EXT01 Table 2 (Supplementary) Exposure Summary Table with grouping options

ext01_2(
  adam_db,
  armvar = .study$actualarm,
  lbl_overall = .study$lbl_overall,
  prune_0 = TRUE,
  deco = std_deco("EXT01"),
  .study = list(actualarm = "ACTARM", lbl_overall = NULL)
)

ext01_2_lyt(
  armvar = .study$actualarm,
  summaryvars = c("AVAL", "AVALCAT1"),
  summaryvars_lbls = c("Summary", "Categories"),
  lbl_overall = .study$lbl_overall,
  deco = std_deco("EXT01"),
  .study = list(actualarm = "ACTARM", lbl_overall = NULL)
)

ext01_2_pre(
  adam_db,
  show_stats = .study$show_cont_stats,
  show_bins = .study$show_cat_stats,
  .study = list(show_cont_stats = c("ALL"), show_cat_stats = c("ALL"))
)

Arguments

adam_db

(dm) object containing the ADaM datasets

armvar

(character) variable used for column splitting

lbl_overall

(character) label used for overall column, if set to NULL the overall column is omitted

prune_0

(logical) remove 0 count rows

deco

(character) decoration with title, subtitles and main_footer content

.study

(list) with default values for the arguments of the function

summaryvars

(string) the name of the variable to be analyzed. By default "AVAL".

summaryvars_lbls

(string) the label associated with the analyzed variable.

show_stats

(vector of character) providing the name of the parameters whose statistical summary should be presented. To analyze all, provide show_stats = "ALL" (Default), to analyze none, provide show_stats = "".

show_bins

(vector of character) providing the name of the parameters whose categorical summary should be presented. To analyze all, provide show_bins = "ALL" (Default), to analyze none, provide show_bins = "".

Details

  • Supplementary Exposure table with binning of desired analysis values.

  • The n row provides the number of non-missing values. The percentages for categorical variables is based on n. The percentages for Total number of patients with at least one dose modification are based on the number of patients in the corresponding analysis population given by N.

  • Split columns by arm, typically ACTARM.

  • Does not include a total column by default.

  • Sorted by alphabetic order of the PARAM value. Transform to factor and re-level for custom order.

  • ANL01FL is not relevant subset

Functions

  • ext01_2_lyt: ext01_2 Layout

  • ext01_2_pre: ext01_2 Preprocessing

Examples

library(dm)

db <- syn_test_data() %>%
  ext01_2_pre()

ext01_2(db)
#> Study Drug Exposure:  {Specify Population}
#> Protocol: {{protocol}}
#> 
#> ————————————————————————————————————————————————————————————————————————————————————————
#>                                         A: Drug X        B: Placebo      C: Combination 
#>                                          (N=134)           (N=134)           (N=132)    
#> ————————————————————————————————————————————————————————————————————————————————————————
#> Total dose administered                                                                 
#>   n                                        134               134               132      
#>   Mean (SD)                          6655.5 (1209.6)   6401.2 (1269.9)   6776.4 (1212.5)
#>   Median                                 6720.0            6360.0            6720.0     
#>   Min - Max                          4320.0 - 9360.0   4080.0 - 9360.0   4320.0 - 9360.0
#>   n                                        134               134               132      
#>   <5000                                 10 (7.5%)        18 (13.4%)         7 (5.3%)    
#>   5000-7000                            72 (53.7%)         71 (53%)         71 (53.8%)   
#>   7000-9000                            50 (37.3%)        42 (31.3%)        51 (38.6%)   
#>   >9000                                 2 (1.5%)          3 (2.2%)          3 (2.3%)    
#> Total number of doses administered                                                      
#>   n                                        134               134               132      
#>   Mean (SD)                             7.0 (0.0)         7.0 (0.0)         7.0 (0.0)   
#>   Median                                   7.0               7.0               7.0      
#>   Min - Max                             7.0 - 7.0         7.0 - 7.0         7.0 - 7.0   
#> ————————————————————————————————————————————————————————————————————————————————————————
#> 
#> Treatment duration is the date of the last study drug administration minus the date of the first study drug administration plus one day.  Dose intensity is {definition}. <Percentages for reasons for dose modification are based on total number of patients with at least one dose modification.>
syn_test_data() %>%
  ext01_2_pre()
#> ── Metadata ────────────────────────────────────────────────────────────────────
#> Tables: `adsl`, `adae`, `adaette`, `adcm`, `addv`, … (15 total)
#> Columns: 846
#> Primary keys: 2
#> Foreign keys: 1