Onconova Implementation Guide
0.2.0 - ci-build

Onconova Implementation Guide - Local Development build (v0.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: OnconovaAdverseEvent - Detailed Descriptions

Active as of 2026-03-18

Definitions for the onconova-adverse-event resource profile.

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

0. AdverseEvent
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.

ShortMedical care, research study or other healthcare event causing physical injury
Control0..*
Is Modifierfalse
Summaryfalse
Alternate NamesAE
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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-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-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
ae-req-1: The subject element is required and must be provided. (subject.exists())
ae-req-2: The date element is required and must be provided. (date.exists() and date.hasValue())
ae-req-3: The event element is required and must be provided. (event.exists() and event.coding.exists())
ae-req-4: The CTC Grade extension is required and must be provided. (extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-ctc-grade').exists())
ae-req-5: The outcome is required and must be provided. (outcome.exists() and outcome.coding.exists())
ae-req-6: If suspectedEntity is provided, then at least one instance must exist. (suspectEntity.exists() implies (suspectEntity.count() > 0 and suspectEntity.instance.exists()))
ae-req-7: If adverseEventMitigation extension is provided, then at least one instance must exist. (extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').exists() implies extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').count() > 0)
2. AdverseEvent.implicitRules
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.

ShortA set of rules under which this content was created
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.

Control0..1
Typeuri
Is Modifiertrue because 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
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. AdverseEvent.extension
Definition

An Extension


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.

ShortExtensionAdditional content defined by implementations
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.

Control10..*
TypeExtension
Is Modifierfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-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())
SlicingThis element introduces a set of slices on AdverseEvent.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 6. AdverseEvent.extension:ctcGrade
    Slice NamectcGrade
    Definition

    The grade of the adverse event as defined by the Common Terminology Criteria for Adverse Events (CTCAE).

    ShortCTCAE Grade
    Control1..1
    This element is affected by the following invariants: ele-1
    TypeExtension(Adverse Event CTCAE Grade) (Extension Type: integer)
    Is Modifierfalse
    Must Supporttrue
    Obligations
      ObligationsActor
      SHALL:populateCreator (Onconova)
      SHOULD:persistConsumer (Onconova)
      Summaryfalse
      Invariantsele-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())
      ctcae-grade: The CTCAE grade must be between 1 and 5, inclusive. (valueInteger() >= 1 and valueInteger() <= 5)
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      8. AdverseEvent.extension:resolvedDate
      Slice NameresolvedDate
      Definition

      The date when the adverse event was resolved (if applicable).

      ShortDate resolved
      Control0..1
      This element is affected by the following invariants: ele-1
      TypeExtension(Adverse Event Resolved Date) (Extension Type: date)
      Is Modifierfalse
      Must Supporttrue
      Obligations
        ObligationsActor
        SHALL:populate-if-knownCreator (Onconova)
        SHOULD:persistConsumer (Onconova)
        Summaryfalse
        Invariantsele-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())
        ctcae-grade: The CTCAE grade must be between 1 and 5, inclusive. (valueInteger() >= 1 and valueInteger() <= 5)
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        10. AdverseEvent.extension:mitigation
        Slice Namemitigation
        Definition

        Details about an action taken to mitigate or manage the adverse event.

        ShortAdverse Event Mitigation Action(s)
        Control0..*
        This element is affected by the following invariants: ele-1
        TypeExtension(Adverse Event Mitigation) (Complex Extension)
        Is Modifierfalse
        Must Supporttrue
        Obligations
          ObligationsActor
          SHOULD:populate-if-knownCreator (Onconova)
          MAY:persistConsumer (Onconova)
          Invariantsele-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())
          drug-mitigation: If the mitigation category is 'Drug', then only mitigation drug must be specified. (extension('category').valueCodeableConcept.coding.code = 'C49158' implies (extension('drug').exists() and extension('procedure').exists().not() and extension('adjustment').exists().not()))
          adjustment-mitigation: If the mitigation category is 'Adjustment', then only mitigation adjustment must be specified. (extension('category').valueCodeableConcept.coding.code = 'C49157' implies (extension('adjustment').exists() and extension('procedure').exists().not() and extension('drug').exists().not()))
          procedural-mitigation: If the mitigation category is 'Procedure', then only mitigation procedure must be specified. (extension('category').valueCodeableConcept.coding.code = 'C49159' implies (extension('procedure').exists() and extension('adjustment').exists().not() and extension('drug').exists().not()))
          12. AdverseEvent.modifierExtension
          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).

