ADAS-Cog (11) - Change from Baseline to Week 24 - Completers at Week 24, Observed Cases, Windowed

Week 24 restricted to subjects who completed it, observed cases only, with no value carried forward. The sensitivity analysis against the primary table's imputation.

Slug: t-eff-adas-wk24-completers
Regulatory ID: EFT04
Type: Table
E3 position: §14.2
Status: evidenced
Current iteration: v002
Datasets: adqsadas d6ee9a3, adsl 70c7278
Evidence: 26/26 passing
Requirements: DSP-ALL-001 DSP-ALL-002 DSP-EFF-001 DSP-EFF-002 DSP-EFF-003 DSP-EFF-004 DSP-EFF-005 DSP-EFF-006 DSP-EFF-007 DSP-EFF-008 DSP-EFF-009 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 14.2.7
Post-Text Display Package Table 14.2.7
Abbreviated Clinical Study Report (ICH E3) Table 14.2.7
Study model: Efficacy Analysis Set EFFFL · grouped by TRTP
Specification: 2 iterations
Environment: R 4.3.3 Darwin 23.6.0
Bound by: No text block binds it
Values: No value is sourced from it

Inputs

adsl254 rows · 70c7278
adqsadas12463 rows · d6ee9a3
analysis.yamlwhat to compute
display.yamlhow to show it
custom.Rthe display's own method
study modelEfficacy Analysis Set

Function

prepare_data()regenerate('t-eff-adas-wk24-completers')
build_ard()one row per statistic
render_display()every variant
render_rtf()the same cells

Outputs

ard.jsonv002 · 95 rows · 9c9aef7
table.htmlthe rendered display
table.rtfsha256 d50f930
manifest.jsonwho, why, every hash

RTFFull displayd50f930

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-eff-adas-wk24-completers · post_text variant · study CDISCPILOT01 · data cut-off 2015-02-17

	Placebo (N=60)	Xanomeline Low Dose (N=28)	Xanomeline High Dose (N=30)
ADAS-Cog (11) - Change from Baseline to Week 24 - Completers at Week 24, Observed Cases, Windowed
Study CDISCPILOT01 — Efficacy Analysis Set, Week 24 completers
Baseline
n	59	27	30
Mean (SD)	23.2 (11.74)	24.0 (13.89)	20.5 (11.50)
Median (Range)	21.0 (5;51)	20.0 (5;57)	18.0 (3;49)
Week 24
n	59	27	30
Mean (SD)	25.3 (13.32)	24.1 (11.87)	21.8 (12.60)
Median (Range)	23.0 (5;58)	22.0 (8;51)	18.5 (3;44)
Change from baseline
n	59	27	30
Mean (SD)	2.1 (5.89)	0.1 (5.86)	1.3 (4.51)
Median (Range)	2.0 (-11;16)	1.0 (-11;12)	1.0 (-7;13)
Statistical comparison of the change from baseline
p-value (dose response) [1][2]			0.234
p-value (Xanomeline - Placebo) [1][3]		0.105	0.461
Difference of LS means (SE)		-2.1 (1.26)	-0.9 (1.22)
95% CI		(-4.6;0.4)	(-3.3;1.5)
p-value (Xanomeline High - Xanomeline Low) [1][3]			0.430
Difference of LS means (SE)			1.2 (1.47)
95% CI			(-1.8;4.1)
[1] Based on an analysis of covariance (ANCOVA) model with treatment and site group as factors and the baseline score as a covariate.
[2] Test for a non-zero coefficient for treatment (dose) as a continuous variable.
[3] Pairwise comparison with treatment as a categorical variable; p-values are not adjusted for multiple comparisons.
Only assessments falling within the Week 24 assessment window are included, and no value is imputed.
Baseline, on-treatment and change statistics are summarised over one record per subject at the analysis visit, so a subject with no assessment in that window contributes to none of the three and n is smaller than the column N.
Treatment columns are planned treatment (TRTP), which is how the CDISCPILOT01 reference report presents them.
CDISCPILOT01 states no data cut-off date. The date shown is the latest ADAS-Cog assessment date present in the vendored ADaM package.
Source: adqsadas (ADAS-Cog (11) total score, PARAMCD ACTOT) and adsl, from the CDISC pilot's own ADaM package (phuse-org/phuse-scripts, MIT). Analysis as specified in the CDISCPILOT01 statistical analysis plan, section 10.1.1. Reference report display: Table 14-3.07. Data cut-off: 2015-02-17.
open.csr display t-eff-adas-wk24-completers (post_text variant); generated from the committed ARD.

