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Class: SurrogateEndpoint

A regulatory surrogate endpoint assertion curated from FDA's surrogate endpoint table or a similar authoritative source. This captures an endpoint used as a substitute for direct clinical benefit in a specified disease/use, patient population, approval-pathway, and therapeutic mechanism context.

URI: dismech:class/SurrogateEndpoint

 classDiagram
    class SurrogateEndpoint
    click SurrogateEndpoint href "../../classes/SurrogateEndpoint/"
      SurrogateEndpoint : age_range

      SurrogateEndpoint : approval_type





        SurrogateEndpoint --> "1" SurrogateEndpointApprovalTypeEnum : approval_type
        click SurrogateEndpointApprovalTypeEnum href "../../enums/SurrogateEndpointApprovalTypeEnum/"



      SurrogateEndpoint : clinical_benefit

      SurrogateEndpoint : clinical_benefit_linkage





        SurrogateEndpoint --> "1" ClinicalBenefitLinkageEnum : clinical_benefit_linkage
        click ClinicalBenefitLinkageEnum href "../../enums/ClinicalBenefitLinkageEnum/"



      SurrogateEndpoint : clinical_benefit_linkage_basis

      SurrogateEndpoint : context_of_use

      SurrogateEndpoint : disease_or_use

      SurrogateEndpoint : drug_mechanism_of_action

      SurrogateEndpoint : endpoint_validation_level





        SurrogateEndpoint --> "1" SurrogateEndpointValidationLevelEnum : endpoint_validation_level
        click SurrogateEndpointValidationLevelEnum href "../../enums/SurrogateEndpointValidationLevelEnum/"



      SurrogateEndpoint : evidence





        SurrogateEndpoint --> "* _recommended_" EvidenceItem : evidence
        click EvidenceItem href "../../classes/EvidenceItem/"



      SurrogateEndpoint : footnotes





        SurrogateEndpoint --> "*" SurrogateEndpointFootnoteEnum : footnotes
        click SurrogateEndpointFootnoteEnum href "../../enums/SurrogateEndpointFootnoteEnum/"



      SurrogateEndpoint : mapped_disease_files

      SurrogateEndpoint : mapped_diseases

      SurrogateEndpoint : mapping_notes

      SurrogateEndpoint : mapping_status





        SurrogateEndpoint --> "1" SurrogateEndpointMappingStatusEnum : mapping_status
        click SurrogateEndpointMappingStatusEnum href "../../enums/SurrogateEndpointMappingStatusEnum/"



      SurrogateEndpoint : notes

      SurrogateEndpoint : patient_population

      SurrogateEndpoint : retrieved_date

      SurrogateEndpoint : row_id

      SurrogateEndpoint : source_content_current_as_of

      SurrogateEndpoint : source_row_number

      SurrogateEndpoint : source_sheet

      SurrogateEndpoint : source_table





        SurrogateEndpoint --> "1" SurrogateEndpointTableEnum : source_table
        click SurrogateEndpointTableEnum href "../../enums/SurrogateEndpointTableEnum/"



