be the target of a Reference
                  2. AdverseEvent.episodeEvent
                  Definition

                  EpisodeEvent element containing the data regarding the patient's cancer

                  ShortEpisode Event reference
                  Control1..1
                  Typehttp://hl7.eu/fhir/ig/idea4rc/StructureDefinition/EpisodeEvent
                  Obligations
                    ObligationsActor
                    SHALL:handle
                    4. AdverseEvent.type
                    Definition

                    the Common Terminology Criteria for Adverse Events (CTCAE) is used to identify the adverse events. It includes details of the adverse event type and grade

                    ShortAdverse event type (CTCAE Term)
                    Control1..1
                    TypeCodeableConcept
                    Obligations
                      ObligationsActor
                      SHALL:handle
                      6. AdverseEvent.eventStartingDate
                      Definition

                      specifies when adverse events begins

                      ShortAdverse event starting date �
                      Control1..1
                      Typedate
                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                      Obligations
                        ObligationsActor
                        SHALL:handle
                        8. AdverseEvent.eventDuration
                        Definition

                        specifies the duration of the adverse event

                        ShortAdverse event duration
                        Comments

                        Less than one week; More than one week but less than a month; More than a month but less than 3 months; More than 3 months; Unknown. Custom

                        Control1..1
                        TypeCodeableConcept
                        Obligations
                          ObligationsActor
                          SHALL:handle