TFL Gallery / t-populations
DST02 · Table
Summary of Populations
How many subjects each analysis is run on — ITT, safety and efficacy — by planned treatment group, with percentages over the group's randomised N. The denominator every other display's N is checked against.
- Slug
- t-populations
- Regulatory ID
- DST02
- Type
- Table
- E3 position
- §14.1
- Status
- evidenced
- Current iteration
- v003
- Datasets
- adsl 70c7278
- Evidence
- 25/25 passing
- Requirements
- DSP-ALL-001 DSP-ALL-002 DSP-INTXT-001 DSP-INTXT-002 DSP-INTXT-003 DSP-POP-001 DSP-POP-002 DSP-POP-003 DSP-POP-004 DSP-REF-001 DSP-REF-002 DSP-REF-003 DSP-REF-004 STD-GATE-001 STD-GATE-002 STD-GATE-003 STD-GATE-004 STD-GATE-005 STD-MODEL-001 STD-MODEL-002 STD-MODEL-003 STD-MODEL-004 STD-MODEL-005 STD-SRC-001 STD-SRC-002
- Used in
- Clinical Study Report Table 14.1.3
- Study Synopsis
- Post-Text Display Package Table 14.1.3
- Abbreviated Clinical Study Report (ICH E3) Table 14.1.3
- Study model
- All Randomised Subjects · grouped by TRT01P
- Specification
- 3 iterations
- Environment
- R 4.3.3 Darwin 23.6.0
- Bound by
- TXT-E3-1101
- Values
- No value is sourced from it
Inputs
- adsl254 rows · 70c7278
- analysis.yamlwhat to compute
- display.yamlhow to show it
- study modelAll Randomised Subjects
Function
- prepare_data()regenerate('t-populations')
- build_ard()one row per statistic
- render_display()every variant
- render_rtf()the same cells
Outputs
- ard.jsonv003 · 60 rows · a78a73c
- table.htmlthe rendered display
- table.rtfsha256 7f11a39
- table-in-text.rtfsha256 06cd8f8
- manifest.jsonwho, why, every hash
Generated by the same pipeline run that wrote the ARD and the HTML above, from the same rendered cells; the short hash is the manifest's record of the file.
| Summary of Populations | ||||
| Study CDISCPILOT01 — All Subjects | ||||
| Placebo (N=86) | Xanomeline Low Dose (N=84) | Xanomeline High Dose (N=84) | Total (N=254) | |
|---|---|---|---|---|
| Intent-To-Treat (ITT) | ||||
| Safety | ||||
| Efficacy | ||||
| Complete Week 24 | ||||
| Complete Study | ||||
| 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. | ||||
| Source: adsl (phuse-org/phuse-scripts, data/adam/cdisc — the CDISC pilot submission's own ADaM package). Data cut-off: 2015-03-05. | ||||
| open.csr display t-populations (post_text variant); generated from the committed ARD. | ||||
Rendered from outputs/t-populations/v003/table.html.
| analysis | group1 | group1_level | group2 | group2_level | variable | variable_level | context | stat_name | stat_label | warning | error | stat |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| itt | TRT01P | Placebo | — | — | ITTFL | Y | subject_count | n | n | — | — | 86 |
| itt | TRT01P | Placebo | — | — | ITTFL | Y | subject_count | N | N | — | — | 86 |
| itt | TRT01P | Placebo | — | — | ITTFL | Y | subject_count | p | % | — | — | 1 |
| itt | TRT01P | Xanomeline Low Dose | — | — | ITTFL | Y | subject_count | n | n | — | — | 84 |
| itt | TRT01P | Xanomeline Low Dose | — | — | ITTFL | Y | subject_count | N | N | — | — | 84 |
| itt | TRT01P | Xanomeline Low Dose | — | — | ITTFL | Y | subject_count | p | % | — | — | 1 |
| itt | TRT01P | Xanomeline High Dose | — | — | ITTFL | Y | subject_count | n | n | — | — | 84 |
| itt | TRT01P | Xanomeline High Dose | — | — | ITTFL | Y | subject_count | N | N | — | — | 84 |
| itt | TRT01P | Xanomeline High Dose | — | — | ITTFL | Y | subject_count | p | % | — | — | 1 |
