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Changelog

random.cdisc.data 0.3.14

Breaking changes

  • Renamed ADSL argument to adsl in radab, radae, radaette, radcm, raddv, radeg, radex, radhy, radlb, radmh, radpc, radpp, radqlqc, radqs, radrs, radsaftte, radsub, radtr, radtte, radvs, and get_qs_data.
  • Renamed ADPC argument to adpc in radab.
  • Renamed event.descr argument event_descr and censor.descr argument to censor_descr in radaette and adtte.

New features

  • Added new random dataset generator: Anti-Drug Antibody Analysis Dataset (radab).
  • Added new random dataset generator: EORTC QLQ-C30 V3 Analysis Dataset (radqlqc).

Enhancements

  • Added variables ASTDY, AENDY, EXDOSFRQ, EXROUTE, VISIT, VISITDY, EXSTDTC, EXENDTC, EXSTDY, EXENDY, TRTSDT, and TRTEDT to adex.
  • Added more default PARAMs and new variables PPSTINT, PPENINT, REGIMEN, and PKARMCD to adpp.
  • Added TNE to PARAMCD, Total Number of Exacerbations to PARAM, and new variable lgTMATRSK to adtte.
  • Added more default PARAMs and post-baseline visits to adab and enhanced variables ADAPBLFL, ABLFL, ADABLFL, PARCAT1, and RELTMU.
  • Added variables AEWITHFL and ADTHAUT to adsl.
  • Added variable ATIREL to admh.
  • Added variables CMSTRTPT, CMENRTPT, ADURN, and ADURU to adcm.
  • Added variables AESCONG, AESDISAB, AESHOSP, AESLIFE, AESMIE, and LDOSEDTM to adae.
  • Added parameter with_trt02 to radsl to make the second treatment period available. When with_trt02 = TRUE (default), add variables TRT02A, TRT02P, TRT02SDTM, TRT02EDTM, AP02SDTM, AP02EDTM, TRT01SDTM, TRT01EDTM, AP01SDTM, and AP01EDTM to adsl, and set TRTSDTM as TRT01SDTM, TRTEDTM as TRT02EDTM.
  • Added variable LDRELTM to adae.
  • Aligned logic for ADTM, ADY, and ONTRTFL variables with AVISIT where applicable within adeg, adlb, adqs, adsub, adtr, and advs.
  • Made AVAL values more realistic and updated derivations of ANRIND, *STRESC, and LOQFL to depend on value of PARAMCD in adlb and advs.
  • Added tests to increase package test coverage.
  • Added “datetime” and “date” as valid variable types to apply in apply_metadata.
  • Implemented the lubridate package in all date/datetime variable derivations.

Bug fixes

  • Updated all the ANL01FL NA values to "" in adae.
  • Updated DVDECOD and DVSCAT values in addv.
  • Fixed adtm calculations so that records with same AVISIT have the same ADTM for each patient.
  • Fixed checks for na_percentage argument that is in most datasets.
  • Updated package for breaking changes in tidyselect.
  • Updated adtte so that the events, analysis values and censor values make logical sense.

Miscellaneous

  • Updated installation method and aligned with other packages.
  • Updated tests to use testthat 3rd edition and added snapshot testing for random rows.
  • Implemented lifecycle package with stable badge for exported functions, and tagged internal functions.
  • Combined ADQLQC helper functions into the same documentation file.
  • Improved usability of examples.
  • Renamed random.cdisc.data.R file to package.R and cleaned up contents.
  • Added more detailed documentation for function parameters.
  • Converted all dataset names to lowercase/snake case for consistency with other NEST packages.
  • Refactor adpc and adab following the new CDISC standard.
  • Refactor abab parameters and visits to align with adpc.
  • Skipping examples in h_adqlqc documentation.
  • Changed example in apply_metadata to reduce example run time.

random.cdisc.data 0.3.13

New features

  • Added new random dataset generator: PK Analysis Dataset (radpc).
  • Added new random dataset generator: PK Parameter Dataset (radpp).

Enhancements

  • Added new variables AGEU, TRT01P, TRT01A to ADSL.
  • Added new variables CMINDC, CMDOSE, CMTRT, CMDOSU, CMROUTE, CMDOSFRQ to ADCM.
  • Added ANRLO and ANRHI column to ADLB and ADVS.
  • Added AERELNST column to ADAE.
  • Added MHDISTAT column to ADMH.
  • Enhanced radpc to add an argument to set the duration in number of days.

Bug fix

  • Fixed a typo in ADSL$BMRKR1’s label.

