pharmaverseadamjnj 0.0.6

Added ADISHUM Dataset
Added vars to ADSL: LASTCTDT, UNBLNDDT, IMFL, SAFEXRS, FASEXRS, PPREXRS, PKEXRES, and IMEXRES
Added restord labels to xpt
Change ONTRFl for ADVS to first dose within 30 days
Added STRAT1D, STRAT2D to ADSL
Added ABODSYS1, ABODSYS2, ADECOD1, and ADECOD2 to ADEX
Added CRITx (1-8) to ADVS
Added VSCLSIG and RACE to ADVS
Added AOCTIFL, AESCAT, SMQzzNAM, and CQzzNAM, AERELSx, AEACNSx, RELGR1, AEDRGSx, DOSSxDY, DOSSxU, DOSSxON to ADAE
Added derived variables AESHOSPP and AESHOSPR
Added ADVS: RESP TEMP and PULSE PARAMCD
Added variables COHORT, GROUP, and EOTDT to ADSL.
Added variables CMSTRTPT and CMSTTPT to ADCM.
Added AOCT01FL, AOCT02FL, AOCT03FL, AOCS01FL, AOCS02FL, AOCS03FL to ADAE
Added ADAECOMP and ADSLCOMP datasets
Added ADDISP dataset
Added RACE variable from ADSL to ADEG dataset

Removed *_DECODE vars in ADSL, ADLB, ADVS, ADAE, ADCM, ADEG, ADEX
Releveled TRT01P and TRT01A (now Xanomeline Low Dose -> Xanomeline High Dose -> Placebo)
Modified “General disorders and administration site conditions” to “Gastrointestinal disorders” in ADEX
Modified ADVS on ORTHYP, ORTHYPS and ORTHYPD parameters for TSFVIT04
Modified RESCRNFL and assigned 01-701-1240 to Subject refused to sign informed consent
Modified ADVS on RESP parameter for gsfvit02a and gsfvit02b
Modified ADVS on week 20 and week 24 AVISIT derivation
Modified ADVS on AVISITN variable
Modified ADVS on CRIT7/CRIT7FL CRIT8/CRIT8FL values of DIABP parameter
Modified ADVS AVISIT, AVISITN and added ADY derivation
Modified REGION1 to “Northern America”
Added DCSREAS and DCTREAS levels
Modified ADAE to update derivation rules for AEREL, AOCCFL, AOCCPFL, AOCCSFL, TRDISCFL, AESCAT and SMQxxNAM
Modified ADAEOCMQ to update derivation rule for OCMQNAM and AEDECOD
Modified ADAGOCMQ for AEDECOD merge logic, ACAT1, and used conversion factor GLUC, HBA1C for standard units to conventional units.
Modified ADDISP to update labels for SxSDY and SxEDY variables.
Fix adeg CRIT1FL and CRIT2FL factor order

[0.0.5] - 2026-05-25

Update ADSL to have all factor levels of RACE and ETHNIC
Update adsl DTH60TFL to DTHB60FL
Updated adae update to include start/end time.
Updated source file OCMQs to reflect FDA changes to FMQ
Renamed adaefmq to adaeocmq
Fixed ADCM to properly handle uncoded terms
Fixed ADLB to use “BEFORE TREATMENT” for ATPT instead of “00:00”
ADSL: Set RANDFL to “Y” for most subjects with SAFFL=“Y”, but also for a few with SAFFL=“N” and non-NA TRT01P
Updated {pharmaverseadam} released a new version 0.1.2 some variable labels have been added accordingly.

Update ADSL to have all factor levels of RACE and ETHNIC
Update adsl DTH60TFL to DTHB60FL
Updated adae update to include start/end time.
Updated source file OCMQs to reflect FDA changes to FMQ
Renamed adaefmq to adaeocmq
Fixed ADCM to properly handle uncoded terms
Fixed ADLB to use “BEFORE TREATMENT” for ATPT instead of “00:00”
ADSL: Set RANDFL to “Y” for most subjects with SAFFL=“Y”, but also for a few with SAFFL=“N” and non-NA TRT01P
Updated {pharmaverseadam} released a new version 0.1.2 some variable labels have been added accordingly.