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pharmaverseadamjnj 0.0.5
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)
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.