safety.viz v1.4.0
safety.viz v1.4.0
The library's first cardiac-safety renderer joins the gallery, hep-explorer gains a baseline-referenced view for subjects with abnormal baseline liver tests, and the Gallery is one click from any chart, anywhere on the site.
-
QT Safety Explorer (Phase 1) (#68, parent obot.roadmap#36): the first cardiac-safety renderer in the library, porting the core displays of SafetyGraphics/qtexplorer onto Chart.js per the CSRC Example QT Tool Display mockup and the draft clinical workflow. One renderer with three coordinated views over a shared correction (QTcF / QTcB / Heart Rate) and filter set: a central-tendency view — per-arm mean/median change over time with a Δ (change-from-baseline) / placebo-corrected ΔΔ toggle, a two-sided 90% CI band, a peak-effect-visit marker, and the ICH-E14 metric (the largest upper bound of the 90% CI for the mean difference against the ~10 ms reference); an outlier scatter — change-from-baseline vs baseline QTc with the 450/480/500 ms absolute-QTc diagonals and the 30/60 ms change lines, colored and shaped by arm; and a categorical by-arm table of the count and percent of participants exceeding each absolute and change threshold. Demo data is CDISC Pilot ADEG (pharmaverseadam) — QTcF / QTcB / Heart Rate across 254 participants and three arms. It ships marked Experimental: individualized QTcI correction, PR/QRS/JT multi-interval rows, per-subject drill-down, the QT-RR hysteresis plot, the guided ICH-E14 workflow, and a moxifloxacin positive-control arm are scoped for Phase 2. Try it live.
-
Composite plot for hep-explorer (#67, #69): a new View on the shipped hep-explorer for assessing potential DILI in subjects with abnormal baseline liver tests — the population the standard ×ULN eDISH both false-alarms on and masks real on-treatment change in. The composite plot anchors the assessment to each subject's own baseline (×BLN) alongside the population reference, following Tesfaldet et al., Drug Safety 2024;47:699–710, ported from the FDA public-domain Composite-eDISH-Plot. A
Viewcontrol switches between the classic eDISH / mDISH scatter and the composite plot — a new view on an existing tool, with no new data domain. Try it live. -
Gallery dropdown in the top nav (#71, #72): the top-nav "Gallery" item now expands into a dropdown of every chart — click Gallery for the index as before, or pick a chart to land straight on its demo page. The menu is data-driven from the renderer registry, so newly-migrated renderers appear with no nav edits. The header nav is also tidier (#73, #74): the repository link is now the GitHub mark icon and the hub link the obot brand mark, rather than the words — with the accessible names preserved.
Vendor the new bundle at dist/safety.viz-1.4.0/ (IIFE + ESM, as before). The new qtExplorer(element, settings) factory joins the library; hep-explorer's existing factory gains the composite view through a documented view setting, and every other renderer API is unchanged.
As with every release, the new work traces to requirement-keyed tests with published evidence reports on the canonical Linux runner and reviewed requirement matrices — the QT Safety Explorer adds 50 unit and 9 e2e tests, and the composite plot adds the HEP-COMP-001..006 requirement-keyed unit and browser rows, all green.
Requirements delivered: obot.roadmap#36 (QT Safety Explorer, Phase 1), the hep-explorer composite plot from the safety-graphics improvement assessment (Initiative 01), and site-nav polish (#71).
This release was drafted by Claude Code using Opus 4.8 and reviewed by @jwildfire
