Subject Disposition

Screened, randomised, treated, completed and discontinued counts with reasons for discontinuation, over the ITT set.

Slug: t-disposition
Regulatory ID: DST01
Type: Table
E3 position: §14.1
Status: evidenced
Current iteration: v003
Datasets: adsl 70c7278
Evidence: 19/19 passing
Requirements: DSP-ALL-001 DSP-ALL-002 DSP-DISP-001 DSP-DISP-002 DSP-INTXT-001 DSP-INTXT-002 DSP-INTXT-003 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 14.1.1
Study Synopsis Table 13.1
Post-Text Display Package Table 14.1.1
Abbreviated Clinical Study Report (ICH E3) Table 14.1.1
Study model: Intent-to-Treat Population ITTFL · grouped by TRT01A
Specification: 3 iterations
Environment: R 4.3.3 Darwin 23.6.0
Bound by: TXT-E3-1001 TXT-E3-1101 TXT-E3-1206 TXT-E3-1300 TXT-E3-0901
Values: randomised-n treated-n completed-n discontinued-n completed-pct

Inputs

adsl254 rows · 70c7278
analysis.yamlwhat to compute
display.yamlhow to show it
study modelIntent-to-Treat Population

Function

prepare_data()regenerate('t-disposition')
build_ard()one row per statistic
render_display()every variant
render_rtf()the same cells

Outputs

ard.jsonv003 · 84 rows · 5a073a0
table.htmlthe rendered display
table.rtfsha256 6579d64
table-in-text.rtfsha256 8d38ef3
manifest.jsonwho, why, every hash

RTFFull display6579d64 RTFIn-text variant8d38ef3

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.

t-disposition · post_text variant · study CDISCPILOT01 · data cut-off 2014-07-01

	Placebo (N=86)	Xanomeline Low Dose (N=84)	Xanomeline High Dose (N=84)	Total (N=254)
Subject Disposition
Study CDISCPILOT01 — Intent-to-Treat Analysis Set
Disposition, n (%)
Subjects randomised	86 (100.0%)	84 (100.0%)	84 (100.0%)	254 (100.0%)
Subjects treated	86 (100.0%)	84 (100.0%)	84 (100.0%)	254 (100.0%)
Completed the study	58 (67.4%)	25 (29.8%)	27 (32.1%)	110 (43.3%)
Discontinued the study	28 (32.6%)	59 (70.2%)	57 (67.9%)	144 (56.7%)
Reason for discontinuation, n (%)
Death	2 (2.3%)	1 (1.2%)	0 (0.0%)	3 (1.2%)
Other / not specified	26 (30.2%)	58 (69.0%)	57 (67.9%)	141 (55.5%)
Deaths, n (%)
Died on study	2 (2.3%)	1 (1.2%)	0 (0.0%)	3 (1.2%)
Percentages are based on the number of randomised subjects in each treatment group.
The ADSL shipped in pharmaverseadam carries no DCSREAS/DCDECOD, so the reason for discontinuation is derived: 'Death' where DTHFL = 'Y', otherwise 'Other / not specified'.
52 screen failures are excluded from every analysis dataset.
Source: adsl (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01.
open.csr display t-disposition (post_text variant); generated from the committed ARD.

Rendered from outputs/t-disposition/v003/table.html.

