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LBT14 Table 2 (High Direction) Laboratory Test Results Shift Table – Highest NCI-CTCAE Grade Post-Baseline by Baseline Grade.

Usage

lbt14_2_main(
  adam_db,
  arm_var = "ACTARM",
  gr_missing = "incl",
  title = "LBT14 - High Direction",
  deco = std_deco("LBT14"),
  ...
)

lbt14_2_lyt(arm_var, gr_missing, title, deco)

lbt14_2_pre(
  adam_db,
  gr_missing = "incl",
  req_tables = c("adsl", "adlb"),
  arm_var = "ACTARM",
  ...
)

lbt14_2_check(adam_db, req_tables = c("adsl", "adlb"), arm_var = "ACTARM")

lbt14_2_post(tlg, prune_0 = TRUE, ...)

lbt14_2

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

gr_missing

how missing baseline grades should be handled. Defaults to "incl" to include the "Missing" level. Other options are "excl" to exclude patients with missing baseline grades and "gr_0" to convert missing baseline grades to grade 0.

title

table title to display. Defaults to "LBT14 - High Direction".

deco

(character) decoration with title, subtitles and main_footer content

...

not used.

req_tables

(character) names of the required tables.

tlg

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

prune_0

(logical) remove 0 count rows

Details

  • Only the worst grade recorded for each patient is included in the table.

  • If no missing baseline lab results, the "Missing" level of BTOXGR is excluded.

  • Grades 0, -1, -2, -3, and -4 are counted as "Not High".

  • Remove zero-count rows unless overridden with prune_0 = FALSE.

  • Split columns by arm, typically ACTARM.

Functions

  • lbt14_2_main(): Main TLG function

  • lbt14_2_lyt(): Layout

  • lbt14_2_pre(): Preprocessing

  • lbt14_2_check(): Checks

  • lbt14_2_post(): Postprocessing

Note

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

Examples

run(lbt14_2, syn_data)
#> LBT14 - High Direction
#> 
#> 
#>   ——————————————————————————————————————————————————————————————————————————————————————
#>   Parameter                                                                             
#>         Baseline NCI-CTCAE Grade                A: Drug X    B: Placebo   C: Combination
#>                 Post-baseline NCI-CTCAE Grade    (N=134)      (N=134)        (N=132)    
#>   ——————————————————————————————————————————————————————————————————————————————————————
#>   Alanine Aminotransferase Measurement                                                  
#>         Not High                                   121          118            118      
#>                 Not High                        72 (59.5%)   70 (59.3%)     59 (50.0%)  
#>                 1                               16 (13.2%)   13 (11.0%)     17 (14.4%)  
#>                 2                               13 (10.7%)   12 (10.2%)     18 (15.3%)  
#>                 3                                9 (7.4%)    14 (11.9%)     12 (10.2%)  
#>                 4                               11 (9.1%)     9 (7.6%)      12 (10.2%)  
#>         1                                           4            4              3       
#>                 Not High                        1 (25.0%)    1 (25.0%)      2 (66.7%)   
#>                 1                               1 (25.0%)        0              0       
#>                 2                               1 (25.0%)        0              0       
#>                 3                                   0        1 (25.0%)      1 (33.3%)   
#>                 4                               1 (25.0%)    2 (50.0%)          0       
#>         2                                           4            4              4       
#>                 Not High                        3 (75.0%)    3 (75.0%)      3 (75.0%)   
#>                 1                                   0        1 (25.0%)      1 (25.0%)   
#>                 2                               1 (25.0%)        0              0       
#>         3                                           2            5              5       
#>                 Not High                         2 (100%)    2 (40.0%)      4 (80.0%)   
#>                 1                                   0        2 (40.0%)          0       
#>                 2                                   0        1 (20.0%)          0       
#>                 4                                   0            0          1 (20.0%)   
#>         4                                           3            3              2       
#>                 Not High                        1 (33.3%)    2 (66.7%)       2 (100%)   
#>                 1                               1 (33.3%)        0              0       
#>                 3                               1 (33.3%)    1 (33.3%)          0       
#>   C-Reactive Protein Measurement                                                        
#>         Not High                                   115          115            114      
#>                 Not High                        60 (52.2%)   68 (59.1%)     70 (61.4%)  
#>                 1                               17 (14.8%)   13 (11.3%)      9 (7.9%)   
#>                 2                               12 (10.4%)   14 (12.2%)     13 (11.4%)  
#>                 3                               16 (13.9%)   10 (8.7%)      13 (11.4%)  
#>                 4                               10 (8.7%)    10 (8.7%)       9 (7.9%)   
#>         1                                           5            5              5       
#>                 Not High                        4 (80.0%)    3 (60.0%)       5 (100%)   
#>                 2                                   0        2 (40.0%)          0       
#>                 4                               1 (20.0%)        0              0       
#>         2                                           6            5              5       
#>                 Not High                        3 (50.0%)    3 (60.0%)      4 (80.0%)   
#>                 1                                   0        1 (20.0%)          0       
#>                 2                               2 (33.3%)        0              0       
#>                 4                               1 (16.7%)    1 (20.0%)      1 (20.0%)   
#>         3                                           2            3              5       
#>                 Not High                         2 (100%)    1 (33.3%)      4 (80.0%)   
#>                 3                                   0        1 (33.3%)      1 (20.0%)   
#>                 4                                   0        1 (33.3%)          0       
#>         4                                           6            6              3       
#>                 Not High                        5 (83.3%)    4 (66.7%)       3 (100%)   
#>                 1                                   0        1 (16.7%)          0       
#>                 2                               1 (16.7%)        0              0       
#>                 3                                   0        1 (16.7%)          0       
#>   Immunoglobulin A Measurement                                                          
#>         Not High                                   119          123            119      
#>                 Not High                        61 (51.3%)   69 (56.1%)     74 (62.2%)  
#>                 1                               24 (20.2%)   12 (9.8%)      13 (10.9%)  
#>                 2                               13 (10.9%)   20 (16.3%)     12 (10.1%)  
#>                 3                               11 (9.2%)    11 (8.9%)      16 (13.4%)  
#>                 4                               10 (8.4%)    11 (8.9%)       4 (3.4%)   
#>         1                                           2            4              6       
#>                 Not High                         2 (100%)    2 (50.0%)      5 (83.3%)   
#>                 2                                   0            0          1 (16.7%)   
#>                 4                                   0        2 (50.0%)          0       
#>         2                                           4            4              3       
#>                 Not High                        3 (75.0%)    2 (50.0%)      1 (33.3%)   
#>                 1                                   0        2 (50.0%)          0       
#>                 2                                   0            0          1 (33.3%)   
#>                 3                                   0            0          1 (33.3%)   
#>                 4                               1 (25.0%)        0              0       
#>         3                                           5            2              2       
#>                 Not High                        3 (60.0%)        0          1 (50.0%)   
#>                 1                               1 (20.0%)        0              0       
#>                 2                                   0            0          1 (50.0%)   
#>                 3                               1 (20.0%)     2 (100%)          0       
#>         4                                           4            1              2       
#>                 Not High                        3 (75.0%)     1 (100%)      1 (50.0%)   
#>                 2                               1 (25.0%)        0          1 (50.0%)