pdt01: 'pdt01' Major Protocol Deviations Table.

In chevron: Standard TLGs for Clinical Trials Reporting

pdt01 Major Protocol Deviations Table.

Description

A major protocol deviations table with the number of subjects and the total number of treatments by medication class sorted alphabetically and medication name sorted by frequencies.

Usage

pdt01_main(
  adam_db,
  arm_var = "ARM",
  lbl_overall = NULL,
  dvcode_var = "DVDECOD",
  dvterm_var = "DVTERM",
  ...
)

pdt01_pre(adam_db, ...)

pdt01_post(
  tlg,
  prune_0 = TRUE,
  dvcode_var = "DVDECOD",
  dvterm_var = "DVTERM",
  ...
)

pdt01

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
dvcode_var	(string) the variable defining the protocol deviation coded term. By default DVDECOD.
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. (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 medication class alphabetically and within medication class by decreasing total number of patients with the specific medication.

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

• pdt01_main(): Main TLG function

• pdt01_pre(): Preprocessing

• pdt01_post(): Postprocessing

Note

• adam_db object must contain an addv table with the columns specified in dvcode_var and dvterm_var as well as "DVSEQ".

Examples

run(pdt01, syn_data)

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