Class: Intercurrent Event (IntercurrentEvent)
An event(s) occurring after treatment initiation that affects either the interpretation or the existence of the measurements associated with the clinical question of interest. (ICH E9 Addendum on Estimands)
URI: https://example.org/usdm/v4/linkml/IntercurrentEvent
classDiagram
class IntercurrentEvent
click IntercurrentEvent href "../../classes/IntercurrentEvent/"
SyntaxTemplate <|-- IntercurrentEvent
click SyntaxTemplate href "../../classes/SyntaxTemplate/"
IntercurrentEvent : description
IntercurrentEvent : dictionaryId
IntercurrentEvent --> "0..1" SyntaxTemplateDictionary : dictionaryId
click SyntaxTemplateDictionary href "../../classes/SyntaxTemplateDictionary/"
IntercurrentEvent : extensionAttributes
IntercurrentEvent --> "*" ExtensionAttribute : extensionAttributes
click ExtensionAttribute href "../../classes/ExtensionAttribute/"
IntercurrentEvent : id
IntercurrentEvent : label
IntercurrentEvent : name
IntercurrentEvent : notes
IntercurrentEvent --> "*" CommentAnnotation : notes
click CommentAnnotation href "../../classes/CommentAnnotation/"
IntercurrentEvent : strategy
IntercurrentEvent : text
Inheritance
- SyntaxTemplate
- IntercurrentEvent
Class Properties
| Property | Value |
|---|---|
| Class URI | usdm:IntercurrentEvent |
Slots
| Name | Cardinality and Range | Description | Inheritance |
|---|---|---|---|
| strategy | 1 string |
A textual description of the planned strategy to manage and/or mitigate intercurrent events. | direct |
| extensionAttributes | * ExtensionAttribute |
direct | |
| id | 1 string |
SyntaxTemplate | |
| name | 1 string |
The literal identifier (i.e., distinctive designation) of the characteristic. | SyntaxTemplate |
| label | 0..1 string |
The short descriptive designation for the characteristic. | SyntaxTemplate |
| description | 0..1 string |
A narrative representation of the characteristic. | SyntaxTemplate |
| text | 1 string |
An instance of structured text that represents the characteristic. | SyntaxTemplate |
| notes | * CommentAnnotation |
A brief written record relevant to the characteristic. | SyntaxTemplate |
| dictionaryId | 0..1 SyntaxTemplateDictionary |
A USDM relationship between the Characteristic and SyntaxTemplateDictionary classes which provides the set of dictionary entries related to characteristics. | SyntaxTemplate |
Usages
| used by | used in | type | used |
|---|---|---|---|
| Estimand | intercurrentEvents | range | IntercurrentEvent |
Identifier and Mapping Information
Schema Source
- from schema: https://example.org/usdm/v4/linkml
Mappings
| Mapping Type | Mapped Value |
|---|---|
| self | https://example.org/usdm/v4/linkml/IntercurrentEvent |
| native | https://example.org/usdm/v4/linkml/IntercurrentEvent |
| exact | ncit:C188815 |
LinkML Source
Direct
name: IntercurrentEvent
description: An event(s) occurring after treatment initiation that affects either
the interpretation or the existence of the measurements associated with the clinical
question of interest. (ICH E9 Addendum on Estimands)
title: Intercurrent Event
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C188815
rank: 1000
is_a: SyntaxTemplate
attributes:
strategy:
name: strategy
description: A textual description of the planned strategy to manage and/or mitigate
intercurrent events.
title: Intercurrent Event Strategy
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C188857
rank: 1000
domain_of:
- IntercurrentEvent
range: string
required: true
extensionAttributes:
name: extensionAttributes
from_schema: https://example.org/usdm/v4/linkml
domain_of:
- Abbreviation
- Activity
- Address
- AdministrableProduct
- AdministrableProductIdentifier
- AdministrableProductProperty
- Administration
- AliasCode
- AnalysisPopulation
- AssignedPerson
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- BiospecimenRetention
- Characteristic
- Code
- CommentAnnotation
- Condition
- ConditionAssignment
- DocumentContentReference
- Duration
- EligibilityCriterion
- EligibilityCriterionItem
- Encounter
- Endpoint
- Estimand
- ExtensionAttribute
- ExtensionClass
- GeographicScope
- GovernanceDate
- Indication
- Ingredient
- IntercurrentEvent
- InterventionalStudyDesign
- Masking
- MedicalDevice
- MedicalDeviceIdentifier
- NarrativeContent
- NarrativeContentItem
- Objective
- ObservationalStudyDesign
- Organization
- ParameterMap
- PersonName
- Procedure
- ProductOrganizationRole
- Quantity
- Range
- ReferenceIdentifier
- ResponseCode
- ScheduleTimeline
- ScheduleTimelineExit
- ScheduledActivityInstance
- ScheduledDecisionInstance
- Strength
- Study
- StudyAmendment
- StudyAmendmentImpact
- StudyAmendmentReason
- StudyArm
- StudyCell
- StudyChange
- StudyCohort
- StudyDefinitionDocument
- StudyDefinitionDocumentVersion
- StudyDesignPopulation
- StudyElement
- StudyEpoch
- StudyIdentifier
- StudyIntervention
- StudyRole
- StudySite
- StudyTitle
- StudyVersion
- SubjectEnrollment
- Substance
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: ExtensionAttribute
required: false
multivalued: true
inlined: true
inlined_as_list: true
class_uri: usdm:IntercurrentEvent
Induced
name: IntercurrentEvent
description: An event(s) occurring after treatment initiation that affects either
the interpretation or the existence of the measurements associated with the clinical
question of interest. (ICH E9 Addendum on Estimands)
title: Intercurrent Event
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C188815
rank: 1000
is_a: SyntaxTemplate
attributes:
strategy:
name: strategy
description: A textual description of the planned strategy to manage and/or mitigate
intercurrent events.