          ShortExtensions that cannot be ignored
          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.

          Control0..*
          TypeExtension
          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
          Summaryfalse
          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.

          Alternate Namesextensions, user content
          Invariantsele-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())
          14. AdverseEvent.actuality
          Definition

          Not used in this profile


          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.

          ShortNot used in this profileactual | potential
          Control1..1
          BindingThe codes SHALL be taken from AdverseEventActualityhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
          (required to http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1)

          Overall nature of the adverse event, e.g. real or potential.

          Typecode
          Is Modifiertrue because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          16. AdverseEvent.category
          Definition

          Not used in this profile


          The overall type of event, intended for search and filtering purposes.

          ShortNot used in this profileproduct-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
          Control0..*
          BindingUnless not suitable, these codes SHALL be taken from AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-category|4.0.1
          (extensible to http://hl7.org/fhir/ValueSet/adverse-event-category|4.0.1)

          Overall categorization of the event, e.g. product-related or situational.

          TypeCodeableConcept
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          18. AdverseEvent.event
          Definition

          This element defines the specific type of event that occurred or that was prevented from occurring.

          ShortType of the event itself in relation to the subject
          Control0..1
          BindingThe codes SHALL be taken from For example codes, see CTC Adverse Events Value Sethttp://hl7.org/fhir/ValueSet/adverse-event-type|4.0.1
          (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-ctc-adverse-events)
          TypeCodeableConcept
          Is Modifierfalse
          Obligations
            ObligationsActor
            SHALL:populateCreator (Onconova)
            SHOULD:persistConsumer (Onconova)
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            20. AdverseEvent.subject
            Definition

            This subject or group impacted by the event.

            ShortSubject impacted by event
            Comments

            If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

            Control1..1
            TypeReference(Cancer Patient Profile, Patient, Group, Practitioner, RelatedPerson)
            Is Modifierfalse
            Obligations
              ObligationsActor
              SHALL:populateCreator (Onconova)
              SHOULD:persistConsumer (Onconova)
              SHALL:populateCreator (Onconova)
              SHOULD:persistConsumer (Onconova)
              Summarytrue
              Requirements

              Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

              Alternate Namespatient
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              22. AdverseEvent.encounter
              Definition

              Not used in this profile


              The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated.

              ShortNot used in this profileEncounter created as part of
              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.

              Control0..1
              TypeReference(Encounter)
              Is Modifierfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              24. AdverseEvent.date
              Definition

              The date (and perhaps time) when the adverse event occurred.

              ShortWhen the event occurred
              Control10..1
              TypedateTime
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supporttrue
              Obligations
                ObligationsActor
                SHALL:populateCreator (Onconova)
                SHOULD:persistConsumer (Onconova)
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                26. AdverseEvent.detected
                Definition

                Not used in this profile


                Estimated or actual date the AdverseEvent began, in the opinion of the reporter.

                ShortNot used in this profileWhen the event was detected
                Control0..1
                TypedateTime
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                28. AdverseEvent.recordedDate
                Definition

                Not used in this profile


                The date on which the existence of the AdverseEvent was first recorded.

                ShortNot used in this profileWhen the event was 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.

                Control0..1
                TypedateTime
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                30. AdverseEvent.resultingCondition
                Definition

                Not used in this profile


                Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical).

                ShortNot used in this profileEffect on the subject due to this event
                Control0..*
                TypeReference(Condition)
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                32. AdverseEvent.location
                Definition

                Not used in this profile


                The information about where the adverse event occurred.

                ShortNot used in this profileLocation where adverse event occurred
                Control0..1
                TypeReference(Location)
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                34. AdverseEvent.seriousness
                Definition

                Not used in this profile


                Assessment whether this event was of real importance.