      SurrogateEndpoint : source_url

      SurrogateEndpoint : source_workbook_sha256

      SurrogateEndpoint : source_workbook_url

      SurrogateEndpoint : surrogate_endpoint

Slots

Name Cardinality and Range Description Inheritance
row_id 1
String		 Stable row identifier assigned during source-table curation direct
source_table 1
SurrogateEndpointTableEnum		 FDA surrogate endpoint table section from which the row was curated direct
source_sheet 1
String		 Spreadsheet worksheet name or source table label direct
source_row_number 1
Integer		 Row number in the source spreadsheet worksheet direct
disease_or_use 1
String		 FDA disease or use text for a surrogate endpoint row direct
patient_population 1
String		 FDA patient population text for a surrogate endpoint row direct
surrogate_endpoint 1
String		 Surrogate endpoint text from the FDA surrogate endpoint table direct
approval_type 1
SurrogateEndpointApprovalTypeEnum		 FDA approval pathway context for the surrogate endpoint row direct
drug_mechanism_of_action 0..1
String		 FDA drug mechanism-of-action context for the surrogate endpoint row direct
age_range 0..1
String		 Age range or stratification, if applicable direct
endpoint_validation_level 1
SurrogateEndpointValidationLevelEnum		 BEST-aligned level direct
clinical_benefit_linkage 1
ClinicalBenefitLinkageEnum		 BEST-aligned relationship to clinical benefit direct
clinical_benefit 0..1
String		 Specific clinical benefit or clinical outcome predicted by the surrogate endp... direct
clinical_benefit_linkage_basis 0..1
String		 Explanation of how the clinical-benefit linkage was inferred or curated direct
footnotes *
SurrogateEndpointFootnoteEnum		 FDA workbook footnote semantics attached to the source row direct
context_of_use 0..1
String		 Concise context-of-use statement combining disease/use, population, endpoint,... direct
mapping_status 1
SurrogateEndpointMappingStatusEnum		 Status of mapping the FDA disease/use row to dismech disease entries direct
mapped_diseases *
String		 Names of dismech disease entries mapped or candidate-mapped to this FDA row direct
mapped_disease_files *
String		 Relative paths of dismech disease YAML files mapped or candidate-mapped to th... direct
mapping_notes 0..1
String		 Notes on code-to-concept mapping decisions for this signal direct
source_url 0..1
Uri		 URL of the source page for a curated assertion or source collection direct
source_workbook_url 0..1
Uri		 URL of the source workbook or downloadable data file direct
source_workbook_sha256 0..1
String		 SHA-256 checksum of the downloaded source workbook used for import direct
source_content_current_as_of 0..1
Date		 Date shown by the source as the content-current-as-of date direct
retrieved_date 0..1
Date		 Date on which the source was retrieved for curation direct
evidence * recommended
EvidenceItem		 direct
notes 0..1
String		 direct

Usages

used by used in type used
SurrogateEndpointCollection surrogate_endpoints range SurrogateEndpoint
Disease surrogate_endpoints range SurrogateEndpoint
FDASurrogateEndpointCollection surrogate_endpoints range SurrogateEndpoint

Identifier and Mapping Information

Schema Source

  • from schema: https://w3id.org/monarch-initiative/dismech

Mappings

Mapping Type Mapped Value
self dismech:SurrogateEndpoint
native dismech:SurrogateEndpoint

LinkML Source

Direct

name: SurrogateEndpoint
description: A regulatory surrogate endpoint assertion curated from FDA's surrogate
  endpoint table or a similar authoritative source. This captures an endpoint used
  as a substitute for direct clinical benefit in a specified disease/use, patient
  population, approval-pathway, and therapeutic mechanism context.
from_schema: https://w3id.org/monarch-initiative/dismech
slots:
- row_id
- source_table
- source_sheet
- source_row_number
- disease_or_use
- patient_population
- surrogate_endpoint
- approval_type
- drug_mechanism_of_action
- age_range
- endpoint_validation_level
- clinical_benefit_linkage
- clinical_benefit
- clinical_benefit_linkage_basis
- footnotes
- context_of_use
- mapping_status
- mapped_diseases
- mapped_disease_files
- mapping_notes
- source_url
- source_workbook_url
- source_workbook_sha256
- source_content_current_as_of
- retrieved_date
- evidence
- notes
slot_usage:
  row_id:
    name: row_id
    required: true
  source_table:
    name: source_table
    required: true
  source_sheet:
    name: source_sheet
    required: true
  source_row_number:
    name: source_row_number
    required: true
  disease_or_use:
    name: disease_or_use
    required: true
  patient_population:
    name: patient_population
    required: true
  surrogate_endpoint:
    name: surrogate_endpoint
    required: true
  approval_type:
    name: approval_type
    required: true
  endpoint_validation_level:
    name: endpoint_validation_level
    description: BEST-aligned level. For FDA-table rows this is derived from approval
      type unless a curator overrides it with more specific evidence.
    required: true
  clinical_benefit_linkage:
    name: clinical_benefit_linkage
    description: BEST-aligned relationship to clinical benefit. FDA table rows usually
      imply this via the approval pathway rather than naming a specific clinical outcome.
    required: true
  clinical_benefit:
    name: clinical_benefit
    description: Specific clinical benefit or clinical outcome predicted by the surrogate
      endpoint, when curated. FDA table rows may leave this blank.
  mapping_status:
    name: mapping_status
    required: true

