Treatment-Emergent Adverse Events by System Organ Class and Preferred Term

id: t-ae-common
title: "Treatment-Emergent Adverse Events by System Organ Class and Preferred Term"
regulatory_id: AET02
type: table
dataset: adae
analysis_set: safety
denominator: adsl
group:
  - TRT01A
total: true
analyses:
  - name: by_soc_pt
    method: hierarchical_count
    label: "Adverse events by system organ class and preferred term"
    hierarchy: [AEBODSYS, AEDECOD]
    filter: "TRTEMFL == 'Y'"

id: t-ae-common
title: "Treatment-Emergent Adverse Events by System Organ Class and Preferred Term"
study: CDISCPILOT01
population_label: "Safety Analysis Set"
cutoff: "2014-07-01"
source: "Source: adae, adsl (pharmaverseadam). Data cut-off: 2014-07-01."
footnotes:
  - "Subjects are counted once per system organ class and once per preferred term, regardless of how many events they reported."
  - "Percentages are based on the number of subjects in the safety analysis set for each treatment group."
  - "System organ classes and preferred terms are sorted by descending subject count."
  - "The Total column pools all treatment groups; the 5% threshold applied to the in-text variant is evaluated on the treatment columns only, never on Total."
columns:
  order: [Placebo, "Xanomeline Low Dose", "Xanomeline High Dose", Total]
format:
  digits:
    p: 1
rows:
  - analysis: by_soc_pt
    type: hierarchical
    levels: [AEBODSYS, AEDECOD]
    pattern: n_pct
variants:
  post_text: {}
  in_text:
    title: "Common Treatment-Emergent Adverse Events (≥5% in any treatment group)"
    filter:
      min_pct: 5
    footnotes:
      - "Reduced variant: only preferred terms reported by at least 5% of subjects in at least one treatment group are shown. The full display is Section 14."