Adverse Event Clinical Research
1.0.1 - STU1

Adverse Event Clinical Research, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-ig/ and changes regularly. See the Directory of published versions

## Resource Profile: AdverseEventClinicalResearch - Detailed Descriptions

Page standards status: Trial-use | Maturity Level: 2

Definitions for the AdverseEvent-clinical-research resource profile.

- Differential Elements Table
- Key Elements Table
- Snapshot Elements Table

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

0. AdverseEvent
Invariants | aeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion. (`(seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria').exists().not() )`)
2. AdverseEvent.extension
Slicing | This element introduces a set of slices on `AdverseEvent.extension`. The slices are unordered and Open, and can be differentiated using the following discriminators: value @ url
4. AdverseEvent.extension:caused-subject-to-discontinue-study
Slice Name | caused-subject-to-discontinue-study
Control | 0..1
Type | Extension(Adverse event caused subject to discontinue the study) (Extension Type: boolean)
6. AdverseEvent.extension:seriousness-criteria
Slice Name | seriousness-criteria
Control | 0..*
Type | Extension(Criteria reviewed in determining serious adverse event) (Complex Extension)
8. AdverseEvent.extension:ae-severity
Slice Name | ae-severity
Short | The degree of something undesirable
Control | 0..1
Type | Extension(Adverse Event Severity) (Extension Type: CodeableConcept)
10. AdverseEvent.extension:ae-grade
Slice Name | ae-grade
Short | The degree of something undesirable, used in oncology trials
Control | 0..1
Type | Extension(Adverse Event Grade) (Extension Type: CodeableConcept)
12. AdverseEvent.actuality
Short | actual
Pattern Value | `actual`
14. AdverseEvent.code
Control | 1..?
16. AdverseEvent.occurrence[x]
Type | Period, dateTime, Timing
[x] Note | See Choice of Data Types for further information about how to use [x]
Must Support | true
18. AdverseEvent.resultingEffect
Definition | Information about the condition that occurred as a result of the adverse event.
20. AdverseEvent.seriousness
Short | Investigator defined severity of the adverse event, in relation to the subject not the resulting condition
Control | 1..?
Binding | The codes SHALL be taken from AdverseEventSeriousness (required to `http://hl7.org/fhir/ValueSet/adverse-event-seriousness` )
Must Support | true
22. AdverseEvent.outcome
Control | 1..1
Binding | The codes SHALL be taken from Adverse Event Clinical Research Outcomes (required to `http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes` )
Must Support | true
24. AdverseEvent.study
Control | 1..1
Must Support | true
26. AdverseEvent.suspectEntity
28. AdverseEvent.suspectEntity.causality
Control | 1..?
Must Support | true
30. AdverseEvent.suspectEntity.causality.assessmentMethod
Short | Method of evaluating the relatedness of the suspected entity to the event.
Binding | The codes SHOULD be taken from AdverseEventCausalityMethod (preferred to `http://hl7.org/fhir/ValueSet/adverse-event-causality-method` ) Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.
32. AdverseEvent.suspectEntity.causality.entityRelatedness
Binding | The codes SHOULD be taken from Adverse Event Clinical Research Causality Relatedness (preferred to `http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness` )
34. AdverseEvent.preventiveAction
Control | 0..0

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

0. AdverseEvent
Definition | An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.
Short | An event that may be related to unintended effects on a patient or research participant
Control | 0..*
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | AE
Invariants | dom-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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()) aeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion. (`(seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria').exists().not() )`)
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.
Short | A 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 its narrative along with other profiles, value sets, etc.
Control | 0..1
Type | uri
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. AdverseEvent.contained
Definition | These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
Short | Contained, 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.
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
Type | Resource
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | inline resources, anonymous resources, contained resources
6. 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 managable, 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.
Short | ExtensionAdditional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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())
Slicing | This element introduces a set of slices on `AdverseEvent.extension`. The slices are unordered and Open, and can be differentiated using the following discriminators: value @ url
8. AdverseEvent.extension:caused-subject-to-discontinue-study
Slice Name | caused-subject-to-discontinue-study
Definition | Indicates if the subject discontinued the study due to the adverse event.