| itt | TRT01P | Total | — | — | ITTFL | Y | subject_count | n | n | — | — | 254 |
| itt | TRT01P | Total | — | — | ITTFL | Y | subject_count | N | N | — | — | 254 |
| itt | TRT01P | Total | — | — | ITTFL | Y | subject_count | p | % | — | — | 1 |
| safety | TRT01P | Placebo | — | — | SAFFL | Y | subject_count | n | n | — | — | 86 |
| safety | TRT01P | Placebo | — | — | SAFFL | Y | subject_count | N | N | — | — | 86 |
| safety | TRT01P | Placebo | — | — | SAFFL | Y | subject_count | p | % | — | — | 1 |
| safety | TRT01P | Xanomeline Low Dose | — | — | SAFFL | Y | subject_count | n | n | — | — | 84 |
| safety | TRT01P | Xanomeline Low Dose | — | — | SAFFL | Y | subject_count | N | N | — | — | 84 |
| safety | TRT01P | Xanomeline Low Dose | — | — | SAFFL | Y | subject_count | p | % | — | — | 1 |
| safety | TRT01P | Xanomeline High Dose | — | — | SAFFL | Y | subject_count | n | n | — | — | 84 |
| safety | TRT01P | Xanomeline High Dose | — | — | SAFFL | Y | subject_count | N | N | — | — | 84 |
| safety | TRT01P | Xanomeline High Dose | — | — | SAFFL | Y | subject_count | p | % | — | — | 1 |
| safety | TRT01P | Total | — | — | SAFFL | Y | subject_count | n | n | — | — | 254 |
| safety | TRT01P | Total | — | — | SAFFL | Y | subject_count | N | N | — | — | 254 |
| safety | TRT01P | Total | — | — | SAFFL | Y | subject_count | p | % | — | — | 1 |
| efficacy | TRT01P | Placebo | — | — | EFFFL | Y | subject_count | n | n | — | — | 79 |
| efficacy | TRT01P | Placebo | — | — | EFFFL | Y | subject_count | N | N | — | — | 86 |
| efficacy | TRT01P | Placebo | — | — | EFFFL | Y | subject_count | p | % | — | — | 0.918604651162791 |
| efficacy | TRT01P | Xanomeline Low Dose | — | — | EFFFL | Y | subject_count | n | n | — | — | 81 |
| efficacy | TRT01P | Xanomeline Low Dose | — | — | EFFFL | Y | subject_count | N | N | — | — | 84 |
| efficacy | TRT01P | Xanomeline Low Dose | — | — | EFFFL | Y | subject_count | p | % | — | — | 0.964285714285714 |
| efficacy | TRT01P | Xanomeline High Dose | — | — | EFFFL | Y | subject_count | n | n | — | — | 74 |
| efficacy | TRT01P | Xanomeline High Dose | — | — | EFFFL | Y | subject_count | N | N | — | — | 84 |
| efficacy | TRT01P | Xanomeline High Dose | — | — | EFFFL | Y | subject_count | p | % | — | — | 0.880952380952381 |
| efficacy | TRT01P | Total | — | — | EFFFL | Y | subject_count | n | n | — | — | 234 |
| efficacy | TRT01P | Total | — | — | EFFFL | Y | subject_count | N | N | — | — | 254 |
| efficacy | TRT01P | Total | — | — | EFFFL | Y | subject_count | p | % | — | — | 0.921259842519685 |
| complete_wk24 | TRT01P | Placebo | — | — | COMP24FL | Y | subject_count | n | n | — | — | 60 |
| complete_wk24 | TRT01P | Placebo | — | — | COMP24FL | Y | subject_count | N | N | — | — | 86 |
| complete_wk24 | TRT01P | Placebo | — | — | COMP24FL | Y | subject_count | p | % | — | — | 0.697674418604651 |
| complete_wk24 | TRT01P | Xanomeline Low Dose | — | — | COMP24FL | Y | subject_count | n | n | — | — | 28 |
| complete_wk24 | TRT01P | Xanomeline Low Dose | — | — | COMP24FL | Y | subject_count | N | N | — | — | 84 |
| complete_wk24 | TRT01P | Xanomeline Low Dose | — | — | COMP24FL | Y | subject_count | p | % | — | — | 0.333333333333333 |
| complete_wk24 | TRT01P | Xanomeline High Dose | — | — | COMP24FL | Y | subject_count | n | n | — | — | 30 |
| complete_wk24 | TRT01P | Xanomeline High Dose | — | — | COMP24FL | Y | subject_count | N | N | — | — | 84 |
| complete_wk24 | TRT01P | Xanomeline High Dose | — | — | COMP24FL | Y | subject_count | p | % | — | — | 0.357142857142857 |
