LBT01 Table 1 (Default) Laboratory Test Results and Change from Baseline by Visitlbt01_1.RdThe LBT01 table provides an overview of the analysis values and its change from baseline of each respective arm over the course of the trial.
lbt01_1(
adam_db,
armvar = .study$actualarm,
summaryvars = c("AVAL", "CHG"),
summaryvars_lbls = c("Value at Visit", "Change from \nBaseline"),
visitvar = "AVISIT",
prune_0 = TRUE,
deco = std_deco("LBT01"),
.study = list(actualarm = "ACTARM")
)
lbt01_1_lyt(
armvar = .study$actualarm,
summaryvars = c("AVAL", "CHG"),
summaryvars_lbls = c("Value at Visit", "Change from \nBaseline"),
visitvar = .study$visitvar,
lbl_avisit = "Visit",
lbl_param = "Parameter",
deco = std_deco("LBT01"),
.study = list(actualarm = "ACTARM", visitvar = "AVISIT")
)
lbt01_1_pre(adam_db)(dm) object containing the ADaM datasets
(character) variable used for column splitting
(vector of character) the variables to be analyzed. For this table, AVAL and CHG by default.
(vector of character) the label of the variables to be analyzed.
(character) typically one of "AVISIT" (Default) or "ATPTN" depending on the type of time point
to be displayed.
(logical) remove 0 count rows
(character) decoration with title, subtitles and main_footer content
(list) with default values for the arguments of the function
(character) label of the visitvar variable.
(character) label of the PARAM variable.
The Analysis Value column, displays the number of patients, the mean, standard deviation, median and range of
the analysis value for each visit.
The Change from Baseline column, displays the number of patient and the mean, standard deviation,
median and range of changes relative to the baseline.
Remove zero-count rows unless overridden with prune_0 = FALSE.
Split columns by arm, typically ACTARM.
Does not include a total column by default.
Sorted based on factor level; first by PARAM labels in alphabetic order then by chronological time point given
by AVISIT. Re-level to customize order
lbt01_1_lyt: lbt01_1 Layout
lbt01_1_pre: lbt01_1 Preprocessing
library(dm)
db <- syn_test_data() %>%
lbt01_1_pre()
lbt01_1(db)
#> Laboratory Test Results and Change from Baseline by Visit, {Specific Lab Test}: {Specify Population}
#> Protocol: {{protocol}}
#>
#> ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Parameter
#> Analysis Visit A: Drug X B: Placebo C: Combination
#> Change from Change from Change from
#> Value at Visit Baseline Value at Visit Baseline Value at Visit Baseline
#> ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Alanine Aminotransferase Measurement
#> BASELINE
#> n 134 134 134 134 132 132
#> Mean (SD) 49.6 (8.3) 0.0 (0.0) 50.3 (8.3) 0.0 (0.0) 50.9 (7.8) 0.0 (0.0)
#> Median 49.6 0.0 50.2 0.0 50.8 0.0
#> Min - Max 24.0 - 70.9 0.0 - 0.0 26.2 - 79.1 0.0 - 0.0 27.6 - 67.4 0.0 - 0.0
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 48.6 (8.0) -1.0 (11.7) 50.4 (7.9) 0.1 (12.1) 51.1 (7.8) 0.2 (10.9)
#> Median 48.4 -1.0 50.2 -1.4 50.8 0.1
#> Min - Max 27.7 - 64.6 -25.0 - 39.4 21.7 - 67.5 -24.6 - 34.8 29.7 - 71.4 -27.4 - 31.1
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 49.4 (8.5) -0.2 (12.0) 50.2 (8.5) -0.1 (12.5) 48.5 (7.2) -2.4 (11.0)
#> Median 48.3 0.1 50.0 -0.7 49.2 -1.0
#> Min - Max 24.3 - 71.1 -26.3 - 34.3 24.4 - 71.1 -36.7 - 28.8 26.2 - 63.4 -28.6 - 31.3
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 50.3 (7.5) 0.7 (11.5) 49.7 (7.7) -0.6 (11.2) 48.9 (7.9) -2.0 (11.1)
#> Median 50.1 0.9 49.7 -0.4 47.7 -2.1
#> Min - Max 33.0 - 69.0 -32.1 - 32.5 33.7 - 66.5 -37.0 - 30.0 30.4 - 67.0 -24.7 - 22.2
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 50.7 (9.2) 1.1 (13.0) 49.3 (8.7) -1.0 (12.6) 49.6 (8.0) -1.3 (10.6)
#> Median 49.5 0.7 48.3 -2.4 49.8 -1.3
#> Min - Max 29.8 - 79.0 -34.0 - 37.6 33.0 - 74.0 -33.2 - 34.5 25.5 - 68.6 -24.3 - 30.6
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 50.8 (7.8) 1.3 (12.1) 49.7 (8.4) -0.6 (12.6) 50.0 (8.3) -0.9 (11.1)