Short | Adverse event caused subject to discontinue the study
Control | 0..1
Type | Extension(Adverse event caused subject to discontinue the study) (Extension Type: boolean)
Is Modifier | false
Must Support | false
Invariants | ele-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())
10. AdverseEvent.extension:seriousness-criteria
Slice Name | seriousness-criteria
Definition | Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.
Short | Criteria reviewed in determining serious adverse event
Control | 0..*
Type | Extension(Criteria reviewed in determining serious adverse event) (Complex Extension)
Is Modifier | false
Must Support | false
Invariants | ele-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()`)
12. AdverseEvent.extension:ae-severity
Slice Name | ae-severity
Definition | Describes the severity of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity.
Short | The degree of something undesirable
Control | 0..1
Type | Extension(Adverse Event Severity) (Extension Type: CodeableConcept)
Is Modifier | false
Must Support | false
Invariants | ele-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.extension:ae-grade
Slice Name | ae-grade
Definition | For cancer related trials, severity is represented as a grade. Describes the grade of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity, in oncology related trials this is reported as grade.
Short | The degree of something undesirable, used in oncology trials
Control | 0..1
Type | Extension(Adverse Event Grade) (Extension Type: CodeableConcept)
Is Modifier | false
Must Support | false
Invariants | ele-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())
16. 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 managable, 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Support | false
Summary | true
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 Names | extensions, user content
Invariants | ele-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())
18. AdverseEvent.status
Definition | The current state of the adverse event or potential adverse event.
Short | in-progress | completed | entered-in-error | unknown
Comments | This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.
Control | 1..1
Binding | The codes SHALL be taken from AdverseEventStatus http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 (required to `http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0` ) Codes identifying the lifecycle stage of an event.
Type | code
Is Modifier | true because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
20. AdverseEvent.actuality
Definition | Whether the event actually happened or was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely.
Short | actualactual | potential
Comments | AllergyIntolerance should be used for the initial capture or recording of the individual's propensity to an adverse reaction to a substance. If an AllergyIntolerance does not exist, then an adverse reaction should be recorded as an AllergyIntolerance. If an AllergyIntolerance does exist and the substance was given, then an adverse reaction should be recorded as an AdverseEvent due to the aberrant workflow.
Control | 1..1
Binding | The codes SHALL be taken from AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 (required to `http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0` ) Overall nature of the adverse event, e.g. real or potential.
Type | code
Is Modifier | true because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Pattern Value | `actual`
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
22. AdverseEvent.code
Definition | Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused.
Short | Event or incident that occurred or was averted
Control | 10..1
Binding | For example codes, see AdverseEventType http://hl7.org/fhir/ValueSet/adverse-event-type (example to `http://hl7.org/fhir/ValueSet/adverse-event-type` ) Detailed type of event.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
24. AdverseEvent.subject
Definition | This subject or group impacted by the event.
Short | Subject impacted by event
Comments | If AdverseEvent.resultingEffect differs among members of the group, then use Patient as the subject.
Control | 1..1
Type | Reference(Patient, Group, Practitioner, RelatedPerson, ResearchSubject)
Is Modifier | false
Must Support | false
Summary | true
Requirements | Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.
Alternate Names | patient
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
26. AdverseEvent.occurrence[x]
Definition | The date (and perhaps time) when the adverse event occurred.
Short | When the event occurred
Control | 0..1
Type | Period, dateTime, Timing
[x] Note | See Choice of Data Types for further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Alternate Names | timing
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
28. AdverseEvent.resultingEffect
Definition | Information about the condition that occurred as a result of the adverse event. Information about the condition that occurred as a result of the adverse event, such as hives due to the exposure to a substance (for example, a drug or a chemical) or a broken leg as a result of the fall.
Short | Effect on the subject due to this event
Control | 0..*
Type | Reference(Condition, Observation)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
30. AdverseEvent.seriousness
Definition | Assessment whether this event, or averted event, was of clinical importance.
