The LBT01 table provides an
overview of the Lab values and its change from baseline of each respective arm
over the course of the trial.
Usage
lbt01_main(
adam_db,
dataset = "adlb",
arm_var = "ACTARM",
lbl_overall = NULL,
row_split_var = NULL,
summaryvars = c("AVAL", "CHG"),
visitvar = "AVISIT",
precision = list(default = 2L),
page_var = "PARAMCD",
.stats = c("n", "mean_sd", "median", "range"),
skip = list(CHG = "BASELINE"),
...
)
lbt01_pre(adam_db, dataset = "adlb", ...)
lbt01Arguments
- adam_db
(
listofdata.frames) object containing theADaMdatasets- dataset
(
string) the name of a table in theadam_dbobject.- arm_var
(
string) variable used for column splitting- lbl_overall
(
string) label used for overall column, if set toNULLthe overall column is omitted- row_split_var
(
character) additional row split variables.- summaryvars
(
character) variables to be analyzed. The label attribute of the corresponding column in table ofadam_dbis used as label.- visitvar
(
string) typically one of"AVISIT"or user-defined visit incorporating"ATPT".- precision
(named
listofinteger) where names are values found in thePARAMCDcolumn and the values indicate the number of digits in statistics. Ifdefaultis set, and parameter precision not specified, the value fordefaultwill be used.- page_var
(
string) variable name prior to which the row split is by page.- .stats
(
character) statistics names, seetern::analyze_vars().- skip
Named (
list) of visit values that need to be inhibited.- ...
additional arguments like
.indent_mods,.labels.
Value
the main function returns an rtables object.
the preprocessing function returns a list of data.frame.
Details
The
Analysis Valuecolumn, displays the number of patients, the mean, standard deviation, median and range of the analysis value for each visit.The
Change from Baselinecolumn, 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
PARAMlabels in alphabetic order then by chronological time point given byAVISIT. Re-level to customize order
Examples
run(lbt01, syn_data)
#> 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
#> Analysis Visit (N=15) (N=15) (N=15) (N=15) (N=15) (N=15)
#> ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Alanine Aminotransferase Measurement
#> BASELINE
#> n 15 15 15
#> Mean (SD) 20.262 (4.982) 19.371 (4.687) 21.724 (3.857)
#> Median 19.216 19.781 22.900
#> Min - Max 13.77 - 30.43 11.58 - 25.59 12.57 - 27.69
#> WEEK 1 DAY 8
#> n 15 15 15 15 15 15
#> Mean (SD) 19.227 (4.492) -1.036 (7.113) 21.622 (3.015) 2.251 (6.830) 20.630 (3.950) -1.094 (4.425)
#> Median 18.666 -2.148 21.790 2.901 20.570 -0.398
#> Min - Max 12.12 - 27.32 -12.07 - 9.07 16.69 - 26.32 -6.73 - 14.36 13.21 - 27.31 -7.84 - 7.84
#> WEEK 2 DAY 15
#> n 15 15 15 15 15 15
#> Mean (SD) 19.458 (4.211) -0.804 (6.309) 21.103 (3.831) 1.732 (5.981) 17.164 (3.089) -4.559 (4.438)
#> Median 18.988 -2.571 20.200 2.499 16.740 -3.463
#> Min - Max 12.96 - 26.92 -12.00 - 13.14 13.42 - 29.93 -9.97 - 14.39 12.94 - 22.80 -10.95 - 1.01
#> WEEK 3 DAY 22
#> n 15 15 15 15 15 15
#> Mean (SD) 19.795 (4.272) -0.467 (6.304) 20.822 (3.234) 1.451 (6.839) 20.165 (3.805) -1.559 (4.042)
#> Median 18.489 0.542 21.541 2.138 20.612 -2.878
#> Min - Max 13.51 - 26.07 -16.04 - 7.43 14.18 - 26.58 -9.21 - 15.00 14.01 - 25.74 -7.48 - 6.92
#> WEEK 4 DAY 29
#> n 15 15 15 15 15 15
#> Mean (SD) 19.517 (3.640) -0.745 (6.200) 19.824 (3.943) 0.453 (5.486) 19.923 (5.026) -1.801 (5.268)
#> Median 17.927 1.239 19.875 -1.242 20.213 -1.254
