aet05: 'AET05' Table 1 (Default) Adverse Event Rate Adjusted for...

In chevron: Standard TLGs for Clinical Trials Reporting

AET05 Table 1 (Default) Adverse Event Rate Adjusted for Patient-Years at Risk - First Occurrence.

Description

The AET05 table produces the standard adverse event rate adjusted for patient-years at risk summary considering first occurrence.

Usage

aet05_main(
  adam_db,
  dataset = "adsaftte",
  arm_var = "ACTARM",
  lbl_overall = NULL,
  ...
)

aet05_pre(adam_db, dataset = "adsaftte", ...)

aet05_post(tlg, prune_0 = FALSE, ...)

aet05

Arguments

adam_db	(list of data.frames) object containing the ADaM datasets
dataset	(string) the name of a table in the adam_db object.
arm_var	(string) the arm variable used for arm splitting.
lbl_overall	(string) label used for overall column, if set to NULL the overall column is omitted
...	Further arguments passed to tern::control_incidence_rate().
tlg	(TableTree, Listing or ggplot) object typically produced by a main function.
prune_0	(flag) remove 0 count rows

Format

An object of class chevron_t of length 1.

Details

• Total patient-years at risk is the sum over all patients of the time intervals (in years).

• Split columns by arm, typically ACTARM.

• Split rows by parameter code.

• AVAL is patient-years at risk.

• N_EVENTS is the number of adverse events observed.

• The table allows confidence level to be adjusted, default is 95%.

• Keep zero count rows by default.

Value

the main function returns an rtables object.

the preprocessing function returns a list of data.frame.

the postprocessing function returns an rtables object or an ElementaryTable (null report).

Functions

• aet05_main(): Main TLG function

• aet05_pre(): Preprocessing

• aet05_post(): Postprocessing

Note

• adam_db object must contain table named as dataset with the columns "PARAMCD", "PARAM", "AVAL", and "CNSR".

Examples

library(dplyr)
library(dunlin)

proc_data <- log_filter(syn_data, PARAMCD == "AETTE1", "adsaftte")

run(aet05, proc_data)

run(aet05, proc_data, conf_level = 0.90, conf_type = "exact")

chevron documentation built on June 20, 2025, 5:08 p.m.