t-populations

id: t-populations
title: "Summary of Populations"
regulatory_id: DST02
type: table
dataset: adsl
# The report runs Table 14-1.01 over "All Subjects" and Table 14-1.02 over
# "Intent-to-Treat" — the population line printed above each table. In this ADSL
# the two sets are the same 254 people, because every randomised subject carries
# ITTFL == 'Y' and the screen failures are not in the file at all (asserted by
# DSP-POP-004). They are still not the same claim, so each display states the one
# its table states.
analysis_set: all
denominator: adsl
# The analysis populations this table reports are stated by the study, not
# derived: ITTFL, SAFFL and EFFFL are carried in the CDISC pilot's own ADSL and
# do not exist in the {pharmaverseadam} re-derivation of the same study.
sources: phuse
# Planned treatment, as in the reference report: every column N and every
# denominator here is a randomised group, not a treated one. In this ADSL
# TRT01P and TRT01A agree for all 254 subjects (asserted by DSP-POP-004).
group:
  - TRT01P
total: true
analyses:
  - name: itt
    method: subject_count
    label: "Intent-To-Treat (ITT)"
    variable: ITTFL
    filter: "ITTFL == 'Y'"
  - name: safety
    method: subject_count
    label: "Safety"
    variable: SAFFL
    filter: "SAFFL == 'Y'"
  - name: efficacy
    method: subject_count
    label: "Efficacy"
    variable: EFFFL
    filter: "EFFFL == 'Y'"
  - name: complete_wk24
    method: subject_count
    label: "Complete Week 24"
    variable: COMP24FL
    filter: "COMP24FL == 'Y'"
  - name: complete_study
    method: subject_count
    label: "Complete Study"
    variable: COMPLFL
    filter: "COMPLFL == 'Y'"

id: t-populations
title: "Summary of Populations"
study: CDISCPILOT01
population_label: "All Subjects"
cutoff: "2015-03-05"
source: "Source: adsl (phuse-org/phuse-scripts, data/adam/cdisc — the CDISC pilot submission's own ADaM package). Data cut-off: 2015-03-05."
footnotes:
  - "N in the column headers is the number of subjects randomised to that treatment group; percentages are based on it. The reference report's note calls this the number of subjects \"entered in study (i.e., signed informed consent)\". This display does not repeat that wording: 306 subjects were screened and 254 randomised, and it is the 254 that N counts."
  - "The ITT population includes all subjects randomised. The Safety population includes all randomised subjects known to have taken at least one dose of randomised study drug. The Efficacy population includes all subjects in the safety population who also have at least one post-baseline ADAS-Cog and CIBIC+ assessment."
  - "Treatment groups are planned (randomised) treatment, TRT01P. In this ADSL planned and actual treatment agree for all 254 subjects."
  - "The population line above reads All Subjects because that is what the reference report prints above this table. In this study it selects the same 254 subjects as the Intent-To-Treat row below, since the analysis dataset contains only randomised subjects and every one of them carries ITTFL = Y."
  - "Complete Week 24 is the study's own COMP24FL. Complete Study is not a variable the study ships: the reference report prints the row but states no definition for it, so this display derives it as the complement of the study's own DISCONFL — a subject who did not discontinue. That derivation is open.csr's, not the study's, and the evidence for it is that it reproduces all four printed figures (58, 25, 27, 110) and the report's own narrative that 110 subjects completed the study through Week 26."
  - "The cut-off shown is the latest subject end date (RFENDT) recorded in the vendored ADSL. The CDISC pilot package states no separate database-lock date."
columns:
  order: [Placebo, "Xanomeline Low Dose", "Xanomeline High Dose", Total]
format:
  digits:
    p: 0
rows:
  - { analysis: itt, label: "Intent-To-Treat (ITT)", pattern: n_pct }
  - { analysis: safety, label: "Safety", pattern: n_pct }
  - { analysis: efficacy, label: "Efficacy", pattern: n_pct }
  - { analysis: complete_wk24, label: "Complete Week 24", pattern: n_pct }
  - { analysis: complete_study, label: "Complete Study", pattern: n_pct }
variants:
  post_text: {}
  in_text:
    title: "Summary of Populations (Summary)"