HL7 FHIR Implementation Guide: Common Terminology Criteria (CTC) Adverse Events Release 1 - DRAFT
0.0.1 - DRAFT
HL7 FHIR Implementation Guide: Common Terminology Criteria (CTC) Adverse Events Release 1 - DRAFT
0.0.1 - DRAFT
HL7 FHIR Implementation Guide: Common Terminology Criteria (CTC) Adverse Events Release 1 - DRAFT, published by HL7 International Clinical Interoperability Council. This guide is not an authorized publication; it is the continuous build for version 0.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/standardhealth/fsh-ae/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/ctc-adverse-event | Version: 0.0.1 | |||
| Draft as of 2024-02-28 | Computable Name: CTCAdverseEvent | |||
Profile of adverse event, using Common Terminology Criteria (CTC).
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from AdverseEvent
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  AdverseEvent | C | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury adverse-event-grade-zero-invariant: If the adverse event grade is 0, seriousness and suspectEntity must not be specified. |
  Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
 grade | S | 1..1 | CodeableConcept | CTC Adverse Event Grade URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/ctcae-grade Binding: CTCAE Grade Value Set (required) |
| expectation | S | 0..1 | CodeableConcept | Adverse Event Expectation URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-expectation Binding: Adverse Event Expectation Value Set (required) |
| resolvedDate | S | 0..1 | dateTime | Adverse Event Resolved Date URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-resolved-date |
| participant | S | 0..* | (Complex) | Adverse Event Participant URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-participant |
| seriousnessOutcome | S | 0..1 | CodeableConcept | Adverse Event Seriousness Outcome URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-seriousness-outcome Binding: Adverse Event Seriousness Outcome Value Set (required) |
 actuality | S | 1..1 | code | actual | potential Required Pattern: actual |
 event | S | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: CTCAE Terms Value Set (preferred) |
 coding | 1..* | Coding | CTCAE Term | |
| version | 0..1 | string | CTCAE Version | |
| code | 0..1 | code | MedDRA or NCIT code | |
 display | 0..1 | string | Preferred name | |
| text | S | 0..1 | string | Verbatim Text |
| subject | S | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event |
| encounter | S | 0..1 | Reference(Encounter) | Encounter created as part of |
| date | S | 0..1 | dateTime | When the event occurred |
| seriousness | S | 0..1 | CodeableConcept | Seriousness of the event Binding: Adverse Event Seriousness Value Set (required) |
| severity | 0..0 | |||
| outcome | S | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown |
 recorder | S | 0..1 | Reference(Practitioner) | Who recorded the adverse event |
| contributor | 0..* | Reference(Practitioner) | Who was involved in the adverse event or the potential adverse event | |
| suspectEntity | S | 0..* | BackboneElement | The suspected agent causing the adverse event |
| instance | S | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event |
 causality | S | 0..* | BackboneElement | Information on the possible cause of the event |
 assessment | S | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: Adverse Event Relatedness Value Set (required) |
| text | S | 0..1 | string | Plain text representation of the concept |
| study | S | 0..* | Reference(ResearchStudy) | AdverseEvent.study |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| AdverseEvent.event | preferred | CTCAETermVShttp://hl7.org/fhir/us/ctcae/ValueSet/ctcae-term-value-setfrom this IG | |
| AdverseEvent.seriousness | required | AdverseEventSeriousnessVShttp://hl7.org/fhir/us/ctcae/ValueSet/adverse-event-seriousness-value-setfrom this IG | |
| AdverseEvent.suspectEntity.causality.assessment | required | AdverseEventRelatednessVShttp://hl7.org/fhir/us/ctcae/ValueSet/adverse-event-relatedness-value-setfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| adverse-event-grade-zero-invariant | error | AdverseEvent | If the adverse event grade is 0, seriousness and suspectEntity must not be specified. : extension('http://hl7.org/fhir/us/mcode/StructureDefinition/ctcae-grade').value.coding.where(code = '0').exists() implies seriousness.exists().not() and suspectEntity.exists().not() |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdverseEvent | C | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury adverse-event-grade-zero-invariant: If the adverse event grade is 0, seriousness and suspectEntity must not be specified. |
 implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| grade | S | 1..1 | CodeableConcept | CTC Adverse Event Grade URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/ctcae-grade Binding: CTCAE Grade Value Set (required) |
| expectation | S | 0..1 | CodeableConcept | Adverse Event Expectation URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-expectation Binding: Adverse Event Expectation Value Set (required) |
| resolvedDate | S | 0..1 | dateTime | Adverse Event Resolved Date URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-resolved-date |
| participant | S | 0..* | (Complex) | Adverse Event Participant URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-participant |
| seriousnessOutcome | S | 0..1 | CodeableConcept | Adverse Event Seriousness Outcome URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-seriousness-outcome Binding: Adverse Event Seriousness Outcome Value Set (required) |
 modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| actuality | ?!SΣ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual |
 event | SΣ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: CTCAE Terms Value Set (preferred) |
| coding | Σ | 1..* | Coding | CTCAE Term |
| version | Σ | 0..1 | string | CTCAE Version |
| code | Σ | 0..1 | code | MedDRA or NCIT code |
| display | Σ | 0..1 | string | Preferred name |
| text | SΣ | 0..1 | string | Verbatim Text |
| subject | SΣ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event |
| encounter | SΣ | 0..1 | Reference(Encounter) | Encounter created as part of |
| date | SΣ | 0..1 | dateTime | When the event occurred |
| seriousness | SΣ | 0..1 | CodeableConcept | Seriousness of the event Binding: Adverse Event Seriousness Value Set (required) |
| outcome | SΣ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). |
| recorder | SΣ | 0..1 | Reference(Practitioner) | Who recorded the adverse event |
| contributor | Σ | 0..* | Reference(Practitioner) | Who was involved in the adverse event or the potential adverse event |
| suspectEntity | SΣ | 0..* | BackboneElement | The suspected agent causing the adverse event |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| instance | SΣ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event |
| causality | SΣ | 0..* | BackboneElement | Information on the possible cause of the event |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| assessment | SΣ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: Adverse Event Relatedness Value Set (required) |
| text | SΣ | 0..1 | string | Plain text representation of the concept |
| study | SΣ | 0..* | Reference(ResearchStudy) | AdverseEvent.study |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| AdverseEvent.actuality | required | Pattern: actualhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1from the FHIR Standard | |
| AdverseEvent.event | preferred | CTCAETermVShttp://hl7.org/fhir/us/ctcae/ValueSet/ctcae-term-value-setfrom this IG | |
| AdverseEvent.seriousness | required | AdverseEventSeriousnessVShttp://hl7.org/fhir/us/ctcae/ValueSet/adverse-event-seriousness-value-setfrom this IG | |
| AdverseEvent.outcome | required | AdverseEventOutcomehttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1from the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.assessment | required | AdverseEventRelatednessVShttp://hl7.org/fhir/us/ctcae/ValueSet/adverse-event-relatedness-value-setfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| adverse-event-grade-zero-invariant | error | AdverseEvent | If the adverse event grade is 0, seriousness and suspectEntity must not be specified. : extension('http://hl7.org/fhir/us/mcode/StructureDefinition/ctcae-grade').value.coding.where(code = '0').exists() implies seriousness.exists().not() and suspectEntity.exists().not() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| AdverseEvent | C | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury adverse-event-grade-zero-invariant: If the adverse event grade is 0, seriousness and suspectEntity must not be specified. | ||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| grade | S | 1..1 | CodeableConcept | CTC Adverse Event Grade URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/ctcae-grade Binding: CTCAE Grade Value Set (required) | ||||
| expectation | S | 0..1 | CodeableConcept | Adverse Event Expectation URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-expectation Binding: Adverse Event Expectation Value Set (required) | ||||
| resolvedDate | S | 0..1 | dateTime | Adverse Event Resolved Date URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-resolved-date | ||||
| participant | S | 0..* | (Complex) | Adverse Event Participant URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-participant | ||||