Induced

name: SurrogateEndpoint
description: A regulatory surrogate endpoint assertion curated from FDA's surrogate
  endpoint table or a similar authoritative source. This captures an endpoint used
  as a substitute for direct clinical benefit in a specified disease/use, patient
  population, approval-pathway, and therapeutic mechanism context.
from_schema: https://w3id.org/monarch-initiative/dismech
slot_usage:
  row_id:
    name: row_id
    required: true
  source_table:
    name: source_table
    required: true
  source_sheet:
    name: source_sheet
    required: true
  source_row_number:
    name: source_row_number
    required: true
  disease_or_use:
    name: disease_or_use
    required: true
  patient_population:
    name: patient_population
    required: true
  surrogate_endpoint:
    name: surrogate_endpoint
    required: true
  approval_type:
    name: approval_type
    required: true
  endpoint_validation_level:
    name: endpoint_validation_level
    description: BEST-aligned level. For FDA-table rows this is derived from approval
      type unless a curator overrides it with more specific evidence.
    required: true
  clinical_benefit_linkage:
    name: clinical_benefit_linkage
    description: BEST-aligned relationship to clinical benefit. FDA table rows usually
      imply this via the approval pathway rather than naming a specific clinical outcome.
    required: true
  clinical_benefit:
    name: clinical_benefit
    description: Specific clinical benefit or clinical outcome predicted by the surrogate
      endpoint, when curated. FDA table rows may leave this blank.
  mapping_status:
    name: mapping_status
    required: true
attributes:
  row_id:
    name: row_id
    description: Stable row identifier assigned during source-table curation
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    identifier: true
    alias: row_id
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: string
    required: true
  source_table:
    name: source_table
    description: FDA surrogate endpoint table section from which the row was curated
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: source_table
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: SurrogateEndpointTableEnum
    required: true
  source_sheet:
    name: source_sheet
    description: Spreadsheet worksheet name or source table label
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: source_sheet
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: string
    required: true
  source_row_number:
    name: source_row_number
    description: Row number in the source spreadsheet worksheet
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: source_row_number
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: integer
    required: true
  disease_or_use:
    name: disease_or_use
    description: FDA disease or use text for a surrogate endpoint row
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: disease_or_use
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: string
    required: true
  patient_population:
    name: patient_population
    description: FDA patient population text for a surrogate endpoint row
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: patient_population
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: string
    required: true
  surrogate_endpoint:
    name: surrogate_endpoint
    description: Surrogate endpoint text from the FDA surrogate endpoint table
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: surrogate_endpoint
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: string
    required: true
  approval_type:
    name: approval_type
    description: FDA approval pathway context for the surrogate endpoint row
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: approval_type
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: SurrogateEndpointApprovalTypeEnum
    required: true
  drug_mechanism_of_action:
    name: drug_mechanism_of_action
    description: FDA drug mechanism-of-action context for the surrogate endpoint row
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: drug_mechanism_of_action
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: string
  age_range:
    name: age_range
    description: Age range or stratification, if applicable
    examples:
    - value: Childhood-Adolescence
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: age_range
    owner: SurrogateEndpoint
    domain_of:
    - PhenotypeContext
    - SurrogateEndpoint
    - ProgressionInfo
    - Demographics
    range: string
  endpoint_validation_level:
    name: endpoint_validation_level
    description: BEST-aligned level. For FDA-table rows this is derived from approval
      type unless a curator overrides it with more specific evidence.
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: endpoint_validation_level
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: SurrogateEndpointValidationLevelEnum
    required: true
  clinical_benefit_linkage:
    name: clinical_benefit_linkage
    description: BEST-aligned relationship to clinical benefit. FDA table rows usually
      imply this via the approval pathway rather than naming a specific clinical outcome.
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: clinical_benefit_linkage
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: ClinicalBenefitLinkageEnum
    required: true
  clinical_benefit:
    name: clinical_benefit
    description: Specific clinical benefit or clinical outcome predicted by the surrogate
      endpoint, when curated. FDA table rows may leave this blank.
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: clinical_benefit
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: string
  clinical_benefit_linkage_basis:
    name: clinical_benefit_linkage_basis
    description: Explanation of how the clinical-benefit linkage was inferred or curated
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: clinical_benefit_linkage_basis