title: Intercurrent Event Strategy
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C188857
rank: 1000
alias: strategy
owner: IntercurrentEvent
domain_of:
- IntercurrentEvent
range: string
required: true
extensionAttributes:
name: extensionAttributes
from_schema: https://example.org/usdm/v4/linkml
alias: extensionAttributes
owner: IntercurrentEvent
domain_of:
- Abbreviation
- Activity
- Address
- AdministrableProduct
- AdministrableProductIdentifier
- AdministrableProductProperty
- Administration
- AliasCode
- AnalysisPopulation
- AssignedPerson
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- BiospecimenRetention
- Characteristic
- Code
- CommentAnnotation
- Condition
- ConditionAssignment
- DocumentContentReference
- Duration
- EligibilityCriterion
- EligibilityCriterionItem
- Encounter
- Endpoint
- Estimand
- ExtensionAttribute
- ExtensionClass
- GeographicScope
- GovernanceDate
- Indication
- Ingredient
- IntercurrentEvent
- InterventionalStudyDesign
- Masking
- MedicalDevice
- MedicalDeviceIdentifier
- NarrativeContent
- NarrativeContentItem
- Objective
- ObservationalStudyDesign
- Organization
- ParameterMap
- PersonName
- Procedure
- ProductOrganizationRole
- Quantity
- Range
- ReferenceIdentifier
- ResponseCode
- ScheduleTimeline
- ScheduleTimelineExit
- ScheduledActivityInstance
- ScheduledDecisionInstance
- Strength
- Study
- StudyAmendment
- StudyAmendmentImpact
- StudyAmendmentReason
- StudyArm
- StudyCell
- StudyChange
- StudyCohort
- StudyDefinitionDocument
- StudyDefinitionDocumentVersion
- StudyDesignPopulation
- StudyElement
- StudyEpoch
- StudyIdentifier
- StudyIntervention
- StudyRole
- StudySite
- StudyTitle
- StudyVersion
- SubjectEnrollment
- Substance
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: ExtensionAttribute
required: false
multivalued: true
inlined: true
inlined_as_list: true
id:
name: id
from_schema: https://example.org/usdm/v4/linkml
identifier: true
alias: id
owner: IntercurrentEvent
domain_of:
- Abbreviation
- Activity
- Address
- AdministrableProduct
- AdministrableProductProperty
- Administration
- AliasCode
- AnalysisPopulation
- AssignedPerson
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- BiospecimenRetention
- Code
- CommentAnnotation
- ConditionAssignment
- DocumentContentReference
- Duration
- EligibilityCriterion
- Encounter
- Estimand
- ExtensionAttribute
- ExtensionClass
- GeographicScope
- GovernanceDate
- Identifier
- Indication
- Ingredient
- Masking
- MedicalDevice
- NarrativeContent
- NarrativeContentItem
- Organization
- ParameterMap
- PersonName
- PopulationDefinition
- Procedure
- ProductOrganizationRole
- QuantityRange
- ResponseCode
- ScheduleTimeline
- ScheduleTimelineExit
- ScheduledInstance
- Strength
- Study
- StudyAmendment
- StudyAmendmentImpact
- StudyAmendmentReason
- StudyArm
- StudyCell
- StudyChange
- StudyDefinitionDocument
- StudyDefinitionDocumentVersion
- StudyDesign
- StudyElement
- StudyEpoch
- StudyIntervention
- StudyRole
- StudySite
- StudyTitle
- StudyVersion
- SubjectEnrollment
- Substance
- SyntaxTemplate
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: string
required: true
name:
name: name
description: The literal identifier (i.e., distinctive designation) of the characteristic.