Short | Investigator defined severity of the adverse event, in relation to the subject not the resulting conditionSeriousness or gravity of the event
Comments | Using an example, a rash can have an AdverseEvent.resultingEffect.severity = severe, yet an AdverseEvent.seriousness = non-serious. Alternatively, a medication given with the wrong dose (chemotherapy given with too low of a dose) can have an AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious. Another example would be a beta blocker clinical trial where patients with asthma should be excluded, yet a patient with asthma was included and had an asthmatic episode where AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious.
Control | 10..1
Binding | The codes SHALL be taken from For example codes, see AdverseEventSeriousness http://hl7.org/fhir/ValueSet/adverse-event-seriousness (required to `http://hl7.org/fhir/ValueSet/adverse-event-seriousness` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
32. AdverseEvent.outcome
Definition | Describes the type of outcome from the adverse event, such as resolved, recovering, ongoing, resolved-with-sequelae, or fatal.
Short | Type of outcome from the adverse event
Control | 10..1*
Binding | The codes SHALL be taken from For example codes, see Adverse Event Clinical Research Outcomes http://hl7.org/fhir/ValueSet/adverse-event-outcome (required to `http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
34. AdverseEvent.study
Definition | The research study that the subject is enrolled in.
Short | Research study that the subject is enrolled in
Control | 10..1*
Type | Reference(ResearchStudy)
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
36. AdverseEvent.suspectEntity
Definition | Describes the entity that is suspected to have caused the adverse event.
Short | The suspected agent causing the adverse event
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
38. 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 managable, 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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())
40. AdverseEvent.suspectEntity.instance[x]
Definition | Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.
Short | Refers to the specific entity that caused the adverse event
Control | 1..1
Type | Choice of: CodeableConcept, Reference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device, BiologicallyDerivedProduct, ResearchStudy)
[x] Note | See Choice of Data Types for further information about how to use [x]
Is Modifier | false
Must Support | false
Summary | true
Alternate Names | Substance or Medication or Device
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
42. AdverseEvent.suspectEntity.causality
Definition | Information on the possible cause of the event.
Short | Information on the possible cause of the event
Control | 10..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
44. 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 managable, 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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())
46. AdverseEvent.suspectEntity.causality.assessmentMethod
Definition | The method of evaluating the relatedness of the suspected entity to the event.
Short | Method of evaluating the relatedness of the suspected entity to the event.
Control | 0..1
Binding | The codes SHOULD be taken from For example codes, see AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method (preferred to `http://hl7.org/fhir/ValueSet/adverse-event-causality-method` ) Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist. TODO.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
48. AdverseEvent.suspectEntity.causality.entityRelatedness
Definition | The result of the assessment regarding the relatedness of the suspected entity to the event.
Short | Result of the assessment regarding the relatedness of the suspected entity to the event
Control | 0..1
Binding | The codes SHOULD be taken from For example codes, see Adverse Event Clinical Research Causality Relatedness http://hl7.org/fhir/ValueSet/adverse-event-causality-assess (preferred to `http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness` )
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
50. AdverseEvent.preventiveAction
Definition | Preventive actions that contributed to avoiding the adverse event.
Short | Preventive actions that contributed to avoiding the adverse event
Control | 0..0*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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 found here

0. AdverseEvent
Definition | An event (i.e. any change to current patient status) that may be related to unintended effects on a patient or research participant. The unintended effects may require additional monitoring, treatment, hospitalization, or may result in death. The AdverseEvent resource also extends to potential or avoided events that could have had such effects. There are two major domains where the AdverseEvent resource is expected to be used. One is in clinical care reported adverse events and the other is in reporting adverse events in clinical research trial management. Adverse events can be reported by healthcare providers, patients, caregivers or by medical products manufacturers. Given the differences between these two concepts, we recommend consulting the domain specific implementation guides when implementing the AdverseEvent Resource. The implementation guides include specific extensions, value sets and constraints.
