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
Data
every dataset the package carries
Reference report
cdisc-pilot-csr · quality/data/reference-report-agreement.json
File
library/study.yaml

Arms, in print order

IdLabel
placeboPlacebo
lowXanomeline Low Dose
highXanomeline 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.

SetLabelFlagPlaceboXanomeline Low DoseXanomeline High DoseTotal
allAll Randomised Subjects—868484254
safetySafety Analysis SetSAFFL868484254
ittIntent-to-Treat PopulationITTFL868484254
efficacyEfficacy Analysis SetEFFFL798174234
completersCompleters at Week 24COMP24FL602830118