LBT07 Table 1 (Default) Laboratory Test Results and Change from Baseline by Visit.
lbt07_1.RdThe 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_1Arguments
- adam_db
(
dm) object containing theADaMdatasets- arm_var
(
character) variable used for column splitting- lbl_overall
(
character) label used for overall column, if set toNULLthe overall column is omitted- grade_var
(
character)PARAMand variables derived from the standard lab grade variableATOXGR: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 fromATOXGRare replaced by their absolute values.
- deco
(
character) decoration withtitle,subtitlesandmain_footercontent- lbl_grade_var
(
character) label of the variables ingrade_var. IfNULL, uses the label attribute of the columns selected ingrade_var.- req_tables
(
character) names of the required tables.- ...
not used.
- lbl_gradedir
(
character) label of theGRADE_DIRvariable.- lbl_param
(
character) label of thePARAMvariable.- map
(
data.frame) mapping ofPARAMs to directions of abnormality.- tlg
(
TableTree,Listingorggplot) object typically produced by amainfunction.- prune_0
(
logical) remove 0 count rows
Functions
lbt07_1_main(): Main TLG functionlbt07_1_lyt(): Layoutlbt07_1_pre(): Preprocessinglbt07_1_check(): Checkslbt07_1_post(): Postprocessing
Note
adam_dbobject must contain anadlbtable with columns"USUBJID","ATOXGR","ONTRTFL"and column specified byarm_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%)