| seriousnessOutcome | S | 0..1 | CodeableConcept | Adverse Event Seriousness Outcome URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-seriousness-outcome Binding: Adverse Event Seriousness Outcome Value Set (required) | ||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..1 | Identifier | Business identifier for the event | ||||
| actuality | ?!SΣ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual | ||||
| category | Σ | 0..* | CodeableConcept | product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational. | ||||
| event | SΣ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: CTCAE Terms Value Set (preferred) | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 1..* | Coding | CTCAE Term | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| system | Σ | 0..1 | uri | Identity of the terminology system | ||||
| version | Σ | 0..1 | string | CTCAE Version | ||||
| code | Σ | 0..1 | code | MedDRA or NCIT code | ||||
| display | Σ | 0..1 | string | Preferred name | ||||
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
| text | SΣ | 0..1 | string | Verbatim Text | ||||
| subject | SΣ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event | ||||
| encounter | SΣ | 0..1 | Reference(Encounter) | Encounter created as part of | ||||
| date | SΣ | 0..1 | dateTime | When the event occurred | ||||
| detected | Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate | Σ | 0..1 | dateTime | When the event was recorded | ||||
| resultingCondition | Σ | 0..* | Reference(Condition) | Effect on the subject due to this event | ||||
| location | Σ | 0..1 | Reference(Location) | Location where adverse event occurred | ||||
| seriousness | SΣ | 0..1 | CodeableConcept | Seriousness of the event Binding: Adverse Event Seriousness Value Set (required) | ||||
| outcome | SΣ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). | ||||
| recorder | SΣ | 0..1 | Reference(Practitioner) | Who recorded the adverse event | ||||
| contributor | Σ | 0..* | Reference(Practitioner) | Who was involved in the adverse event or the potential adverse event | ||||
| suspectEntity | SΣ | 0..* | BackboneElement | The suspected agent causing the adverse event | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| instance | SΣ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event | ||||
| causality | SΣ | 0..* | BackboneElement | Information on the possible cause of the event | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| assessment | SΣ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: Adverse Event Relatedness Value Set (required) | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text | SΣ | 0..1 | string | Plain text representation of the concept | ||||
| productRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | ||||
| author | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | ||||
| method | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO. | ||||
| subjectMedicalHistory | Σ | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory | ||||
| referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | ||||
| study | SΣ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI | |||
| AdverseEvent.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| AdverseEvent.actuality | required | Pattern: actualhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1from the FHIR Standard | ||||
| AdverseEvent.category | extensible | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-categoryfrom the FHIR Standard | ||||
| AdverseEvent.event | preferred | CTCAETermVShttp://hl7.org/fhir/us/ctcae/ValueSet/ctcae-term-value-setfrom this IG | ||||
| AdverseEvent.seriousness | required | AdverseEventSeriousnessVShttp://hl7.org/fhir/us/ctcae/ValueSet/adverse-event-seriousness-value-setfrom this IG | ||||
| AdverseEvent.outcome | required | AdverseEventOutcomehttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1from the FHIR Standard | ||||
| AdverseEvent.suspectEntity.causality.assessment | required | AdverseEventRelatednessVShttp://hl7.org/fhir/us/ctcae/ValueSet/adverse-event-relatedness-value-setfrom this IG | ||||
| AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| adverse-event-grade-zero-invariant | error | AdverseEvent | If the adverse event grade is 0, seriousness and suspectEntity must not be specified. : extension('http://hl7.org/fhir/us/mcode/StructureDefinition/ctcae-grade').value.coding.where(code = '0').exists() implies seriousness.exists().not() and suspectEntity.exists().not() |
This structure is derived from AdverseEvent
Summary
Mandatory: 4 elements
Must-Support: 20 elements
Prohibited: 1 element
Extensions
This structure refers to these extensions:
Differential View
This structure is derived from AdverseEvent
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdverseEvent | C | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury adverse-event-grade-zero-invariant: If the adverse event grade is 0, seriousness and suspectEntity must not be specified. |
