domain:
  name: ADAE
  label: Adverse Events Analysis Dataset

variables:
  ASEQ:
    label: Analysis Sequence Number
    type: integer
  AESEQ:
    label: Sponsor-Defined Identifier
    type: integer
  AETERM:
    label: Reported Term for the Adverse Event
    type: factor
  AELLT:
    label: Lowest Level Term
    type: factor
  AEDECOD:
    label: Dictionary-Derived Term
    type: factor
  AEHLT:
    label: High Level Term
    type: factor
  AEHLGT:
    label: High Level Group Term
    type: factor
  AEBODSYS:
    label: Body System or Organ Class
    type: factor
  AESOC:
    label: Primary System Organ Class
    type: factor
  AESEV:
    label: Severity/Intensity
    type: factor
  AESER:
    label: Serious Event
    type: factor
  AEACN:
    label: Action Taken With Study Treatment
    type: character
  AEREL:
    label: Analysis Causality
    type: factor
  AEOUT:
    label: Outcome of Adverse Event
    type: character
  AESDTH:
    label: Results in Death
    type: factor
  AESCONG:
    label: Congenital Anomaly or Birth Defect
    type: factor
  AESDISAB:
    label: Persist or Signif Disability/Incapacity
    type: factor
  AESHOSP:
    label: Requires or Prolongs Hospitalization
    type: factor
  AESLIFE:
    label: Is Life Threatening
    type: factor
  AESMIE:
    label: Other Medically Important Serious Event
    type: factor
  TRTEMFL:
    label: Treatment Emergent Analysis Flag
    type: factor
  AECONTRT:
    label: Concomitant or Additional Trtmnt Given
    type: factor
  ASTDTM:
    label: Analysis Start Datetime
    type: datetime
  AENDTM:
    label: Analysis End Datetime
    type: datetime
  ASTDY:
    label: Analysis Start Relative Day
    type: integer
  AENDY:
    label: Analysis End Relative Day
    type: integer
  LDOSEDTM:
    label: End Date/Time of Last Dose
    type: datetime
  LDRELTM:
    label: Last Dose Relative Time
    type: numeric
  AETOXGR:
    label: Analysis Toxicity Grade
    type: factor
  SMQ01NAM:
    label: SMQ 01 Reference Name
    type: character
  SMQ02NAM:
    label: SMQ 02 Reference Name
    type: character
  SMQ01SC:
    label: SMQ 01 Scope
    type: character
  SMQ02SC:
    label: SMQ 02 Scope
    type: character
  CQ01NAM:
    label: CQ 01 Reference Name
    type: character
  ANL01FL:
    label: Analysis Flag 01
    type: factor
  AERELNST:
    label: Relationship to Non-Study Treatment
    type: factor
  AEACNOTH:
    label: Other Action Taken
    type: factor
