IDEA4RC FHIR Implementation Guide, published by IDEA4RC Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/idea4rc/ and changes regularly. See the Directory of published versions
| Draft as of 2025-09-10 | 
Definitions for the AdverseEvent logical model.
Guidance on how to interpret the contents of this table can be foundhere
| 0. AdverseEvent | |||||
| Definition | Adverse Event Maturity Level: 0 Draft  | ||||
| Short | Adverse Event | ||||
| Control | 0..* | ||||
| Is Modifier | false | ||||
| Logical Model | Instances of this logical model are not marked to be the target of a Reference | ||||
| 2. AdverseEvent.treatmentReference[x] | |||||
| Definition | Treatment element containing the data regarding the specific treatment. It can be SystemicTreatment, Surgery, Radiotherapy, Isolated Limb Perfusion or Regional Deep Hyperthemia OBSERVATION or CONDITION  | ||||
| Short | Treatment reference (M) | ||||
| Control | 1..* | ||||
| Type | Choice of: http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/SystemicTreatment, http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Radiotherapy, http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Surgery | ||||
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] | ||||
| Obligations | 
  | ||||
| 4. AdverseEvent.adverseEventType | |||||
| Definition | the Common Terminology Criteria for Adverse Events (CTCAE) is used to identify the adverse events. It includes details of the adverse event type and grade OBSERVATION or CONDITION (check)  | ||||
| Short | Adverse event type (CTCAE Term) (M) | ||||
| Control | 1..* | ||||
| Type | CodeableConcept | ||||
| Obligations | 
  | ||||
| 6. AdverseEvent.adverseEventStartingDate | |||||
| Definition | specifies when adverse events begins OBSERVATION or CONDITION (check)  | ||||
| Short | Adverse event starting date (M) | ||||
| Control | 1..* | ||||
| Type | date | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Obligations | 
  | ||||
| 8. AdverseEvent.adverseEventDuration | |||||
| Definition | specifies the duration of the adverse event OBSERVATION or CONDITION (check) Adverse Events in OMOP ar standard conditions or observations and duration must be derived from that data https://forums.ohdsi.org/t/mapping-adverse-event-data-to-omop-and-to-fhir/15373  | ||||
| Short | Adverse event duration (M) | ||||
| Comments | Less than one week - 2000100050 More than one week but less than a month - 2000100051 More than a month but less than 3 months - 2000100052 More than 3 months - 2000100053  | ||||
| Control | 1..* | ||||
| Type | CodeableConcept | ||||
| Obligations | 
  | ||||
Guidance on how to interpret the contents of this table can be foundhere
| 0. AdverseEvent | |||||
| Definition | Adverse Event Maturity Level: 0 Draft  | ||||
| Short | Adverse Event | ||||
| Logical Model | Instances of this logical model are not marked to be the target of a Reference | ||||
| 2. AdverseEvent.treatmentReference[x] | |||||
| Definition | Treatment element containing the data regarding the specific treatment. It can be SystemicTreatment, Surgery, Radiotherapy, Isolated Limb Perfusion or Regional Deep Hyperthemia OBSERVATION or CONDITION  | ||||
| Short | Treatment reference (M) | ||||
| Control | 1..* | ||||
| Type | Choice of: http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/SystemicTreatment, http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Radiotherapy, http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Surgery | ||||
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] | ||||
| Obligations | 
  | ||||
| 4. AdverseEvent.adverseEventType | |||||
| Definition | the Common Terminology Criteria for Adverse Events (CTCAE) is used to identify the adverse events. It includes details of the adverse event type and grade OBSERVATION or CONDITION (check)  | ||||
| Short | Adverse event type (CTCAE Term) (M) | ||||
| Control | 1..* | ||||
| Type | CodeableConcept | ||||
| Obligations | 
  | ||||
| 6. AdverseEvent.adverseEventStartingDate | |||||
| Definition | specifies when adverse events begins OBSERVATION or CONDITION (check)  | ||||
| Short | Adverse event starting date (M) | ||||
| Control | 1..* | ||||
| Type | date | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Obligations | 
  | ||||
| 8. AdverseEvent.adverseEventDuration | |||||
| Definition | specifies the duration of the adverse event OBSERVATION or CONDITION (check) Adverse Events in OMOP ar standard conditions or observations and duration must be derived from that data https://forums.ohdsi.org/t/mapping-adverse-event-data-to-omop-and-to-fhir/15373  | ||||
| Short | Adverse event duration (M) | ||||
| Comments | Less than one week - 2000100050 More than one week but less than a month - 2000100051 More than a month but less than 3 months - 2000100052 More than 3 months - 2000100053  | ||||
| Control | 1..* | ||||
| Type | CodeableConcept | ||||
| Obligations | 
  | ||||
Guidance on how to interpret the contents of this table can be foundhere
| 0. AdverseEvent | |||||
| Definition | Adverse Event Maturity Level: 0 Draft  | ||||
| Short | Adverse Event | ||||
| Control | 0..* | ||||
| Is Modifier | false | ||||
| Logical Model | Instances of this logical model are not marked to be the target of a Reference | ||||
| 2. AdverseEvent.treatmentReference[x] | |||||
| Definition | Treatment element containing the data regarding the specific treatment. It can be SystemicTreatment, Surgery, Radiotherapy, Isolated Limb Perfusion or Regional Deep Hyperthemia OBSERVATION or CONDITION  | ||||
| Short | Treatment reference (M) | ||||
| Control | 1..* | ||||
| Type | Choice of: http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/SystemicTreatment, http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Radiotherapy, http://hl7.eu/fhir/ig/idea4rc/StructureDefinition/Surgery | ||||
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] | ||||
| Obligations | 
  | ||||
| 4. AdverseEvent.adverseEventType | |||||
| Definition | the Common Terminology Criteria for Adverse Events (CTCAE) is used to identify the adverse events. It includes details of the adverse event type and grade OBSERVATION or CONDITION (check)  | ||||
| Short | Adverse event type (CTCAE Term) (M) | ||||
| Control | 1..* | ||||
| Type | CodeableConcept | ||||
| Obligations | 
  | ||||
| 6. AdverseEvent.adverseEventStartingDate | |||||
| Definition | specifies when adverse events begins OBSERVATION or CONDITION (check)  | ||||
| Short | Adverse event starting date (M) | ||||
| Control | 1..* | ||||
| Type | date | ||||
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension | ||||
| Obligations | 
  | ||||
| 8. AdverseEvent.adverseEventDuration | |||||
| Definition | specifies the duration of the adverse event OBSERVATION or CONDITION (check) Adverse Events in OMOP ar standard conditions or observations and duration must be derived from that data https://forums.ohdsi.org/t/mapping-adverse-event-data-to-omop-and-to-fhir/15373  | ||||
| Short | Adverse event duration (M) | ||||
| Comments | Less than one week - 2000100050 More than one week but less than a month - 2000100051 More than a month but less than 3 months - 2000100052 More than 3 months - 2000100053  | ||||
| Control | 1..* | ||||
| Type | CodeableConcept | ||||
| Obligations | 
  | ||||