TFL Gallery / t-eff-adas-wk24-male

t-eff-adas-wk24-male

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Slug: t-eff-adas-wk24-male
Regulatory ID: —
Type: Table
E3 position: unassigned
Status: built
Current iteration: v001
Datasets: —
Evidence: not yet generated
Requirements: —
Used in: Clinical Study Report Table 14.2.8
Post-Text Display Package Table 14.2.8
Abbreviated Clinical Study Report (ICH E3) Table 14.2.8

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-male · post_text variant · study CDISCPILOT01 · data cut-off 2015-02-17

	Placebo (N=33)	Xanomeline Low Dose (N=34)	Xanomeline High Dose (N=39)
ADAS-Cog (11) - Change from Baseline to Week 24 in Male Subjects - LOCF
Study CDISCPILOT01 — Efficacy Analysis Set, male subjects
Baseline
n	33	34	39
Mean (SD)	22.8 (13.45)	23.3 (14.03)	20.8 (11.11)
Median (Range)	19.0 (5;61)	21.5 (7;57)	17.0 (3;51)
Week 24
n	33	34	39
Mean (SD)	24.7 (13.89)	25.7 (14.72)	22.7 (12.32)
Median (Range)	20.0 (5;62)	24.0 (6;57)	21.0 (3;51)
Change from baseline
n	33	34	39
Mean (SD)	1.9 (6.14)	2.5 (5.61)	1.8 (3.77)
Median (Range)	1.0 (-11;16)	1.0 (-6;14)	1.0 (-7;13)
Statistical comparison of the change from baseline
p-value (dose response) [1][2]			0.873
p-value (Xanomeline - Placebo) [1][3]		0.712	0.915
Difference of LS means (SE)		0.5 (1.30)	0.1 (1.25)
95% CI		(-2.1;3.1)	(-2.4;2.6)
p-value (Xanomeline High - Xanomeline Low) [1][3]			0.783
Difference of LS means (SE)			-0.3 (1.26)
95% CI			(-2.9;2.2)
[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.
Missing post-baseline values are imputed by last observation carried forward, over assessments assigned to visit windows (CDISCPILOT01 statistical analysis plan, sections 8.1 and 8.2).
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 14-3.08. Data cut-off: 2015-02-17.
open.csr display t-eff-adas-wk24-male (post_text variant); generated from the committed ARD.

