Summary of Weight and Weight Change from Baseline at End of Treatment

Weight and weight change from baseline at Week 24 and end of treatment.

Slug: t-weight
Regulatory ID: VST03
Type: Table
E3 position: §14.3.5
Status: evidenced
Current iteration: v004
Datasets: advs ccc9f70, adsl b022f78
Evidence: 20/20 passing
Requirements: DSP-ALL-001 DSP-ALL-002 DSP-INTXT-001 DSP-INTXT-002 DSP-INTXT-003 DSP-VWC-001 DSP-VWC-002 DSP-WT-001 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 14.3.5.3
Post-Text Display Package Table 14.3.5.3
Study model: Safety Analysis Set SAFFL · grouped by TRT01P
Specification: 4 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 · b022f78
advs32139 rows · ccc9f70
analysis.yamlwhat to compute
display.yamlhow to show it
study modelSafety Analysis Set

Function

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

Outputs

ard.jsonv004 · 129 rows · 39d684c
table.htmlthe rendered display
table.rtfsha256 550876b
table-in-text.rtfsha256 c79ef78
manifest.jsonwho, why, every hash

RTFFull display550876b RTFIn-text variantc79ef78

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

	Placebo (N=86)	Xanomeline Low Dose (N=84)	Xanomeline High Dose (N=84)
Summary of Weight and Weight Change from Baseline at End of Treatment
Study CDISCPILOT01 — Safety Analysis Set
Weight (kg)
Baseline
n	86	83	84
Mean (SD)	62.8 (12.77)	67.3 (14.13)	70.0 (14.65)
Median	60.6	64.9	69.2
Min, Max	34.0, 86.2	45.4, 106.1	41.7, 108.0
Week 24
n	59	27	30
Mean (SD)	63.2 (12.58)	67.4 (14.07)	71.1 (15.82)
Median	63.5	62.6	68.7
Min, Max	34.0, 86.6	45.5, 106.1	49.9, 105.7
End of treatment
n	84	84	81
Mean (SD)	63.3 (12.66)	66.7 (14.32)	69.7 (14.00)
Median	64.0	65.9	70.3
Min, Max	34.0, 86.6	41.7, 106.1	42.2, 105.7
Weight change from baseline (kg)
Week 24
n	59	27	30
Mean (SD)	0.1 (2.30)	-0.3 (2.04)	1.0 (6.47)
Median	0.0	0.0	-0.2
Min, Max	-4.5, 8.2	-5.4, 3.2	-4.5, 33.3
End of treatment
n	84	83	81
Mean (SD)	0.2 (2.05)	-0.4 (2.41)	0.1 (4.19)
Median	0.0	0.0	-0.4
Min, Max	-4.5, 8.2	-14.5, 5.9	-5.5, 33.3
Treatment groups are PLANNED treatment (TRT01P). Twelve subjects in this study received a treatment other than the one they were randomised to; grouping by actual treatment (TRT01A) would give column sizes of 86, 96 and 72.
Baseline is the subject's observed Week 0 weight. Change from baseline is that subject's value minus that baseline, so a subject with no Week 0 weight contributes to the weight rows but not to the change rows.
End of treatment is the last observed weight at a planned visit after Week 0 up to and including Week 24. Unscheduled visits, the Week 26 follow-up visit and records derived by averaging or carry-forward are never selected.
n is the number of subjects contributing a measurement; N in the column header is the number of subjects in the safety analysis set.
Source: advs, adsl (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01.
open.csr display t-weight (post_text variant); generated from the committed ARD.

Rendered from outputs/t-weight/v004/table.html.

