LBT01 Lab Results and Change from Baseline by Visit Table.
lbt01.RdThe 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.
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=134) (N=134) (N=134) (N=134) (N=132) (N=132)
#> ——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Alanine Aminotransferase Measurement
#> BASELINE
#> n 134 134 132
#> Mean (SD) 19.786 (4.161) 20.153 (4.171) 20.451 (3.911)
#> Median 19.786 20.077 20.387
#> Min - Max 6.99 - 30.43 8.11 - 34.56 8.82 - 28.72
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 19.301 (3.981) -0.485 (5.850) 20.221 (3.974) 0.068 (6.036) 20.553 (3.895) 0.102 (5.461)
#> Median 19.209 -0.511 20.090 -0.725 20.402 0.025
#> Min - Max 8.86 - 27.32 -12.52 - 19.70 5.84 - 28.75 -12.29 - 17.41 9.87 - 30.70 -13.69 - 15.54
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 19.704 (4.233) -0.082 (6.003) 20.123 (4.265) -0.030 (6.263) 19.247 (3.592) -1.204 (5.485)
#> Median 19.168 0.038 19.986 -0.371 19.608 -0.482
#> Min - Max 7.17 - 30.53 -13.15 - 17.17 7.19 - 30.54 -18.37 - 14.39 8.11 - 26.68 -14.28 - 15.65
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 20.130 (3.757) 0.344 (5.761) 19.837 (3.871) -0.316 (5.604) 19.428 (3.944) -1.023 (5.550)
#> Median 20.044 0.451 19.873 -0.178 18.838 -1.065
#> Min - Max 11.52 - 29.49 -16.04 - 16.26 11.86 - 28.24 -18.52 - 15.00 10.20 - 28.49 -12.33 - 11.10
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 20.351 (4.583) 0.565 (6.506) 19.632 (4.346) -0.521 (6.293) 19.823 (3.995) -0.627 (5.311)
#> Median 19.763 0.353 19.151 -1.186 19.884 -0.646
#> Min - Max 9.88 - 34.50 -17.00 - 18.79 11.49 - 31.98 -16.58 - 17.23 7.76 - 29.31 -12.13 - 15.30
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 20.418 (3.925) 0.632 (6.053) 19.859 (4.223) -0.294 (6.315) 19.990 (4.169) -0.460 (5.570)
#> Median 20.718 0.926 20.113 0.728 20.503 -0.990
#> Min - Max 10.95 - 30.17 -16.03 - 16.09 10.32 - 29.06 -19.04 - 12.64 7.41 - 27.78 -15.62 - 16.61
#> C-Reactive Protein Measurement
#> BASELINE
#> n 134 134 132
#> Mean (SD) 0.974 (0.236) 1.002 (0.197) 1.005 (0.210)
#> Median 0.989 1.003 0.996
#> Min - Max 0.47 - 1.63 0.50 - 1.58 0.51 - 1.56
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 1.047 (0.202) 0.073 (0.312) 1.007 (0.220) 0.005 (0.289) 1.006 (0.234) 0.001 (0.327)
#> Median 1.031 0.074 1.031 0.015 1.017 -0.008
#> Min - Max 0.46 - 1.57 -0.71 - 1.03 0.42 - 1.43 -0.78 - 0.93 0.44 - 1.53 -0.80 - 0.75
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 0.994 (0.207) 0.020 (0.314) 1.022 (0.186) 0.020 (0.267) 0.978 (0.206) -0.027 (0.278)
#> Median 1.011 0.012 1.038 0.021 0.967 -0.035
#> Min - Max 0.48 - 1.48 -0.85 - 0.76 0.52 - 1.44 -0.55 - 0.68 0.27 - 1.51 -0.76 - 0.50
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 1.002 (0.208) 0.028 (0.309) 0.982 (0.188) -0.020 (0.266) 0.995 (0.191) -0.010 (0.301)
#> Median 0.998 0.078 0.969 0.004 0.987 -0.029
#> Min - Max 0.42 - 1.48 -0.92 - 0.79 0.52 - 1.44 -0.77 - 0.75 0.50 - 1.57 -0.72 - 0.86
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 1.040 (0.203) 0.067 (0.306) 0.987 (0.205) -0.015 (0.278) 0.994 (0.190) -0.011 (0.289)
#> Median 1.056 0.079 0.970 -0.032 1.004 0.018
#> Min - Max 0.54 - 1.53 -0.78 - 1.04 0.43 - 1.43 -0.62 - 0.59 0.55 - 1.46 -0.82 - 0.82
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 0.993 (0.219) 0.019 (0.334) 1.021 (0.190) 0.019 (0.282) 0.976 (0.191) -0.029 (0.290)
#> Median 0.981 -0.006 1.006 0.011 0.980 -0.037
#> Min - Max 0.40 - 1.49 -1.00 - 0.84 0.58 - 1.51 -0.64 - 0.83 0.55 - 1.59 -0.84 - 0.79
#> Immunoglobulin A Measurement
#> BASELINE
#> n 134 134 132
#> Mean (SD) 1.996 (0.372) 1.987 (0.415) 2.015 (0.453)
#> Median 1.934 1.964 1.987
#> Min - Max 1.19 - 2.80 0.79 - 3.07 0.80 - 3.00
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 1.970 (0.404) -0.026 (0.534) 2.056 (0.409) 0.069 (0.562) 2.038 (0.421) 0.022 (0.645)
#> Median 1.989 -0.007 2.026 0.077 2.055 0.023
#> Min - Max 0.97 - 2.97 -1.42 - 1.08 1.06 - 3.23 -1.27 - 1.78 0.81 - 3.05 -1.49 - 1.55
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 2.036 (0.393) 0.040 (0.576) 1.994 (0.417) 0.007 (0.583) 1.969 (0.374) -0.046 (0.602)
#> Median 1.989 0.068 2.034 0.047 1.978 -0.010
#> Min - Max 1.17 - 3.09 -1.29 - 1.61 0.89 - 2.99 -1.48 - 1.38 0.97 - 2.75 -1.64 - 1.45
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 1.974 (0.402) -0.022 (0.519) 1.999 (0.396) 0.012 (0.577) 2.048 (0.391) 0.033 (0.602)
#> Median 1.964 0.023 1.957 0.039 2.056 0.013
#> Min - Max 0.71 - 2.81 -1.44 - 1.21 0.75 - 2.89 -1.60 - 1.21 0.99 - 2.99 -1.81 - 1.23
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 1.962 (0.384) -0.035 (0.543) 1.955 (0.381) -0.032 (0.551) 1.979 (0.420) -0.037 (0.622)
#> Median 2.025 -0.001 1.945 0.028 1.993 -0.068
#> Min - Max 0.80 - 2.73 -1.53 - 1.33 1.07 - 2.81 -1.38 - 1.09 0.99 - 2.95 -1.35 - 1.59
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 1.983 (0.384) -0.013 (0.505) 2.018 (0.433) 0.031 (0.635) 1.965 (0.427) -0.050 (0.609)
#> Median 1.961 -0.012 1.987 0.071 2.009 0.034
#> Min - Max 1.04 - 3.07 -1.69 - 1.28 0.92 - 3.35 -1.38 - 1.64 0.62 - 2.88 -1.60 - 1.32