TFL Builder + Library
One directory per display — an analysis spec, a display spec, and every saved iteration. Open a display to see the rendered table, the ARD behind it, the specs that produced it, and its change-request timeline.
Demo study CDISCPILOT01 · CDISCPILOT01 ADaM package (phuse-org/phuse-scripts) · data cut-off 2014-07-01
Age, sex, race and baseline characteristics by treatment arm over the safety analysis set.
In Clinical Study Report, Study Synopsis, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v007 · 548 ARD rows · 7 iterations
Screened, randomised, treated, completed and discontinued counts with reasons for discontinuation, over the ITT set.
In Clinical Study Report, Study Synopsis, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v003 · 84 ARD rows · 3 iterations
How many subjects each analysis is run on — ITT, safety and efficacy — by planned treatment group, with percentages over the group's randomised N. The denominator every other display's N is checked against.
In Clinical Study Report, Study Synopsis, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v003 · 60 ARD rows · 3 iterations
Who finished and who left, with the reason. Nine reasons for early termination plus a missing-reason row, partitioning the early terminations exactly, and a p-value on only the three rows the analysis plan names.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v003 · 162 ARD rows · 3 iterations
The study's only figure: Kaplan-Meier curves for time to a first dermatologic event, by treatment group, with medians, confidence limits and a log-rank test. Xanomeline is delivered transdermally, so this is the tolerability question the delivery route raises.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v002 · 51 ARD rows · 2 iterations
The study's other primary endpoint: the clinician's global impression of change at Week 24, with the same ANCOVA structure as the ADAS-Cog table beside it.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v004 · 43 ARD rows · 4 iterations
The CIBIC+ global impression read at Week 8, same model.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v002 · 43 ARD rows · 2 iterations
The CIBIC+ global impression read at Week 16, same model.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v002 · 43 ARD rows · 2 iterations
CIBIC+ as categories rather than a mean — how many subjects fell in each impression band at three visits, with a stratified Cochran-Mantel-Haenszel test across treatment groups.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v002 · 147 ARD rows · 2 iterations
The study's primary efficacy result: change in ADAS-Cog (11) from baseline to Week 24, with the ANCOVA dose response and both pairwise comparisons against placebo.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v002 · 95 ARD rows · 2 iterations
The same primary analysis read at Week 8, with the same model and the same last-observation-carried-forward rule.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v002 · 95 ARD rows · 2 iterations
The same primary analysis read at Week 16 — the middle of the three scheduled reads.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v002 · 95 ARD rows · 2 iterations
Week 24 restricted to subjects who completed it, observed cases only, with no value carried forward. The sensitivity analysis against the primary table's imputation.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v002 · 95 ARD rows · 2 iterations
The Week 24 primary analysis in male subjects alone. Subgroup, not a separate endpoint.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v002 · 95 ARD rows · 2 iterations
The Week 24 primary analysis in female subjects alone. Subgroup, not a separate endpoint.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v002 · 95 ARD rows · 2 iterations
ADAS-Cog scores and their change from baseline at every scheduled visit, so the shape of the trajectory is visible rather than just its endpoints. Presented with treatment across the columns.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v002 · 459 ARD rows · 2 iterations
The supportive repeated-measures analysis: a mixed model with an unstructured within-subject covariance, which handles a missed visit through the covariance rather than by carrying a value forward. Its fit reproduces the reference report's own PROC MIXED output to six significant figures.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v004 · 34 ARD rows · 4 iterations
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.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v003 · 71 ARD rows · 3 iterations
Subject counts for any AE, related AEs, serious AEs, and AEs leading to discontinuation or death.
In Clinical Study Report, Study Synopsis, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v003 · 88 ARD rows · 3 iterations
Hierarchical subject incidence of treatment-emergent adverse events, SOC rows expanded to preferred terms.
In Clinical Study Report, Study Synopsis, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v004 · 3048 ARD rows · 4 iterations
Duration and cumulative dose of study treatment by arm.
In Clinical Study Report, Study Synopsis, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v004 · 208 ARD rows · 4 iterations
Subject-level listing of serious adverse events with onset, severity, outcome and relationship.
In Clinical Study Report, Study Synopsis, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v003 · 33 ARD rows · 3 iterations
Subjects taking at least one concomitant medication, and subject counts by therapeutic class and coded medication.
In Clinical Study Report, Post-Text Display Package
v003 · 414 ARD rows · 3 iterations
Blood pressure and pulse in three positions, at baseline, Week 24 and end of treatment, by planned treatment.
In Clinical Study Report, Post-Text Display Package
v002 · 657 ARD rows · 2 iterations
The same measurements as a change from each subject's own observed Week 0 value.
In Clinical Study Report, Post-Text Display Package
v002 · 441 ARD rows · 2 iterations
Weight and weight change from baseline at Week 24 and end of treatment.
In Clinical Study Report, Post-Text Display Package
v004 · 129 ARD rows · 4 iterations
The reference report's Table 14-5.01: subjects, percentages and event counts per system organ class and preferred term, with Fisher's exact test of placebo against each active arm.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v007 · 4826 ARD rows · 7 iterations
The reference report's Table 14-5.02: the serious treatment-emergent events, counted and tested the same way as the full incidence table.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v006 · 64 ARD rows · 6 iterations
The reference report's Table 14-1.03: intent-to-treat, efficacy and Week 24 completer counts per site and treatment group, small sites pooled under id 900.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v002 · 612 ARD rows · 2 iterations
The reference report's Figure 10-1: subjects screened, screen failures, randomised, completed Week 24 and completed the study, drawn as a flow from the study's SDTM DM and its ADSL.
In Clinical Study Report, Post-Text Display Package, Abbreviated Clinical Study Report (ICH E3)
v001 · 5 ARD rows