TFL Gallery / t-eff-npix-mean

EFT09 · Table

Mean NPI-X Total Score from Week 4 through Week 24 - Windowed

The secondary endpoint — mean NPI-X total score across the Weeks 4 to 24 window. The one display where the study's analysis metadata and its own published report disagree about which score to use, and the footnotes say which side was taken.

Slug
t-eff-npix-mean
Regulatory ID
EFT09
Type
Table
E3 position
§14.2
Status
evidenced
Current iteration
v003
Datasets
adqsnpix a8db42f, 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
Study model
Efficacy Analysis Set EFFFL · grouped by TRTP
Specification
3 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
Function
Outputs

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

Mean NPI-X Total Score from Week 4 through Week 24 - Windowed
Study CDISCPILOT01 — Efficacy Analysis Set
Placebo (N=79) Xanomeline Low Dose (N=81) Xanomeline High Dose (N=74)
Baseline
   n 79 81 74
   Mean (SD) 9.5 (12.10) 8.7 (9.82) 11.9 (13.70)
   Median (Range) 5.0 (0;66) 4.0 (0;32) 8.0 (0;61)
Mean of Weeks 4-24
   n 78 75 69
   Mean (SD) 9.3 (11.18) 9.1 (12.10) 9.6 (11.60)
   Median (Range) 5.5 (0;65) 3.8 (0;51) 4.4 (0;46)
Statistical comparison of the mean over Weeks 4 to 24
   p-value (dose response) [1][2] 0.637
   p-value (Xanomeline - Placebo) [1][3] 0.760 0.517
      Difference of LS means (SE) 0.3 (1.13) -0.7 (1.15)
      95% CI (-1.9;2.6) (-3.0;1.5)
   p-value (Xanomeline High - Xanomeline Low) [1][3] 0.350
      Difference of LS means (SE) -1.1 (1.17)
      95% CI (-3.4;1.2)
[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.
The Week 4 to Week 24 endpoint is the mean of a subject's available NPI-X (9) total scores over the Week 4 to Week 24 assessment windows, as the statistical analysis plan defines it in section 10.2.1. A subject contributes one value however many assessments it averages, and a subject with no assessment in that span contributes none, so n is smaller than the column N.
DEFINED HERE, NOT INHERITED: this endpoint is derived from the per-visit NPTOT records rather than read from the study's own NPTOTMN parameter, because the study's two authoritative statements about this table disagree. Its analysis results metadata (define.xml, Table_14-3.12) selects PARAMCD NPTOTMN, which covers 210 of the 222 efficacy subjects who have an assessment in the Week 4 to Week 24 span: it omits 12 — eleven contributing a single assessment and one contributing two — and adds none. Selecting it reports n = 76, 69, 65. Its own reference report reports n = 78, 75, 69, which is every subject with an assessment in the span, and which the analysis plan's wording ('the mean of all available total scores between Weeks 4 and 24, inclusive') describes. The derivation used here follows the analysis plan and reproduces the reference report to every cell, including the ANCOVA. The divergence is measured and recorded in quality/data/efficacy-agreement.json.
Assessments are selected by AVISITN, not AVISIT: adqsnpix ships AVISIT right-aligned in a 16-character field, so a comparison against the visible label silently selects no records.
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 assessment date present in the vendored ADaM package.
Source: adqsnpix (NPI-X (9) total score, PARAMCD NPTOT) 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 10.2.1. Reference report display: Table 14-3.12. Data cut-off: 2015-02-17.
open.csr display t-eff-npix-mean (post_text variant); generated from the committed ARD.

Rendered from outputs/t-eff-npix-mean/v003/table.html.

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