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

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

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 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 (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.

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.