Miscellaneous

  • Updated required R version to >= 3.6.
  • Removed deprecated package utils.nest from imports and now use checkmate for validation functions.
  • Removed deprecated dependency test.nest.

random.cdisc.data 0.3.12

Enhancements

  • Added EOTSTT variable to ADSL dataset.
  • Enabled users to define mean analysis value for each lab test in radlb with new argument aval_mean.
  • Added AERELNST and AEACNOTH variables to ADAE dataset.

Miscellaneous

  • Updated LICENCE and README with new package references.
  • Corrected the EVNTDESC and CNSR variable values for the “OS” parameter in ADTTE dataset.
  • Fixed typo in label for BASE2 variable in ADQS dataset.
  • Added error_on_lint: TRUE to .lintr.

random.cdisc.data 0.3.11

Enhancements

  • Added AECONTRT variable to ADAE dataset.
  • Added new parameters in ADAETTE dataset.
  • Added new parameters in ADHY dataset.
  • Added period variables APERIOD and APERIODC to ADHY dataset.

random.cdisc.data 0.3.10

  • Added parameters to ADHY data.
  • Fix bug to make internal helper rel_var work with tibbles.
  • Added new random dataset generator: Hys Law Analysis Dataset (radhy) .
  • Updated the sampling of TRTSDTM in radsl to be more efficient.

random.cdisc.data 0.3.9

  • Fix warnings of binding factors to characters.

random.cdisc.data 0.3.8

  • Added variables ATC1CD, ATC2CD, ATC3CD, and ATC4CD to ADCM data.
  • Enhanced ADAETTE data set generation via radaette():
    • lookup argument now takes the parameters CATCD and CAT instead of PARAMCD and PARAM. CATCD specifies the code for study specific treatment emergent adverse events (e.g. “1”) and CAT specifies the corresponding text (e.g. “any adverse event”).
    • The resulting data set contains now the number of total occurrences per patient of each specific AE category (PARAMCD starting with AETOT and ending with CATCD).
    • Added parameter AEREPTTE, the time to end of the AE reporting period.
    • Generation of the time to and number of adverse events now is conditional on the censoring information, i.e. no longer possible to have a situation with patient censored but time to first AE larger than the AE reporting period.
  • Updated examples to not use cached = TRUE.
  • Added ADSUB dataset.

random.cdisc.data 0.3.7

  • Added parameters BNRIND and ONTRTFL to ADVS data set.
  • Added new parameter “Duration of Confirmed Response” to ADTTE data set.

random.cdisc.data 0.3.6

  • Fixed radsl where N < 4.

random.cdisc.data 0.3.5

  • Added ADTR dataset from osprey.
  • Added 10 variables to ADAE dataset: AEOUT, AEACN, AESDTH, TRTEMFL, ANL01FL, SMQ01NAM, SMQ02NAM, SMQ01SC, SMQ02SC, CQ01NAM.
  • Added WORS02FL (Worst Post-Baseline Observation) to ADEG dataset.
  • Added ADEG dataset.
  • Added 11 variables to ADLB dataset: BNRIND, SHIFT1, ATOXGR, BTOXGR, WOS01FL, ANL01FL, WGRHIFL, WGRLOFL, WGRHIVFL, WGRLOVFL, ONTRTFL.

random.cdisc.data 0.3.4

  • Simple refactor for examples.

random.cdisc.data 0.3.3

  • Remove test.nest dependency.

random.cdisc.data 0.3.2

  • Added ADMH dataset.
  • Renamed AREL column in ADAE to AEREL.

random.cdisc.data 0.3.1

  • Refactored after renaming functions in utils.nest.
  • Added ADEX dataset.

random.cdisc.data 0.3.0

  • Columns classes configuration in .yml file.
  • Added Medical History Analysis Dataset (radmh).
  • Added missing columns based on Roche standards.
  • Introduced missing values in random datasets generators (i.e. r<name>).
  • Updated lists of dataset columns.
  • Enhanced auto-testing.

random.cdisc.data 0.2.1

  • Added cached versions of the datasets c<name>.

random.cdisc.data 0.2.0

  • New consistent approach of creating random data for the different domains.
  • Switch to new CDISC names (e.g. ADSL instead of ASL).
  • Random dataset generators are:
    • Subject-Level Analysis Dataset (radsl).
    • Adverse Event Analysis Dataset (radae).
    • Time to Adverse Event Analysis Dataset (radaette).
    • Previous and Concomitant Medications Analysis Dataset (radcm).
    • Laboratory Data Analysis Dataset (radlb).
    • Questionnaires Analysis Dataset (radqs).
    • Time-to-Event Dataset (radtte).
    • Tumor Response Analysis Dataset (radrs).
    • Vital Signs Analysis Dataset (radvs).

random.cdisc.data 0.1.0

  • Initial release.