Add-Supplemental-to-Domain

Vignette Build Datetime

message(paste0('Datetime: ',Sys.Date(),':',Sys.time()))
#> Datetime: 2026-01-21:2026-01-21 09:13:53

Load Libraries

library(repfun)
library(dplyr)

Define data library

tmpdr <- tempdir()
datdir <- file.path(gsub("\\","/",tmpdr,fixed=TRUE),"datdir")
dir.create(datdir,showWarnings=FALSE)
repfun::copydata(datdir)
sdtmdata <- repfun::ru_libname(datdir)

Read SDTM DM and SUPPDM domains

sdtm.dm <- sdtmdata$dm()
sdtm.suppdm <- sdtmdata$suppdm()

Show Supplemental Data to Append

sdtm.suppdm %>% distinct(QNAM,QLABEL) -> usupp
knitr::kable(usupp, caption = "Supplemental Variables to be Added")
Supplemental Variables to be Added
QNAM QLABEL
COMPLT16 Completers of Week 16 Population Flag
COMPLT24 Completers of Week 24 Population Flag
COMPLT8 Completers of Week 8 Population Flag
EFFICACY Efficacy Population Flag
ITT Intent to Treat Population Flag
SAFETY Safety Population Flag

Combine DM and SUPPDM data sets

suppae <- repfun::ru_addsupp(dsetin=sdtm.dm,dsetinsupp=sdtm.suppdm)

Display the Results

lbls <- sapply(suppae,function(x){attr(x,"label")})
knitr::kable(head(suppae,10), col.names=paste(names(lbls),lbls,sep=" "), 
             caption = "Add Supplemental Data to DM Domain")
Add Supplemental Data to DM Domain
STUDYID Study Identifier DOMAIN Domain Abbreviation USUBJID Unique Subject Identifier SUBJID Subject Identifier for the Study RFSTDTC Subject Reference Start Date/Time RFENDTC Subject Reference End Date/Time RFXSTDTC Date/Time of First Study Treatment RFXENDTC Date/Time of Last Study Treatment RFICDTC Date/Time of Informed Consent RFPENDTC Date/Time of End of Participation DTHDTC Date/Time of Death DTHFL Subject Death Flag SITEID Study Site Identifier AGE Age AGEU Age Units SEX Sex RACE Race ETHNIC Ethnicity ARMCD Planned Arm Code ARM Description of Planned Arm ACTARMCD Actual Arm Code ACTARM Description of Actual Arm COUNTRY Country DMDTC Date/Time of Collection DMDY Study Day of Collection COMPLT16 Completers of Week 16 Population Flag COMPLT24 Completers of Week 24 Population Flag COMPLT8 Completers of Week 8 Population Flag EFFICACY Efficacy Population Flag ITT Intent to Treat Population Flag SAFETY Safety Population Flag
CDISCPILOT01 DM 01-701-1015 1015 2014-01-02 2014-07-02 2014-01-02 2014-07-02 NA 2014-07-02T11:45 NA NA 701 63 YEARS F WHITE HISPANIC OR LATINO Pbo Placebo Pbo Placebo USA 2013-12-26 -7 Y Y Y Y Y Y
CDISCPILOT01 DM 01-701-1023 1023 2012-08-05 2012-09-02 2012-08-05 2012-09-01 NA 2013-02-18 NA NA 701 64 YEARS M WHITE HISPANIC OR LATINO Pbo Placebo Pbo Placebo USA 2012-07-22 -14 NA NA NA Y Y Y
CDISCPILOT01 DM 01-701-1028 1028 2013-07-19 2014-01-14 2013-07-19 2014-01-14 NA 2014-01-14T11:10 NA NA 701 71 YEARS M WHITE NOT HISPANIC OR LATINO Xan_Hi Xanomeline High Dose Xan_Hi Xanomeline High Dose USA 2013-07-11 -8 Y Y Y Y Y Y
CDISCPILOT01 DM 01-701-1033 1033 2014-03-18 2014-04-14 2014-03-18 2014-03-31 NA 2014-09-15 NA NA 701 74 YEARS M WHITE NOT HISPANIC OR LATINO Xan_Lo Xanomeline Low Dose Xan_Lo Xanomeline Low Dose USA 2014-03-10 -8 NA NA NA Y Y Y
CDISCPILOT01 DM 01-701-1034 1034 2014-07-01 2014-12-30 2014-07-01 2014-12-30 NA 2014-12-30T09:50 NA NA 701 77 YEARS F WHITE NOT HISPANIC OR LATINO Xan_Hi Xanomeline High Dose Xan_Hi Xanomeline High Dose USA 2014-06-24 -7 Y Y Y Y Y Y
CDISCPILOT01 DM 01-701-1047 1047 2013-02-12 2013-03-29 2013-02-12 2013-03-09 NA 2013-07-28 NA NA 701 85 YEARS F WHITE NOT HISPANIC OR LATINO Pbo Placebo Pbo Placebo USA 2013-01-22 -21 NA NA NA Y Y Y
CDISCPILOT01 DM 01-701-1057 1057 NA NA NA NA NA 2013-12-27 NA NA 701 59 YEARS F WHITE HISPANIC OR LATINO Scrnfail Screen Failure Scrnfail Screen Failure USA 2013-12-20 NA NA NA NA NA NA NA
CDISCPILOT01 DM 01-701-1097 1097 2014-01-01 2014-07-09 2014-01-01 2014-07-09 NA 2014-07-09T09:39 NA NA 701 68 YEARS M WHITE NOT HISPANIC OR LATINO Xan_Lo Xanomeline Low Dose Xan_Lo Xanomeline Low Dose USA 2013-12-23 -9 Y Y Y Y Y Y
CDISCPILOT01 DM 01-701-1111 1111 2012-09-07 2012-09-17 2012-09-07 2012-09-16 NA 2013-02-22 NA NA 701 81 YEARS F WHITE NOT HISPANIC OR LATINO Xan_Lo Xanomeline Low Dose Xan_Lo Xanomeline Low Dose USA 2012-08-25 -13 NA NA NA Y Y Y
CDISCPILOT01 DM 01-701-1115 1115 2012-11-30 2013-01-23 2012-11-30 2013-01-23 NA 2013-05-20 NA NA 701 84 YEARS M WHITE NOT HISPANIC OR LATINO Xan_Lo Xanomeline Low Dose Xan_Lo Xanomeline Low Dose USA 2012-11-23 -7 NA NA Y Y Y Y