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pdt01 Major Protocol Deviations Table.

Source: R/pdt01.R
pdt01.Rd

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

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

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

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).

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.

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)
#>   Category                                                              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   2 (13.3%)   4 (26.7%)          0       
#>   Total number of major protocol deviations                                 2           5              0       
#>   EXCLUSION CRITERIA                                                                                           
#>     Active or untreated or other excluded cns metastases                    0        1 (6.7%)          0       
#>     Pregnancy criteria                                                      0        1 (6.7%)          0       
#>   INCLUSION CRITERIA                                                                                           
#>     Ineligible cancer type or current cancer stage                      1 (6.7%)        0              0       
#>   MEDICATION                                                                                                   
#>     Discontinued study drug for unspecified reason                          0        1 (6.7%)          0       
#>     Received prohibited concomitant medication                              0        1 (6.7%)          0       
#>   PROCEDURAL                                                                                                   
#>     Eligibility-related test not done/out of window                         0        1 (6.7%)          0       
#>     Failure to sign updated ICF within two visits                       1 (6.7%)        0              0