Changelog

random.cdisc.data 0.3.13.9009

New features

  • Added new random dataset generator: Anti-Drug Antibody Analysis Dataset (radab).

Bug fix

  • Update all the NA and “” to “” in ADAE$ANL01FL.
  • Updated DVDECOD and DVSCAT values in ADDV Dataset (raddv, caddv).

Enhancements

  • Enhanced radpp with additional default PARAMs.
  • Add new variables PPSTINT PPENINT to radpp.

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 R version requirement 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 “Overall Survival 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 additional 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

  • Four variables ATC1CD, ATC2CD, ATC3CD, ATC4CD have been added to ADCM data.
  • ADAETTE data set generation via radaette() has been enhanced:
    • lookup argument now takes the parameters CATCD and CAT instead of PARAMCD and PARAM. CATCD specifies the code to be used 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), in addition to the already available time to first occurrence (PARAMCD starting with AETTE and ending with CATCD).
    • An additional parameter included is 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. it is no longer possible to have a situation where the patient is censored but the time to first AE is larger than the AE reporting period.
  • Updated examples to not use cached = TRUE.
  • Added ADSUB dataset.

random.cdisc.data 0.3.7

  • ADVS data set was updated. Two additional parameters were included: BNRIND and ONTRTFL.
  • ADTTE data set was updated. There is a new parameter in this data set: “PARAM == Duration of Confirmed Response”.

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>).
  • Updating list of created columns in multiple datasets.
  • 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.