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: string
  footnotes:
    name: footnotes
    description: FDA workbook footnote semantics attached to the source row
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: footnotes
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: SurrogateEndpointFootnoteEnum
    multivalued: true
  context_of_use:
    name: context_of_use
    description: Concise context-of-use statement combining disease/use, population,
      endpoint, approval type, and therapeutic mechanism
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: context_of_use
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: string
  mapping_status:
    name: mapping_status
    description: Status of mapping the FDA disease/use row to dismech disease entries
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: mapping_status
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: SurrogateEndpointMappingStatusEnum
    required: true
  mapped_diseases:
    name: mapped_diseases
    description: Names of dismech disease entries mapped or candidate-mapped to this
      FDA row
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: mapped_diseases
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: string
    multivalued: true
  mapped_disease_files:
    name: mapped_disease_files
    description: Relative paths of dismech disease YAML files mapped or candidate-mapped
      to this FDA row
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: mapped_disease_files
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    range: string
    multivalued: true
  mapping_notes:
    name: mapping_notes
    description: Notes on code-to-concept mapping decisions for this signal
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: mapping_notes
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    - AssociationSignal
    range: string
  source_url:
    name: source_url
    description: URL of the source page for a curated assertion or source collection
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: source_url
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    - SurrogateEndpointCollection
    range: uri
  source_workbook_url:
    name: source_workbook_url
    description: URL of the source workbook or downloadable data file
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: source_workbook_url
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    - SurrogateEndpointCollection
    range: uri
  source_workbook_sha256:
    name: source_workbook_sha256
    description: SHA-256 checksum of the downloaded source workbook used for import
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: source_workbook_sha256
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    - SurrogateEndpointCollection
    range: string
  source_content_current_as_of:
    name: source_content_current_as_of
    description: Date shown by the source as the content-current-as-of date
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: source_content_current_as_of
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    - SurrogateEndpointCollection
    range: date
  retrieved_date:
    name: retrieved_date
    description: Date on which the source was retrieved for curation
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: retrieved_date
    owner: SurrogateEndpoint
    domain_of:
    - SurrogateEndpoint
    - SurrogateEndpointCollection
    range: date
  evidence:
    name: evidence
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: evidence
    owner: SurrogateEndpoint
    domain_of:
    - PhenotypeContext
    - Dataset
    - ExperimentalModel
    - Experiment
    - ExperimentalPerturbation
    - ExperimentalReadout
    - ExperimentalControl
    - ClinicalTrial
    - ComputationalModel
    - DifferentialDiagnosis
    - Subtype
    - CausalEdge
    - TreatmentMechanismTarget
    - ModelMechanismLink
    - BiomarkerReadout
    - ReferenceRange
    - SurrogateEndpoint
    - ExternalAssertion
    - Finding
    - Prevalence
    - ProgressionInfo
    - EpidemiologyInfo
    - Pathophysiology
    - Phenotype
    - Biochemical
    - HistopathologyFinding
    - Genetic
    - Environmental
    - Stage
    - AgentLifeCycle
    - AgentLifeCycleStage
    - AnimalModel
    - Treatment
    - InfectiousAgent
    - Transmission
    - Diagnosis
    - Inheritance
    - Variant
    - ModelingConsideration
    - ClassificationAssignment
    - Definition
    - CriteriaSet
    - AssociationSignal
    - AssociationStatistics
    - ComorbidityHypothesis
    - UpstreamConditionHypothesis
    - MechanisticHypothesis
    - Discussion
    range: EvidenceItem
    recommended: true
    multivalued: true
    inlined: true
    inlined_as_list: true
  notes:
    name: notes
    examples:
    - value: Contagious stage where symptoms appear and the bacteria can be spread
        to others.
    from_schema: https://w3id.org/monarch-initiative/dismech
    rank: 1000
    alias: notes
    owner: SurrogateEndpoint
    domain_of:
    - GeneticContext
    - OnsetDescriptor
    - PhenotypeContext
    - Dataset
    - ExperimentalModel
    - Experiment
    - ExperimentalPerturbation
    - ExperimentalReadout
    - ExperimentalControl
    - ClinicalTrial
    - ComputationalModel
    - ModelVariable
    - DifferentialDiagnosis
    - ReferenceRange
    - SurrogateEndpoint
    - SurrogateEndpointCollection
    - ExternalAssertion
    - TrackedIssue
    - Prevalence
    - ProgressionInfo
    - EpidemiologyInfo
    - Pathophysiology
    - Phenotype
    - Biochemical
    - HistopathologyFinding
    - Genetic
    - Environmental
    - Disease
    - Stage
    - AgentLifeCycle
    - AgentLifeCycleStage
    - Treatment
    - Transmission
    - Diagnosis
    - ClassificationAssignment
    - Definition
    - CriteriaSet
    - TermMapping
    - MappingConsistency
    - ComorbidityAssociation
    - AssociationSignal
    - AssociationMetric
    - AssociationStatistics
    - MechanisticHypothesis
    - Discussion
    range: string