gsm.safety v1.1.0
See it move: the annotated v1.1 demo walks the new metrics running live on the DEMO-301 study site, with captures and try-it-yourself steps.
gsm.safety could draw the eDISH chart but could not tell you how many participants were in the Hy's Law quadrant. This release adds the metrics phase that answers that — three participant-level safety metrics plus the denominators a safety overview leads with — and moves the report workflows into the standard gsm phase layout on the way. One path changes: workflows formerly under inst/workflow/3_reports/ now live in inst/workflow/4_modules/.
What's new
- A
2_metricsworkflow phase: three participant-level safety metrics (#45, PR #47; hub obot.roadmap#138).saf0001Hy's Law candidate,saf0002QTcF prolongation, andsaf0003serious / related AE — each scores one row per participant with an ordinal tier through the standard gsm contract (Analyze_Identity()+Flag(), following gsm.kri'spat0015precedent), so subject-level rows land inReporting_Resultsbeside site and country rows with nothing downstream changing. The liver and QT cut-points come from the vendored data contracts of the charts they correspond to, so the metric and the chart cannot drift apart. Measured on demo data before being treated as real (the hub#138 gate): 9 / 11 / 68 red-tier participants of 765 scored. See them live. SafetyCensus()(PR #47) — reduces the mapped domains to the denominators a safety overview leads with: enrollment, exposure, person-years, deaths, and data coverage per visit — the figure that decides whether a quiet visit is reassuring or empty. New exported helpers behind the metrics:Input_HysLaw(),Input_QtProlongation(),Input_SafetyAE().- Report workflows move to
inst/workflow/4_modules/(#46, PR #47; hub obot.roadmap#136) — the standard gsm phase directory formeta.Type: Reportworkflows, the one gsm.kri already uses. Update any pipeline that globbed3_reports/.
1 286 tests pass; R CMD check clean.
This release was drafted by Claude Code using Opus 5 and reviewed by @jwildfire