Rendered from outputs/t-eff-adas-wk24-male/v001/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	—	—	33
population	TRTP	Xanomeline High Dose	—	—	USUBJID	—	population	N	N	—	—	39
population	TRTP	Xanomeline Low Dose	—	—	USUBJID	—	population	N	N	—	—	34
summary	TRTP	Placebo	—	—	BASE	—	continuous	N	N	—	—	33
summary	TRTP	Placebo	—	—	BASE	—	continuous	mean	Mean	—	—	22.7878787878788
summary	TRTP	Placebo	—	—	BASE	—	continuous	sd	SD	—	—	13.453060933663
summary	TRTP	Placebo	—	—	BASE	—	continuous	median	Median	—	—	19
summary	TRTP	Placebo	—	—	BASE	—	continuous	p25	Q1	—	—	14
summary	TRTP	Placebo	—	—	BASE	—	continuous	p75	Q3	—	—	26
summary	TRTP	Placebo	—	—	BASE	—	continuous	min	Min	—	—	5
summary	TRTP	Placebo	—	—	BASE	—	continuous	max	Max	—	—	61
summary	TRTP	Placebo	—	—	AVAL	—	continuous	N	N	—	—	33
summary	TRTP	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	24.6833855799373
summary	TRTP	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	13.8943788798887
summary	TRTP	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	20
summary	TRTP	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	15
summary	TRTP	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	32
summary	TRTP	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	5
summary	TRTP	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	61.551724137931
summary	TRTP	Placebo	—	—	CHG	—	continuous	N	N	—	—	33
summary	TRTP	Placebo	—	—	CHG	—	continuous	mean	Mean	—	—	1.89550679205852
summary	TRTP	Placebo	—	—	CHG	—	continuous	sd	SD	—	—	6.13834561783028
summary	TRTP	Placebo	—	—	CHG	—	continuous	median	Median	—	—	1
summary	TRTP	Placebo	—	—	CHG	—	continuous	p25	Q1	—	—	-1
summary	TRTP	Placebo	—	—	CHG	—	continuous	p75	Q3	—	—	5
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	—	—	39
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	mean	Mean	—	—	20.8205128205128
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	sd	SD	—	—	11.1115676919236
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	median	Median	—	—	17
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	p25	Q1	—	—	14
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	p75	Q3	—	—	30
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	min	Min	—	—	3
summary	TRTP	Xanomeline High Dose	—	—	BASE	—	continuous	max	Max	—	—	51
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	39
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	22.658709106985
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	12.3194052147251
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	21
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	12
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	31
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	3
summary	TRTP	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	50.6896551724138
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	N	N	—	—	39
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	mean	Mean	—	—	1.83819628647215
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	sd	SD	—	—	3.7707902843178
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	median	Median	—	—	1
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	p25	Q1	—	—	-0.310344827586206
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	p75	Q3	—	—	4
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	min	Min	—	—	-7
summary	TRTP	Xanomeline High Dose	—	—	CHG	—	continuous	max	Max	—	—	13
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	N	N	—	—	34
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	mean	Mean	—	—	23.2565922920892
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	sd	SD	—	—	14.02819556059
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	median	Median	—	—	21.5
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	p25	Q1	—	—	11
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	p75	Q3	—	—	29
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	min	Min	—	—	7
summary	TRTP	Xanomeline Low Dose	—	—	BASE	—	continuous	max	Max	—	—	56.7241379310345
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	34
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	25.7271805273834
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	14.7231440316254
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	24
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	14
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	36
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	6
summary	TRTP	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	56.7241379310345
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	N	N	—	—	34
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	mean	Mean	—	—	2.47058823529412
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	sd	SD	—	—	5.61477198308856
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	median	Median	—	—	1
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	p25	Q1	—	—	-1
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	p75	Q3	—	—	5
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	min	Min	—	—	-6
summary	TRTP	Xanomeline Low Dose	—	—	CHG	—	continuous	max	Max	—	—	14
ancova	TRTP	Xanomeline High Dose	—	—	CHG	dose_response	ancova	pvalue	pvalue	—	—	0.873132032195556
ancova	TRTP	Xanomeline High Dose	—	—	CHG	dose_response	ancova	n_model	n_model	—	—	106
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	estimate	estimate	—	—	0.481931509491068
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	se	se	—	—	1.30232642166638
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	pvalue	pvalue	—	—	0.712192558151321
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	lcl	lcl	—	—	-2.10460117678446
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	ucl	ucl	—	—	3.06846419576659
ancova	TRTP	Xanomeline Low Dose	—	—	CHG	xan_vs_placebo	ancova	n_model	n_model	—	—	106
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	estimate	estimate	—	—	0.133188091593772
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	se	se	—	—	1.25062531216554
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	pvalue	pvalue	—	—	0.915419757959288
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	lcl	lcl	—	—	-2.35066172853094
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	ucl	ucl	—	—	2.61703791171849
ancova	TRTP	Xanomeline High Dose	—	—	CHG	xan_vs_placebo	ancova	n_model	n_model	—	—	106
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	estimate	estimate	—	—	-0.348743417897296
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	se	se	—	—	1.26115362920616
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	pvalue	pvalue	—	—	0.782763376149838
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	lcl	lcl	—	—	-2.85350338443691
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	ucl	ucl	—	—	2.15601654864231
ancova	TRTP	Xanomeline High Dose	—	—	CHG	high_vs_low	ancova	n_model	n_model	—	—	106

95 rows, one per computed statistic.

Schema: opencsr/ard/v1
Generated: 2026-08-27T03:41:23Z
Spec hash: sha256:f08b78fe8e88aaa42862be64c962f7ee814e55d42a7c2137a2a8356c5152e1a9
Display hash: sha256:cc16d8375545d5c6c41f0646c94fb7e5350844eff172c0dae87f16f84c06d2d7
ARD file: outputs/t-eff-adas-wk24-male/v001/ard.json
ARD hash: sha256:f4ecc3b36b6a75bc97799cbcd7efad17139f1edad38f8aa25c68474cbb343ba5

Source datasets

Dataset	Rows	Package	Hash
adsl	254	phuse-org/phuse-scripts:data/adam 398a6d33ced9359ffb58c46650a6d488811176b1	sha256:6534192e6ae2a8789015148d2068ecdd8421791ea6d7f9cc307fef1db97945f9
adqsadas	12463	phuse-org/phuse-scripts:data/adam 398a6d33ced9359ffb58c46650a6d488811176b1	sha256:0f3e481baf734dc3e5ce7373d255269c2285400ff5bee77be525d832bade80cf

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-male/analysis.yaml

id: t-eff-adas-wk24-male
title: "ADAS-Cog (11) - Change from Baseline to Week 24 in Male Subjects - LOCF"
regulatory_id: EFT05
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' & SEX == 'M'"
  - 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' & SEX == 'M' & 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' & SEX == 'M' & 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-male/display.yaml

id: t-eff-adas-wk24-male
title: "ADAS-Cog (11) - Change from Baseline to Week 24 in Male Subjects - LOCF"
study: CDISCPILOT01
population_label: "Efficacy Analysis Set, male subjects"
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 14-3.08. 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."
  - "Missing post-baseline values are imputed by last observation carried forward, over assessments assigned to visit windows (CDISCPILOT01 statistical analysis plan, sections 8.1 and 8.2)."
  - "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-male/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-male/vNNN/ holds the spec snapshot, the ARD, the rendered output, and a manifest recording who regenerated it, why, and from which commit.