                ShortNot used in this profileSeriousness of the event
                Control0..1
                BindingFor example codes, see AdverseEventSeriousnesshttp://hl7.org/fhir/ValueSet/adverse-event-seriousness|4.0.1
                (example to http://hl7.org/fhir/ValueSet/adverse-event-seriousness|4.0.1)

                Overall seriousness of this event for the patient.

                TypeCodeableConcept
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                36. AdverseEvent.severity
                Definition

                Not used in this profile


                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.

                ShortNot used in this profilemild | moderate | severe
                Control0..1
                BindingThe codes SHALL be taken from AdverseEventSeverityhttp://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
                (required to http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1)

                The severity of the adverse event itself, in direct relation to the subject.

                TypeCodeableConcept
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                38. AdverseEvent.outcome
                Definition

                Describes the type of outcome from the adverse event.

                Shortresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
                Control10..1
                BindingThe codes SHALL be taken from AdverseEventOutcomehttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
                (required to http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1)

                TODO (and should this be required?).

                TypeCodeableConcept
                Is Modifierfalse
                Must Supporttrue
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                40. AdverseEvent.recorder
                Definition

                Not used in this profile


                Information on who recorded the adverse event. May be the patient or a practitioner.

                ShortNot used in this profileWho recorded the adverse event
                Control0..1
                TypeReference(Patient, Practitioner, PractitionerRole, RelatedPerson)
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                42. AdverseEvent.contributor
                Definition

                Not used in this profile


                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).

                ShortNot used in this profileWho was involved in the adverse event or the potential adverse event
                Control0..*
                TypeReference(Practitioner, PractitionerRole, Device)
                Is Modifierfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                44. AdverseEvent.suspectEntity
                Definition

                Describes the entity that is suspected to have caused the adverse event.

                ShortThe suspected agent causing the adverse event
                Control0..*
                TypeBackboneElement
                Is Modifierfalse
                Must Supporttrue
                Obligations
                  ObligationsActor
                  SHOULD:populate-if-knownCreator (Onconova)
                  MAY:persistConsumer (Onconova)
                  Summarytrue
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                  46. AdverseEvent.suspectEntity.modifierExtension
                  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).

                  ShortExtensions that cannot be ignored even if unrecognized
                  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.

                  Control0..*
                  TypeExtension
                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                  Summarytrue
                  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.

                  Alternate Namesextensions, user content, modifiers
                  Invariantsele-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())
                  48. AdverseEvent.suspectEntity.instance
                  Definition

                  Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

                  ShortRefers to the specific entity that caused the adverse event
                  Control1..1
                  TypeReference(Medication Administration Profile, Radiotherapy Summary Profile, Surgical Procedure Profile, Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device)
                  Is Modifierfalse
                  Summarytrue
                  Alternate NamesSubstance or Medication or Device
                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

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

                  0. AdverseEvent
                  Invariantsae-req-1: The subject element is required and must be provided. (subject.exists())
                  ae-req-2: The date element is required and must be provided. (date.exists() and date.hasValue())
                  ae-req-3: The event element is required and must be provided. (event.exists() and event.coding.exists())
                  ae-req-4: The CTC Grade extension is required and must be provided. (extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-ctc-grade').exists())
                  ae-req-5: The outcome is required and must be provided. (outcome.exists() and outcome.coding.exists())
                  ae-req-6: If suspectedEntity is provided, then at least one instance must exist. (suspectEntity.exists() implies (suspectEntity.count() > 0 and suspectEntity.instance.exists()))
                  ae-req-7: If adverseEventMitigation extension is provided, then at least one instance must exist. (extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').exists() implies extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').count() > 0)
                  2. AdverseEvent.extension
                  Control1..?
                  SlicingThis element introduces a set of slices on AdverseEvent.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ url
                  • 4. AdverseEvent.extension:ctcGrade
                    Slice NamectcGrade
                    ShortCTCAE Grade
                    Control1..1
                    TypeExtension(Adverse Event CTCAE Grade) (Extension Type: integer)
                    Must Supporttrue
                    Obligations
                      ObligationsActor
                      SHALL:populateCreator (Onconova)
                      SHOULD:persistConsumer (Onconova)
                      6. AdverseEvent.extension:resolvedDate
                      Slice NameresolvedDate
                      ShortDate resolved
                      Control0..1
                      TypeExtension(Adverse Event Resolved Date) (Extension Type: date)
                      Must Supporttrue
                      Obligations
                        ObligationsActor
                        SHALL:populate-if-knownCreator (Onconova)
                        SHOULD:persistConsumer (Onconova)
                        8. AdverseEvent.extension:mitigation
                        Slice Namemitigation
                        ShortAdverse Event Mitigation Action(s)
                        Control0..*
                        TypeExtension(Adverse Event Mitigation) (Complex Extension)
                        Must Supporttrue
                        Obligations
                          ObligationsActor
                          SHOULD:populate-if-knownCreator (Onconova)
                          MAY:persistConsumer (Onconova)
                          10. AdverseEvent.actuality
                          Definition

