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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_1_main(
  adam_db,
  arm_var = "ACTARM",
  lbl_overall = NULL,
  grade_var = c("PARAM", "GRADE_DIR", "GRADE_ANL"),
  deco = std_deco("LBT07"),
  lbl_grade_var = c("Parameter", "Direction of Abnormality", "Toxicity Grade"),
  req_tables = c("adsl", "adlb"),
  ...
)

lbt07_1_lyt(
  arm_var,
  lbl_overall,
  lbl_gradedir,
  lbl_param,
  grade_var,
  lbl_grade_var,
  deco,
  map
)

lbt07_1_pre(adam_db, ...)

lbt07_1_check(adam_db, req_tables = c("adsl", "adlb"), arm_var = "ACTARM")

lbt07_1_post(tlg, prune_0 = TRUE, ...)

lbt07_1

Format

An object of class chevron_t of length 1.

Arguments

adam_db

(dm) object containing the ADaM datasets

arm_var

(character) variable used for column splitting

lbl_overall

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

grade_var

(character) PARAM and variables derived from the standard lab grade variable ATOXGR:

  • A grade direction variable (GRADE_DIR) is required in order to obtain the correct denominators when building the layout as it is used to define row splitting.

  • A toxicity grade variable (e.g. GRADE_ANL) where all negative values from ATOXGR are replaced by their absolute values.

deco

(character) decoration with title, subtitles and main_footer content

lbl_grade_var

(character) label of the variables in grade_var. If NULL, uses the label attribute of the columns selected in grade_var.

req_tables

(character) names of the required tables.

...

not used.

lbl_gradedir

(character) label of the GRADE_DIR variable.

lbl_param

(character) label of the PARAM variable.

map

(data.frame) mapping of PARAMs to directions of abnormality.

tlg

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

prune_0

(logical) remove 0 count rows

Details

  • Split columns by arm, typically ACTARM.

Functions

  • lbt07_1_main(): Main TLG function

  • lbt07_1_lyt(): Layout

  • lbt07_1_pre(): Preprocessing

  • lbt07_1_check(): Checks

  • lbt07_1_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_1, syn_data)
#>   Parameter                                                                          
#>     Direction of Abnormality                 A: Drug X    B: Placebo   C: Combination
#>               Highest NCI CTCAE Grade         (N=134)      (N=134)        (N=132)    
#>   ———————————————————————————————————————————————————————————————————————————————————
#>   Alanine Aminotransferase Measurement (n)      134          133            132      
#>     LOW                                                                              
#>               1                              14 (10.4%)   15 (11.3%)     10 (7.6%)   
#>               2                              13 (9.7%)    18 (13.5%)     11 (8.3%)   
#>               3                              20 (14.9%)   12 (9.0%)      10 (7.6%)   
#>               4                               7 (5.2%)     8 (6.0%)      10 (7.6%)   
#>               Any                            54 (40.3%)   53 (39.8%)     41 (31.1%)  
#>     HIGH                                                                             
#>               1                              18 (13.4%)   16 (12.0%)     18 (13.6%)  
#>               2                              15 (11.2%)   13 (9.8%)      17 (12.9%)  
#>               3                              10 (7.5%)    16 (12.0%)     13 (9.8%)   
#>               4                              12 (9.0%)    11 (8.3%)      13 (9.8%)   
#>               Any                            55 (41.0%)   56 (42.1%)     61 (46.2%)  
#>   C-Reactive Protein Measurement (n)            134          134            132      
#>     LOW                                                                              
#>               1                              16 (11.9%)   19 (14.2%)     15 (11.4%)  
#>               2                              21 (15.7%)   13 (9.7%)      16 (12.1%)  
#>               3                              12 (9.0%)     9 (6.7%)      18 (13.6%)  
#>               4                              11 (8.2%)     7 (5.2%)       5 (3.8%)   
#>               Any                            60 (44.8%)   48 (35.8%)     54 (40.9%)  
#>     HIGH                                                                             
#>               1                              17 (12.7%)   15 (11.2%)      9 (6.8%)   
#>               2                              15 (11.2%)   16 (11.9%)     13 (9.8%)   
#>               3                              16 (11.9%)   12 (9.0%)      14 (10.6%)  
#>               4                              12 (9.0%)    12 (9.0%)      10 (7.6%)   
#>               Any                            60 (44.8%)   55 (41.0%)     46 (34.8%)  
#>   Immunoglobulin A Measurement (n)              133          133            132      
#>     LOW                                                                              
#>               1                              17 (12.8%)   23 (17.3%)     17 (12.9%)  
#>               2                              12 (9.0%)    15 (11.3%)     14 (10.6%)  
#>               3                              15 (11.3%)   11 (8.3%)      14 (10.6%)  
#>               4                              10 (7.5%)    16 (12.0%)     10 (7.6%)   
#>               Any                            54 (40.6%)   65 (48.9%)     55 (41.7%)  
#>     HIGH                                                                             
#>               1                              25 (18.8%)   14 (10.5%)     13 (9.8%)   
#>               2                              14 (10.5%)   19 (14.3%)     16 (12.1%)  
#>               3                              12 (9.0%)    12 (9.0%)      17 (12.9%)  
#>               4                              11 (8.3%)    13 (9.8%)       4 (3.0%)   
#>               Any                            62 (46.6%)   58 (43.6%)     50 (37.9%)