Rendered from outputs/t-eff-adas-wk24-completers/v002/table.html.

analysis	group1	group1_level	group2	group2_level	variable	variable_level	context	stat_name	stat_label	warning	error	stat
population	TRTP	Placebo	—	—	USUBJID	—	population	N	N	—	—	60
population	TRTP	Xanomeline High Dose	—	—	USUBJID	—	population	N	N	—	—	30
population	TRTP	Xanomeline Low Dose	—	—	USUBJID	—	population	N	N	—	—	28
summary	TRTP	Placebo	—	—	BASE	—	continuous	N	N	—	—	59
summary	TRTP	Placebo	—	—	BASE	—	continuous	mean	Mean	—	—	23.1969608416131
summary	TRTP	Placebo	—	—	BASE	—	continuous	sd	SD	—	—	11.7412602305514
summary	TRTP	Placebo	—	—	BASE	—	continuous	median	Median	—	—	21
summary	TRTP	Placebo	—	—	BASE	—	continuous	p25	Q1	—	—	15
summary	TRTP	Placebo	—	—	BASE	—	continuous	p75	Q3	—	—	29
summary	TRTP	Placebo	—	—	BASE	—	continuous	min	Min	—	—	5
summary	TRTP	Placebo	—	—	BASE	—	continuous	max	Max	—	—	51
summary	TRTP	Placebo	—	—	AVAL	—	continuous	N	N	—	—	59
summary	TRTP	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	25.2559906487434
summary	TRTP	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	13.3155008456192
summary	TRTP	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	23
summary	TRTP	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	16
summary	TRTP	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	31
summary	TRTP	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	5
summary	TRTP	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	58
summary	TRTP	Placebo	—	—	CHG	—	continuous	N	N	—	—	59
summary	TRTP	Placebo	—	—	CHG	—	continuous	mean	Mean	—	—	2.05902980713033
summary	TRTP	Placebo	—	—	CHG	—	continuous	sd	SD	—	—	5.88919042785207
summary	TRTP	Placebo	—	—	CHG	—	continuous	median	Median	—	—	2
summary	TRTP	Placebo	—	—	CHG	—	continuous	p25	Q1	—	—	-1
summary	TRTP	Placebo	—	—	CHG	—	continuous	p75	Q3	—	—	6
summary	TRTP	Placebo	—	—	CHG	—	continuous	min	Min	—	—	-11
summary	TRTP	Placebo	—	—	CHG	—	continuous	max	Max	—	—	16
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	N	N	—	—	30
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	mean	Mean	—	—	20.5333333333333
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	sd	SD	—	—	11.5033228582705
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	median	Median	—	—	18
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	p25	Q1	—	—	11
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	p75	Q3	—	—	26
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	min	Min	—	—	3
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	max	Max	—	—	49
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	30
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	21.8080459770115
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	12.6007772693716
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	18.5
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	11
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	34
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	3
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	44
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	N	N	—	—	30
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	mean	Mean	—	—	1.27471264367816
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	sd	SD	—	—	4.51026485921586
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	median	Median	—	—	1
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	p25	Q1	—	—	-2
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	p75	Q3	—	—	4
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	min	Min	—	—	-6.75862068965517
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	max	Max	—	—	13
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	N	N	—	—	27
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	mean	Mean	—	—	24.0063856960409
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	sd	SD	—	—	13.8856643512354
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	median	Median	—	—	20
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	p25	Q1	—	—	14
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	p75	Q3	—	—	30
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	min	Min	—	—	5
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	max	Max	—	—	56.7241379310345
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	27
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	24.0689655172414
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	11.8740532268791
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	22
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	15
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	32
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	8
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	51
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	N	N	—	—	27
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	mean	Mean	—	—	0.0625798212005104
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	sd	SD	—	—	5.86215507065048
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	median	Median	—	—	1
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	p25	Q1	—	—	-5
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	p75	Q3	—	—	3
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	min	Min	—	—	-11
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	max	Max	—	—	12
ancova	TRTP	Xanomeline High Dose	—	—	CHG	dose_response	ancova	pvalue	pvalue	—	—	0.2343441504705
ancova	TRTP	Xanomeline High Dose	—	—	CHG	dose_response	ancova	n_model	n_model	—	—	116
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	estimate	estimate	—	—	-2.06524913382622
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	se	se	—	—	1.26417635297979
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	pvalue	pvalue	—	—	0.105410836110464
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	lcl	lcl	—	—	-4.57273693594894
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	ucl	ucl	—	—	0.442238668296504
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	n_model	n_model	—	—	116
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	estimate	estimate	—	—	-0.900505625695855
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	se	se	—	—	1.21607624885566
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	pvalue	pvalue	—	—	0.460697277382587
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	lcl	lcl	—	—	-3.31258709935199
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	ucl	ucl	—	—	1.51157584796028
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	n_model	n_model	—	—	116
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	estimate	estimate	—	—	1.16474350813036
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	se	se	—	—	1.47020793386968
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	pvalue	pvalue	—	—	0.430064989693755
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	lcl	lcl	—	—	-1.75140695780167
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	ucl	ucl	—	—	4.0808939740624
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	n_model	n_model	—	—	116