                          Not used in this profile

                          ShortNot used in this profile
                          12. AdverseEvent.category
                          Definition

                          Not used in this profile

                          ShortNot used in this profile
                          14. AdverseEvent.event
                          BindingThe codes SHALL be taken from CTC Adverse Events Value Set
                          (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-ctc-adverse-events)
                          Obligations
                            ObligationsActor
                            SHALL:populateCreator (Onconova)
                            SHOULD:persistConsumer (Onconova)
                            16. AdverseEvent.subject
                            TypeReference(Cancer Patient Profile)
                            Obligations
                              ObligationsActor
                              SHALL:populateCreator (Onconova)
                              SHOULD:persistConsumer (Onconova)
                              SHALL:populateCreator (Onconova)
                              SHOULD:persistConsumer (Onconova)
                              18. AdverseEvent.encounter
                              Definition

                              Not used in this profile

                              ShortNot used in this profile
                              20. AdverseEvent.date
                              Control1..?
                              Must Supporttrue
                              Obligations
                                ObligationsActor
                                SHALL:populateCreator (Onconova)
                                SHOULD:persistConsumer (Onconova)
                                22. AdverseEvent.detected
                                Definition

                                Not used in this profile

                                ShortNot used in this profile
                                24. AdverseEvent.recordedDate
                                Definition

                                Not used in this profile

                                ShortNot used in this profile
                                26. AdverseEvent.resultingCondition
                                Definition

                                Not used in this profile

                                ShortNot used in this profile
                                28. AdverseEvent.location
                                Definition

                                Not used in this profile

                                ShortNot used in this profile
                                30. AdverseEvent.seriousness
                                Definition

                                Not used in this profile

                                ShortNot used in this profile
                                32. AdverseEvent.severity
                                Definition

                                Not used in this profile

                                ShortNot used in this profile
                                34. AdverseEvent.outcome
                                Control1..?
                                Must Supporttrue
                                36. AdverseEvent.recorder
                                Definition

                                Not used in this profile

                                ShortNot used in this profile
                                38. AdverseEvent.contributor
                                Definition

                                Not used in this profile

                                ShortNot used in this profile
                                40. AdverseEvent.suspectEntity
                                Must Supporttrue
                                Obligations
                                  ObligationsActor
                                  SHOULD:populate-if-knownCreator (Onconova)
                                  MAY:persistConsumer (Onconova)
                                  42. AdverseEvent.suspectEntity.instance
                                  TypeReference(Medication Administration Profile, Radiotherapy Summary Profile, Surgical Procedure Profile)

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

                                  0. AdverseEvent
                                  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.

                                  ShortMedical care, research study or other healthcare event causing physical injury
                                  Control0..*
                                  Is Modifierfalse
                                  Summaryfalse
                                  Alternate NamesAE
                                  Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.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-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-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
                                  dom-6: A resource should have narrative for robust management (text.`div`.exists())
                                  ae-req-1: The subject element is required and must be provided. (subject.exists())
                                  ae-req-2: The date element is required and must be provided. (date.exists() and date.hasValue())
                                  ae-req-3: The event element is required and must be provided. (event.exists() and event.coding.exists())
                                  ae-req-4: The CTC Grade extension is required and must be provided. (extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-ctc-grade').exists())
                                  ae-req-5: The outcome is required and must be provided. (outcome.exists() and outcome.coding.exists())
                                  ae-req-6: If suspectedEntity is provided, then at least one instance must exist. (suspectEntity.exists() implies (suspectEntity.count() > 0 and suspectEntity.instance.exists()))
                                  ae-req-7: If adverseEventMitigation extension is provided, then at least one instance must exist. (extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').exists() implies extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').count() > 0)
                                  2. AdverseEvent.id
                                  Definition

                                  The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

                                  ShortLogical id of this artifact
                                  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.

