Summary-data dictionary and provenance

Source and sample

The clinical illustration uses IBScovars from DoseFinding 1.4-1. The source is the CRAN package archive. The analysis retained all 369 released observations, with dose counts 71, 78, 75, 72, and 73 at codes 0, 1, 2, 3, and 4. No observation was excluded, imputed, standardized, or transformed for this analysis. The released outcome is a baseline-adjusted abdominal-pain response score; larger values indicate greater improvement according to the source documentation.

The release contains completers, so this is not an intention-to-treat reconstruction. Active physical doses and spacing are not supplied. The equal-spacing code convention is explicit and affects the integrated target.

Bundled aggregate files

clinical_dose_summary.tsv contains dose-level summaries derived from the unchanged released sample. clinical_intervals.tsv contains the saved completed interval results. The package contains no individual-level clinical data.

File Field Meaning
Dose summary dose Ordered dose code, 0 through 4; not a physical dose
Dose summary n Number of released observations at that dose
Dose summary mean Sample mean of the released response
Dose summary sd Sample standard deviation with denominator n - 1
Interval results method / label Recorded method identifier and display label
Interval results status Recorded numerical status
Interval results estimate / qhat Common fitted target estimate and shape estimate
Interval results lower / upper / width Reported interval endpoints and width in response units
Interval results calibration Description of the method’s calibration

Pooled variance

Let \(s_j\) be the dose-specific sample standard deviation and \(n_j\) its count. The pooled within-dose variance for \(m\) dose levels is computed as

\[S^2=\frac{\sum_{j=1}^m(n_j-1)s_j^2}{\sum_{j=1}^m n_j-m}.\]

This expression pools pure error under the common-variance assumption; its denominator is the pure-error degrees of freedom. It reproduces the variance used by the confidence region, up to the precision of the saved summary text. It is not estimated from deviations about a fitted Emax curve.

Reuse and publication status

The source package and aggregate summaries are available from the package website and GitHub repository. Source-dataset documentation and applicable reuse conditions should accompany any future deposition.