NEWS.md

In pharmaverseadamjnj: J&J Innovative Medicine ADaM Test Data

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)

pharmaverseadamjnj documentation built on May 7, 2026, 5:07 p.m.