Class: Analysis Population (AnalysisPopulation)

A target study population on which an analysis is performed. These may be represented by the entire study population, a subgroup defined by a particular characteristic measured at baseline, or a principal stratum defined by the occurrence (or non-occurrence, depending on context) of a specific intercurrent event. (ICH E9 R1 Addendum)

URI: https://example.org/usdm/v4/linkml/AnalysisPopulation

 classDiagram
    class AnalysisPopulation
    click AnalysisPopulation href "../../classes/AnalysisPopulation/"
      AnalysisPopulation : description

      AnalysisPopulation : extensionAttributes





        AnalysisPopulation --> "*" ExtensionAttribute : extensionAttributes
        click ExtensionAttribute href "../../classes/ExtensionAttribute/"



      AnalysisPopulation : id

      AnalysisPopulation : label

      AnalysisPopulation : name

      AnalysisPopulation : notes





        AnalysisPopulation --> "*" CommentAnnotation : notes
        click CommentAnnotation href "../../classes/CommentAnnotation/"



      AnalysisPopulation : subsetOfIds





        AnalysisPopulation --> "*" PopulationDefinition : subsetOfIds
        click PopulationDefinition href "../../classes/PopulationDefinition/"



      AnalysisPopulation : text

Class Properties

Property	Value
Class URI	usdm:AnalysisPopulation

Slots

Name	Cardinality and Range	Description	Inheritance
id	1 string		direct
text	1 string	An instance of unstructured text that represents the analysis population.	direct
name	1 string	The literal identifier (i.e., distinctive designation) of the analysis population.	direct
label	0..1 string	The short descriptive designation for the analysis population.	direct
description	0..1 string	A narrative representation of the analysis population.	direct
notes	* CommentAnnotation	A brief written record relevant to the analysis population.	direct
subsetOfIds	* PopulationDefinition	A USDM relationship between the AnalysisPopulation and PopulationDefinition classes which identifies the population definition of which the analysis population is a subset.	direct
extensionAttributes	* ExtensionAttribute		direct

Usages

used by	used in	type	used
Estimand	analysisPopulationId	range	AnalysisPopulation
InterventionalStudyDesign	analysisPopulations	range	AnalysisPopulation
ObservationalStudyDesign	analysisPopulations	range	AnalysisPopulation
StudyDesign	analysisPopulations	range	AnalysisPopulation

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/AnalysisPopulation
native	https://example.org/usdm/v4/linkml/AnalysisPopulation
exact	ncit:C188814

Examples

Example: AnalysisPopulation-01-Minimal-Data-Instance

id: AnalysisPopulation_Min_01
text: All-Subjects-Enrolled Population
name: Enrolled Population

Example: AnalysisPopulation-02-Standard-Instance

id: AnalysisPopulation_Std_01
text: The Safety Population includes all participants who received at least one dose of the study intervention.
name: Safety Population
label: Safety Set
description: Primary population for the evaluation of safety and tolerability.

Example: AnalysisPopulation-03-Detailed-Instance

id: AnalysisPopulation_Det_01
text: The Intent-to-Treat (ITT) Population includes all randomized participants who have at least one post-baseline efficacy assessment.
name: Intent-to-Treat Population
label: ITT Population
description: This population will be used as the primary set for all efficacy analyses based on the treatment assigned at randomization.
notes:
  - id: Comment_AP_01
    text: Consistent with ICH E9 guidelines for statistical principles in clinical trials.
subsetOfIds:
  - PopulationDefinition_Randomized_01