Short | An event that may be related to unintended effects on a patient or research participant
Control | 0..*
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | AE
Invariants | dom-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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()`) aeClinRes-seriousness-1: If seriousness is serious then must have at least one seriousness criterion. (`(seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious') and extension('http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria').exists() and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious').not() ) or (seriousness.coding.exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='non-serious') and seriousness.coding .exists(system='http://terminology.hl7.org/CodeSystem/adverse-event-seriousness' and code='serious').not() and extension('http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria').exists().not() )`)
2. AdverseEvent.id
Definition | The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Short | Logical id of this artifact
Comments | Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
Control | 0..1
Type | id
Is Modifier | false
Must Support | false
Summary | true
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.
Short | Metadata about the resource
Control | 0..1
Type | Meta
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-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.
Short | A 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 its narrative along with other profiles, value sets, etc.
Control | 0..1
Type | uri
Is Modifier | true because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-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.
Short | Language 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).
Control | 0..1
Binding | The codes SHALL be taken from AllLanguages (required to `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` ) IETF language tag for a human language
Type | code
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | false
Invariants | ele-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.
Short | Text summary of the resource, for human interpretation
Comments | Contained resources do not have a 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.
Control | 0..1 This element is affected by the following invariants: dom-6
Type | Narrative
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | narrative, html, xhtml, display
Invariants | ele-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, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
Short | Contained, 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.
Control | 0..* This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
Type | Resource
Is Modifier | false
Must Support | false
Summary | false
Alternate Names | inline resources, anonymous resources, contained resources
14. AdverseEvent.extension
Definition | An Extension
Short | Extension
Control | 0..*
Type | Extension
Is Modifier | false
Must Support | false
Summary | false
Invariants | ele-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()`)
Slicing | This element introduces a set of slices on `AdverseEvent.extension`. The slices are unordered and Open, and can be differentiated using the following discriminators: value @ url
16. AdverseEvent.extension:caused-subject-to-discontinue-study
Slice Name | caused-subject-to-discontinue-study
Definition | Indicates if the subject discontinued the study due to the adverse event.
Short | Adverse event caused subject to discontinue the study
Control | 0..1
Type | Extension(Adverse event caused subject to discontinue the study) (Extension Type: boolean)
Is Modifier | false
Must Support | false
Invariants | ele-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()`)
18. AdverseEvent.extension:seriousness-criteria
Slice Name | seriousness-criteria
Definition | Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.
Short | Criteria reviewed in determining serious adverse event
Control | 0..*
Type | Extension(Criteria reviewed in determining serious adverse event) (Complex Extension)
Is Modifier | false
Must Support | false
Invariants | ele-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()`)
20. AdverseEvent.extension:ae-severity
Slice Name | ae-severity
Definition | Describes the severity of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity.
Short | The degree of something undesirable
Control | 0..1
Type | Extension(Adverse Event Severity) (Extension Type: CodeableConcept)
Is Modifier | false
Must Support | false
Invariants | ele-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()`)
22. AdverseEvent.extension:ae-grade
Slice Name | ae-grade
Definition | For cancer related trials, severity is represented as a grade. Describes the grade of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity, in oncology related trials this is reported as grade.
Short | The degree of something undesirable, used in oncology trials
Control | 0..1
Type | Extension(Adverse Event Grade) (Extension Type: CodeableConcept)
Is Modifier | false
Must Support | false
Invariants | ele-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.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 managable, 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Must Support | false
Summary | true
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 Names | extensions, user content
Invariants | ele-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()`)
26. 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.
Short | Business 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.
Note | This is a business identifier, not a resource identifier (see discussion)
Control | 0..*
Type | Identifier
Is Modifier | false
Must Support | false
Summary | true
Requirements | Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers.
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
28. AdverseEvent.status
Definition | The current state of the adverse event or potential adverse event.
Short | in-progress | completed | entered-in-error | unknown
Comments | This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition.
Control | 1..1
Binding | The codes SHALL be taken from AdverseEventStatus (required to `http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0` ) Codes identifying the lifecycle stage of an event.
