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Changelog

pharmaverseadamjnj 0.0.5

CRAN release: 2026-05-08

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)