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

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

Usage

lbt14_main(
  adam_db,
  arm_var = "ACTARM",
  lbl_overall = NULL,
  gr_missing = "incl",
  page_var = "PARAMCD",
  ...
)

lbt14_pre(adam_db, gr_missing = "incl", direction = "low", ...)

lbt14_post(tlg, prune_0 = TRUE, ...)

lbt14

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
gr_missing: (string) 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.
page_var: (string) variable name prior to which the row split is by page.
...: not used.
direction: (string) one of "high" or "low" indicating which shift direction should be detailed.
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

This table follows ADaMIG v1.1.
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.
Grading takes value from -4 to 4, negative value means the abnormality direction is low, positive value means the abnormality direction is high.
Grades 0, 1, 2, 3, and 4 are counted as "Not Low" when direction = "low". Conversely, when direction = "high", 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_main(): Main TLG function
lbt14_pre(): Preprocessing
lbt14_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, syn_data)
#>   Baseline Toxicity Grade                 A: Drug X   B: Placebo   C: Combination
#>           Post-baseline NCI-CTCAE Grade    (N=15)       (N=15)         (N=15)    
#>   ———————————————————————————————————————————————————————————————————————————————
#>   Alanine Aminotransferase Measurement                                           
#>     Not Low                                  12           12             14      
#>             Not Low                       5 (41.7%)   8 (66.7%)      5 (35.7%)   
#>             1                             3 (25.0%)       0              0       
#>             2                             2 (16.7%)    1 (8.3%)       1 (7.1%)   
#>             3                                 0        1 (8.3%)      5 (35.7%)   
#>             4                             2 (16.7%)   2 (16.7%)      3 (21.4%)   
#>     1                                         1           2              0       
#>             Not Low                       1 (100%)     2 (100%)          0       
#>     2                                         1           1              0       
#>             Not Low                           0        1 (100%)          0       
#>             4                             1 (100%)        0              0       
#>     3                                         1           0              1       
#>             3                             1 (100%)        0           1 (100%)   
#>   C-Reactive Protein Measurement                                                 
#>     Not Low                                  14           13             12      
#>             Not Low                       5 (35.7%)   7 (53.8%)      4 (33.3%)   
#>             1                             2 (14.3%)       0          2 (16.7%)   
#>             2                             5 (35.7%)   2 (15.4%)      4 (33.3%)   
#>             3                             2 (14.3%)   3 (23.1%)      2 (16.7%)   
#>             4                                 0        1 (7.7%)          0       
#>     1                                         0           0              2       
#>             Not Low                           0           0          1 (50.0%)   
#>             2                                 0           0          1 (50.0%)   
#>     2                                         0           1              0       
#>             1                                 0        1 (100%)          0       
#>     3                                         1           1              1       
#>             3                             1 (100%)     1 (100%)       1 (100%)   
#>   Immunoglobulin A Measurement                                                   
#>     Not Low                                  15           15             15      
#>             Not Low                       15 (100%)   15 (100%)      15 (100%)