inst/app/docs/about.md

In RConsortium/submissions-pilot2: R Consortium R Submission Pilot 2

Introduction

This application is intended for a pilot submission to the FDA composing of a Shiny application, as part of the R Submissions Working Group Pilot 2. The data sets and results displayed in the application originate from the Pilot 1 project. Visit the Usage Guide for information on using the application. Below is a brief description of the application components:

Table 14-2.01 Summary of Demographic and Baseline Characteristics

In this interface, summary statistics associated with baseline clinical characteristics and other demographic factors is shown.

Figure 14-1 Time to Dermatologic Event by Treatment Group

A Kaplan-Meier (KM) plot of the Time to First Dermatologic Event (TTDE) with strata defined by treatment group is displayed along with an informative risk set table across time.

Table 14-3.01 Primary Endpoint Analysis: ADAS Cog (11) - Change from Baseline to Week 24 - LOCF

A summary table of the primary efficacy analysis is shown for each of the time points of assessment (baseline and week 24) comparing each treatment group. The primary efficacy variable (change from baseline in ADAS Cog (11)) was analyzed using an Analysis of Covariance (ANCOVA) model with treatment and baseline value as covariates, comparing Placebo to Xanomeline High Dose.

Table 14-3.02 Primary Endpoint Analysis: Glucose (mmol/L) - Summary at Week 20 - LOCF

A summary table of an additional efficacy analysis is shown for baseline and week 20. The efficacy variable (Glucose) was analzying using ANCOVA model with treatment and baseline value as covariates, comparing Placebo to Xanomeline High Dose.

Table 14-4.01 Visit Completion

A summary table of the number of patients remaining in the treatment period for each scheduled visit from baseline to week 24.

RConsortium/submissions-pilot2 documentation built on Feb. 7, 2025, 1:24 a.m.