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EXT01 Exposure Summary Table.

ext01.Rd

The EXT01 table provides an overview of the of the exposure of the patients in terms of Total dose administered or missed, and treatment duration.

Usage

ext01_main(
  adam_db,
  arm_var = "ACTARM",
  summaryvars = "AVAL",
  lbl_overall = NULL,
  ...
)

ext01_pre(
  adam_db,
  paramcd_order = c("TNDOSE", "DOSE", "NDOSE", "TDOSE"),
  show_stats = "ALL",
  show_bins = "ALL",
  ...
)

ext01_post(tlg, prune_0 = TRUE, ...)

ext01

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

summaryvars

(character) variables to be analyzed. The label attribute of the corresponding column in adex table of adam_db is used as label.

lbl_overall

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

...

not used.

paramcd_order

(character) providing the PARAMCD values in the desired order.

show_stats

(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

(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 = "".

tlg

(TableTree, Listing or ggplot) object typically produced by a main function.

prune_0

(flag) remove 0 count rows

Details

  • Default Exposure table

  • 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_main(): Main TLG function

  • ext01_pre(): Preprocessing

  • ext01_post(): Postprocessing

Note

  • adam_db object must contain an adex table with columns specified in summaryvars.

Examples

run(ext01, syn_data)
#>                                           A: Drug X        B: Placebo      C: Combination 
#>                                            (N=134)           (N=134)           (N=132)    
#>   ————————————————————————————————————————————————————————————————————————————————————————
#>   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   
#>   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
run(ext01, syn_data, summaryvars = c("AVAL", "AVALCAT1"))
#>                                           A: Drug X        B: Placebo      C: Combination 
#>                                            (N=134)           (N=134)           (N=132)    
#>   ————————————————————————————————————————————————————————————————————————————————————————
#>   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   
#>     n                                        134               134               132      
#>     7                                    134 (100%)        134 (100%)        132 (100%)   
#>   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 (53.0%)        71 (53.8%)   
#>     7000-9000                            50 (37.3%)        42 (31.3%)        51 (38.6%)   
#>     >9000                                 2 (1.5%)          3 (2.2%)          3 (2.3%)