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.


Reference manual

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install.packages("cardinalfda")

0.3.0 by Joe Zhu, a month ago


https://github.com/pharmaverse/cardinal/, https://pharmaverse.github.io/cardinal/


Report a bug at https://github.com/pharmaverse/cardinal/issues


Browse source code at https://github.com/cran/cardinalfda


Authors: Pawel Rucki [ctb] , Abinaya Yogasekaram [aut] (ORCID: , Joe Zhu [cre] , Daniel D. Sjoberg [ctb] (ORCID: , Emily de la Rua [aut] , Davide Garolini [aut] , Vincent Shen [aut] , Benoit Falquet [ctb] , LluĂ­s Revilla Sancho [ctb] (ORCID: , Huan Lu [ctb] , Alex Assuied [ctb] , Yoshito Koujin [ctb] , Korbinian Matthias [ctb] , Jessica Knizia [ctb] , Freeman Wang [ctb]


Documentation:   PDF Manual  


Apache License (>= 2) license


Imports dplyr

Depends on cards, cardx, crane, gtsummary

Suggests cowplot, forcats, ggplot2, ggsurvfit, gt, knitr, labelled, lubridate, pharmaverseadam, purrr, random.cdisc.data, rlang, rtables, svglite, tern, testthat, tidyr, withr


See at CRAN