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| grade | S | 1..1 | CodeableConcept | CTC Adverse Event Grade URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/ctcae-grade Binding: CTCAE Grade Value Set (required) |
| expectation | S | 0..1 | CodeableConcept | Adverse Event Expectation URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-expectation Binding: Adverse Event Expectation Value Set (required) |
| resolvedDate | S | 0..1 | dateTime | Adverse Event Resolved Date URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-resolved-date |
| participant | S | 0..* | (Complex) | Adverse Event Participant URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-participant |
| seriousnessOutcome | S | 0..1 | CodeableConcept | Adverse Event Seriousness Outcome URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-seriousness-outcome Binding: Adverse Event Seriousness Outcome Value Set (required) |
| actuality | S | 1..1 | code | actual | potential Required Pattern: actual |
| event | S | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: CTCAE Terms Value Set (preferred) |
| coding | 1..* | Coding | CTCAE Term | |
| version | 0..1 | string | CTCAE Version | |
| code | 0..1 | code | MedDRA or NCIT code | |
| display | 0..1 | string | Preferred name | |
| text | S | 0..1 | string | Verbatim Text |
| subject | S | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event |
| encounter | S | 0..1 | Reference(Encounter) | Encounter created as part of |
| date | S | 0..1 | dateTime | When the event occurred |
| seriousness | S | 0..1 | CodeableConcept | Seriousness of the event Binding: Adverse Event Seriousness Value Set (required) |
| severity | 0..0 | |||
| outcome | S | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown |
| recorder | S | 0..1 | Reference(Practitioner) | Who recorded the adverse event |
| contributor | 0..* | Reference(Practitioner) | Who was involved in the adverse event or the potential adverse event | |
| suspectEntity | S | 0..* | BackboneElement | The suspected agent causing the adverse event |
| instance | S | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event |
| causality | S | 0..* | BackboneElement | Information on the possible cause of the event |
| assessment | S | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: Adverse Event Relatedness Value Set (required) |
| text | S | 0..1 | string | Plain text representation of the concept |
| study | S | 0..* | Reference(ResearchStudy) | AdverseEvent.study |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| AdverseEvent.event | preferred | CTCAETermVShttp://hl7.org/fhir/us/ctcae/ValueSet/ctcae-term-value-setfrom this IG | |
| AdverseEvent.seriousness | required | AdverseEventSeriousnessVShttp://hl7.org/fhir/us/ctcae/ValueSet/adverse-event-seriousness-value-setfrom this IG | |
| AdverseEvent.suspectEntity.causality.assessment | required | AdverseEventRelatednessVShttp://hl7.org/fhir/us/ctcae/ValueSet/adverse-event-relatedness-value-setfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| adverse-event-grade-zero-invariant | error | AdverseEvent | If the adverse event grade is 0, seriousness and suspectEntity must not be specified. : extension('http://hl7.org/fhir/us/mcode/StructureDefinition/ctcae-grade').value.coding.where(code = '0').exists() implies seriousness.exists().not() and suspectEntity.exists().not() |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| AdverseEvent | C | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury adverse-event-grade-zero-invariant: If the adverse event grade is 0, seriousness and suspectEntity must not be specified. |
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created |
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |
| grade | S | 1..1 | CodeableConcept | CTC Adverse Event Grade URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/ctcae-grade Binding: CTCAE Grade Value Set (required) |
| expectation | S | 0..1 | CodeableConcept | Adverse Event Expectation URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-expectation Binding: Adverse Event Expectation Value Set (required) |
| resolvedDate | S | 0..1 | dateTime | Adverse Event Resolved Date URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-resolved-date |
| participant | S | 0..* | (Complex) | Adverse Event Participant URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-participant |
| seriousnessOutcome | S | 0..1 | CodeableConcept | Adverse Event Seriousness Outcome URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-seriousness-outcome Binding: Adverse Event Seriousness Outcome Value Set (required) |
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored |
| actuality | ?!SΣ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual |
| event | SΣ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: CTCAE Terms Value Set (preferred) |