LinkML Source

Direct

name: AnalysisPopulation
description: A target study population on which an analysis is performed. These may
  be represented by the entire study population, a subgroup defined by a particular
  characteristic measured at baseline, or a principal stratum defined by the occurrence
  (or non-occurrence, depending on context) of a specific intercurrent event. (ICH
  E9 R1 Addendum)
title: Analysis Population
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C188814
rank: 1000
attributes:
  id:
    name: id
    from_schema: https://example.org/usdm/v4/linkml
    identifier: true
    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
  text:
    name: text
    description: An instance of unstructured text that represents the analysis population.
    title: Analysis Population Text
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C207468
    domain_of:
    - Address
    - AdministrableProductProperty
    - AnalysisPopulation
    - CommentAnnotation
    - Duration
    - Identifier
    - Masking
    - NarrativeContentItem
    - PersonName
    - StudyAmendmentImpact
    - StudyTitle
    - SyntaxTemplate
    - TransitionRule
    range: string
    required: true
  name:
    name: name
    description: The literal identifier (i.e., distinctive designation) of the analysis
      population.
    title: Analysis Population Name
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C207467
    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 analysis population.
    title: Analysis Population Label
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C207466
    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 analysis population.
    title: Analysis Population Description
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C188854
    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
  notes:
    name: notes
    description: A brief written record relevant to the analysis population.
    title: Analysis Population Notes
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215525
    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
  subsetOfIds:
    name: subsetOfIds
    description: A USDM relationship between the AnalysisPopulation and PopulationDefinition
      classes which identifies the population definition of which the analysis population
      is a subset.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    domain_of:
    - AnalysisPopulation
    range: PopulationDefinition
    required: false
    multivalued: true
    inlined: false
  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:AnalysisPopulation

Induced

name: AnalysisPopulation
description: A target study population on which an analysis is performed. These may
  be represented by the entire study population, a subgroup defined by a particular
  characteristic measured at baseline, or a principal stratum defined by the occurrence
  (or non-occurrence, depending on context) of a specific intercurrent event. (ICH
  E9 R1 Addendum)
title: Analysis Population
from_schema: https://example.org/usdm/v4/linkml
exact_mappings:
- ncit:C188814
rank: 1000
attributes:
  id:
    name: id
    from_schema: https://example.org/usdm/v4/linkml
    identifier: true
    alias: id
    owner: AnalysisPopulation
    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
  text:
    name: text
    description: An instance of unstructured text that represents the analysis population.
    title: Analysis Population Text
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C207468
    alias: text
    owner: AnalysisPopulation
    domain_of:
    - Address
    - AdministrableProductProperty
    - AnalysisPopulation
    - CommentAnnotation
    - Duration
    - Identifier
    - Masking
    - NarrativeContentItem
    - PersonName
    - StudyAmendmentImpact
    - StudyTitle
    - SyntaxTemplate
    - TransitionRule
    range: string
    required: true
  name:
    name: name
    description: The literal identifier (i.e., distinctive designation) of the analysis
      population.
    title: Analysis Population Name
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C207467
    alias: name
    owner: AnalysisPopulation
    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 analysis population.
    title: Analysis Population Label
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C207466
    alias: label
    owner: AnalysisPopulation
    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 analysis population.
    title: Analysis Population Description
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C188854
    alias: description
    owner: AnalysisPopulation
    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
  notes:
    name: notes
    description: A brief written record relevant to the analysis population.
    title: Analysis Population Notes
    from_schema: https://example.org/usdm/v4/linkml
    exact_mappings:
    - ncit:C215525
    alias: notes
    owner: AnalysisPopulation
    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
  subsetOfIds:
    name: subsetOfIds
    description: A USDM relationship between the AnalysisPopulation and PopulationDefinition
      classes which identifies the population definition of which the analysis population
      is a subset.
    from_schema: https://example.org/usdm/v4/linkml
    rank: 1000
    alias: subsetOfIds
    owner: AnalysisPopulation
    domain_of:
    - AnalysisPopulation
    range: PopulationDefinition
    required: false
    multivalued: true
    inlined: false
  extensionAttributes:
    name: extensionAttributes
    from_schema: https://example.org/usdm/v4/linkml
    alias: extensionAttributes
    owner: AnalysisPopulation
    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:AnalysisPopulation

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