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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)
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.