| coding | Σ | 1..* | Coding | CTCAE Term |
| version | Σ | 0..1 | string | CTCAE Version |
| code | Σ | 0..1 | code | MedDRA or NCIT code |
| display | Σ | 0..1 | string | Preferred name |
| text | SΣ | 0..1 | string | Verbatim Text |
| subject | SΣ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event |
| encounter | SΣ | 0..1 | Reference(Encounter) | Encounter created as part of |
| date | SΣ | 0..1 | dateTime | When the event occurred |
| seriousness | SΣ | 0..1 | CodeableConcept | Seriousness of the event Binding: Adverse Event Seriousness Value Set (required) |
| outcome | SΣ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). |
| recorder | SΣ | 0..1 | Reference(Practitioner) | Who recorded the adverse event |
| contributor | Σ | 0..* | Reference(Practitioner) | Who was involved in the adverse event or the potential adverse event |
| suspectEntity | SΣ | 0..* | BackboneElement | The suspected agent causing the adverse event |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| instance | SΣ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event |
| causality | SΣ | 0..* | BackboneElement | Information on the possible cause of the event |
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| assessment | SΣ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: Adverse Event Relatedness Value Set (required) |
| text | SΣ | 0..1 | string | Plain text representation of the concept |
| study | SΣ | 0..* | Reference(ResearchStudy) | AdverseEvent.study |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| AdverseEvent.actuality | required | Pattern: actualhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1from the FHIR Standard | |
| AdverseEvent.event | preferred | CTCAETermVShttp://hl7.org/fhir/us/ctcae/ValueSet/ctcae-term-value-setfrom this IG | |
| AdverseEvent.seriousness | required | AdverseEventSeriousnessVShttp://hl7.org/fhir/us/ctcae/ValueSet/adverse-event-seriousness-value-setfrom this IG | |
| AdverseEvent.outcome | required | AdverseEventOutcomehttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1from the FHIR Standard | |
| AdverseEvent.suspectEntity.causality.assessment | required | AdverseEventRelatednessVShttp://hl7.org/fhir/us/ctcae/ValueSet/adverse-event-relatedness-value-setfrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| adverse-event-grade-zero-invariant | error | AdverseEvent | If the adverse event grade is 0, seriousness and suspectEntity must not be specified. : extension('http://hl7.org/fhir/us/mcode/StructureDefinition/ctcae-grade').value.coding.where(code = '0').exists() implies seriousness.exists().not() and suspectEntity.exists().not() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| AdverseEvent | C | 0..* | AdverseEvent | Medical care, research study or other healthcare event causing physical injury adverse-event-grade-zero-invariant: If the adverse event grade is 0, seriousness and suspectEntity must not be specified. | ||||
| id | Σ | 0..1 | id | Logical id of this artifact | ||||
| meta | Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language | 0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained | 0..* | Resource | Contained, inline Resources | |||||
| Slices for extension | 1..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| grade | S | 1..1 | CodeableConcept | CTC Adverse Event Grade URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/ctcae-grade Binding: CTCAE Grade Value Set (required) | ||||
| expectation | S | 0..1 | CodeableConcept | Adverse Event Expectation URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-expectation Binding: Adverse Event Expectation Value Set (required) | ||||
| resolvedDate | S | 0..1 | dateTime | Adverse Event Resolved Date URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-resolved-date | ||||
| participant | S | 0..* | (Complex) | Adverse Event Participant URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-participant | ||||
| seriousnessOutcome | S | 0..1 | CodeableConcept | Adverse Event Seriousness Outcome URL: http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-seriousness-outcome Binding: Adverse Event Seriousness Outcome Value Set (required) | ||||
| modifierExtension | ?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier | Σ | 0..1 | Identifier | Business identifier for the event | ||||
| actuality | ?!SΣ | 1..1 | code | actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual | ||||
| category | Σ | 0..* | CodeableConcept | product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational. | ||||
| event | SΣ | 1..1 | CodeableConcept | Type of the event itself in relation to the subject Binding: CTCAE Terms Value Set (preferred) | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 1..* | Coding | CTCAE Term | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| system | Σ | 0..1 | uri | Identity of the terminology system | ||||
