Adverse Event Clinical Research R4 Backport
1.0.1 - STU1

Adverse Event Clinical Research R4 Backport, 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-backport-ig/ and changes regularly. See the Directory of published versions

## Extension: SupportingInfo - Detailed Descriptions

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

Definitions for the supporting-info extension.

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

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

0. Extension
Definition | Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin 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 | Supporting information relevant to the event
2. Extension.extension
Control | 1..?
4. Extension.extension:item
Slice Name | item
Short | Subject medical history or document relevant to this adverse event
Control | 1..1
6. Extension.extension:item.extension
Control | 0..0
8. Extension.extension:item.url
Fixed Value | `item`
10. Extension.extension:item.value[x]
[x] Note | See Choice of Data Types for further information about how to use [x]
Slicing | This element introduces a set of slices on `Extension.extension.value[x]`. The slices are unordered and Open, and can be differentiated using the following discriminators: type @ $this
12. Extension.extension:item.value[x]:valueReference
Slice Name | valueReference
Control | 0..1
Type | Reference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, DocumentReference, MedicationAdministration, MedicationStatement, QuestionnaireResponse)
[x] Note | See Choice of Data Types for further information about how to use [x]
14. Extension.extension:item.value[x]:valueCodeableConcept
Slice Name | valueCodeableConcept
Control | 0..1
Binding | For example codes, see AdverseEvent Supporting Information (example to `http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-supporting-info` ) Codes describing the supporting information relevant to the event.
Type | CodeableConcept
[x] Note | See Choice of Data Types for further information about how to use [x]
16. Extension.url
Fixed Value | `http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info`
18. Extension.value[x]
Control | 0..0

