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.
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 byrandom.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
R/fda-table_XX.R
file with your table-generating function.@details
, document all parameters,@return
,@examples
,@export
.tests/testthat/test-table_XX.R
file with tests for the table function and then run these tests.quarto/table-templates/template-table_XX.qmd
file your table template.table_XX.png
to thequarto/assets/images/screenshots
folder._quarto.yml
file.quarto/assets/generate-template_index.R
script to update the template index.NEWS.md
.