analysis	group1	group1_level	group2	group2_level	variable	variable_level	context	stat_name	stat_label	warning	error	stat
randomised	TRT01A	Placebo	—	—	RANDFL	Y	subject_count	n	n	—	—	86
randomised	TRT01A	Placebo	—	—	RANDFL	Y	subject_count	N	N	—	—	86
randomised	TRT01A	Placebo	—	—	RANDFL	Y	subject_count	p	%	—	—	1
randomised	TRT01A	Xanomeline Low Dose	—	—	RANDFL	Y	subject_count	n	n	—	—	84
randomised	TRT01A	Xanomeline Low Dose	—	—	RANDFL	Y	subject_count	N	N	—	—	84
randomised	TRT01A	Xanomeline Low Dose	—	—	RANDFL	Y	subject_count	p	%	—	—	1
randomised	TRT01A	Xanomeline High Dose	—	—	RANDFL	Y	subject_count	n	n	—	—	84
randomised	TRT01A	Xanomeline High Dose	—	—	RANDFL	Y	subject_count	N	N	—	—	84
randomised	TRT01A	Xanomeline High Dose	—	—	RANDFL	Y	subject_count	p	%	—	—	1
randomised	TRT01A	Total	—	—	RANDFL	Y	subject_count	n	n	—	—	254
randomised	TRT01A	Total	—	—	RANDFL	Y	subject_count	N	N	—	—	254
randomised	TRT01A	Total	—	—	RANDFL	Y	subject_count	p	%	—	—	1
treated	TRT01A	Placebo	—	—	SAFFL	Y	subject_count	n	n	—	—	86
treated	TRT01A	Placebo	—	—	SAFFL	Y	subject_count	N	N	—	—	86
treated	TRT01A	Placebo	—	—	SAFFL	Y	subject_count	p	%	—	—	1
treated	TRT01A	Xanomeline Low Dose	—	—	SAFFL	Y	subject_count	n	n	—	—	84
treated	TRT01A	Xanomeline Low Dose	—	—	SAFFL	Y	subject_count	N	N	—	—	84
treated	TRT01A	Xanomeline Low Dose	—	—	SAFFL	Y	subject_count	p	%	—	—	1
treated	TRT01A	Xanomeline High Dose	—	—	SAFFL	Y	subject_count	n	n	—	—	84
treated	TRT01A	Xanomeline High Dose	—	—	SAFFL	Y	subject_count	N	N	—	—	84
treated	TRT01A	Xanomeline High Dose	—	—	SAFFL	Y	subject_count	p	%	—	—	1
treated	TRT01A	Total	—	—	SAFFL	Y	subject_count	n	n	—	—	254
treated	TRT01A	Total	—	—	SAFFL	Y	subject_count	N	N	—	—	254
treated	TRT01A	Total	—	—	SAFFL	Y	subject_count	p	%	—	—	1
completed	TRT01A	Placebo	—	—	COMPLFL	Y	subject_count	n	n	—	—	58
completed	TRT01A	Placebo	—	—	COMPLFL	Y	subject_count	N	N	—	—	86
completed	TRT01A	Placebo	—	—	COMPLFL	Y	subject_count	p	%	—	—	0.674418604651163
completed	TRT01A	Xanomeline Low Dose	—	—	COMPLFL	Y	subject_count	n	n	—	—	25
completed	TRT01A	Xanomeline Low Dose	—	—	COMPLFL	Y	subject_count	N	N	—	—	84
completed	TRT01A	Xanomeline Low Dose	—	—	COMPLFL	Y	subject_count	p	%	—	—	0.297619047619048
completed	TRT01A	Xanomeline High Dose	—	—	COMPLFL	Y	subject_count	n	n	—	—	27
completed	TRT01A	Xanomeline High Dose	—	—	COMPLFL	Y	subject_count	N	N	—	—	84
completed	TRT01A	Xanomeline High Dose	—	—	COMPLFL	Y	subject_count	p	%	—	—	0.321428571428571
completed	TRT01A	Total	—	—	COMPLFL	Y	subject_count	n	n	—	—	110
completed	TRT01A	Total	—	—	COMPLFL	Y	subject_count	N	N	—	—	254
completed	TRT01A	Total	—	—	COMPLFL	Y	subject_count	p	%	—	—	0.433070866141732
discontinued	TRT01A	Placebo	—	—	DISCFL	Y	subject_count	n	n	—	—	28
discontinued	TRT01A	Placebo	—	—	DISCFL	Y	subject_count	N	N	—	—	86
discontinued	TRT01A	Placebo	—	—	DISCFL	Y	subject_count	p	%	—	—	0.325581395348837
discontinued	TRT01A	Xanomeline Low Dose	—	—	DISCFL	Y	subject_count	n	n	—	—	59
discontinued	TRT01A	Xanomeline Low Dose	—	—	DISCFL	Y	subject_count	N	N	—	—	84
discontinued	TRT01A	Xanomeline Low Dose	—	—	DISCFL	Y	subject_count	p	%	—	—	0.702380952380952