Type | code
Is Modifier | true because This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
30. AdverseEvent.actuality
Definition | Whether the event actually happened or was a near miss. Note that this is independent of whether anyone was affected or harmed or how severely.
Short | actual
Comments | AllergyIntolerance should be used for the initial capture or recording of the individual's propensity to an adverse reaction to a substance. If an AllergyIntolerance does not exist, then an adverse reaction should be recorded as an AllergyIntolerance. If an AllergyIntolerance does exist and the substance was given, then an adverse reaction should be recorded as an AdverseEvent due to the aberrant workflow.
Control | 1..1
Binding | The codes SHALL be taken from AdverseEventActuality (required to `http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0` ) Overall nature of the adverse event, e.g. real or potential.
Type | code
Is Modifier | true because This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen.
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Pattern Value | `actual`
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
32. AdverseEvent.category
Definition | The overall type of event, intended for search and filtering purposes.
Short | wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site
Control | 0..*
Binding | For example codes, see AdverseEventCategory (example to `http://hl7.org/fhir/ValueSet/adverse-event-category` ) Overall categorization of the event, e.g. product-related or situational.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
34. AdverseEvent.code
Definition | Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused.
Short | Event or incident that occurred or was averted
Control | 1..1
Binding | For example codes, see AdverseEventType (example to `http://hl7.org/fhir/ValueSet/adverse-event-type` ) Detailed type of event.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
36. AdverseEvent.subject
Definition | This subject or group impacted by the event.
Short | Subject impacted by event
Comments | If AdverseEvent.resultingEffect differs among members of the group, then use Patient as the subject.
Control | 1..1
Type | Reference(Patient, Group, Practitioner, RelatedPerson, ResearchSubject)
Is Modifier | false
Must Support | false
Summary | true
Requirements | Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital.
Alternate Names | patient
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
38. AdverseEvent.encounter
Definition | The Encounter associated with the start of the AdverseEvent.
Short | The Encounter associated with the start of the AdverseEvent
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 associated encounter. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the associated encounter.
Control | 0..1
Type | Reference(Encounter)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
40. AdverseEvent.occurrence[x]
Definition | The date (and perhaps time) when the adverse event occurred.
Short | When the event occurred
Control | 0..1
Type | Period
[x] Note | See Choice of Data Types for further information about how to use [x]
Is Modifier | false
Must Support | true
Summary | true
Alternate Names | timing
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
42. AdverseEvent.detected
Definition | Estimated or actual date the AdverseEvent began, in the opinion of the reporter.
Short | When the event was detected
Control | 0..1
Type | dateTime
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
44. AdverseEvent.recordedDate
Definition | The date on which the existence of the AdverseEvent was first recorded.
Short | When 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.
Control | 0..1
Type | dateTime
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
46. AdverseEvent.resultingEffect
Definition | Information about the condition that occurred as a result of the adverse event.
Short | Effect on the subject due to this event
Control | 0..*
Type | Reference(Condition, Observation)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
48. AdverseEvent.location
Definition | The information about where the adverse event occurred.
Short | Location where adverse event occurred
Control | 0..1
Type | Reference(Location)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
50. AdverseEvent.seriousness
Definition | Assessment whether this event, or averted event, was of clinical importance.
Short | Investigator defined severity of the adverse event, in relation to the subject not the resulting condition
Comments | Using an example, a rash can have an AdverseEvent.resultingEffect.severity = severe, yet an AdverseEvent.seriousness = non-serious. Alternatively, a medication given with the wrong dose (chemotherapy given with too low of a dose) can have an AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious. Another example would be a beta blocker clinical trial where patients with asthma should be excluded, yet a patient with asthma was included and had an asthmatic episode where AdverseEvent.resultingEffect.severity = mild, yet an adverseEvent.seriousness = serious.
Control | 1..1
Binding | The codes SHALL be taken from AdverseEventSeriousness (required to `http://hl7.org/fhir/ValueSet/adverse-event-seriousness` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
52. AdverseEvent.outcome
Definition | Describes the type of outcome from the adverse event, such as resolved, recovering, ongoing, resolved-with-sequelae, or fatal.
