Changes in version 0.0.5 (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)