pharmaverseadamjnj 0.0.7
Added
- Added DDPCDTHC and NCTXSDT variables to ADSL
- Added AESEVN, EXSTDT, DOSEDT, ADATRES, and NABSTAT variables to
ADAE
- Added EXSTDT, ADATRES, and NABSTAT variables to ADEX
- Added ADATRES and NABSTAT variables to ADEXSUM
- Updated ATOXDSCL & ATOXDSCH variables as per latest lbtoxgrade
file on ADLB dataset
- Updated AVISIT for baseline on ADLB dataset
- Added CRITy and CRITyFL on ADLB based on MCRITy and MCRITyML values
since details missing on markedlyabnormal file
- Added PKRFL variable to ADPC dataset
- Added PARCAT3N to ADLB dataset
- Added AVALCAT1 for DOSEDAYS parameter in ADEXSUM dataset
Changed
- Modified ADSL death-related variable derivations (DTHFL, DTHDT,
DTHCAUS, DDPCDTHC)
- Modified ADSL to add DCTDT label
- Modified ADEXSUM to add DURFUPD parameter
- Modified ADLB toxicity grade detail ATOXDSCL and ATOXDSCH
- Modified ADLB.PARAM values to display as per paramlookup file to
replace x10E with 10^.
- Modified MCRITy and MCRITyFL variable values to assign based on
PARAM instead of random values.
- Modified ADEG for AVAL variable to include “ABNORMAL, CS”,
“ABNORMAL, NCS”, “NORMAL”
- Modified ADEG for PARAMCD converted ‘msec’ to ‘ms’
- Modified ADPC for CRIT1 variable
- Modified ADEX to add ATPT, ATPTN, ADURC, ARSDSDO, ATDPRP, and
ATDPRPU variables
- Modified ADEX for APERIOD and updated ATPT values
- Modified ADEX to add AVAMT, AVAMTU, ADOSFRQP, ADOSDLY, ARSDOSD,
ACDOSE, ACDOSU, ASTDY, ALL ANL flags ex. ANL01FL, ANL02FL, ANL03FL,
ANL04FL, INTCAT, SKPCAT, DLYCAT variables.
- Updated PARAMN values in ADVS domain
- Added CRIT6, CRIT6FL, CRIT7 & CRIT7FL on ADILLI for [AST or ALT]
PARCAT
- Added CRIT2, CRIT2FL, CRIT3, CRIT3FL on ADILLI for TBILI & ALP
PARCAT
- Modified ADEXSUM to add TRTDURD parameter
- Modified ECOCCUR, ADOSE, ACDOSE, ASCHDOSE, AVAMT, ADOSU, ACDOSU.
ASCHDOSU and AVAMTU variables
- Modified PARAM unit to ‘mg’ in ADEXSUM dataset
- Modified PARAM and PARAMCD to add CUMDOSS1, CUMDOSS2
- Modified PARCAT1, PARCAT3 categories tests on ADLB
- Modified MCRITyML, MCRITyMN and MCRITy variables as per standards in
ADLB
- Modified CRITy and CRITYFL variables on ADLB
- Modified ADURC values to HH:MM format on ADEX dataset
- Modified AVALC, BASE, CHG, PCHG and ATPT on ADLB dataset
- Modified ONTRTFL values to consider all non missing visit records on
ADDILI dataset
- Modified CRIT2FL and CRIT2 on ADDILI dataset
[0.0.6] - 2026-09-24
Added
- Added ADISHUM Dataset
- Added DDPCDTHC and NCTXSDT variables to ADSL
- Added AESEVN, EXSTDT, DOSEDT, ADATRES, and NABSTAT variables to
ADAE
- Added EXSTDT, ADATRES, and NABSTAT variables to ADEX
- Added ADATRES and NABSTAT variables to ADEXSUM
- 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, AERELSx, AEACNSx,
RELGR1, AEDRGSx, DOSSxDY, DOSSxU, DOSSxON to ADAE
- Added derived variables
AESHOSPP and
AESHOSPR
- Added ADVS: RESP TEMP and PULSE PARAMCD
- Added variables
COHORT, GROUP, and
EOTDT to ADSL.
- Added variables
CMSTRTPT and CMSTTPT to
ADCM.