Short | Type of outcome from the adverse event
Control | 1..1
Binding | The codes SHALL be taken from Adverse Event Clinical Research Outcomes (required to `http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes` )
Type | CodeableConcept
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
54. AdverseEvent.recorder
Definition | Information on who recorded the adverse event. May be the patient or a practitioner.
Short | Who recorded the adverse event
Control | 0..1
Type | Reference(Patient, Practitioner, PractitionerRole, RelatedPerson, ResearchSubject)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
56. AdverseEvent.participant
Definition | Indicates who or what participated in the adverse event and how they were involved.
Short | Who was involved in the adverse event or the potential adverse event and what they did
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
58. AdverseEvent.participant.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
60. AdverseEvent.participant.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 managable, 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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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.participant.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 managable, 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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.participant.function
Definition | Distinguishes the type of involvement of the actor in the adverse event, such as contributor or informant.
Short | Type of involvement
Control | 0..1
Binding | For example codes, see AdverseEventParticipantFunction (example to `http://hl7.org/fhir/ValueSet/adverse-event-participant-function` ) Codes describing the type of involvement of the actor in the adverse event.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
66. AdverseEvent.participant.actor
Definition | Indicates who or what participated in the event.
Short | Who was involved in the adverse event or the potential adverse event
Comments | For example, the physician prescribing a drug, a nurse administering the drug, a device that administered the drug, a witness to the event, or an informant of clinical history.
Control | 1..1
Type | Reference(Practitioner, PractitionerRole, Organization, CareTeam, Patient, Device, RelatedPerson, ResearchSubject)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
68. AdverseEvent.study
Definition | The research study that the subject is enrolled in.
Short | Research study that the subject is enrolled in
Control | 1..1
Type | Reference(ResearchStudy)
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
70. AdverseEvent.expectedInResearchStudy
Definition | Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely.
Short | Considered likely or probable or anticipated in the research study
Control | 0..1
Type | boolean
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Must Support | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
72. AdverseEvent.suspectEntity
Definition | Describes the entity that is suspected to have caused the adverse event.
Short | The suspected agent causing the adverse event
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
74. 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.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
76. 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 managable, 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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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()`)
78. 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 managable, 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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()`)
80. AdverseEvent.suspectEntity.instance[x]
Definition | Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device.
Short | Refers to the specific entity that caused the adverse event
Control | 1..1
Type | Choice of: CodeableConcept, Reference(Immunization, Procedure, Substance, Medication, MedicationAdministration, MedicationStatement, Device, BiologicallyDerivedProduct, ResearchStudy)
[x] Note | See Choice of Data Types for further information about how to use [x]
Is Modifier | false
Must Support | false
Summary | true
Alternate Names | Substance or Medication or Device
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
82. AdverseEvent.suspectEntity.causality
Definition | Information on the possible cause of the event.
Short | Information on the possible cause of the event
Control | 1..1
Type | BackboneElement
Is Modifier | false
Must Support | true
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
84. 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.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
86. 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 managable, 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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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()`)
88. 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 managable, 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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()`)
90. AdverseEvent.suspectEntity.causality.assessmentMethod
Definition | The method of evaluating the relatedness of the suspected entity to the event.
Short | Method of evaluating the relatedness of the suspected entity to the event.
Control | 0..1
Binding | The codes SHOULD be taken from AdverseEventCausalityMethod (preferred to `http://hl7.org/fhir/ValueSet/adverse-event-causality-method` ) Codes for the method of evaluating the relatedness of the suspected entity to the event, such as ProbabilityScale | Bayesian | Checklist.
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
92. AdverseEvent.suspectEntity.causality.entityRelatedness
Definition | The result of the assessment regarding the relatedness of the suspected entity to the event.
Short | Result of the assessment regarding the relatedness of the suspected entity to the event
Control | 0..1
Binding | The codes SHOULD be taken from Adverse Event Clinical Research Causality Relatedness (preferred to `http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-causality-relatedness` )
Type | CodeableConcept
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
94. AdverseEvent.suspectEntity.causality.author
Definition | The author of the information on the possible cause of the event.