                                  Control0..1
                                  Typeid
                                  Is Modifierfalse
                                  Summarytrue
                                  4. AdverseEvent.meta
                                  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.

                                  ShortMetadata about the resource
                                  Control0..1
                                  TypeMeta
                                  Is Modifierfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  6. AdverseEvent.implicitRules
                                  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.

                                  ShortA set of rules under which this content was created
                                  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.

                                  Control0..1
                                  Typeuri
                                  Is Modifiertrue because 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
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  8. AdverseEvent.language
                                  Definition

                                  The base language in which the resource is written.

                                  ShortLanguage of the resource content
                                  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).

                                  Control0..1
                                  BindingThe codes SHOULD be taken from CommonLanguages
                                  (preferred to http://hl7.org/fhir/ValueSet/languages|4.0.1)

                                  A human language.

                                  Additional BindingsPurpose
                                  AllLanguagesMax Binding
                                  Typecode
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Summaryfalse
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  10. AdverseEvent.text
                                  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.

                                  ShortText summary of the resource, for human interpretation
                                  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.

                                  Control0..1
                                  TypeNarrative
                                  Is Modifierfalse
                                  Summaryfalse
                                  Alternate Namesnarrative, html, xhtml, display
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  12. AdverseEvent.contained
                                  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.

                                  ShortContained, inline Resources
                                  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.

                                  Control0..*
                                  TypeResource
                                  Is Modifierfalse
                                  Summaryfalse
                                  Alternate Namesinline resources, anonymous resources, contained resources
                                  14. AdverseEvent.extension
                                  Definition

                                  An Extension

                                  ShortExtension
                                  Control1..*
                                  TypeExtension
                                  Is Modifierfalse
                                  Summaryfalse
                                  Invariantsele-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())
                                  SlicingThis element introduces a set of slices on AdverseEvent.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                  • value @ url
                                  • 16. AdverseEvent.extension:ctcGrade
                                    Slice NamectcGrade
                                    Definition

                                    The grade of the adverse event as defined by the Common Terminology Criteria for Adverse Events (CTCAE).

                                    ShortCTCAE Grade
                                    Control1..1
                                    This element is affected by the following invariants: ele-1
                                    TypeExtension(Adverse Event CTCAE Grade) (Extension Type: integer)
                                    Is Modifierfalse
                                    Must Supporttrue
                                    Obligations
                                      ObligationsActor
                                      SHALL:populateCreator (Onconova)
                                      SHOULD:persistConsumer (Onconova)
                                      Summaryfalse
                                      Invariantsele-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())
                                      ctcae-grade: The CTCAE grade must be between 1 and 5, inclusive. (valueInteger() >= 1 and valueInteger() <= 5)
                                      18. AdverseEvent.extension:resolvedDate
                                      Slice NameresolvedDate
                                      Definition

                                      The date when the adverse event was resolved (if applicable).

                                      ShortDate resolved
                                      Control0..1
                                      This element is affected by the following invariants: ele-1
                                      TypeExtension(Adverse Event Resolved Date) (Extension Type: date)
                                      Is Modifierfalse
                                      Must Supporttrue
                                      Obligations
                                        ObligationsActor
                                        SHALL:populate-if-knownCreator (Onconova)
                                        SHOULD:persistConsumer (Onconova)
                                        Summaryfalse
                                        Invariantsele-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())
                                        ctcae-grade: The CTCAE grade must be between 1 and 5, inclusive. (valueInteger() >= 1 and valueInteger() <= 5)
                                        20. AdverseEvent.extension:mitigation
                                        Slice Namemitigation
                                        Definition

                                        Details about an action taken to mitigate or manage the adverse event.

