pharmaverseadamjnj 0.0.4
Added
- 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 to ADAE
- Added derived variables
AESHOSPP and
AESHOSPR
Changed
- 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
[0.0.3] - 2026-01-27
Added
- Add DCTADY to ADSL #32
- Add new addili dataset
- Add LBNAM variable to adlb
- Add REGION1 = “North America”
[0.0.2] - 2025-12-03
- Added ADAGOCMQ & ADPC dataset
- Added
LBSPEC and LBFAST to ADLB
dataset
Changed
- 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.
[0.0.1] - 2024-07-02
Added
- Initial CRAN release
- Provides ADaM datasets that comply with J&J Innovative Medicine
standards
- Built on top of the ‘pharmaverseadam’ package
- Implements data conversion from pharmaverse format to J&J
standards format
- Provides reproducible and consistent test data
Implemented ADaM Domains
- ADSL (Subject Level Analysis Dataset)
- ADAE (Adverse Events Analysis Dataset)
- ADCM (Concomitant Medications Analysis Dataset)
- ADEG (ECG Analysis Dataset)
- ADEX (Exposure Analysis Dataset)
- ADESUM (Exposure Analysis Summary Dataset)
- ADLB (Laboratory Test Results Analysis Dataset)
- ADVS (Vital Signs Analysis Dataset)
- ADTTESAF (Time-to-Event Safety Analysis Dataset)
- ADAEFMQ (Adverse Events Analysis Dataset FDA Medical Query)