Short | Author of the information on the possible cause of the event
Control | 0..1
Type | Reference(Practitioner, PractitionerRole, Patient, RelatedPerson, ResearchSubject)
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
96. AdverseEvent.contributingFactor
Definition | The contributing factors suspected to have increased the probability or severity of the adverse event.
Short | Contributing factors suspected to have increased the probability or severity of the adverse event
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
98. AdverseEvent.contributingFactor.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
100. AdverseEvent.contributingFactor.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 managable, 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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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()`)
102. AdverseEvent.contributingFactor.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 managable, 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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()`)
104. AdverseEvent.contributingFactor.item[x]
Definition | The item that is suspected to have increased the probability or severity of the adverse event.
Short | Item suspected to have increased the probability or severity of the adverse event
Control | 1..1
Binding | For example codes, see AdverseEventContributingFactor (example to `http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor` ) Codes describing the contributing factors suspected to have increased the probability or severity of the adverse event.
Type | Choice of: Reference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, Device, DeviceUsage, DocumentReference, MedicationAdministration, MedicationStatement), CodeableConcept
[x] Note | See Choice of Data Types for further information about how to use [x]
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
106. AdverseEvent.preventiveAction
Definition | Preventive actions that contributed to avoiding the adverse event.
Short | Preventive actions that contributed to avoiding the adverse event
Control | 0..0
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
112. AdverseEvent.mitigatingAction
Definition | The ameliorating action taken after the adverse event occured in order to reduce the extent of harm.
Short | Ameliorating actions taken after the adverse event occured in order to reduce the extent of harm
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
114. AdverseEvent.mitigatingAction.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
116. AdverseEvent.mitigatingAction.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 managable, 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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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()`)
118. AdverseEvent.mitigatingAction.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 managable, 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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()`)
120. AdverseEvent.mitigatingAction.item[x]
Definition | The ameliorating action taken after the adverse event occured in order to reduce the extent of harm.
Short | Ameliorating action taken after the adverse event occured in order to reduce the extent of harm
Control | 1..1
Binding | For example codes, see AdverseEventMitigatingAction (example to `http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action` ) Codes describing the ameliorating actions taken after the adverse event occured in order to reduce the extent of harm.
Type | Choice of: Reference(Procedure, DocumentReference, MedicationAdministration, MedicationRequest), CodeableConcept
[x] Note | See Choice of Data Types for further information about how to use [x]
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
122. AdverseEvent.supportingInfo
Definition | Supporting information relevant to the event.
Short | Supporting information relevant to the event
Control | 0..*
Type | BackboneElement
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
124. AdverseEvent.supportingInfo.id
Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Short | Unique id for inter-element referencing
Control | 0..1 This element is affected by the following invariants: ele-1
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
126. AdverseEvent.supportingInfo.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 managable, 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.
Short | Additional 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.
Control | 0..*
Type | Extension
Is Modifier | false
Summary | false
Alternate Names | extensions, user content
Invariants | ele-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()`)
128. AdverseEvent.supportingInfo.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 managable, 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).
Short | Extensions 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.
Control | 0..*
Type | Extension
Is Modifier | true because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Summary | true
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 Names | extensions, user content, modifiers
Invariants | ele-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()`)
130. AdverseEvent.supportingInfo.item[x]
Definition | Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a pencillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action.
Short | Subject medical history or document relevant to this adverse event
Control | 1..1
Binding | For example codes, see AdverseEventSupportingInforation (example to `http://hl7.org/fhir/ValueSet/adverse-event-supporting-info` ) Codes describing the supporting information relevant to the event.
Type | Choice of: Reference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, DocumentReference, MedicationAdministration, MedicationStatement, QuestionnaireResponse), CodeableConcept
[x] Note | See Choice of Data Types for further information about how to use [x]
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
132. AdverseEvent.note
Definition | Comments made about the adverse event by the performer, subject or other participants.
Short | Comment on adverse event
Control | 0..*
Type | Annotation
Is Modifier | false
Must Support | false
Summary | true
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)