aet04: 'AET04' Table 1 (Default) Adverse Events by Highest 'NCI'...

In chevron: Standard TLGs for Clinical Trials Reporting

AET04 Table 1 (Default) Adverse Events by Highest NCI CTACAE AE Grade Table 1.

Description

The AET04 table provides an overview of adverse event with the highest NCI CTCAE grade per individual.

Usage

aet04_main(
  adam_db,
  arm_var = "ACTARM",
  lbl_overall = NULL,
  grade_groups = NULL,
  ...
)

aet04_pre(adam_db, ...)

aet04_post(tlg, prune_0 = TRUE, ...)

aet04

Arguments

adam_db	(list of data.frames) object containing the ADaM datasets
arm_var	(string) variable used for column splitting
lbl_overall	(string) label used for overall column, if set to NULL the overall column is omitted
grade_groups	(list) putting in correspondence toxicity grades and labels.
...	not used.
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

• Numbers represent absolute numbers of patients and fraction of N, or absolute number of event when specified.

• Remove zero-count rows unless overridden with prune_0 = FALSE.

• Events with missing grading values are excluded.

• Split columns by arm, typically ACTARM.

• Does not include a total column by default.

• Sort Body System or Organ Class and Dictionary-Derived Term by highest overall frequencies. Analysis Toxicity Grade is sorted by severity.

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

• aet04_main(): Main TLG function

• aet04_pre(): Preprocessing

• aet04_post(): Postprocessing

Note

• adam_db object must contain an adae table with the columns "AEBODSYS", "AEDECOD" and "ATOXGR".

Examples

grade_groups <- list(
  "Grade 1-2" = c("1", "2"),
  "Grade 3-4" = c("3", "4"),
  "Grade 5" = c("5")
)
proc_data <- dunlin::log_filter(syn_data, AEBODSYS == "cl A.1", "adae")
run(aet04, proc_data, grade_groups = grade_groups)

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