TFL Gallery / t-weight
VST03 · Table
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
- v001
- Datasets
- advs, adsl
- Evidence
- 5/5 passing
- Requirements
- DSP-AE-001 DSP-AE-002 DSP-AE-003 DSP-AE-004 DSP-AE-005 DSP-ALL-001 DSP-ALL-002 DSP-CM-001 DSP-CM-002 DSP-CM-003 DSP-DEMO-001 DSP-DEMO-002 DSP-DISP-001 DSP-DISP-002 DSP-EXP-001 DSP-EXP-002 DSP-SAE-001 DSP-VS-001 DSP-VS-002 DSP-VSC-001 DSP-VWC-001 DSP-VWC-002 DSP-WT-001
- Used in
- Clinical Study Report Table 14.3.5.3
- Post-Text Display Package Table 14.3.5.3
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 Weight and Weight Change from Baseline at End of Treatment | |||
| Study CDISCPILOT01 — Safety Analysis Set | |||
| Placebo (N=86) | Xanomeline Low Dose (N=84) | Xanomeline High Dose (N=84) | |
|---|---|---|---|
| Weight (kg) | |||
| Baseline | |||
| n | |||
| Mean (SD) | |||
| Median | |||
| Min, Max | |||
| Week 24 | |||
| n | |||
| Mean (SD) | |||
| Median | |||
| Min, Max | |||
| End of treatment | |||
| n | |||
| Mean (SD) | |||
| Median | |||
| Min, Max | |||
| Weight change from baseline (kg) | |||
| Week 24 | |||
| n | |||
| Mean (SD) | |||
| Median | |||
| Min, Max | |||
| End of treatment | |||
| n | |||
| Mean (SD) | |||
| Median | |||
| Min, Max | |||
| 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 (pharmaverseadam). Data cut-off: 2014-07-01. | |||
| open.csr display t-weight (post_text variant); generated from the committed ARD. | |||
Rendered from outputs/t-weight/v001/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
- 2026-08-27T04:10:09Z
- Spec hash
- sha256:14be68b3bc1d72d8c3e7ff6c067edb41004ad68be9286479c3c2e9a9891dfff3
- Display hash
- sha256:c1a16fd08c4c081a335923ab9efb7260cfb7e031db4384c9695c301dfa64e0a3
- ARD file
- outputs/t-weight/v001/ard.json
- ARD hash
- sha256:ce01673cbf084419c92e2f3d7b0383c09aada0bd6b1283d0c9425b1b7ee03853
Source datasets
| Dataset | Rows | Package | Hash |
|---|---|---|---|
| adsl | 254 | pharmaverseadam 1.1.0 | sha256:83b1d423d2b40766af8138864699137cfb6e0ccb064ca25369c1ed7216936918 |
| advs | 65032 | pharmaverseadam 1.1.0 | sha256:7be440388501966144aa18f3d460cc9e4bb783eb8312df196aa6dfb7502e685b |
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
# ------------------------------------------------------------------------------
# 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)'
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 (pharmaverseadam). 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 only. The reference report's in-text weight table is a genuine
# reduction of this one -- baseline and change means, nothing else -- and a
# variant cannot express that: `variants` can retitle, add footnotes and apply a
# percentage threshold, and none of those subsets rows of a continuous summary.
# An in_text variant here would have been this whole table under a title that
# said "summary", which is worse than not having one.
post_text: {}
v001current
Initial generation of VST03, targeting Table 14-7.03 of the reference clinical study report: weight and weight change from baseline at Week 24 and end of treatment.
2026-08-27T04:10:09Z · @w-vitals
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.