[New Table]: Table 38

[YoshitoKoujin]

Table Layout & Design

Please refer to page 78 of the FDA guideline document for more details.

Table Description

Table 38. Patients With Adverse Events by System Organ Class, FDA Medical Query (Broad) and Preferred Term, Safety Population, Pooled Analysis (or Trial X)

Analysis Datasets

ADAE
ADSL

Data from the random.cdisc.data package, can be retrieved by random.cdisc.data::c followed by your
dataset name.

Analysis Filters

Safety population: SAFFL == "Y"
Treatment-emergent adverse event: TRTEMFL == "Y"

Additional Information

No response

Developer To Dos

• Table Function: Create R/fda-table_XX.R file with your table-generating function.
  • Roxygen Documentation: title, @details, document all parameters, @return, @examples, @export.
• Tests: Create tests/testthat/test-table_XX.R file with tests for the table function and then run these tests.
• Quarto Template: Create quarto/table-templates/template-table_XX.qmd file your table template.
• Screenshot: Add table screenshot as table_XX.png to the quarto/assets/images/screenshots folder.
• _quarto.yml: Add template to the "Template Library" section of the _quarto.yml file.
• Template Index: Run quarto/assets/generate-template_index.R script to update the template index.
• NEWS: Update NEWS.md.