QT Safety Explorer: test evidence Experimental

QT-CTRL-001 A View control switches between the three views — central tendency, outlier scatter, and categorical exceedance — rendering one styled, clickable row per view with the active view marked.

QT-CTRL-002 A Correction control offers the configured parameter/correction options (default QTcF, QTcB, Heart Rate) and selects start_measure (QTcF) on first render, falling back to the first available measure when start_measure is unlisted.

QT-CTRL-003 Statistic (mean / median), display (Δ / ΔΔ), timepoint, and categorical filter controls narrow the view; applyFilters constrains rows on the active selections only, so an empty selection constrains nothing.

QT-CT-002 In mean mode the Δ series carries each arm's mean change with a two-sided 90% CI at every visit; in median mode the series carries no CI (lo/hi NaN). The chart draws per-arm lines with the CI band.

QT-CT-003 A mode-labelled horizontal reference line marks the ICH-E14 threshold of regulatory concern on the central-tendency chart.

QT-CT-006 Each arm's peak-effect visit — the visit of maximum effect — is marked on the central-tendency chart.

QT-CT-004 The placebo-corrected ΔΔ mode drops the placebo arm and subtracts the placebo mean change at each visit; the placebo arm is auto-detected (matching /placebo/i) and ordered first.

QT-CT-005 The ICH-E14 metric is the largest upper bound of the two-sided 90% CI for the placebo-corrected mean difference (ΔΔ) across visits, flagged against the ~10 ms reference; the metric is reported only in mean + ΔΔ mode.

QT-OUT-002 With a specific timepoint selected the scatter picks that visit's row per subject (matching a numeric-typed visit against a string timepoint); otherwise the maximum post-baseline value is used.

QT-OUT-003 The outlier scatter draws the 450/480/500 ms absolute-QTc diagonals, and in per-visit mode adds the 30/60 ms change-from-baseline horizontal lines; the absolute cut-lines apply only to QTc corrections.

QT-OUT-004 Each subject point is coloured and shaped by treatment arm, with a distinct cycling point style per arm.

QT-OUT-003 The outlier scatter draws the 450/480/500 ms absolute-QTc diagonals, and in per-visit mode adds the 30/60 ms change-from-baseline horizontal lines; the absolute cut-lines apply only to QTc corrections.

QT-CAT-001 The categorical view hides the chart and tabulates by-arm exceedance, with denominators of post-baseline subjects per arm, tracking each subject's maximum value and maximum change independently.

QT-CAT-002 Absolute-QTc thresholds (>450 / >480 / >500 ms) are counted per arm with a strict greater-than, so a value exactly at a threshold (e.g. 500) is excluded.

QT-CAT-003 Change-from-baseline thresholds (>30 / >60 ms) are counted per arm using each subject's maximum change, independently of the maximum value.

QT-CT-007 Heart rate is offered as a central-tendency measure without the QTc ICH-E14 reference line (the ~10 ms threshold applies to QTc only).

QT-OUT-007 Heart rate shows a QTc-only note in the outlier scatter view, since the absolute and change diagonals apply to QTc corrections only.

QT-DATA-003 cleanData drops rows with a missing or non-numeric value and reports the removed count; the on-page removed-count path leaves no page errors.

QT-CFG-001 syncSettings fills defaults and normalizes field-list settings (arrayifying single values).

QT-CFG-002 syncSettings sorts and numifies the threshold lists (absolute_thresholds, change_thresholds).

QT-CFG-003 syncSettings falls back start_measure to the first available measure when the configured start_measure is not in the measure list.

QT-CFG-004 syncSettings rejects an out-of-range ci_level, keeping the default (0.9).

QT-CFG-005 The VIEWS list and the TIMEPOINT_MAX ("maximum post-baseline") sentinel are stable constants the controls and timepoint selection read from.

QT-CFG-006 zForCi returns the two-sided z multiplier for a confidence level, interpolating between table points and clamping at the ends.

QT-CFG-007 resolvePlaceboArm prefers the explicit placebo setting when present and otherwise auto-detects the placebo arm by matching /placebo/i.