#> Min - Max 14.23 - 26.40 -13.17 - 7.57 13.56 - 26.43 -6.52 - 8.87 11.32 - 26.59 -12.13 - 6.95
#> WEEK 5 DAY 36
#> n 15 15 15 15 15 15
#> Mean (SD) 19.952 (2.895) -0.310 (6.188) 19.495 (3.459) 0.124 (6.533) 18.854 (3.392) -2.869 (4.309)
#> Median 20.300 0.443 19.900 0.822 19.358 -3.248
#> Min - Max 14.40 - 24.56 -16.03 - 6.90 10.76 - 25.16 -12.63 - 11.81 12.69 - 23.49 -11.07 - 6.79
#> C-Reactive Protein Measurement
#> BASELINE
#> n 15 15 15
#> Mean (SD) 0.971 (0.246) 1.026 (0.136) 0.995 (0.172)
#> Median 1.045 1.073 0.997
#> Min - Max 0.54 - 1.41 0.73 - 1.19 0.64 - 1.32
#> WEEK 1 DAY 8
#> n 15 15 15 15 15 15
#> Mean (SD) 1.042 (0.261) 0.072 (0.402) 1.025 (0.161) -0.001 (0.229) 0.972 (0.235) -0.023 (0.312)
#> Median 1.052 0.040 1.038 -0.001 0.983 -0.019
#> Min - Max 0.58 - 1.57 -0.49 - 1.03 0.68 - 1.35 -0.41 - 0.37 0.57 - 1.39 -0.39 - 0.75
#> WEEK 2 DAY 15
#> n 15 15 15 15 15 15
#> Mean (SD) 1.025 (0.268) 0.055 (0.286) 0.956 (0.228) -0.070 (0.229) 1.010 (0.189) 0.015 (0.255)
#> Median 1.026 0.048 0.973 -0.100 0.983 -0.066
#> Min - Max 0.67 - 1.46 -0.34 - 0.57 0.59 - 1.32 -0.40 - 0.26 0.67 - 1.37 -0.28 - 0.50
#> WEEK 3 DAY 22
#> n 15 15 15 15 15 15
#> Mean (SD) 1.006 (0.218) 0.035 (0.308) 0.954 (0.154) -0.072 (0.191) 1.036 (0.162) 0.042 (0.267)
#> Median 0.982 0.014 0.926 -0.050 1.061 0.021
#> Min - Max 0.61 - 1.43 -0.71 - 0.56 0.71 - 1.26 -0.44 - 0.25 0.81 - 1.33 -0.45 - 0.45
#> WEEK 4 DAY 29
#> n 15 15 15 15 15 15
#> Mean (SD) 0.984 (0.185) 0.014 (0.303) 0.953 (0.233) -0.073 (0.291) 1.032 (0.198) 0.038 (0.337)
#> Median 1.006 -0.046 0.897 -0.157 0.959 -0.043
#> Min - Max 0.70 - 1.25 -0.46 - 0.61 0.60 - 1.42 -0.41 - 0.59 0.80 - 1.46 -0.51 - 0.82
#> WEEK 5 DAY 36
#> n 15 15 15 15 15 15
#> Mean (SD) 0.943 (0.186) -0.028 (0.334) 0.989 (0.155) -0.037 (0.226) 0.956 (0.158) -0.039 (0.220)
#> Median 0.953 -0.065 0.960 -0.099 0.993 -0.049
#> Min - Max 0.60 - 1.25 -0.81 - 0.71 0.71 - 1.29 -0.36 - 0.56 0.66 - 1.26 -0.44 - 0.34
#> Immunoglobulin A Measurement
#> BASELINE
#> n 15 15 15
#> Mean (SD) 1.843 (0.341) 2.074 (0.452) 1.890 (0.486)
#> Median 1.815 1.978 1.750
#> Min - Max 1.32 - 2.76 1.25 - 2.95 1.15 - 2.65
#> WEEK 1 DAY 8
#> n 15 15 15 15 15 15
#> Mean (SD) 2.029 (0.343) 0.186 (0.561) 2.261 (0.422) 0.187 (0.565) 1.884 (0.430) -0.006 (0.738)
#> Median 1.979 0.257 2.288 0.284 1.832 -0.099
#> Min - Max 1.56 - 2.67 -1.10 - 1.08 1.54 - 3.02 -0.85 - 1.05 1.07 - 2.52 -1.44 - 1.14
#> WEEK 2 DAY 15
#> n 15 15 15 15 15 15
#> Mean (SD) 2.006 (0.361) 0.163 (0.559) 2.010 (0.332) -0.064 (0.368) 1.944 (0.325) 0.054 (0.597)
#> Median 1.944 0.140 2.051 -0.045 1.976 0.171
#> Min - Max 1.59 - 2.88 -0.84 - 1.04 1.25 - 2.55 -0.83 - 0.57 1.32 - 2.52 -0.79 - 0.95
#> WEEK 3 DAY 22
#> n 15 15 15 15 15 15
#> Mean (SD) 2.001 (0.382) 0.158 (0.468) 2.001 (0.500) -0.073 (0.572) 2.040 (0.389) 0.150 (0.578)
#> Median 1.958 0.214 2.174 -0.022 2.068 -0.030
#> Min - Max 1.34 - 2.80 -0.80 - 0.94 0.75 - 2.68 -1.13 - 0.96 1.37 - 2.70 -0.57 - 1.17
#> WEEK 4 DAY 29
#> n 15 15 15 15 15 15
#> Mean (SD) 1.988 (0.231) 0.145 (0.445) 1.697 (0.404) -0.377 (0.605) 2.113 (0.432) 0.223 (0.828)
#> Median 2.080 0.081 1.697 -0.284 2.240 0.583
#> Min - Max 1.44 - 2.25 -0.87 - 0.88 1.10 - 2.43 -1.32 - 0.90 1.31 - 2.68 -1.02 - 1.50
#> WEEK 5 DAY 36
#> n 15 15 15 15 15 15
#> Mean (SD) 2.087 (0.179) 0.243 (0.397) 1.935 (0.442) -0.139 (0.636) 1.933 (0.386) 0.043 (0.662)
#> Median 2.102 0.379 1.832 -0.176 1.924 0.100
#> Min - Max 1.81 - 2.41 -0.81 - 0.78 1.33 - 2.72 -1.17 - 0.85 1.11 - 2.55 -1.23 - 1.15