NEWS

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pharmaversesdtmjnj 0.0.6 (2026-09-23)

Added

• Added SDTM datasets that comply with J&J standards:

  • TS (Trial Summary Information)
  • AE (Adverse Events)
  • HO (Healthcare Encounters)
  • SUPPHO (Supplemental Qualifiers for HO)
  • SUPPPR (Supplemental Qualifiers for Procedures)
    • SUPPPC (Supplemental Pharmacokinetic Concentrations)
  • PR (Procedures)

• Added variables to MH:

  • MHSTDY
  • MHENDY
  • Updated MH for MHCAT values

• Added

[0.0.2] - 2026-03-19

Added

• Added SDTM datasets that comply with J&J standards:
  • DV (Protocol Deviations)
  • IE (Inclusion/Exclusion Criteria Not Met)

Changed

[0.0.1] - 2024-07-02

• Added SDTM datasets that comply with J&J standards:
  • MH (Medical History)
  • DS (Disposition)
• Built on top of the 'pharmaversesdtm' package
• Implemented data conversion from pharmaverse format to J&J standards format
• Provided reproducible and consistent test data