                                        ShortAdverse Event Mitigation Action(s)
                                        Control0..*
                                        This element is affected by the following invariants: ele-1
                                        TypeExtension(Adverse Event Mitigation) (Complex Extension)
                                        Is Modifierfalse
                                        Must Supporttrue
                                        Obligations
                                          ObligationsActor
                                          SHOULD:populate-if-knownCreator (Onconova)
                                          MAY:persistConsumer (Onconova)
                                          Invariantsele-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())
                                          drug-mitigation: If the mitigation category is 'Drug', then only mitigation drug must be specified. (extension('category').valueCodeableConcept.coding.code = 'C49158' implies (extension('drug').exists() and extension('procedure').exists().not() and extension('adjustment').exists().not()))
                                          adjustment-mitigation: If the mitigation category is 'Adjustment', then only mitigation adjustment must be specified. (extension('category').valueCodeableConcept.coding.code = 'C49157' implies (extension('adjustment').exists() and extension('procedure').exists().not() and extension('drug').exists().not()))
                                          procedural-mitigation: If the mitigation category is 'Procedure', then only mitigation procedure must be specified. (extension('category').valueCodeableConcept.coding.code = 'C49159' implies (extension('procedure').exists() and extension('adjustment').exists().not() and extension('drug').exists().not()))
                                          22. AdverseEvent.modifierExtension
                                          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).

                                          ShortExtensions that cannot be ignored
                                          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.

                                          Control0..*
                                          TypeExtension
                                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                                          Summaryfalse
                                          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.

                                          Alternate Namesextensions, user content
                                          Invariantsele-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())
                                          24. AdverseEvent.identifier
                                          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.

                                          ShortBusiness identifier for the event
                                          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.

                                          NoteThis is a business identifier, not a resource identifier (see discussion)
                                          Control0..1
                                          TypeIdentifier
                                          Is Modifierfalse
                                          Summarytrue
                                          Requirements

                                          Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          26. AdverseEvent.actuality
                                          Definition

                                          Not used in this profile

                                          ShortNot used in this profile
                                          Control1..1
                                          BindingThe codes SHALL be taken from AdverseEventActuality
                                          (required to http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1)

                                          Overall nature of the adverse event, e.g. real or potential.

                                          Typecode
                                          Is Modifiertrue because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          28. AdverseEvent.category
                                          Definition

                                          Not used in this profile

                                          ShortNot used in this profile
                                          Control0..*
                                          BindingUnless not suitable, these codes SHALL be taken from AdverseEventCategory
                                          (extensible to http://hl7.org/fhir/ValueSet/adverse-event-category|4.0.1)

                                          Overall categorization of the event, e.g. product-related or situational.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          30. AdverseEvent.event
                                          Definition

                                          This element defines the specific type of event that occurred or that was prevented from occurring.

                                          ShortType of the event itself in relation to the subject
                                          Control0..1
                                          BindingThe codes SHALL be taken from CTC Adverse Events Value Set
                                          (required to http://onconova.github.io/fhir/ValueSet/onconova-vs-ctc-adverse-events)
                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Obligations
                                            ObligationsActor
                                            SHALL:populateCreator (Onconova)
                                            SHOULD:persistConsumer (Onconova)
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            32. AdverseEvent.subject
                                            Definition

                                            This subject or group impacted by the event.

                                            ShortSubject impacted by event
                                            Comments

                                            If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject.

                                            Control1..1
                                            TypeReference(Cancer Patient Profile)
                                            Is Modifierfalse
                                            Obligations
                                              ObligationsActor
                                              SHALL:populateCreator (Onconova)
                                              SHOULD:persistConsumer (Onconova)
                                              SHALL:populateCreator (Onconova)
                                              SHOULD:persistConsumer (Onconova)
                                              Summarytrue
                                              Requirements

                                              Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.

                                              Alternate Namespatient
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              34. AdverseEvent.encounter
                                              Definition

                                              Not used in this profile

                                              ShortNot used in this profile
                                              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.

