LBT14 Laboratory Test Results Shift Table – Highest NCI-CTCAE Grade Post-Baseline by
Baseline Grade (Low or High Direction).
Source: R/lbt14.R
lbt14.RdLBT14 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, ...)
lbt14Arguments
- adam_db
(
listofdata.frames) object containing theADaMdatasets- arm_var
(
string) variable used for column splitting- lbl_overall
(
string) label used for overall column, if set toNULLthe 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,Listingorggplot) object typically produced by amainfunction.- 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
BTOXGRis 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"whendirection = "low". Conversely, whendirection = "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.
Note
adam_dbobject must contain anadlbtable with columns"USUBJID","PARAM","BTOXGR","ATOXGR", and the column specified byarm_var.
Examples
run(lbt14, syn_data)
#> Baseline Toxicity Grade A: Drug X B: Placebo C: Combination
#> Post-baseline NCI-CTCAE Grade (N=134) (N=134) (N=132)
#> ————————————————————————————————————————————————————————————————————————————————
#> Alanine Aminotransferase Measurement
#> Not Low 124 122 117
#> Not Low 74 (55.2%) 76 (56.7%) 80 (60.6%)
#> 1 13 (9.7%) 12 (9.0%) 9 (6.8%)
#> 2 13 (9.7%) 16 (11.9%) 11 (8.3%)
#> 3 17 (12.7%) 11 (8.2%) 9 (6.8%)
#> 4 7 (5.2%) 7 (5.2%) 8 (6.1%)
#> 1 3 6 7
#> Not Low 0 2 (1.5%) 5 (3.8%)
#> 1 1 (0.7%) 2 (1.5%) 0
#> 2 0 1 (0.7%) 0
#> 3 2 (1.5%) 1 (0.7%) 0
#> 4 0 0 2 (1.5%)
#> 2 2 1 4
#> Not Low 2 (1.5%) 0 3 (2.3%)
#> 2 0 1 (0.7%) 0
#> 3 0 0 1 (0.8%)
#> 3 2 3 4
#> Not Low 2 (1.5%) 2 (1.5%) 3 (2.3%)
#> 1 0 1 (0.7%) 1 (0.8%)
#> 4 3 2 0
#> Not Low 2 (1.5%) 1 (0.7%) 0
#> 3 1 (0.7%) 0 0
#> 4 0 1 (0.7%) 0
#> C-Reactive Protein Measurement
#> Not Low 122 125 120
#> Not Low 67 (50.0%) 81 (60.4%) 70 (53.0%)
#> 1 14 (10.4%) 17 (12.7%) 13 (9.8%)
#> 2 20 (14.9%) 11 (8.2%) 16 (12.1%)
#> 3 12 (9.0%) 9 (6.7%) 17 (12.9%)
#> 4 9 (6.7%) 7 (5.2%) 4 (3.0%)
#> 1 2 5 5
#> Not Low 0 3 (2.2%) 4 (3.0%)
#> 1 0 1 (0.7%) 1 (0.8%)
#> 2 1 (0.7%) 1 (0.7%) 0
#> 4 1 (0.7%) 0 0
#> 2 5 1 1
#> Not Low 3 (2.2%) 0 1 (0.8%)
#> 1 2 (1.5%) 0 0
#> 2 0 1 (0.7%) 0
#> 3 2 2 1
#> Not Low 2 (1.5%) 1 (0.7%) 0
#> 1 0 1 (0.7%) 0
#> 3 0 0 1 (0.8%)
#> 4 3 1 5
#> Not Low 2 (1.5%) 1 (0.7%) 3 (2.3%)
#> 1 0 0 1 (0.8%)
#> 4 1 (0.7%) 0 1 (0.8%)
#> Immunoglobulin A Measurement
#> Not Low 120 119 120
#> Not Low 69 (51.5%) 58 (43.3%) 70 (53.0%)
#> 1 16 (11.9%) 20 (14.9%) 16 (12.1%)
#> 2 12 (9.0%) 14 (10.4%) 14 (10.6%)
#> 3 14 (10.4%) 11 (8.2%) 13 (9.8%)
#> 4 9 (6.7%) 16 (11.9%) 7 (5.3%)
#> 1 8 8 3
#> Not Low 7 (5.2%) 4 (3.0%) 2 (1.5%)
#> 1 1 (0.7%) 3 (2.2%) 0
#> 2 0 1 (0.7%) 0
#> 4 0 0 1 (0.8%)
#> 2 2 1 2
#> Not Low 2 (1.5%) 1 (0.7%) 2 (1.5%)
#> 3 3 3 4
#> Not Low 1 (0.7%) 3 (2.2%) 2 (1.5%)
#> 1 0 0 1 (0.8%)
#> 3 1 (0.7%) 0 0
#> 4 1 (0.7%) 0 1 (0.8%)
#> 4 1 3 3
#> Not Low 1 (0.7%) 3 (2.2%) 1 (0.8%)
#> 3 0 0 1 (0.8%)
#> 4 0 0 1 (0.8%)