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cardinalfda: FDA Safety Tables and Figures

Provides implementations of safety tables and figures recommended by the FDA (U.S. Food and Drug Administration) for clinical trial reporting. Functions generate standard outputs for adverse events, laboratory abnormalities, vital signs, exposure, and other safety domains following the FDA's Safety Reporting guidelines. Outputs are built on the 'gtsummary', 'cards', and 'cardx' frameworks, enabling reproducible and submission-ready clinical trial safety summaries.

Version: 0.2.0
Depends: R (≥ 4.2), cards (≥ 0.8.1), cardx (≥ 0.3.4), gtsummary (≥ 2.5.1)
Imports: dplyr (≥ 1.2.1)
Suggests: cowplot (≥ 1.2.0), crane (≥ 0.3.1), forcats (≥ 1.0.1), ggplot2 (≥ 4.0), ggsurvfit (≥ 1.2.0), gt (≥ 1.3.0), knitr (≥ 1.50), labelled (≥ 2.16.0), lubridate (≥ 1.9), pharmaverseadam (≥ 1.3.0), purrr (≥ 1.2), random.cdisc.data (≥ 0.3.16), rlang (≥ 1.1.7), rtables (≥ 0.6.11), tern (≥ 0.9.8), svglite (≥ 2.2.2), testthat (≥ 3.3.1), tidyr (≥ 1.3.1), withr (≥ 3.0.2)
Published: 2026-08-04
DOI: 10.32614/CRAN.package.cardinalfda (may not be active yet)
Author: Pawel Rucki [ctb], Abinaya Yogasekaram ORCID iD [aut], Joe Zhu ORCID iD [cre], Daniel D. Sjoberg ORCID iD [ctb], Emily de la Rua ORCID iD [aut], Vincent Shen [aut], Benoit Falquet ORCID iD [ctb], LluĂ­s Revilla Sancho ORCID iD [ctb], Huan Lu [ctb], Alex Assuied [ctb], Yoshito Koujin [ctb], Korbinian Matthias [ctb], Jessica Knizia [ctb], Freeman Wang [ctb]
Maintainer: Joe Zhu <joe.zhu at roche.com>
BugReports: https://github.com/pharmaverse/cardinal/issues
License: Apache License (≥ 2)
URL: https://github.com/pharmaverse/cardinal/, https://pharmaverse.github.io/cardinal/
NeedsCompilation: no
Language: en-US
Materials: NEWS
CRAN checks: cardinalfda results

Documentation:

Reference manual: cardinalfda.html , cardinalfda.pdf

Downloads:

Package source: cardinalfda_0.2.0.tar.gz
Windows binaries: r-devel: not available, r-release: not available, r-oldrel: not available
macOS binaries: r-release (arm64): cardinalfda_0.2.0.tgz, r-oldrel (arm64): cardinalfda_0.2.0.tgz, r-release (x86_64): cardinalfda_0.2.0.tgz, r-oldrel (x86_64): cardinalfda_0.2.0.tgz

Linking:

Please use the canonical form https://CRAN.R-project.org/package=cardinalfda to link to this page.

These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.