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LBT07 Table 1 (Default) Laboratory Test Results and Change from Baseline by Visit.

Source: R/lbt07.R
lbt07.Rd

The LBT07 table provides an overview of the analysis values and its change from baseline of each respective arm over the course of the trial.

Usage

lbt07_main(
  adam_db,
  arm_var = "ACTARM",
  lbl_overall = NULL,
  param_var = "PARAM",
  grad_dir_var = "GRADE_DIR",
  grad_anl_var = "GRADE_ANL",
  ...
)

lbt07_pre(adam_db, ...)

lbt07_post(tlg, prune_0 = TRUE, ...)

lbt07

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

param_var

(string) the name of the column storing the parameters name.

grad_dir_var

(string) the name of the column storing the grade direction variable which is required in order to obtain the correct denominators when building the layout as it is used to define row splitting.

grad_anl_var

(string) the name of the column storing toxicity grade variable where all negative values from ATOXGR are replaced by their absolute values.

...

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

  • Split columns by arm, typically ACTARM.

Functions

  • lbt07_main(): Main TLG function

  • lbt07_pre(): Preprocessing

  • lbt07_post(): Postprocessing

Note

  • adam_db object must contain an adlb table with columns "USUBJID", "ATOXGR", "ONTRTFL" and column specified by arm_var.

Examples

run(lbt07, syn_data)
#>   Parameter                                                                         
#>     Direction of Abnormality                 A: Drug X   B: Placebo   C: Combination
#>               Highest NCI CTCAE Grade         (N=15)       (N=15)         (N=15)    
#>   ——————————————————————————————————————————————————————————————————————————————————
#>   Alanine Aminotransferase Measurement (n)      15           15             15      
#>     LOW                                                                             
#>               1                              3 (20.0%)   2 (13.3%)      2 (13.3%)   
#>               2                                  0        1 (6.7%)       1 (6.7%)   
#>               3                              5 (33.3%)   3 (20.0%)      2 (13.3%)   
#>               4                              1 (6.7%)    2 (13.3%)          0       
#>               Any                            9 (60.0%)   8 (53.3%)      5 (33.3%)   
#>     HIGH                                                                            
#>               1                              3 (20.0%)   2 (13.3%)      3 (20.0%)   
#>               2                              2 (13.3%)       0          4 (26.7%)   
#>               3                              1 (6.7%)     1 (6.7%)       1 (6.7%)   
#>               4                                  0        1 (6.7%)          0       
#>               Any                            6 (40.0%)   4 (26.7%)      8 (53.3%)   
#>   C-Reactive Protein Measurement (n)            15           15             15      
#>     LOW                                                                             
#>               1                              2 (13.3%)    1 (6.7%)      3 (20.0%)   
#>               2                                  0       2 (13.3%)      2 (13.3%)   
#>               3                              2 (13.3%)       0          4 (26.7%)   
#>               4                              1 (6.7%)        0           1 (6.7%)   
#>               Any                            5 (33.3%)   3 (20.0%)      10 (66.7%)  
#>     HIGH                                                                            
#>               1                              1 (6.7%)        0              0       
#>               2                              3 (20.0%)       0              0       
#>               3                              1 (6.7%)        0           1 (6.7%)   
#>               4                              1 (6.7%)     1 (6.7%)          0       
#>               Any                            6 (40.0%)    1 (6.7%)       1 (6.7%)   
#>   Immunoglobulin A Measurement (n)              15           15             15      
#>     LOW                                                                             
#>               1                              2 (13.3%)    1 (6.7%)          0       
#>               2                              1 (6.7%)     1 (6.7%)      2 (13.3%)   
#>               3                              2 (13.3%)    1 (6.7%)      4 (26.7%)   
#>               4                              1 (6.7%)    2 (13.3%)      2 (13.3%)   
#>               Any                            6 (40.0%)   5 (33.3%)      8 (53.3%)   
#>     HIGH                                                                            
#>               1                              4 (26.7%)   2 (13.3%)          0       
#>               2                              1 (6.7%)     1 (6.7%)       1 (6.7%)   
#>               3                              1 (6.7%)     1 (6.7%)          0       
#>               4                                  0        1 (6.7%)       1 (6.7%)   
#>               Any                            6 (40.0%)   5 (33.3%)      2 (13.3%)