#> Median 51.4 1.9 50.2 1.5 51.0 -2.0
#> Min - Max 31.9 - 70.3 -32.1 - 32.2 30.6 - 68.1 -38.1 - 25.3 24.8 - 65.6 -31.2 - 33.2
#> C-Reactive Protein Measurement
#> BASELINE
#> n 134 134 134 134 132 132
#> Mean (SD) 48.9 (9.4) 0.0 (0.0) 50.1 (7.9) 0.0 (0.0) 50.2 (8.4) 0.0 (0.0)
#> Median 49.6 0.0 50.1 0.0 49.8 0.0
#> Min - Max 29.0 - 75.2 0.0 - 0.0 29.9 - 73.4 0.0 - 0.0 30.5 - 72.3 0.0 - 0.0
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 51.9 (8.1) 2.9 (12.5) 50.3 (8.8) 0.2 (11.6) 50.3 (9.4) 0.0 (13.1)
#> Median 51.2 2.9 51.2 0.6 50.7 -0.3
#> Min - Max 28.5 - 72.9 -28.2 - 41.2 26.9 - 67.3 -31.3 - 37.2 27.8 - 71.2 -32.0 - 30.1
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 49.7 (8.3) 0.8 (12.6) 50.9 (7.4) 0.8 (10.7) 49.1 (8.2) -1.1 (11.1)
#> Median 50.4 0.5 51.5 0.8 48.7 -1.4
#> Min - Max 29.0 - 69.1 -34.1 - 30.4 30.7 - 67.7 -22.2 - 27.2 20.6 - 70.5 -30.2 - 19.8
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 50.1 (8.3) 1.1 (12.4) 49.3 (7.5) -0.8 (10.6) 49.8 (7.7) -0.4 (12.1)
#> Median 49.9 3.1 48.8 0.2 49.5 -1.2
#> Min - Max 26.7 - 69.4 -36.7 - 31.8 30.7 - 67.8 -30.7 - 29.9 30.1 - 72.9 -28.8 - 34.6
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 51.6 (8.1) 2.7 (12.2) 49.5 (8.2) -0.6 (11.1) 49.8 (7.6) -0.5 (11.6)
#> Median 52.3 3.2 48.8 -1.3 50.2 0.7
#> Min - Max 31.5 - 71.2 -31.3 - 41.6 27.1 - 67.3 -24.9 - 23.5 32.1 - 68.5 -33.0 - 32.8
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 49.7 (8.8) 0.8 (13.4) 50.8 (7.6) 0.8 (11.3) 49.1 (7.7) -1.1 (11.6)
#> Median 49.2 -0.3 50.3 0.5 49.2 -1.5
#> Min - Max 26.0 - 69.6 -40.0 - 33.6 33.3 - 70.3 -25.6 - 33.1 32.2 - 73.6 -33.5 - 31.6
#> Immunoglobulin A Measurement
#> BASELINE
#> n 134 134 134 134 132 132
#> Mean (SD) 49.9 (7.4) 0.0 (0.0) 49.7 (8.3) 0.0 (0.0) 50.3 (9.1) 0.0 (0.0)
#> Median 48.7 0.0 49.3 0.0 49.7 0.0
#> Min - Max 33.7 - 65.9 0.0 - 0.0 25.8 - 71.5 0.0 - 0.0 26.0 - 70.0 0.0 - 0.0
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 49.4 (8.1) -0.5 (10.7) 51.1 (8.2) 1.4 (11.2) 50.8 (8.4) 0.4 (12.9)
#> Median 49.8 -0.1 50.5 1.5 51.1 0.5
#> Min - Max 29.3 - 69.3 -28.5 - 21.6 31.2 - 74.5 -25.4 - 35.7 26.2 - 71.0 -29.7 - 31.0
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 50.7 (7.9) 0.8 (11.5) 49.9 (8.3) 0.1 (11.7) 49.4 (7.5) -0.9 (12.0)
#> Median 49.8 1.4 50.7 0.9 49.6 -0.2
#> Min - Max 33.3 - 71.9 -25.8 - 32.3 27.9 - 69.8 -29.5 - 27.6 29.4 - 65.1 -32.8 - 28.9
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 49.5 (8.0) -0.4 (10.4) 50.0 (7.9) 0.2 (11.5) 51.0 (7.8) 0.7 (12.0)
#> Median 49.3 0.5 49.1 0.8 51.1 0.3
#> Min - Max 24.1 - 66.1 -28.7 - 24.2 25.0 - 67.7 -32.1 - 24.1 29.9 - 69.8 -36.2 - 24.6
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 49.2 (7.7) -0.7 (10.9) 49.1 (7.6) -0.6 (11.0) 49.6 (8.4) -0.7 (12.4)
#> Median 50.5 -0.0 48.9 0.6 49.9 -1.4
#> Min - Max 26.0 - 64.5 -30.5 - 26.5 31.5 - 66.1 -27.6 - 21.9 29.7 - 69.1 -26.9 - 31.8
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 49.7 (7.7) -0.3 (10.1) 50.4 (8.7) 0.6 (12.7) 49.3 (8.5) -1.0 (12.2)
#> Median 49.2 -0.2 49.7 1.4 50.2 0.7
#> Min - Max 30.8 - 71.3 -33.8 - 25.6 28.5 - 77.0 -27.5 - 32.7 22.4 - 67.6 -32.0 - 26.5
#> ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#>
#> Baseline is the patient's last observation prior to initiation of study drug. Any values collected more than {specify time interval} after
#> the last dose of study drug are not included. The minimum and maximum values are, respectively, the smallest and largest values obtained
#> after baseline through {specify time interval} after the last dose of study drug, including repeat and unscheduled tests.
#>
syn_test_data() %>%
lbt01_1_pre()
#> ── Metadata ────────────────────────────────────────────────────────────────────
#> Tables: `adsl`, `adae`, `adaette`, `adcm`, `addv`, … (15 total)
#> Columns: 846
#> Primary keys: 2
#> Foreign keys: 1