aet01_aesi_main {chevron}

AET01_AESI Table 1 (Default) Adverse Event of Special Interest Summary Table.

Description

AET01_AESI Table 1 (Default) Adverse Event of Special Interest Summary Table.

Usage

aet01_aesi_main(
  adam_db,
  arm_var = "ACTARM",
  lbl_overall = NULL,
  aesi_vars = NULL,
  grade_groups = NULL,
  ...
)

aet01_aesi_pre(adam_db, ...)

aet01_aesi_post(tlg, prune_0 = FALSE, ...)

aet01_aesi

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

aesi_vars

(character) the AESI variables to be included in the summary. Defaults to NA.

grade_groups

(list) the grade groups to be displayed.

...

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

• Does not remove rows with zero counts 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

• aet01_aesi_main(): Main TLG function

• aet01_aesi_pre(): Preprocessing

• aet01_aesi_post(): Postprocessing

Note

• adam_db object must contain an adae table with columns "AEOUT", "AEACN", "AECONTRT", "AESER", "AREL", and the column specified by arm_var.

• aesi_vars may contain any/all of the following variables to display: "ALLRESWD", "ALLRESDSM", "ALLRESCONTRT", "NOTRESWD", "NOTRESDSM", "NOTRESCONTRT", "SERWD", "SERDSM", "SERCONTRT", "RELWD", "RELDSM", "RELCONTRT", "RELSER".

• aesi_vars variable prefixes are defined as follows:

  • "ALLRES" = "all non-fatal adverse events resolved"

  • "NOTRES" = "at least one unresolved or ongoing non-fatal adverse event"

  • "SER" = "serious adverse event"

  • "REL" = "related adverse event"

• aesi_vars variable suffixes are defined as follows:

  • "WD" = "patients with study drug withdrawn"

  • "DSM" = "patients with dose modified/interrupted"

  • "CONTRT" = "patients with treatment received"

• Several aesi_vars can be added to the table at once:

  • aesi_vars = "ALL" will include all possible aesi_vars.

  • Including "ALL_XXX" in aesi_vars where XXX is one of the prefixes listed above will include all aesi_vars with that prefix.

Examples

run(aet01_aesi, syn_data)