analysis	group1	group1_level	group2	group2_level	variable	variable_level	context	stat_name	stat_label	warning	error	stat
population	TRT01P	Placebo	—	—	POPFL	Y	subject_count	n	n	—	—	86
population	TRT01P	Placebo	—	—	POPFL	Y	subject_count	N	N	—	—	86
population	TRT01P	Placebo	—	—	POPFL	Y	subject_count	p	%	—	—	1
population	TRT01P	Xanomeline Low Dose	—	—	POPFL	Y	subject_count	n	n	—	—	84
population	TRT01P	Xanomeline Low Dose	—	—	POPFL	Y	subject_count	N	N	—	—	84
population	TRT01P	Xanomeline Low Dose	—	—	POPFL	Y	subject_count	p	%	—	—	1
population	TRT01P	Xanomeline High Dose	—	—	POPFL	Y	subject_count	n	n	—	—	84
population	TRT01P	Xanomeline High Dose	—	—	POPFL	Y	subject_count	N	N	—	—	84
population	TRT01P	Xanomeline High Dose	—	—	POPFL	Y	subject_count	p	%	—	—	1
wt_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	N	N	—	—	86
wt_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	62.7574418604651
wt_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	12.7703880070075
wt_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	60.56
wt_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	53.52
wt_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	74.39
wt_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	34.02
wt_bl	TRT01P	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	86.18
wt_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	83
wt_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	67.2742168674699
wt_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	14.1250692310397
wt_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	64.86
wt_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	55.79
wt_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	77.79
wt_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	45.36
wt_bl	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	106.14
wt_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	84
wt_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	69.9988095238095
wt_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	14.6511724441213
wt_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	69.175
wt_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	56.7
wt_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	80.29
wt_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	41.73
wt_bl	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	107.96
wt_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	N	N	—	—	59
wt_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	63.2242372881356
wt_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	12.5833653471544
wt_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	63.5
wt_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	53.52
wt_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	75.3
wt_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	34.02
wt_wk24	TRT01P	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	86.64
wt_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	27
wt_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	67.4337037037037
wt_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	14.0715482577565
wt_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	62.6
wt_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	56.7
wt_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	76.2
wt_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	45.54
wt_wk24	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	106.14
wt_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	30
wt_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	71.072
wt_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	15.815454990348
wt_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	68.72
wt_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	55.79
wt_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	83.01
wt_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	49.9
wt_wk24	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	105.69
wt_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	N	N	—	—	84
wt_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	mean	Mean	—	—	63.3066666666667
wt_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	sd	SD	—	—	12.6587663166137
wt_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	median	Median	—	—	63.955
wt_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	p25	Q1	—	—	54.155
wt_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	p75	Q3	—	—	75.07
wt_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	min	Min	—	—	34.02
wt_eot	TRT01P	Placebo	—	—	AVAL	—	continuous	max	Max	—	—	86.64
wt_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	N	N	—	—	84
wt_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	66.7032142857143
wt_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	sd	SD	—	—	14.3233355104982
wt_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	median	Median	—	—	65.89
wt_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	55.455
wt_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	76.885
wt_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	min	Min	—	—	41.73
wt_eot	TRT01P	Xanomeline Low Dose	—	—	AVAL	—	continuous	max	Max	—	—	106.14
wt_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	N	N	—	—	81
wt_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	mean	Mean	—	—	69.6924691358025
wt_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	sd	SD	—	—	13.9979441821705
wt_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	median	Median	—	—	70.31
wt_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p25	Q1	—	—	58.06
wt_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	p75	Q3	—	—	77.79
wt_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	min	Min	—	—	42.18
wt_eot	TRT01P	Xanomeline High Dose	—	—	AVAL	—	continuous	max	Max	—	—	105.69
chg_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	N	N	—	—	59
chg_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	mean	Mean	—	—	0.147118644067796
chg_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	sd	SD	—	—	2.29693878053878
chg_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	median	Median	—	—	0
chg_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	p25	Q1	—	—	-0.910000000000004
chg_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	p75	Q3	—	—	0.899999999999999
chg_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	min	Min	—	—	-4.54000000000001
chg_wk24	TRT01P	Placebo	—	—	CHGBL	—	continuous	max	Max	—	—	8.16999999999999
chg_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	N	N	—	—	27
chg_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-0.336666666666665
chg_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	2.04482837346391
chg_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	median	Median	—	—	0
chg_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-1.36
chg_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	0.910000000000004
chg_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-5.44
chg_wk24	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	max	Max	—	—	3.18
chg_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	N	N	—	—	30
chg_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	0.994999999999999
chg_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	6.4710329346542
chg_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-0.225000000000001
chg_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-1.80999999999999
chg_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	1.81
chg_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-4.53
chg_wk24	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	max	Max	—	—	33.34
chg_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	N	N	—	—	84
chg_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	mean	Mean	—	—	0.199761904761905
chg_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	sd	SD	—	—	2.05047216201683
chg_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	median	Median	—	—	0
chg_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	p25	Q1	—	—	-0.909999999999997
chg_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	p75	Q3	—	—	0.899999999999999
chg_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	min	Min	—	—	-4.54000000000001
chg_eot	TRT01P	Placebo	—	—	CHGBL	—	continuous	max	Max	—	—	8.16999999999999
chg_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	N	N	—	—	83
chg_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	-0.379397590361445
chg_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	2.41366705596843
chg_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	median	Median	—	—	0
chg_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-0.910000000000004
chg_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	0.909999999999997
chg_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-14.52
chg_eot	TRT01P	Xanomeline Low Dose	—	—	CHGBL	—	continuous	max	Max	—	—	5.88999999999999
chg_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	N	N	—	—	81
chg_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	mean	Mean	—	—	0.0579012345679008
chg_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	sd	SD	—	—	4.18975378633679
chg_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	median	Median	—	—	-0.449999999999989
chg_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p25	Q1	—	—	-1.36
chg_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	p75	Q3	—	—	0.460000000000001
chg_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	min	Min	—	—	-5.45
chg_eot	TRT01P	Xanomeline High Dose	—	—	CHGBL	—	continuous	max	Max	—	—	33.34

129 rows, one per computed statistic.