95 rows, one per computed statistic.

Schema: opencsr/ard/v1
Generated: 2026-09-02T15:23:24Z
Spec hash: sha256:09b745393b790b3d3fe47b5fa5dc6172d368d476e5a89e02dfb03d668c83cbeb
Display hash: sha256:4cf74d8b96155eb9b2da498fa61cb953216d457fa0ccacec5aecfe19a77cebcf
ARD file: outputs/t-eff-adas-wk24-completers/v002/ard.json
ARD hash: sha256:9c9aef70416902d5e01cb7492d4c9969b7c0b9e8c0638f96226494c85d75a85b

Source datasets

Dataset	Rows	Package	Hash
adsl	254	phuse-org/phuse-scripts:data/adam 398a6d33ced9359ffb58c46650a6d488811176b1	sha256:70c7278e83e571a7d4a94fd864c98bf8ca243c7c2cc9eec8b99a40fa7bc98e35
adqsadas	12463	phuse-org/phuse-scripts:data/adam 398a6d33ced9359ffb58c46650a6d488811176b1	sha256:d6ee9a321a2a9d338285cc702d750624eefd6da11b0da0ae260a4133a492215f

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-eff-adas-wk24-completers/analysis.yaml

id: t-eff-adas-wk24-completers
title: "ADAS-Cog (11) - Change from Baseline to Week 24 - Completers at Week 24, Observed Cases, Windowed"
regulatory_id: EFT04
type: table
dataset: adqsadas
analysis_set: efficacy
denominator: adsl
sources: phuse
group:
  - TRTP
total: false
analyses:
  - name: population
    method: continuous
    custom: population_n
    label: "Subjects in the analysis population"
    filter: "PARAMCD == 'ACTOT' & COMP24FL == 'Y'"
  - name: summary
    method: continuous
    label: "ADAS-Cog (11) total score at baseline, at Week 24, and its change"
    variables: [BASE, AVAL, CHG]
    filter: "PARAMCD == 'ACTOT' & ANL01FL == 'Y' & COMP24FL == 'Y' & !(DTYPE %in% 'LOCF') & AVISIT == 'Week 24'"
  - name: ancova
    method: continuous
    custom: ancova_change
    label: "ANCOVA of the change from baseline to Week 24"
    variables: [CHG]
    filter: "PARAMCD == 'ACTOT' & ANL01FL == 'Y' & COMP24FL == 'Y' & !(DTYPE %in% 'LOCF') & AVISIT == 'Week 24'"
    response: CHG
    covariates: [BASE]
    factors: [SITEGR1]
    treatment: TRTP
    treatment_levels: ["Placebo", "Xanomeline Low Dose", "Xanomeline High Dose"]
    dose: TRTPN
    conf_level: 0.95
    contrasts:
      - { name: dose_response, type: dose, column: "Xanomeline High Dose" }
      - { name: xan_vs_placebo, type: pairwise, test: "Xanomeline Low Dose",
          reference: "Placebo", column: "Xanomeline Low Dose" }
      - { name: xan_vs_placebo, type: pairwise, test: "Xanomeline High Dose",
          reference: "Placebo", column: "Xanomeline High Dose" }
      - { name: high_vs_low, type: pairwise, test: "Xanomeline High Dose",
          reference: "Xanomeline Low Dose", column: "Xanomeline High Dose" }