- Added AOCT01FL, AOCT02FL, AOCT03FL, AOCS01FL, AOCS02FL, AOCS03FL to
ADAE
- Added ADAECOMP and ADSLCOMP datasets
- Added ADDISP dataset
- Added RACE variable from ADSL to ADEG dataset
- Updated ATOXDSCL & ATOXDSCH variables as per latest lbtoxgrade
file on ADLB dataset
- Updated AVISIT for baseline on ADLB dataset
- Added CRITy and CRITyFL on ADLB based on MCRITy and MCRITyML values
since details missing on markedlyabnormal file
- Added PKRFL variable to ADPC dataset
- Added PARCAT3N to ADLB dataset
- Added AVALCAT1 for DOSEDAYS parameter in ADEXSUM dataset
Changed
- Modified ADSL death-related variable derivations (DTHFL, DTHDT,
DTHCAUS, DDPCDTHC)
- Modified ADSL to add DCTDT label
- Modified ADEXSUM to add DURFUPD parameter
- 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
- Modified RESCRNFL and assigned 01-701-1240 to Subject refused to
sign informed consent
- Modified ADVS on RESP parameter for gsfvit02a and gsfvit02b
- Modified ADVS on week 20 and week 24 AVISIT derivation
- Modified ADVS on AVISITN variable
- Modified ADVS on CRIT7/CRIT7FL CRIT8/CRIT8FL values of DIABP
parameter
- Modified ADVS AVISIT, AVISITN and added ADY derivation
- Modified REGION1 to “Northern America”
- Added DCSREAS and DCTREAS levels
- Modified ADAE to update derivation rules for AEREL, AOCCFL, AOCCPFL,
AOCCSFL, TRDISCFL, AESCAT and SMQxxNAM
- Modified ADAEOCMQ to update derivation rule for OCMQNAM and
AEDECOD
- Modified ADAGOCMQ for AEDECOD merge logic, ACAT1, and used
conversion factor GLUC, HBA1C for standard units to conventional
units.
- Modified ADDISP to update labels for SxSDY and SxEDY variables.
- Fix adeg CRIT1FL and CRIT2FL factor order
- Modified ADLB toxicity grade detail ATOXDSCL and ATOXDSCH
- Modified ADLB.PARAM values to display as per paramlookup file to
replace x10E with 10^.
- Modified MCRITy and MCRITyFL variable values to assign based on
PARAM instead of random values.
- Modified ADEG for AVAL variable to include “ABNORMAL, CS”,
“ABNORMAL, NCS”, “NORMAL”
- Modified ADEG for PARAMCD converted ‘msec’ to ‘ms’
- Modified ADPC for CRIT1 variable
- Modified ADEX to add ATPT, ATPTN, ADURC, ARSDSDO, ATDPRP, and
ATDPRPU variables
- Modified ADEX for APERIOD and updated ATPT values
- Modified ADEX to add AVAMT, AVAMTU, ADOSFRQP, ADOSDLY, ARSDOSD,
ACDOSE, ACDOSU, ASTDY, ALL ANL flags ex. ANL01FL, ANL02FL, ANL03FL,
ANL04FL, INTCAT, SKPCAT, DLYCAT variables.
- Updated PARAMN values in ADVS domain
- Added CRIT6, CRIT6FL, CRIT7 & CRIT7FL on ADILLI for [AST or ALT]
PARCAT
- Added CRIT2, CRIT2FL, CRIT3, CRIT3FL on ADILLI for TBILI & ALP
PARCAT
- Modified ADEXSUM to add TRTDURD parameter
- Modified ECOCCUR, ADOSE, ACDOSE, ASCHDOSE, AVAMT, ADOSU, ACDOSU.
ASCHDOSU and AVAMTU variables
- Modified PARAM unit to ‘mg’ in ADEXSUM dataset
- Modified PARAM and PARAMCD to add CUMDOSS1, CUMDOSS2
- Modified PARCAT1, PARCAT3 categories tests on ADLB
- Modified MCRITyML, MCRITyMN and MCRITy variables as per standards in
ADLB
- Modified CRITy and CRITYFL variables on ADLB
- Modified ADURC values to HH:MM format on ADEX dataset
- Modified AVALC, BASE, CHG, PCHG and ATPT on ADLB dataset
- Modified ONTRTFL values to consider all non missing visit records on
ADDILI dataset
- Modified CRIT2FL and CRIT2 on ADDILI dataset
[0.0.5] - 2026-05-25
Added
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)
[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)