domain:
  name: ADSL
  label: Subject Level Analysis Dataset

variables:
  STUDYID:
    label: Study Identifier
    type: character
  USUBJID:
    label: Unique Subject Identifier
    type: character
  SUBJID:
    label: Subject Identifier for the Study
    type: character
  SITEID:
    label: Study Site Identifier
    type: character
  AGE:
    label: Age
    type: integer
  AGEU:
    label: Age Units
    type: factor
  SEX:
    label: Sex
    type: factor
  RACE:
    label: Race
    type: factor
  ETHNIC:
    label: Ethnicity
    type: factor
  COUNTRY:
    label: Country
    type: factor
  DTHFL:
    label: Subject Death Flag
    type: factor
  INVID:
    label: Investigator Identifier
    type: character
  INVNAM:
    label: Investigator Name
    type: character
  ARM:
    label: Description of Planned Arm
    type: factor
  ARMCD:
    label: Planned Arm Code
    type: factor
  ACTARM:
    label: Description of Actual Arm
    type: factor
  ACTARMCD:
    label: Actual Arm Code
    type: factor
  TRT01P:
    label: Planned Treatment for Period 01
    type: factor
  TRT01A:
    label: Actual Treatment for Period 01
    type: factor
  TRT02P:
    label: Planned Treatment for Period 02
    type: factor
  TRT02A:
    label: Actual Treatment for Period 02
    type: factor
  REGION1:
    label: Geographic Region 1
    type: factor
  STRATA1:
    label: Stratification Factor 1
    type: factor
  STRATA2:
    label: Stratification Factor 2
    type: factor
  BMRKR1:
    label: Continuous Level Biomarker 1
    type: numeric
  BMRKR2:
    label: Categorical Level Biomarker 2
    type: factor
  ITTFL:
    label: Intent-To-Treat Population Flag
    type: factor
  SAFFL:
    label: Safety Population Flag
    type: factor
  BMEASIFL:
    label: Response Evaluable Population Flag
    type: factor
  BEP01FL:
    label: Biomarker Evaluable Population Flag
    type: factor
  AEWITHFL:
    label: AE Leading to Drug Withdrawal Flag
    type: factor
  RANDDT:
    label: Date of Randomization
    type: date
  TRTSDTM:
    label: Datetime of First Exposure to Treatment
    type: datetime
  TRTEDTM:
    label: Datetime of Last Exposure to Treatment
    type: datetime
  TRT01SDTM:
    label: Datetime of First Exposure to Treatment in Period 01
    type: datetime
  TRT01EDTM:
    label: Datetime of Last Exposure in Period 01
    type: datetime
  TRT02SDTM:
    label: Datetime of First Exposure to Treatment in Period 02
    type: datetime
  TRT02EDTM:
    label: Datetime of Last Exposure to Treatment in Period 02
    type: datetime
  AP01SDTM:
    label: Period 01 Start Datetime
    type: datetime
  AP01EDTM:
    label: Period 01 End Datetime
    type: datetime
  AP02SDTM:
    label: Period 02 Start Datetime
    type: datetime
  AP02EDTM:
    label: Period 02 End Datetime
    type: datetime
  EOSSTT:
    label: End of Study Status
    type: factor
  EOTSTT:
    label: End of Treatment Status
    type: factor
  EOSDT:
    label: End of Study Date
    type: date
  EOSDY:
    label: End of Study Relative Day
    type: integer
  DCSREAS:
    label: Reason for Discontinuation from Study
    type: factor
  DTHDT:
    label: Date of Death
    type: date
  DTHCAUS:
    label: Cause of Death
    type: factor
  DTHCAT:
    label: Cause of Death Category
    type: factor
  LDDTHELD:
    label: Elapsed Days from Last Dose to Death
    type: integer
  LDDTHGR1:
    label: Last Dose to Death - Days Elapsed Grp 1
    type: factor
  LSTALVDT:
    label: Date Last Known Alive
    type: date
  DTHADY:
    label: Relative Day of Death
    type: integer
  ADTHAUT:
    label: Autopsy Performed
    type: factor
