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pdt02 Major Protocol Deviations Related to Epidemic/Pandemic Table.

Source: R/pdt02.R
pdt02.Rd

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

Format

An object of class chevron_t of length 1.

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

Value

the preprocessing function returns a list of data.frame.

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

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.

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)
#>   Primary Reason                                                                                     A: Drug X   B: Placebo   C: Combination
#>     Description                                                                                       (N=15)       (N=15)         (N=15)    
#>   ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#>   Total number of patients with at least one major protocol deviation related to epidemic/pandemic   1 (6.7%)        0              0       
#>   Total number of major protocol deviations related to epidemic/pandemic                                 1           0              0       
#>   Site action due to epidemic/pandemic                                                               1 (6.7%)        0              0       
#>     Failure to sign updated ICF within two visits                                                    1 (6.7%)        0              0