discontinued	TRT01A	Xanomeline High Dose	—	—	DISCFL	Y	subject_count	n	n	—	—	57
discontinued	TRT01A	Xanomeline High Dose	—	—	DISCFL	Y	subject_count	N	N	—	—	84
discontinued	TRT01A	Xanomeline High Dose	—	—	DISCFL	Y	subject_count	p	%	—	—	0.678571428571429
discontinued	TRT01A	Total	—	—	DISCFL	Y	subject_count	n	n	—	—	144
discontinued	TRT01A	Total	—	—	DISCFL	Y	subject_count	N	N	—	—	254
discontinued	TRT01A	Total	—	—	DISCFL	Y	subject_count	p	%	—	—	0.566929133858268
disc_death	TRT01A	Placebo	—	—	DISCREAS	Y	subject_count	n	n	—	—	2
disc_death	TRT01A	Placebo	—	—	DISCREAS	Y	subject_count	N	N	—	—	86
disc_death	TRT01A	Placebo	—	—	DISCREAS	Y	subject_count	p	%	—	—	0.0232558139534884
disc_death	TRT01A	Xanomeline Low Dose	—	—	DISCREAS	Y	subject_count	n	n	—	—	1
disc_death	TRT01A	Xanomeline Low Dose	—	—	DISCREAS	Y	subject_count	N	N	—	—	84
disc_death	TRT01A	Xanomeline Low Dose	—	—	DISCREAS	Y	subject_count	p	%	—	—	0.0119047619047619
disc_death	TRT01A	Xanomeline High Dose	—	—	DISCREAS	Y	subject_count	n	n	—	—	0
disc_death	TRT01A	Xanomeline High Dose	—	—	DISCREAS	Y	subject_count	N	N	—	—	84
disc_death	TRT01A	Xanomeline High Dose	—	—	DISCREAS	Y	subject_count	p	%	—	—	0
disc_death	TRT01A	Total	—	—	DISCREAS	Y	subject_count	n	n	—	—	3
disc_death	TRT01A	Total	—	—	DISCREAS	Y	subject_count	N	N	—	—	254
disc_death	TRT01A	Total	—	—	DISCREAS	Y	subject_count	p	%	—	—	0.0118110236220472
disc_other	TRT01A	Placebo	—	—	DISCREAS	Y	subject_count	n	n	—	—	26
disc_other	TRT01A	Placebo	—	—	DISCREAS	Y	subject_count	N	N	—	—	86
disc_other	TRT01A	Placebo	—	—	DISCREAS	Y	subject_count	p	%	—	—	0.302325581395349
disc_other	TRT01A	Xanomeline Low Dose	—	—	DISCREAS	Y	subject_count	n	n	—	—	58
disc_other	TRT01A	Xanomeline Low Dose	—	—	DISCREAS	Y	subject_count	N	N	—	—	84
disc_other	TRT01A	Xanomeline Low Dose	—	—	DISCREAS	Y	subject_count	p	%	—	—	0.69047619047619
disc_other	TRT01A	Xanomeline High Dose	—	—	DISCREAS	Y	subject_count	n	n	—	—	57
disc_other	TRT01A	Xanomeline High Dose	—	—	DISCREAS	Y	subject_count	N	N	—	—	84
disc_other	TRT01A	Xanomeline High Dose	—	—	DISCREAS	Y	subject_count	p	%	—	—	0.678571428571429
disc_other	TRT01A	Total	—	—	DISCREAS	Y	subject_count	n	n	—	—	141
disc_other	TRT01A	Total	—	—	DISCREAS	Y	subject_count	N	N	—	—	254
disc_other	TRT01A	Total	—	—	DISCREAS	Y	subject_count	p	%	—	—	0.55511811023622
died	TRT01A	Placebo	—	—	DTHFL	Y	subject_count	n	n	—	—	2
died	TRT01A	Placebo	—	—	DTHFL	Y	subject_count	N	N	—	—	86
died	TRT01A	Placebo	—	—	DTHFL	Y	subject_count	p	%	—	—	0.0232558139534884
died	TRT01A	Xanomeline Low Dose	—	—	DTHFL	Y	subject_count	n	n	—	—	1
died	TRT01A	Xanomeline Low Dose	—	—	DTHFL	Y	subject_count	N	N	—	—	84
died	TRT01A	Xanomeline Low Dose	—	—	DTHFL	Y	subject_count	p	%	—	—	0.0119047619047619
died	TRT01A	Xanomeline High Dose	—	—	DTHFL	Y	subject_count	n	n	—	—	0
died	TRT01A	Xanomeline High Dose	—	—	DTHFL	Y	subject_count	N	N	—	—	84
died	TRT01A	Xanomeline High Dose	—	—	DTHFL	Y	subject_count	p	%	—	—	0
died	TRT01A	Total	—	—	DTHFL	Y	subject_count	n	n	—	—	3
died	TRT01A	Total	—	—	DTHFL	Y	subject_count	N	N	—	—	254
died	TRT01A	Total	—	—	DTHFL	Y	subject_count	p	%	—	—	0.0118110236220472

