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pharmaverseadamjnj

0.0.8Package record

J&J Innovative Medicine ADaM Test Data

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Overview

About
Maintained by David Munoz TordCRAN page ↗Declared funder: J&J Innovative Medicine

A set of Analysis Data Model (ADaM) datasets constructed by modifying the ADaM datasets in the 'pharmaverseadam' package to meet J&J Innovative Medicine's standard data structure for Clinical and Statistical Programming.

Changes in 0.0.8

Changed

  • updated adlb code for ANL01FL related to AVALC values

[0.0.7] - 2026-09-30

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
Show all changes in 0.0.8Hide the rest of the changes in 0.0.8
  • 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)

From NEWS.md in the release

Install

Health

CRAN checks
13OK
Slowest check: 7.1 min · r-release-macos-x86_64
Status changes
  • OK13 OK2026-08-05
  • NOTE12 OK, 1 NOTE2026-08-01
  • OK13 OK2026-07-16
  • WARNING12 OK, 1 WARNING2026-07-15
  • OK14 OK2026-03-10
Advisories

none known

Documentation

In release 0.0.8
READMEYes · 201 wordsVignettesNoNEWSYes · 67% structured · mentions 0.0.8Citation fileNoWebsitenot declared in DESCRIPTION
Help pages
18 (1 internal)includes a package overview page
Examples that run
100%17 run in a plain check
Exported functions with examples
not tracked
Documented parameters
not tracked
Return-value docs
not tracked
Help pages citing references
0%

Downloads

4.3K
CRAN downloads in the past year
Rank #5,727 · ~12/day · ~355/mo
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52030 days
1.4K90 days
4.3K1 year
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Dependencies

Declared dependencies
1 external dependency (excludes base and recommended)

Installing pharmaverseadamjnj adds 11 packages (7 with compiled code, 8.1 MB of source tarballs). Heaviest: pharmaverseadam 4.1 MB, vctrs 1.0 MB, rlang 766 KB.

Depends (2)
Imports (0)
none
LinkingTo (0)
none
Suggests (0)
none
Enhances (0)
none
Reverse dependencies
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0indirect
Suggested by 1
Suggests, most downloaded first

Datasets

People & History

People (7)
Author, Maintainer since 0.0.1 (2025)
Contributor
Contributor · added in 0.0.6
Contributor · added in 0.0.8
Copyright holder, Funder
Releases (7)

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Package metadata

First published
2025-07-15
Total releases
7 / 1 yrs
License
Apache License (>= 2)
Minimum R
≥ 3.5
Bundled data
3.5 MB / 17 files
Download size
3.5 MB

Cite

Cite this package

Run in R for the authors' preferred citation:

citation("pharmaverseadamjnj")
Munoz Tord, D., J&J Innovative Medicine, Divakaran, M., Kovach, J., Mao, R., Masel, N., & Shanmugam, S. (2026). pharmaverseadamjnj: J&J Innovative Medicine ADaM Test Data (Version 0.0.8) [Computer software]. https://doi.org/10.32614/CRAN.package.pharmaverseadamjnj

This package has no citation file, so citation() returns this entry built from DESCRIPTION.

Cite the R Observatory

For a number measured here: a download total, a coverage figure, an archival date.

APA

Balamuta, J. J. (2026). R Observatory: Metrics for pharmaverseadamjnj version 0.0.8 [Data set]. HJJB, LLC. Data release v2026-10-18. https://doi.org/10.5281/zenodo.21843040

From data release v2026-10-18, which the citation names so these numbers can be found later. More on citing and the projects behind them.

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