Enum: FDAIDAAdverseEventEnum

please consult with the FDA guidelines as proposed in this document: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.32

URI: FDAIDAAdverseEventEnum

Permissible Values

Value	Meaning	Description
life_threatening_adverse_event	None	An adverse event or suspected adverse reaction is considered 'life-threatenin...
serious_adverse_event	None	An adverse event or suspected adverse reaction is considered 'serious' if, in...
suspected_adverse_reaction	None	means any adverse event for which there is a reasonable possibility that the ...
unexpected_adverse_event	None	An adverse event or suspected adverse reaction is considered 'unexpected' if ...

Slots

Name	Description
FDA_adverse_event_level

Identifier and Mapping Information

Schema Source

• from schema: https://w3id.org/biolink/biolink-model

LinkML Source

name: FDAIDAAdverseEventEnum
description: 'please consult with the FDA guidelines as proposed in this document:
  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.32'
from_schema: https://w3id.org/biolink/biolink-model
permissible_values:
  life_threatening_adverse_event:
    text: life_threatening_adverse_event
    description: An adverse event or suspected adverse reaction is considered 'life-threatening'
      if, in the view of either  the investigator or sponsor, its occurrence places
      the patient or subject at immediate risk of death.  It does not include an adverse
      event or suspected adverse reaction that, had it occurred in a more  severe
      form, might have caused death.
  serious_adverse_event:
    text: serious_adverse_event
    description: 'An adverse event or suspected adverse reaction is considered ''serious''
      if, in the view of either the  investigator or sponsor, it results in any of
      the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization
      or prolongation of existing hospitalization, a persistent or significant incapacity  or
      substantial disruption of the ability to conduct normal life functions, or a
      congenital anomaly/birth  defect. Important medical events that may not result
      in death, be life-threatening, or require hospitalization may be considered
      serious when, based upon appropriate medical judgment, they may jeopardize the
      patient or  subject and may require medical or surgical intervention to prevent
      one of the outcomes listed in this  definition. Examples of such medical events
      include allergic bronchospasm requiring intensive treatment  in an emergency
      room or at home, blood dyscrasias or convulsions that do not result in inpatient  hospitalization,
      or the development of drug dependency or drug abuse.'
  suspected_adverse_reaction:
    text: suspected_adverse_reaction
    description: means any adverse event for which there is a reasonable possibility
      that the drug caused the adverse event.  For the purposes of IND safety reporting,
      'reasonable possibility' means there is evidence to suggest a  causal relationship
      between the drug and the adverse event. Suspected adverse reaction implies a
      lesser  degree of certainty about causality than adverse reaction, which means
      any adverse event caused by a drug.
  unexpected_adverse_event:
    text: unexpected_adverse_event
    description: An adverse event or suspected adverse reaction is considered 'unexpected'
      if it is not listed in the  investigator brochure or is not listed at the specificity
      or severity that has been observed; or, if an  investigator brochure is not
      required or available, is not consistent with the risk information described  in
      the general investigational plan or elsewhere in the current application, as
      amended. For example,  under this definition, hepatic necrosis would be unexpected
      (by virtue of greater severity) if the  investigator brochure referred only
      to elevated hepatic enzymes or hepatitis. Similarly, cerebral  thromboembolism
      and cerebral vasculitis would be unexpected (by virtue of greater specificity)
      if the  investigator brochure listed only cerebral vascular accidents. 'Unexpected',
      as used in this definition,  also refers to adverse events or suspected adverse
      reactions that are mentioned in the investigator brochure as occurring with
      a class of drugs or as anticipated from the pharmacological properties of the
      drug, but  are not specifically mentioned as occurring with the particular drug
      under investigation.