Metadata / study
Metadata
Study
What the study is, declared once
Study
library/study.yaml declares what the study is; everything that names an arm, an analysis set or the cut-off reads it.
- Id
- CDISCPILOT01
- Title
- Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer's Disease
- Phase
- Phase 2
- Cut-off
- 2014-07-01
- Source
- CDISCPILOT01 ADaM package (phuse-org/phuse-scripts, data/adam/cdiscpilot01) phuse
alternate: pharmaverseadam - Reference report
- cdisc-pilot-csr · quality/data/reference-report-agreement.json
Arms, in print order
| Id | Label |
|---|---|
| placebo | Placebo |
| low | Xanomeline Low Dose |
| high | Xanomeline High Dose |
Columns that carry an arm label
- TRT01P
- planned
- TRT01A
- actual
- TRTP
- planned
- TRTA
- actual
Analysis sets
The subjects each set holds per arm are data, measured from the package and re-measured by test-study-model.R on every run; the assembler's treatment-consistency gate holds every placed display to them.
| Set | Label | Flag | Placebo | Xanomeline Low Dose | Xanomeline High Dose | Total |
|---|---|---|---|---|---|---|
| all | All Randomised Subjects | — | 86 | 84 | 84 | 254 |
| safety | Safety Analysis Set | SAFFL | 86 | 84 | 84 | 254 |
| itt | Intent-to-Treat Population | ITTFL | 86 | 84 | 84 | 254 |
| efficacy | Efficacy Analysis Set | EFFFL | 79 | 81 | 74 | 234 |
| completers | Completers at Week 24 | COMP24FL | 60 | 28 | 30 | 118 |