pharmaversesdtm 1.4.0 Release | R bloggers

🧠 New neurological SDTM test datasets

Version 1.4.0 introduces a set of neurology-oriented SDTM test datasetsexpansion of package coverage of therapeutic areas:

• dm_neuro – demographic data for neurological examination
• nv_neuro – neurological findings
• suppnv_neuro – additional qualifications for neurological findings
• ag_neuro – associated groups for neurological domains
• lb_neuro – neurological laboratory test data

These datasets are intended to support the development, testing, and examples of neurology-specific workflows.

📊 New and updated variables

Several existing datasets have been improved:

• VISITDY has been added to the pc domain to support consistent derivations of visiting days.
• BRTHDTC has been added to both dm And dm_metabolicthus improving demographic completeness.
• The qs_ophtha dataset now uses an updated QSTESTCD aligned with CDISC terminology and simplified for easier use in examples.

🧬Oncology data improvements

This release also includes important updates for oncology use cases:

• Corrections to rs_onco_pcwg3addressing misclassified progress indicators and response records.
• A new dataset for oncological biomarkers, lb_onco_pcwg3which provides PSA measurements aligned with PCWG criteria.

🧠 Improvements to neurological datasets

Neurological laboratory data included biomarkers Alpha Synuclein Seed Amplification Assay (CSF), Lumipulse G pTau217, Lumipulse G β-Amyloid 1-42, and the ratio of pTau217 to β-Amyloid 1-42.

📚 Documentation and developer updates

To help you explore datasets by therapeutic area, the reference pages have been reorganized to group datasets under meaningful categories such as metabolic, neurological, and oncology. This makes navigation easier for both researchers and developers.