id: ADAE
label: Adverse Events Analysis Dataset
class: OCCURRENCE DATA STRUCTURE
subclass: ADVERSE EVENT
structure: One record per adverse event per subject
keys: [USUBJID, AESEQ]

population:
  base:
    - domain: AE
      depends:
        - USUBJID
      filter: USUBJID != ""
  global:
    - filter: SAFFL == "Y"
      depends:
        - SAFFL

columns:
  - id: STUDYID
    label: Study Identifier
    method: AE.STUDYID
    core: Req

  - id: USUBJID
    label: Unique Subject Identifier
    method: AE.USUBJID
    core: Req

  - id: AESEQ
    label: Sequence Number
    method: AE.AESEQ
    core: Cond

  - id: AETERM
    label: Reported Term for the Adverse Event
    method: AE.AETERM
    core: Req

  - id: AEDECOD
    label: Dictionary-Derived Term
    method: AE.AEDECOD
    core: Cond

  - id: AEBODSYS
    label: Body System or Organ Class
    method: AE.AEBODSYS
    core: Cond

  - id: ASTDT
    label: Analysis Start Date
    method: Derived from AE.AESTDTC
    format:
      type: date
      length: 8
      display: date9.
    core: Cond

  - id: AENDT
    label: Analysis End Date
    method: Derived from AE.AEENDTC
    format:
      type: date
      length: 8
      display: date9.
    core: Cond

  - id: TRTEMFL
    label: Treatment Emergent Flag
    method: Derived based on treatment period
    format:
      type: text
      length: 1
    core: Cond
