pdt02 Major Protocol Deviations Related to Epidemic/Pandemic Table.

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

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=134)     (N=134)        (N=132)    
#>   ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#>   Total number of patients with at least one major protocol deviation related to epidemic/pandemic   9 (6.7%)     2 (1.5%)       5 (3.8%)   
#>   Total number of major protocol deviations related to epidemic/pandemic                                 9           2              6       
#>   Site action due to epidemic/pandemic                                                               9 (6.7%)     2 (1.5%)       5 (3.8%)   
#>     Significant deviation from planned dose                                                          3 (2.2%)     1 (0.7%)       2 (1.5%)   
#>     Failure to sign updated ICF within two visits                                                    2 (1.5%)     1 (0.7%)       1 (0.8%)   
#>     Dose missed or significantly out of window                                                       2 (1.5%)        0           1 (0.8%)   
#>     Missed 2 or more efficacy assessments                                                            2 (1.5%)        0           1 (0.8%)