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

0. Extension
Definition | Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin 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. Optional Extension Element - found in all resources.
Short | Supporting information relevant to the eventOptional Extensions Element
Control | 0..* This element is affected by the following invariants: ele-1
Is Modifier | 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()`) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
2. Extension.extension
Definition | An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
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 | 10..*
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())
Slicing | This element introduces a set of slices on `Extension.extension`. The slices are unordered and Open, and can be differentiated using the following discriminators: value @ url
4. Extension.extension:item
Slice Name | item
Definition | An Extension
Short | Subject medical history or document relevant to this adverse eventAdditional content defined by implementations
Control | 10..1*
Type | Extension
Is Modifier | 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())
6. Extension.extension:item.extension
Definition | An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
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..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())
Slicing | This element introduces a set of slices on `Extension.extension.extension`. The slices are unordered and Open, and can be differentiated using the following discriminators: value @ url
8. Extension.extension:item.url
Definition | Source of the definition for the extension code - a logical name or a URL.
Short | identifies the meaning of the extension
Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control | 1..1
Type | uri
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
Fixed Value | `item`
10. Extension.extension:item.value[x]
Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short | Value of extension
Control | 0..1
Type | Choice of: CodeableConcept, Reference, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
[x] Note | See Choice of Data Types for further information about how to use [x]
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
Slicing | This element introduces a set of slices on `Extension.extension.value[x]`. The slices are unordered and Closed, and can be differentiated using the following discriminators: type @ $this
12. Extension.extension:item.value[x]:valueReference
Slice Name | valueReference
Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short | Value of extension
Control | 0..1
Type | Reference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, DocumentReference, MedicationAdministration, MedicationStatement, QuestionnaireResponse), date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, CodeableConcept, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
[x] Note | See Choice of Data Types for further information about how to use [x]
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
14. Extension.extension:item.value[x]:valueCodeableConcept
Slice Name | valueCodeableConcept
Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short | Value of extension
Control | 0..1
Binding | For example codes, see For codes, see AdverseEvent Supporting Information (example to `http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-supporting-info` ) Codes describing the supporting information relevant to the event.
Type | CodeableConcept, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, Coding, SampledData, id, positiveInt, Distance, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ParameterDefinition, dateTime, code, string, Contributor, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, boolean, Expression, Signature, unsignedInt, time
[x] Note | See Choice of Data Types for further information about how to use [x]
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
16. Extension.url
Definition | Source of the definition for the extension code - a logical name or a URL.
Short | identifies the meaning of the extension
Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control | 1..1
Type | uri
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
Fixed Value | `http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info`
18. Extension.value[x]
Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short | Value of extension
Control | 0..01
Type | Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
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. Extension
Definition | Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin 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 | Supporting information relevant to the event
Control | 0..* This element is affected by the following invariants: ele-1
Is Modifier | 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()`)
2. Extension.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
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
4. Extension.extension
Definition | An Extension
Short | Extension
Control | 1..*
Type | Extension
Is Modifier | 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 `Extension.extension`. The slices are unordered and Open, and can be differentiated using the following discriminators: value @ url
6. Extension.extension:item
Slice Name | item
Definition | An Extension
Short | Subject medical history or document relevant to this adverse event
Control | 1..1
Type | Extension
Is Modifier | 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()`)
8. Extension.extension:item.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
Type | string
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
10. Extension.extension:item.extension
Definition | An Extension
Short | Extension
Control | 0..0
Type | Extension
Is Modifier | 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 `Extension.extension.extension`. The slices are unordered and Open, and can be differentiated using the following discriminators: value @ url
12. Extension.extension:item.url
Definition | Source of the definition for the extension code - a logical name or a URL.
Short | identifies the meaning of the extension
Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control | 1..1
Type | uri
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
Fixed Value | `item`
14. Extension.extension:item.value[x]
Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short | Value of extension
Control | 0..1
Type | Choice of: CodeableConcept, Reference
[x] Note | See Choice of Data Types for further information about how to use [x]
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
Slicing | This element introduces a set of slices on `Extension.extension.value[x]`. The slices are unordered and Closed, and can be differentiated using the following discriminators: type @ $this
16. Extension.extension:item.value[x]:valueReference
Slice Name | valueReference
Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short | Value of extension
Control | 0..1
Type | Reference(Condition, Observation, AllergyIntolerance, FamilyMemberHistory, Immunization, Procedure, DocumentReference, MedicationAdministration, MedicationStatement, QuestionnaireResponse)
[x] Note | See Choice of Data Types for further information about how to use [x]
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
18. Extension.extension:item.value[x]:valueCodeableConcept
Slice Name | valueCodeableConcept
Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short | Value of extension
Control | 0..1
Binding | For example codes, see AdverseEvent Supporting Information (example to `http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-supporting-info` ) Codes describing the supporting information relevant to the event.
Type | CodeableConcept
[x] Note | See Choice of Data Types for further information about how to use [x]
Is Modifier | false
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)
20. Extension.url
Definition | Source of the definition for the extension code - a logical name or a URL.
Short | identifies the meaning of the extension
Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
Control | 1..1
Type | uri
Is Modifier | false
XML Format | In the XML format, this property is represented as an attribute.
Summary | false
Fixed Value | `http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info`
22. Extension.value[x]
Definition | Value of extension - must be one of a constrained set of the data types (see Extensibility for a list).
Short | Value of extension
Control | 0..0
Type | Choice of: base64Binary, boolean, canonical, code, date, dateTime, decimal, id, instant, integer, markdown, oid, positiveInt, string, time, unsignedInt, uri, url, uuid, Address, Age, Annotation, Attachment, CodeableConcept, Coding, ContactPoint, Count, Distance, Duration, HumanName, Identifier, Money, Period, Quantity, Range, Ratio, Reference, SampledData, Signature, Timing, ContactDetail, Contributor, DataRequirement, Expression, ParameterDefinition, RelatedArtifact, TriggerDefinition, UsageContext, Dosage, Meta
Is Modifier | false
Primitive Value | This primitive element may be present, or absent, or replaced by an extension
Summary | false
Invariants | ele-1: All FHIR elements must have a @value or children (`hasValue() or (children().count() > id.count())`)