title: Characteristic Name
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207477
alias: name
owner: IntercurrentEvent
domain_of:
- Activity
- AdministrableProduct
- AdministrableProductProperty
- Administration
- AnalysisPopulation
- AssignedPerson
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- BiospecimenRetention
- EligibilityCriterion
- Encounter
- Estimand
- GovernanceDate
- Indication
- MedicalDevice
- NarrativeContent
- NarrativeContentItem
- Organization
- PopulationDefinition
- Procedure
- ProductOrganizationRole
- ResponseCode
- ScheduleTimeline
- ScheduledInstance
- Strength
- Study
- StudyAmendment
- StudyArm
- StudyChange
- StudyDefinitionDocument
- StudyDesign
- StudyElement
- StudyEpoch
- StudyIntervention
- StudyRole
- StudySite
- SubjectEnrollment
- Substance
- SyntaxTemplate
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: string
required: true
label:
name: label
description: The short descriptive designation for the characteristic.
title: Characteristic Label
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207476
alias: label
owner: IntercurrentEvent
domain_of:
- Activity
- AdministrableProduct
- Administration
- AnalysisPopulation
- AssignedPerson
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- BiospecimenRetention
- EligibilityCriterion
- Encounter
- Estimand
- GovernanceDate
- Indication
- MedicalDevice
- Organization
- PopulationDefinition
- Procedure
- ProductOrganizationRole
- ResponseCode
- ScheduleTimeline
- ScheduledInstance
- Strength
- Study
- StudyAmendment
- StudyArm
- StudyChange
- StudyDefinitionDocument
- StudyDesign
- StudyElement
- StudyEpoch
- StudyIntervention
- StudyRole
- StudySite
- SubjectEnrollment
- Substance
- SyntaxTemplate
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: string
required: false
description:
name: description
description: A narrative representation of the characteristic.
title: Characteristic Description
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207475
alias: description
owner: IntercurrentEvent
domain_of:
- Activity
- AdministrableProduct
- Administration
- AnalysisPopulation
- AssignedPerson
- BiomedicalConceptCategory
- BiomedicalConceptSurrogate
- BiospecimenRetention
- EligibilityCriterion
- Encounter
- Estimand
- GovernanceDate
- Indication
- MedicalDevice
- PopulationDefinition
- Procedure
- ProductOrganizationRole
- ScheduleTimeline
- ScheduledInstance
- Strength
- Study
- StudyAmendment
- StudyArm
- StudyChange
- StudyDefinitionDocument
- StudyDesign
- StudyElement
- StudyEpoch
- StudyIntervention
- StudyRole
- StudySite
- SubjectEnrollment
- Substance
- SyntaxTemplate
- SyntaxTemplateDictionary
- Timing
- TransitionRule
range: string
required: false
text:
name: text
description: An instance of structured text that represents the characteristic.
title: Characteristic Text
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C207478
alias: text
owner: IntercurrentEvent
domain_of:
- Address
- AdministrableProductProperty
- AnalysisPopulation
- CommentAnnotation
- Duration
- Identifier
- Masking
- NarrativeContentItem
- PersonName
- StudyAmendmentImpact
- StudyTitle
- SyntaxTemplate
- TransitionRule
range: string
required: true
notes:
name: notes
description: A brief written record relevant to the characteristic.
title: Characteristic Notes
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C215548
alias: notes
owner: IntercurrentEvent
domain_of:
- Abbreviation
- Activity
- AdministrableProduct
- Administration
- AnalysisPopulation
- BiomedicalConcept
- BiomedicalConceptCategory
- BiomedicalConceptProperty
- BiomedicalConceptSurrogate
- EligibilityCriterion
- Encounter
- Estimand
- Indication
- MedicalDevice
- PopulationDefinition
- Procedure
- StudyAmendment
- StudyAmendmentImpact
- StudyArm
- StudyDefinitionDocument
- StudyDefinitionDocumentVersion
- StudyDesign
- StudyElement
- StudyEpoch
- StudyIntervention
- StudyRole
- StudyVersion
- SyntaxTemplate
range: CommentAnnotation
required: false
multivalued: true
inlined: true
inlined_as_list: true
dictionaryId:
name: dictionaryId
description: A USDM relationship between the Characteristic and SyntaxTemplateDictionary
classes which provides the set of dictionary entries related to characteristics.
from_schema: https://example.org/usdm/v4/linkml
rank: 1000
alias: dictionaryId
owner: IntercurrentEvent
domain_of:
- SyntaxTemplate
range: SyntaxTemplateDictionary
required: false
inlined: false
class_uri: usdm:IntercurrentEvent