                                              Control0..1
                                              TypeReference(Encounter)
                                              Is Modifierfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              36. AdverseEvent.date
                                              Definition

                                              The date (and perhaps time) when the adverse event occurred.

                                              ShortWhen the event occurred
                                              Control1..1
                                              TypedateTime
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Must Supporttrue
                                              Obligations
                                                ObligationsActor
                                                SHALL:populateCreator (Onconova)
                                                SHOULD:persistConsumer (Onconova)
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                38. AdverseEvent.detected
                                                Definition

                                                Not used in this profile

                                                ShortNot used in this profile
                                                Control0..1
                                                TypedateTime
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                40. AdverseEvent.recordedDate
                                                Definition

                                                Not used in this profile

                                                ShortNot used in this profile
                                                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.

                                                Control0..1
                                                TypedateTime
                                                Is Modifierfalse
                                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                42. AdverseEvent.resultingCondition
                                                Definition

                                                Not used in this profile

                                                ShortNot used in this profile
                                                Control0..*
                                                TypeReference(Condition)
                                                Is Modifierfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                44. AdverseEvent.location
                                                Definition

                                                Not used in this profile

                                                ShortNot used in this profile
                                                Control0..1
                                                TypeReference(Location)
                                                Is Modifierfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                46. AdverseEvent.seriousness
                                                Definition

                                                Not used in this profile

                                                ShortNot used in this profile
                                                Control0..1
                                                BindingFor example codes, see AdverseEventSeriousness
                                                (example to http://hl7.org/fhir/ValueSet/adverse-event-seriousness|4.0.1)

                                                Overall seriousness of this event for the patient.

                                                TypeCodeableConcept
                                                Is Modifierfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                48. AdverseEvent.severity
                                                Definition

                                                Not used in this profile

                                                ShortNot used in this profile
                                                Control0..1
                                                BindingThe codes SHALL be taken from AdverseEventSeverity
                                                (required to http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1)

                                                The severity of the adverse event itself, in direct relation to the subject.

                                                TypeCodeableConcept
                                                Is Modifierfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                50. AdverseEvent.outcome
                                                Definition

                                                Describes the type of outcome from the adverse event.

                                                Shortresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
                                                Control1..1
                                                BindingThe codes SHALL be taken from AdverseEventOutcome
                                                (required to http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1)

                                                TODO (and should this be required?).

                                                TypeCodeableConcept
                                                Is Modifierfalse
                                                Must Supporttrue
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                52. AdverseEvent.recorder
                                                Definition

                                                Not used in this profile

                                                ShortNot used in this profile
                                                Control0..1
                                                TypeReference(Patient, Practitioner, PractitionerRole, RelatedPerson)
                                                Is Modifierfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                54. AdverseEvent.contributor
                                                Definition

                                                Not used in this profile

                                                ShortNot used in this profile
                                                Control0..*
                                                TypeReference(Practitioner, PractitionerRole, Device)
                                                Is Modifierfalse
                                                Summarytrue
                                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                56. AdverseEvent.suspectEntity
                                                Definition

                                                Describes the entity that is suspected to have caused the adverse event.

                                                ShortThe suspected agent causing the adverse event
                                                Control0..*
                                                TypeBackboneElement
                                                Is Modifierfalse
                                                Must Supporttrue
                                                Obligations
                                                  ObligationsActor
                                                  SHOULD:populate-if-knownCreator (Onconova)
                                                  MAY:persistConsumer (Onconova)
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  58. AdverseEvent.suspectEntity.id
                                                  Definition

                                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                  ShortUnique id for inter-element referencing
                                                  Control0..1
                                                  Typestring
                                                  Is Modifierfalse
                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                  Summaryfalse
                                                  60. AdverseEvent.suspectEntity.extension
                                                  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.

                                                  ShortAdditional content defined by implementations
                                                  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.

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Alternate Namesextensions, user content
                                                  Invariantsele-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())
                                                  62. AdverseEvent.suspectEntity.modifierExtension
                                                  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).

                                                  ShortExtensions that cannot be ignored even if unrecognized
                                                  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.

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                  Summarytrue
                                                  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.

