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Enum: SurrogateEndpointFootnoteEnum

Footnotes and symbols used in the FDA surrogate endpoint workbook

URI: dismech:enum/SurrogateEndpointFootnoteEnum

Permissible Values

Value Meaning Description Additional Info
COMPOSITE_BIOMARKER_SURROGATE None Surrogate endpoint is part of a composite of biomarker surrogate endpoints Title: Composite biomarker surrogate
MECHANISM_AGNOSTIC None Many mechanisms of action are associated with the surrogate endpoint, so it i... Title: Mechanism agnostic
TUMOR_BURDEN_CONTEXT_DEPENDENT None Tumor-burden endpoints may support accelerated or traditional approval depend... Title: Tumor burden context dependent
ANTICIPATED_PRIMARY_EFFICACY_USE None FDA anticipates the endpoint could be appropriate as a primary efficacy endpo... Title: Anticipated primary efficacy use
BONE_MINERAL_DENSITY_CONTEXT None Bone mineral density footnote for male or glucocorticoid-induced osteoporosis... Title: Bone mineral density context
CLINICAL_ENDPOINTS_REQUIRED None Clinical endpoints were required for the approvals Title: Clinical endpoints required
ARRHYTHMIA_RESPONSE_DEFINITION None Specialized response definition footnote for supraventricular tachycardia end... Title: Arrhythmia response definition

Slots

Name Description
footnotes FDA workbook footnote semantics attached to the source row

Identifier and Mapping Information

Schema Source

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

LinkML Source

name: SurrogateEndpointFootnoteEnum
description: Footnotes and symbols used in the FDA surrogate endpoint workbook
from_schema: https://w3id.org/monarch-initiative/dismech
rank: 1000
permissible_values:
  COMPOSITE_BIOMARKER_SURROGATE:
    text: COMPOSITE_BIOMARKER_SURROGATE
    description: Surrogate endpoint is part of a composite of biomarker surrogate
      endpoints
    title: Composite biomarker surrogate
  MECHANISM_AGNOSTIC:
    text: MECHANISM_AGNOSTIC
    description: Many mechanisms of action are associated with the surrogate endpoint,
      so it is not directly related to a particular causal pathway
    title: Mechanism agnostic
  TUMOR_BURDEN_CONTEXT_DEPENDENT:
    text: TUMOR_BURDEN_CONTEXT_DEPENDENT
    description: Tumor-burden endpoints may support accelerated or traditional approval
      depending on context of use
    title: Tumor burden context dependent
  ANTICIPATED_PRIMARY_EFFICACY_USE:
    text: ANTICIPATED_PRIMARY_EFFICACY_USE
    description: FDA anticipates the endpoint could be appropriate as a primary efficacy
      endpoint although it has not yet supported an approved NDA or BLA
    title: Anticipated primary efficacy use
  BONE_MINERAL_DENSITY_CONTEXT:
    text: BONE_MINERAL_DENSITY_CONTEXT
    description: Bone mineral density footnote for male or glucocorticoid-induced
      osteoporosis contexts
    title: Bone mineral density context
  CLINICAL_ENDPOINTS_REQUIRED:
    text: CLINICAL_ENDPOINTS_REQUIRED
    description: Clinical endpoints were required for the approvals
    title: Clinical endpoints required
  ARRHYTHMIA_RESPONSE_DEFINITION:
    text: ARRHYTHMIA_RESPONSE_DEFINITION
    description: Specialized response definition footnote for supraventricular tachycardia
      endpoint
    title: Arrhythmia response definition