| version | Σ | 0..1 | string | CTCAE Version | ||||
| code | Σ | 0..1 | code | MedDRA or NCIT code | ||||
| display | Σ | 0..1 | string | Preferred name | ||||
| userSelected | Σ | 0..1 | boolean | If this coding was chosen directly by the user | ||||
| text | SΣ | 0..1 | string | Verbatim Text | ||||
| subject | SΣ | 1..1 | Reference(Patient | Group | Practitioner | RelatedPerson) | Subject impacted by event | ||||
| encounter | SΣ | 0..1 | Reference(Encounter) | Encounter created as part of | ||||
| date | SΣ | 0..1 | dateTime | When the event occurred | ||||
| detected | Σ | 0..1 | dateTime | When the event was detected | ||||
| recordedDate | Σ | 0..1 | dateTime | When the event was recorded | ||||
| resultingCondition | Σ | 0..* | Reference(Condition) | Effect on the subject due to this event | ||||
| location | Σ | 0..1 | Reference(Location) | Location where adverse event occurred | ||||
| seriousness | SΣ | 0..1 | CodeableConcept | Seriousness of the event Binding: Adverse Event Seriousness Value Set (required) | ||||
| outcome | SΣ | 0..1 | CodeableConcept | resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). | ||||
| recorder | SΣ | 0..1 | Reference(Practitioner) | Who recorded the adverse event | ||||
| contributor | Σ | 0..* | Reference(Practitioner) | Who was involved in the adverse event or the potential adverse event | ||||
| suspectEntity | SΣ | 0..* | BackboneElement | The suspected agent causing the adverse event | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| instance | SΣ | 1..1 | Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) | Refers to the specific entity that caused the adverse event | ||||
| causality | SΣ | 0..* | BackboneElement | Information on the possible cause of the event | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| assessment | SΣ | 0..1 | CodeableConcept | Assessment of if the entity caused the event Binding: Adverse Event Relatedness Value Set (required) | ||||
| id | 0..1 | string | Unique id for inter-element referencing | |||||
| extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| coding | Σ | 0..* | Coding | Code defined by a terminology system | ||||
| text | SΣ | 0..1 | string | Plain text representation of the concept | ||||
| productRelatedness | Σ | 0..1 | string | AdverseEvent.suspectEntity.causalityProductRelatedness | ||||
| author | Σ | 0..1 | Reference(Practitioner | PractitionerRole) | AdverseEvent.suspectEntity.causalityAuthor | ||||
| method | Σ | 0..1 | CodeableConcept | ProbabilityScale | Bayesian | Checklist Binding: AdverseEventCausalityMethod (example): TODO. | ||||
| subjectMedicalHistory | Σ | 0..* | Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) | AdverseEvent.subjectMedicalHistory | ||||
| referenceDocument | Σ | 0..* | Reference(DocumentReference) | AdverseEvent.referenceDocument | ||||
| study | SΣ | 0..* | Reference(ResearchStudy) | AdverseEvent.study | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI | |||
| AdverseEvent.language | preferred | CommonLanguages
http://hl7.org/fhir/ValueSet/languagesfrom the FHIR Standard | ||||
| AdverseEvent.actuality | required | Pattern: actualhttp://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1from the FHIR Standard | ||||
| AdverseEvent.category | extensible | AdverseEventCategoryhttp://hl7.org/fhir/ValueSet/adverse-event-categoryfrom the FHIR Standard | ||||
| AdverseEvent.event | preferred | CTCAETermVShttp://hl7.org/fhir/us/ctcae/ValueSet/ctcae-term-value-setfrom this IG | ||||
| AdverseEvent.seriousness | required | AdverseEventSeriousnessVShttp://hl7.org/fhir/us/ctcae/ValueSet/adverse-event-seriousness-value-setfrom this IG | ||||
| AdverseEvent.outcome | required | AdverseEventOutcomehttp://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1from the FHIR Standard | ||||
| AdverseEvent.suspectEntity.causality.assessment | required | AdverseEventRelatednessVShttp://hl7.org/fhir/us/ctcae/ValueSet/adverse-event-relatedness-value-setfrom this IG | ||||
| AdverseEvent.suspectEntity.causality.method | example | AdverseEventCausalityMethodhttp://hl7.org/fhir/ValueSet/adverse-event-causality-methodfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| adverse-event-grade-zero-invariant | error | AdverseEvent | If the adverse event grade is 0, seriousness and suspectEntity must not be specified. : extension('http://hl7.org/fhir/us/mcode/StructureDefinition/ctcae-grade').value.coding.where(code = '0').exists() implies seriousness.exists().not() and suspectEntity.exists().not() |
This structure is derived from AdverseEvent
Summary
Mandatory: 4 elements
Must-Support: 20 elements
Prohibited: 1 element
Extensions
This structure refers to these extensions:
Other representations of profile: CSV, Excel, Schematron