library/tfl/t-eff-adas-wk24-completers/display.yaml

id: t-eff-adas-wk24-completers
title: "ADAS-Cog (11) - Change from Baseline to Week 24 - Completers at Week 24, Observed Cases, Windowed"
study: CDISCPILOT01
population_label: "Efficacy Analysis Set, Week 24 completers"
cutoff: "2015-02-17"
source: "Source: adqsadas (ADAS-Cog (11) total score, PARAMCD ACTOT) and adsl, from the CDISC pilot's own ADaM package (phuse-org/phuse-scripts, MIT). Analysis as specified in the CDISCPILOT01 statistical analysis plan, section 10.1.1. Reference report display: Table 14-3.07. Data cut-off: 2015-02-17."
footnotes:
  - "[1] Based on an analysis of covariance (ANCOVA) model with treatment and site group as factors and the baseline score as a covariate."
  - "[2] Test for a non-zero coefficient for treatment (dose) as a continuous variable."
  - "[3] Pairwise comparison with treatment as a categorical variable; p-values are not adjusted for multiple comparisons."
  - "Only assessments falling within the Week 24 assessment window are included, and no value is imputed."
  - "Baseline, on-treatment and change statistics are summarised over one record per subject at the analysis visit, so a subject with no assessment in that window contributes to none of the three and n is smaller than the column N."
  - "Treatment columns are planned treatment (TRTP), which is how the CDISCPILOT01 reference report presents them."
  - "CDISCPILOT01 states no data cut-off date. The date shown is the latest ADAS-Cog assessment date present in the vendored ADaM package."
columns:
  order: ["Placebo", "Xanomeline Low Dose", "Xanomeline High Dose"]
format:
  mean_sd: "{mean} ({sd})"
  median_range: "{median} ({min};{max})"
  est_se: "{estimate} ({se})"
  ci: "({lcl};{ucl})"
  p_value: "{pvalue}"
  digits:
    mean: 1
    sd: 2
    median: 1
    min: 0
    max: 0
    estimate: 1
    se: 2
    lcl: 1
    ucl: 1
    pvalue: 3
rows:
  - { label: "Baseline", section: true }
  - { analysis: summary, variable: BASE, pattern: "N", label: "n", indent: 1 }
  - { analysis: summary, variable: BASE, pattern: mean_sd, label: "Mean (SD)", indent: 1 }
  - { analysis: summary, variable: BASE, pattern: median_range, label: "Median (Range)", indent: 1 }
  - { label: "Week 24", section: true }
  - { analysis: summary, variable: AVAL, pattern: "N", label: "n", indent: 1 }
  - { analysis: summary, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 1 }
  - { analysis: summary, variable: AVAL, pattern: median_range, label: "Median (Range)", indent: 1 }
  - { label: "Change from baseline", section: true }
  - { analysis: summary, variable: CHG, pattern: "N", label: "n", indent: 1 }
  - { analysis: summary, variable: CHG, pattern: mean_sd, label: "Mean (SD)", indent: 1 }
  - { analysis: summary, variable: CHG, pattern: median_range, label: "Median (Range)", indent: 1 }
  - { label: "Statistical comparison of the change from baseline", section: true }
  - { analysis: ancova, variable: CHG, level: dose_response, pattern: p_value,
      label: "p-value (dose response) [1][2]", indent: 1 }
  - { analysis: ancova, variable: CHG, level: xan_vs_placebo, pattern: p_value,
      label: "p-value (Xanomeline - Placebo) [1][3]", indent: 1 }
  - { analysis: ancova, variable: CHG, level: xan_vs_placebo, pattern: est_se,
      label: "Difference of LS means (SE)", indent: 2 }
  - { analysis: ancova, variable: CHG, level: xan_vs_placebo, pattern: ci,
      label: "95% CI", indent: 2 }
  - { analysis: ancova, variable: CHG, level: high_vs_low, pattern: p_value,
      label: "p-value (Xanomeline High - Xanomeline Low) [1][3]", indent: 1 }
  - { analysis: ancova, variable: CHG, level: high_vs_low, pattern: est_se,
      label: "Difference of LS means (SE)", indent: 2 }
  - { analysis: ancova, variable: CHG, level: high_vs_low, pattern: ci,
      label: "95% CI", indent: 2 }
variants:
  post_text: {}

library/tfl/t-eff-adas-wk24-completers/custom.R

# Display-specific statistics (contract section 2).
#
# Both functions are thin wrappers: the statistics themselves live in
# {opencsr} so that the seven ADAS-Cog displays share one tested
# implementation, and every model term is declared in this display's
# analysis.yaml rather than written in code.

ancova_change <- function(data, spec, denominator = NULL) {
  opencsr::ard_ancova(data, spec, denominator)
}

population_n <- function(data, spec, denominator = NULL) {
  opencsr::ard_population_n(data, spec, denominator)
}

Every iteration is kept: outputs/t-eff-adas-wk24-completers/vNNN/ holds the spec snapshot, the ARD, the rendered output, and a manifest recording who regenerated it, why, and from which commit.