pdt02: 'pdt02' Major Protocol Deviations Related to...

In chevron: Standard TLGs for Clinical Trials Reporting

pdt02 Major Protocol Deviations Related to Epidemic/Pandemic Table.

Description

A major protocol deviations table with the number of subjects and the total number of Major Protocol Deviations Related to Epidemic/Pandemic sorted alphabetically and deviations name sorted by frequencies.

Usage

pdt02_main(
  adam_db,
  arm_var = "ARM",
  lbl_overall = NULL,
  dvreas_var = "DVREAS",
  dvterm_var = "DVTERM",
  ...
)

pdt02_pre(adam_db, ...)

pdt02_post(
  tlg,
  prune_0 = TRUE,
  dvreas_var = "DVREAS",
  dvterm_var = "DVTERM",
  ...
)

pdt02

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
dvreas_var	(string) the variable defining the reason for deviation. By default DVREAS.
dvterm_var	(string) the variable defining the protocol deviation term. By default DVTERM.
...	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

• Data should be filtered for major protocol deviations related to epidemic/pandemic. (AEPRELFL == "Y" & DVCAT == "MAJOR").

• Numbers represent absolute numbers of subjects and fraction of N, or absolute numbers when specified.

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

• Split columns by arm.

• Does not include a total column by default.

• Sort by deviation reason alphabetically and within deviation reason by decreasing total number of patients with the specific deviation term.

Value

the preprocessing function returns a list of data.frame.

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

Functions

• pdt02_main(): Main TLG function

• pdt02_pre(): Preprocessing

• pdt02_post(): Postprocessing

Note

• adam_db object must contain an addv table with the columns specified in dvreas_var and dvterm_var.

Examples

run(pdt02, syn_data)

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