Closed rpodcast closed 1 year ago
thanks a lot @rpodcast !!
Two questions from my review:
1) in the 5th table (# patient left per visit) , should week20 in the placebo group be 65 instead of 67? (efficacy table shows 65, and paul's table also shows 65). is this something to do with patients with week20 data but not baseline data?
2) I probably missed this earlier - in primary table, we used to have N = 84 and 86 for baseline in pilot 1. I guess in pilot 1 we were taking the population regardless whether they have w20 measurement? in pilot 2 we have N = 31 and 65 for baseline. Then the mean(SD) and RMSE are different between pilot 1 and 2. (maybe a question to @hoppanda )
If we want to match the CDISC pilot CSR, I think the population used were the larger population (N = 84 and 86)
ADRG feedback:
This PR addresses comments raised by FDA reviewers after their recent evaluation of the deployed Pilot 2 application:
The application has been re-deployed to https://rconsortium.shinyapps.io/submissions-pilot2 . I'd appreciate any feedback on the new table and the other revisions made to address the other comments.