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Get-Data-for-Population

Vignette Build Datetime

message(paste0('Datetime: ',Sys.Date(),':',Sys.time()))
#> Datetime: 2026-01-21:2026-01-21 09:14:35

Load Libraries

library(repfun)
library(dplyr)
library(kableExtra)

Set Up the Reporting Environment

tmpdr <- tempdir()
datdir <- file.path(gsub("\\","/",tmpdr,fixed=TRUE),"datdir")
dir.create(datdir,showWarnings=FALSE)
repfun::copydata(datdir)
repfun::rs_setup(D_POP="SAFFL",D_POPLBL="Safety",D_POPDATA=repfun::adsl, 
         D_SUBJID=c("STUDYID","USUBJID"), R_ADAMDATA=datdir)
repfun:::rfenv$G_POPDATA %>% dplyr::mutate(TRT01AN=ifelse(TRT01A=='Placebo',1,ifelse(TRT01A=='Xanomeline Low Dose',2,3)),
                     SAFFL=ifelse((row_number() %% 10) == 0,'N',SAFFL)) %>% 
              repfun::ru_labels(varlabels=list('TRT01AN'='Actual Treatment for Period 01 (n)',
                                       'SAFFL'='Safety Population Flag')) -> G_POPDATA

Read in ADAE, Restrict to Population and Add Population Variables

adae <- repfun:::rfenv$adamdata$adae.rda() %>% dplyr::select(-c('SAFFL','TRT01A')) %>% 
  repfun::ru_getdata(G_POPDATA, c("STUDYID", "USUBJID"), 
             keeppopvars=c("TRT01AN", "TRT01A", "SAFFL")) %>%
 dplyr::select(STUDYID,USUBJID,AEBODSYS,AEDECOD,SAFFL,TRT01AN,TRT01A) %>% 
  dplyr::arrange(STUDYID,USUBJID,AEBODSYS,AEDECOD,SAFFL,TRT01AN,TRT01A)

Display the Results for AE Body System and Preferred Term

lbls <- sapply(adae,function(x){attr(x,"label")})
knitr::kable(head(adae,10), col.names=paste(names(lbls),lbls,sep=": "), 
             caption = "Results of Restricting to Population and Adding Population Variables")
Results of Restricting to Population and Adding Population Variables
STUDYID: Study Identifier USUBJID: Unique Subject Identifier AEBODSYS: Body System or Organ Class AEDECOD: Dictionary-Derived Term SAFFL: Safety Population Flag TRT01AN: Actual Treatment for Period 01 (n) TRT01A: Actual Treatment for Period 01
CDISCPILOT01 01-701-1015 GASTROINTESTINAL DISORDERS DIARRHOEA Y 1 Placebo
CDISCPILOT01 01-701-1015 GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS APPLICATION SITE ERYTHEMA Y 1 Placebo
CDISCPILOT01 01-701-1015 GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS APPLICATION SITE PRURITUS Y 1 Placebo
CDISCPILOT01 01-701-1023 CARDIAC DISORDERS ATRIOVENTRICULAR BLOCK SECOND DEGREE Y 1 Placebo
CDISCPILOT01 01-701-1023 SKIN AND SUBCUTANEOUS TISSUE DISORDERS ERYTHEMA Y 1 Placebo
CDISCPILOT01 01-701-1023 SKIN AND SUBCUTANEOUS TISSUE DISORDERS ERYTHEMA Y 1 Placebo
CDISCPILOT01 01-701-1023 SKIN AND SUBCUTANEOUS TISSUE DISORDERS ERYTHEMA Y 1 Placebo
CDISCPILOT01 01-701-1028 GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS APPLICATION SITE ERYTHEMA Y 3 Xanomeline High Dose
CDISCPILOT01 01-701-1028 GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS APPLICATION SITE PRURITUS Y 3 Xanomeline High Dose
CDISCPILOT01 01-701-1034 GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS APPLICATION SITE PRURITUS Y 3 Xanomeline High Dose

These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.
Health stats visible at Monitor.