                                                  Alternate Namesextensions, user content, modifiers
                                                  Invariantsele-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())
                                                  64. AdverseEvent.suspectEntity.instance
                                                  Definition

                                                  Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.

                                                  ShortRefers to the specific entity that caused the adverse event
                                                  Control1..1
                                                  TypeReference(Medication Administration Profile, Radiotherapy Summary Profile, Surgical Procedure Profile)
                                                  Is Modifierfalse
                                                  Summarytrue
                                                  Alternate NamesSubstance or Medication or Device
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  66. AdverseEvent.suspectEntity.causality
                                                  Definition

                                                  Information on the possible cause of the event.

                                                  ShortInformation on the possible cause of the event
                                                  Control0..*
                                                  TypeBackboneElement
                                                  Is Modifierfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  68. AdverseEvent.suspectEntity.causality.id
                                                  Definition

                                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                                  ShortUnique id for inter-element referencing
                                                  Control0..1
                                                  Typestring
                                                  Is Modifierfalse
                                                  XML FormatIn the XML format, this property is represented as an attribute.
                                                  Summaryfalse
                                                  70. AdverseEvent.suspectEntity.causality.extension
                                                  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.

                                                  ShortAdditional content defined by implementations
                                                  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.

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifierfalse
                                                  Summaryfalse
                                                  Alternate Namesextensions, user content
                                                  Invariantsele-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())
                                                  72. AdverseEvent.suspectEntity.causality.modifierExtension
                                                  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).

                                                  ShortExtensions that cannot be ignored even if unrecognized
                                                  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.

                                                  Control0..*
                                                  TypeExtension
                                                  Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                                  Summarytrue
                                                  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.

                                                  Alternate Namesextensions, user content, modifiers
                                                  Invariantsele-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())
                                                  74. AdverseEvent.suspectEntity.causality.assessment
                                                  Definition

                                                  Assessment of if the entity caused the event.

                                                  ShortAssessment of if the entity caused the event
                                                  Control0..1
                                                  BindingFor example codes, see AdverseEventCausalityAssessment
                                                  (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-assess|4.0.1)

                                                  Codes for the assessment of whether the entity caused the event.

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  76. AdverseEvent.suspectEntity.causality.productRelatedness
                                                  Definition

                                                  AdverseEvent.suspectEntity.causalityProductRelatedness.

                                                  ShortAdverseEvent.suspectEntity.causalityProductRelatedness
                                                  Control0..1
                                                  Typestring
                                                  Is Modifierfalse
                                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  78. AdverseEvent.suspectEntity.causality.author
                                                  Definition

                                                  AdverseEvent.suspectEntity.causalityAuthor.

                                                  ShortAdverseEvent.suspectEntity.causalityAuthor
                                                  Control0..1
                                                  TypeReference(Practitioner, PractitionerRole)
                                                  Is Modifierfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  80. AdverseEvent.suspectEntity.causality.method
                                                  Definition

                                                  ProbabilityScale | Bayesian | Checklist.

                                                  ShortProbabilityScale | Bayesian | Checklist
                                                  Control0..1
                                                  BindingFor example codes, see AdverseEventCausalityMethod
                                                  (example to http://hl7.org/fhir/ValueSet/adverse-event-causality-method|4.0.1)

                                                  TODO.

                                                  TypeCodeableConcept
                                                  Is Modifierfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  82. AdverseEvent.subjectMedicalHistory
                                                  Definition

                                                  AdverseEvent.subjectMedicalHistory.

                                                  ShortAdverseEvent.subjectMedicalHistory
                                                  Control0..*
                                                  TypeReference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Media, DocumentReference)
                                                  Is Modifierfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  84. AdverseEvent.referenceDocument
                                                  Definition

                                                  AdverseEvent.referenceDocument.

                                                  ShortAdverseEvent.referenceDocument
                                                  Control0..*
                                                  TypeReference(DocumentReference)
                                                  Is Modifierfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                                  86. AdverseEvent.study
                                                  Definition

                                                  AdverseEvent.study.

                                                  ShortAdverseEvent.study
                                                  Control0..*
                                                  TypeReference(ResearchStudy)
                                                  Is Modifierfalse
                                                  Summarytrue
                                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))