| complete_wk24 | TRT01P | Total | — | — | COMP24FL | Y | subject_count | n | n | — | — | 118 |
| complete_wk24 | TRT01P | Total | — | — | COMP24FL | Y | subject_count | N | N | — | — | 254 |
| complete_wk24 | TRT01P | Total | — | — | COMP24FL | Y | subject_count | p | % | — | — | 0.464566929133858 |
| complete_study | TRT01P | Placebo | — | — | COMPLFL | Y | subject_count | n | n | — | — | 58 |
| complete_study | TRT01P | Placebo | — | — | COMPLFL | Y | subject_count | N | N | — | — | 86 |
| complete_study | TRT01P | Placebo | — | — | COMPLFL | Y | subject_count | p | % | — | — | 0.674418604651163 |
| complete_study | TRT01P | Xanomeline Low Dose | — | — | COMPLFL | Y | subject_count | n | n | — | — | 25 |
| complete_study | TRT01P | Xanomeline Low Dose | — | — | COMPLFL | Y | subject_count | N | N | — | — | 84 |
| complete_study | TRT01P | Xanomeline Low Dose | — | — | COMPLFL | Y | subject_count | p | % | — | — | 0.297619047619048 |
| complete_study | TRT01P | Xanomeline High Dose | — | — | COMPLFL | Y | subject_count | n | n | — | — | 27 |
| complete_study | TRT01P | Xanomeline High Dose | — | — | COMPLFL | Y | subject_count | N | N | — | — | 84 |
| complete_study | TRT01P | Xanomeline High Dose | — | — | COMPLFL | Y | subject_count | p | % | — | — | 0.321428571428571 |
| complete_study | TRT01P | Total | — | — | COMPLFL | Y | subject_count | n | n | — | — | 110 |
| complete_study | TRT01P | Total | — | — | COMPLFL | Y | subject_count | N | N | — | — | 254 |
| complete_study | TRT01P | Total | — | — | COMPLFL | Y | subject_count | p | % | — | — | 0.433070866141732 |
60 rows, one per computed statistic.
- Schema
- opencsr/ard/v1
- Generated
- 2026-09-02T15:23:26Z
- Spec hash
- sha256:c8dbaff2d4a4cad9b25ac1dcad574d029394f9730e76116bd44b52f60af38414
- Display hash
- sha256:9ac815d290f719b956f05fbc8d2353a3d49e676edd6ddb6daedc7481524cccd0
- ARD file
- outputs/t-populations/v003/ard.json
- ARD hash
- sha256:a78a73c17c1a5ae078f0fdf5a098aac06805bf9387675d823a8b849dce24fb2c
Source datasets
| Dataset | Rows | Package | Hash |
|---|---|---|---|
| adsl | 254 | phuse-org/phuse-scripts:data/adam 398a6d33ced9359ffb58c46650a6d488811176b1 | sha256:70c7278e83e571a7d4a94fd864c98bf8ca243c7c2cc9eec8b99a40fa7bc98e35 |
Environment
R 4.3.3 · Darwin 23.6.0 · cards 0.6.1 · cardx 0.2.5 · gtsummary 2.3.0 · gt 1.0.0 · dplyr 1.1.4 · pharmaverseadam 1.1.0 · jsonlite 2.0.0 · yaml 2.3.10 · digest 0.6.37
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)"
v003current
One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical.
2026-09-02T15:23:26Z · @obotclaw
v002
Correct the population line. The reference report runs Table 14-1.01 over All Subjects; this display claimed Intent-to-Treat, and t-end-of-study claimed the reverse — the two were transcribed the wrong way round. In this study both select the same 254 subjects, so no figure moves; the table now states the population its reference states. The footnotes now name the two things this display defines that the reference does not: the derivation of Complete Study, and the meaning of N.
2026-08-27T03:44:48Z · @obotclaw
v001
Initial generation of DST02 from the CDISCPILOT01 statistical analysis plan (Attachment 13.1.1 Template 1).
2026-08-27T02:18:05Z · @jwildfire
Every iteration is kept: outputs/t-populations/vNNN/ holds the spec snapshot, the ARD, the rendered output, and a manifest recording who regenerated it, why, and from which commit.