VST01 Vital Sign Results and change from Baseline By Visit Table.
vst01.RdThe VST01 table provides an
overview of the Vital Sign values and its change from baseline of each respective arm
over the course of the trial.
Usage
vst01_main(
adam_db,
dataset = "advs",
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"),
...
)
vst01_pre(adam_db, dataset = "advs", ...)
vst01Arguments
- 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
library(dunlin)
proc_data <- log_filter(
syn_data,
PARAMCD %in% c("DIABP", "SYSBP"), "advs"
)
run(vst01, proc_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)
#> —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Diastolic Blood Pressure
#> SCREENING
#> n 134 0 134 0 132 0
#> Mean (SD) 49.968 (7.197) NE (NE) 50.753 (8.429) NE (NE) 50.192 (7.627) NE (NE)
#> Median 49.706 NE 50.087 NE 49.641 NE
#> Min - Max 31.69 - 71.19 NE - NE 29.26 - 69.21 NE - NE 26.89 - 69.98 NE - NE
#> BASELINE
#> n 134 134 132
#> Mean (SD) 48.602 (7.962) 50.442 (7.948) 51.107 (7.790)
#> Median 48.418 50.179 50.804
#> Min - Max 27.71 - 64.64 21.68 - 67.51 29.75 - 71.40
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 50.260 (7.514) 1.658 (10.774) 49.674 (7.743) -0.767 (10.947) 48.855 (7.888) -2.251 (10.380)
#> Median 50.088 0.607 49.747 -1.114 47.677 -2.229
#> Min - Max 33.04 - 68.98 -20.37 - 29.94 33.71 - 66.49 -25.80 - 28.37 30.39 - 66.99 -22.06 - 22.44
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 50.836 (7.850) 2.234 (11.752) 49.718 (8.445) -0.724 (12.444) 49.981 (8.338) -1.126 (11.639)
#> Median 51.437 3.126 50.227 -0.709 51.007 -2.271
#> Min - Max 31.89 - 70.34 -23.88 - 39.23 30.64 - 68.11 -28.40 - 36.97 24.82 - 65.57 -29.24 - 30.72
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 50.712 (7.815) 2.110 (10.865) 49.092 (7.941) -1.350 (11.104) 49.944 (7.662) -1.162 (10.901)
#> Median 50.157 2.611 49.533 -2.317 50.025 -0.617
#> Min - Max 29.07 - 74.89 -25.78 - 30.66 24.50 - 67.11 -28.09 - 33.90 31.52 - 68.55 -29.72 - 26.98
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 50.074 (8.071) 1.472 (10.885) 49.624 (7.102) -0.818 (10.634) 49.707 (8.048) -1.399 (11.047)
#> Median 49.269 1.202 49.193 -0.757 49.844 -0.182
#> Min - Max 29.41 - 71.36 -30.92 - 24.76 32.71 - 66.98 -33.18 - 35.95 28.75 - 68.45 -35.47 - 28.36
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 50.569 (7.531) 1.967 (11.206) 48.366 (7.959) -2.075 (11.736) 49.091 (7.570) -2.015 (10.658)
#> Median 49.422 1.573 47.721 -2.871 49.237 -2.247
#> Min - Max 35.06 - 72.21 -25.22 - 31.47 30.42 - 70.61 -31.23 - 29.16 30.59 - 72.91 -30.45 - 34.57
#> Systolic Blood Pressure
#> SCREENING
#> n 134 0 134 0 132 0
#> Mean (SD) 49.572 (8.322) NE (NE) 50.306 (8.343) NE (NE) 50.902 (7.822) NE (NE)
#> Median 49.571 NE 50.155 NE 50.774 NE
#> Min - Max 23.97 - 70.85 NE - NE 26.22 - 79.12 NE - NE 27.63 - 67.45 NE - NE
#> BASELINE
#> n 134 134 132
#> Mean (SD) 49.407 (8.467) 50.245 (8.531) 48.494 (7.184)
#> Median 48.335 49.971 49.217
#> Min - Max 24.34 - 71.06 24.38 - 71.07 26.22 - 63.35
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 50.702 (9.166) 1.295 (12.814) 49.263 (8.693) -0.982 (11.221) 49.647 (7.991) 1.153 (10.185)
#> Median 49.526 0.129 48.302 -1.678 49.768 0.085
#> Min - Max 29.75 - 78.99 -29.51 - 37.65 32.99 - 73.97 -27.62 - 24.77 25.52 - 68.62 -22.79 - 31.30
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 49.369 (8.469) -0.038 (11.936) 49.377 (7.009) -0.869 (10.968) 49.260 (7.683) 0.766 (9.716)
#> Median 49.489 -0.243 49.386 -0.929 48.289 -0.216
#> Min - Max 24.18 - 65.44 -39.12 - 32.72 27.62 - 69.23 -37.10 - 33.85 29.39 - 74.75 -24.92 - 28.99
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 49.682 (7.776) 0.275 (11.383) 49.034 (7.844) -1.211 (12.123) 50.544 (8.303) 2.050 (11.059)
#> Median 50.136 1.479 48.794 -1.190 51.672 1.951
#> Min - Max 31.30 - 70.31 -27.49 - 27.15 15.58 - 66.17 -35.56 - 36.36 29.62 - 69.40 -29.72 - 30.62
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 49.424 (7.637) 0.017 (11.473) 49.400 (8.640) -0.846 (12.599) 50.657 (7.395) 2.162 (10.495)
#> Median 49.783 0.599 49.927 -1.288 50.823 2.965
#> Min - Max 22.92 - 69.57 -32.30 - 28.46 22.14 - 72.06 -29.71 - 38.11 29.72 - 65.12 -28.75 - 34.15
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 49.395 (7.898) -0.012 (11.876) 50.222 (8.653) -0.023 (11.828) 50.367 (8.176) 1.873 (10.490)
#> Median 49.565 0.730 49.934 0.192 50.811 2.431
#> Min - Max 26.11 - 69.66 -39.25 - 33.93 27.91 - 74.17 -27.70 - 36.16 34.27 - 74.52 -23.70 - 32.42