QT-DATA-005 checkInputs validates the schema's required column settings (measure_col, value_col, arm_col, baseline_col) against the remapped names and throws naming every missing column; the baseline record is identified by the baseline flag (ABLFL=Y) and excluded from the post-baseline extremes, and when no baseline-flag column is present a change-of-0 row is treated as the baseline.

QT-DATA-003 cleanData drops rows with a missing or non-numeric value and reports the removed count; the on-page removed-count path leaves no page errors.

QT-DATA-004 Change from baseline is the source change column when present, and is otherwise derived as value − baseline when that column is blank.

QT-DATA-006 measuresPresent lists the distinct measures actually present in the data, so the correction control offers only measures the dataset carries.

QT-STAT-001 The unique helper keeps first-seen non-empty values, preserving order for the arm/visit/measure lists.

QT-STAT-002 The statistics helpers (mean, sd, quantile, median) match hand-computed values, backing the central-tendency means, the CI, and the categorical summaries.

QT-CT-001 The central-tendency view plots per-arm change-from-baseline over ordered study visits (visits sorted by numeric visit), one series per treatment arm.

QT-CT-002 In mean mode the Δ series carries each arm's mean change with a two-sided 90% CI at every visit; in median mode the series carries no CI (lo/hi NaN). The chart draws per-arm lines with the CI band.

QT-CT-004 The placebo-corrected ΔΔ mode drops the placebo arm and subtracts the placebo mean change at each visit; the placebo arm is auto-detected (matching /placebo/i) and ordered first.

QT-CT-005 The ICH-E14 metric is the largest upper bound of the two-sided 90% CI for the placebo-corrected mean difference (ΔΔ) across visits, flagged against the ~10 ms reference; the metric is reported only in mean + ΔΔ mode.

QT-CT-006 Each arm's peak-effect visit — the visit of maximum effect — is marked on the central-tendency chart.

QT-OUT-001 The outlier scatter plots one point per subject at the subject's maximum post-baseline QTc value against their baseline QTc.

QT-OUT-002 With a specific timepoint selected the scatter picks that visit's row per subject (matching a numeric-typed visit against a string timepoint); otherwise the maximum post-baseline value is used.

QT-CAT-001 The categorical view hides the chart and tabulates by-arm exceedance, with denominators of post-baseline subjects per arm, tracking each subject's maximum value and maximum change independently.

QT-CAT-002 Absolute-QTc thresholds (>450 / >480 / >500 ms) are counted per arm with a strict greater-than, so a value exactly at a threshold (e.g. 500) is excluded.

QT-CAT-003 Change-from-baseline thresholds (>30 / >60 ms) are counted per arm using each subject's maximum change, independently of the maximum value.

QT-SCL-001 correctionSuffix maps the QTc formulas to their axis-title suffix (QTcF → Fridericia, QTcB → Bazett).

QT-SCL-002 isQtcMeasure and measureUnit distinguish a QTc correction (msec, cut-lines apply) from heart rate (bpm, no QTc cut-lines).

QT-SCL-003 The central-tendency axis title carries the mode prefix (Δ / ΔΔ) plus the correction suffix and units.

QT-SCL-004 The outlier-scatter axis titles mirror the design mockup (baseline QTc on x, change-from-baseline on y, with the correction suffix).

QT-SCL-005 formatNumber trims trailing zeros and guards non-finite values in tick and tooltip formatting.

QT-SCL-006 formatSigned signs the change value with a real minus glyph (−) for the tooltip and change labels.

QT-SCL-007 paddedDomain covers the data values plus any forced inclusions (the threshold cut-lines), and handles an empty or degenerate sample without collapsing.

QT-SCL-008 The scatter assigns a distinct cycling point style per arm so arms are distinguishable by shape as well as colour.

QT-PLG-001 hexToRgba converts a hex colour to an rgba string at a given opacity, backing the CI band and point fills.

QT-PLG-002 armColorScale assigns stable, cycling colours per arm, consistent across the central-tendency, scatter, and categorical views.

QT-PLG-003 scatterTooltip renders the outlier-point tooltip lines — id, arm, baseline, value, change, and visit.

QT-API-001 The public safety.viz collection exposes a qtExplorer factory function, identical to the named qtExplorer export.