84 rows, one per computed statistic.

Schema: opencsr/ard/v1
Generated: 2026-09-02T15:19:12Z
Spec hash: sha256:8c432e510cf8fe58349f0315cb25c51231c261a2276707cfd7168cd064a3d62d
Display hash: sha256:c00f24720932be1d3c05e8af6faef5feaec615578a2da9ebd5ea8b145d5a9a1b
ARD file: outputs/t-disposition/v003/ard.json
ARD hash: sha256:5a073a0a558678bc67b89573bc98619270f854d3af5d5cbdc18cd0ce8ed4f530

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

library/tfl/t-disposition/analysis.yaml

id: t-disposition
title: "Subject Disposition"
regulatory_id: DST01
type: table
dataset: adsl
analysis_set: itt
denominator: adsl
group:
  - TRT01A
total: true
analyses:
  - name: randomised
    method: subject_count
    label: "Subjects randomised"
    variable: RANDFL
    filter: null
  - name: treated
    method: subject_count
    label: "Subjects treated"
    variable: SAFFL
    filter: "SAFFL == 'Y'"
  - name: completed
    method: subject_count
    label: "Completed the study"
    variable: COMPLFL
    filter: "COMPLFL == 'Y'"
  - name: discontinued
    method: subject_count
    label: "Discontinued the study"
    variable: DISCFL
    filter: "COMPLFL == 'N'"
  - name: disc_death
    method: subject_count
    label: "Discontinued: death"
    variable: DISCREAS
    filter: "!is.na(DISCREAS) & DISCREAS == 'Death'"
  - name: disc_other
    method: subject_count
    label: "Discontinued: other / not specified"
    variable: DISCREAS
    filter: "!is.na(DISCREAS) & DISCREAS == 'Other/Not specified'"
  - name: died
    method: subject_count
    label: "Died"
    variable: DTHFL
    filter: "!is.na(DTHFL) & DTHFL == 'Y'"

library/tfl/t-disposition/display.yaml

id: t-disposition
title: "Subject Disposition"
study: CDISCPILOT01
population_label: "Intent-to-Treat Analysis Set"
cutoff: "2014-07-01"
source: "Source: adsl (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01."
footnotes:
  - "Percentages are based on the number of randomised subjects in each treatment group."
  - "The ADSL shipped in pharmaverseadam carries no DCSREAS/DCDECOD, so the reason for discontinuation is derived: 'Death' where DTHFL = 'Y', otherwise 'Other / not specified'."
  - "52 screen failures are excluded from every analysis dataset."
columns:
  order: [Placebo, "Xanomeline Low Dose", "Xanomeline High Dose", Total]
format:
  digits:
    p: 1
rows:
  - { label: "Disposition, n (%)", section: true }
  - { analysis: randomised, label: "Subjects randomised", pattern: n_pct, indent: 1 }
  - { analysis: treated, label: "Subjects treated", pattern: n_pct, indent: 1 }
  - { analysis: completed, label: "Completed the study", pattern: n_pct, indent: 1 }
  - { analysis: discontinued, label: "Discontinued the study", pattern: n_pct, indent: 1 }
  - { label: "Reason for discontinuation, n (%)", section: true }
  - { analysis: disc_death, label: "Death", pattern: n_pct, indent: 1 }
  - { analysis: disc_other, label: "Other / not specified", pattern: n_pct, indent: 1 }
  - { label: "Deaths, n (%)", section: true }
  - { analysis: died, label: "Died on study", pattern: n_pct, indent: 1 }
variants:
  post_text: {}
  in_text:
    title: "Subject Disposition (Summary)"

Every iteration is kept: outputs/t-disposition/vNNN/ holds the spec snapshot, the ARD, the rendered output, and a manifest recording who regenerated it, why, and from which commit.