Schema: opencsr/ard/v1
Generated: 2026-09-02T16:11:30Z
Spec hash: sha256:14be68b3bc1d72d8c3e7ff6c067edb41004ad68be9286479c3c2e9a9891dfff3
Display hash: sha256:e1621d705be3014cb6dafb6ba474593b148dd81347258775cccc4cb7d4f90807
ARD file: outputs/t-weight/v004/ard.json
ARD hash: sha256:39d684c1187758435aa1a2f084385ba5b1b49fda32b0dd11084b0e53ee82cf0e

Source datasets

Dataset	Rows	Package	Hash
adsl	254	phuse-org/phuse-scripts:data/adam 398a6d33ced9359ffb58c46650a6d488811176b1	sha256:b022f78fdd0ade028f6c4e9e7cc5187284a5249f30c16646931a1856d5fff2f6
advs	32139	phuse-org/phuse-scripts:data/adam 398a6d33ced9359ffb58c46650a6d488811176b1	sha256:ccc9f70e768c4c6529f31714c501e606c2edb69e8096da6cf4157785d428fcb0

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-weight/analysis.yaml

# ------------------------------------------------------------------------------
# t-weight — Summary of Weight and Weight Change from Baseline at End of Treatment
# ------------------------------------------------------------------------------
# Target: Table 14-7.03 of the CDISCPILOT01 clinical study report (27 June 2006).
#
# Two definitions this display owns rather than inherits, both stated in
# display.yaml's footnotes so a reader of the table sees them:
#
#   * `group: [TRT01P]` — planned treatment. The 2006 report summarises its
#     safety displays by planned treatment (N = 86 / 84 / 84); twelve subjects
#     in this study received a treatment other than the one planned. The rest of
#     the open.csr library groups by TRT01A, so this is a deliberate departure,
#     made to keep the display comparable with the document it targets.
#   * Baseline and end-of-treatment are `prepare_data()` derivations (BLVAL,
#     CHGBL, EOTFL), not the shipped BASE/CHG or the AVISIT == "End of
#     Treatment" record. See the roxygen block on `prepare_data()`.
# ------------------------------------------------------------------------------
id: t-weight
title: "Summary of Weight and Weight Change from Baseline at End of Treatment"
regulatory_id: VST03
type: table
dataset: advs
analysis_set: safety
denominator: adsl
group:
  - TRT01P
total: false
analyses:
  # Supplies the column denominators (N = subjects in the safety analysis set),
  # which is the population the display describes rather than the number of
  # subjects with a weight measurement at any one visit.
  - name: population
    method: subject_count
    label: "Subjects in the safety analysis set"
    variable: POPFL

  - name: wt_bl
    method: continuous
    label: "Weight at baseline (kg)"
    variables: [AVAL]
    filter: 'PARAMCD == "WEIGHT" & AVISIT == "Baseline" & is.na(DTYPE) & !is.na(AVAL)'
  - name: wt_wk24
    method: continuous
    label: "Weight at Week 24 (kg)"
    variables: [AVAL]
    filter: 'PARAMCD == "WEIGHT" & AVISIT == "Week 24" & is.na(DTYPE) & !is.na(AVAL)'
  - name: wt_eot
    method: continuous
    label: "Weight at end of treatment (kg)"
    variables: [AVAL]
    filter: 'PARAMCD == "WEIGHT" & EOTFL == "Y" & !is.na(AVAL)'

  - name: chg_wk24
    method: continuous
    label: "Weight change from baseline at Week 24 (kg)"
    variables: [CHGBL]
    filter: 'PARAMCD == "WEIGHT" & AVISIT == "Week 24" & is.na(DTYPE) & !is.na(CHGBL)'
  - name: chg_eot
    method: continuous
    label: "Weight change from baseline at end of treatment (kg)"
    variables: [CHGBL]
    filter: 'PARAMCD == "WEIGHT" & EOTFL == "Y" & !is.na(CHGBL)'

library/tfl/t-weight/display.yaml

id: t-weight
title: "Summary of Weight and Weight Change from Baseline at End of Treatment"
study: CDISCPILOT01
population_label: "Safety Analysis Set"
cutoff: "2014-07-01"
source: "Source: advs, adsl (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01."
footnotes:
  - "Treatment groups are PLANNED treatment (TRT01P). Twelve subjects in this study received a treatment other than the one they were randomised to; grouping by actual treatment (TRT01A) would give column sizes of 86, 96 and 72."
  - "Baseline is the subject's observed Week 0 weight. Change from baseline is that subject's value minus that baseline, so a subject with no Week 0 weight contributes to the weight rows but not to the change rows."
  - "End of treatment is the last observed weight at a planned visit after Week 0 up to and including Week 24. Unscheduled visits, the Week 26 follow-up visit and records derived by averaging or carry-forward are never selected."
  - "n is the number of subjects contributing a measurement; N in the column header is the number of subjects in the safety analysis set."
columns:
  order: [Placebo, "Xanomeline Low Dose", "Xanomeline High Dose"]
format:
  digits:
    # `N:` and `n:` are deliberately absent. R's YAML reader resolves BOTH bare
    # `N` and bare `n` to the boolean FALSE, so declaring the two together is a
    # duplicate-key parse error, and declaring either one alone silently keys the
    # digit plan under "FALSE" instead of the statistic. Counts default to zero
    # decimals in default_digits(), which is what this display wants anyway.
    p: 1
    mean: 1
    sd: 2
    median: 1
    min: 1
    max: 1
rows:
  - { label: "Weight (kg)", section: true }

  - { label: "Baseline", section: true, indent: 1 }
  - { analysis: wt_bl, variable: AVAL, pattern: "{N}", label: "n", indent: 2 }
  - { analysis: wt_bl, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 2 }
  - { analysis: wt_bl, variable: AVAL, pattern: median, label: "Median", indent: 2 }
  - { analysis: wt_bl, variable: AVAL, pattern: range, label: "Min, Max", indent: 2 }

  - { label: "Week 24", section: true, indent: 1 }
  - { analysis: wt_wk24, variable: AVAL, pattern: "{N}", label: "n", indent: 2 }
  - { analysis: wt_wk24, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 2 }
  - { analysis: wt_wk24, variable: AVAL, pattern: median, label: "Median", indent: 2 }
  - { analysis: wt_wk24, variable: AVAL, pattern: range, label: "Min, Max", indent: 2 }

  - { label: "End of treatment", section: true, indent: 1 }
  - { analysis: wt_eot, variable: AVAL, pattern: "{N}", label: "n", indent: 2 }
  - { analysis: wt_eot, variable: AVAL, pattern: mean_sd, label: "Mean (SD)", indent: 2 }
  - { analysis: wt_eot, variable: AVAL, pattern: median, label: "Median", indent: 2 }
  - { analysis: wt_eot, variable: AVAL, pattern: range, label: "Min, Max", indent: 2 }

  - { label: "Weight change from baseline (kg)", section: true }

  - { label: "Week 24", section: true, indent: 1 }
  - { analysis: chg_wk24, variable: CHGBL, pattern: "{N}", label: "n", indent: 2 }
  - { analysis: chg_wk24, variable: CHGBL, pattern: mean_sd, label: "Mean (SD)", indent: 2 }
  - { analysis: chg_wk24, variable: CHGBL, pattern: median, label: "Median", indent: 2 }
  - { analysis: chg_wk24, variable: CHGBL, pattern: range, label: "Min, Max", indent: 2 }

  - { label: "End of treatment", section: true, indent: 1 }
  - { analysis: chg_eot, variable: CHGBL, pattern: "{N}", label: "n", indent: 2 }
  - { analysis: chg_eot, variable: CHGBL, pattern: mean_sd, label: "Mean (SD)", indent: 2 }
  - { analysis: chg_eot, variable: CHGBL, pattern: median, label: "Median", indent: 2 }
  - { analysis: chg_eot, variable: CHGBL, pattern: range, label: "Min, Max", indent: 2 }
variants:
  post_text: {}
  # The report's in-text Table 12-4: n and mean per arm for baseline weight and
  # the change from baseline at Week 24 and at end of treatment.
  in_text:
    title: "Summary of Change from Baseline in Weight"
    columns:
      order:
        - { label: "Placebo n", group: Placebo, pattern: "{N}" }
        - { label: "Placebo Mean", group: Placebo, pattern: "{mean}" }
        - { label: "Low Dose n", group: "Xanomeline Low Dose", pattern: "{N}" }
        - { label: "Low Dose Mean", group: "Xanomeline Low Dose", pattern: "{mean}" }
        - { label: "High Dose n", group: "Xanomeline High Dose", pattern: "{N}" }
        - { label: "High Dose Mean", group: "Xanomeline High Dose", pattern: "{mean}" }
    format:
      digits:
        mean: 1
    rows:
      - { label: "Weight (kg)", section: true }
      - { analysis: wt_bl, variable: AVAL, pattern: "{N}", label: "Baseline", indent: 1 }
      - { analysis: chg_wk24, variable: CHGBL, pattern: "{N}", label: "Change at Week 24", indent: 1 }
      - { analysis: chg_eot, variable: CHGBL, pattern: "{N}", label: "Change at End of Treatment", indent: 1 }

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