The 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(DIABP = 0, PUL = 0, SYSBP = 0, 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. Ifdefaultis not set, the default precision is 2.- 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
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=15) (N=15) (N=15) (N=15) (N=15) (N=15)
#> ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Diastolic Blood Pressure
#> SCREENING
#> n 15 0 15 0 15 0
#> Mean (SD) 94.4 (17.1) NE (NE) 106.4 (20.6) NE (NE) 106.5 (12.6) NE (NE)
#> Median 94.9 NE 111.1 NE 108.4 NE
#> Min - Max 56 - 122 NE - NE 60 - 132 NE - NE 83 - 127 NE - NE
#> BASELINE
#> n 15 15 15
#> Mean (SD) 96.1 (22.5) 108.1 (15.1) 103.1 (19.8)
#> Median 93.3 109.0 102.8
#> Min - Max 61 - 137 83 - 132 66 - 137
#> WEEK 1 DAY 8
#> n 15 15 15 15 15 15
#> Mean (SD) 99.0 (21.4) 2.8 (28.1) 104.1 (16.2) -4.0 (21.9) 100.8 (19.0) -2.3 (25.0)
#> Median 92.4 -4.1 107.7 3.2 103.1 -2.5
#> Min - Max 68 - 130 -33 - 48 71 - 133 -53 - 29 70 - 129 -55 - 42
#> WEEK 2 DAY 15
#> n 15 15 15 15 15 15
#> Mean (SD) 99.8 (14.5) 3.6 (21.2) 97.5 (17.3) -10.6 (20.8) 94.3 (17.0) -8.9 (27.2)
#> Median 101.5 1.7 99.5 -9.7 96.8 -10.2
#> Min - Max 72 - 123 -40 - 48 54 - 126 -55 - 25 63 - 117 -73 - 47
#> WEEK 3 DAY 22
#> n 15 15 15 15 15 15
#> Mean (SD) 99.1 (26.1) 3.0 (34.3) 92.0 (16.9) -16.1 (21.9) 94.6 (13.6) -8.6 (21.7)
#> Median 101.1 -0.3 91.2 -14.4 98.4 -16.1
#> Min - Max 48 - 162 -48 - 77 68 - 120 -53 - 23 74 - 115 -38 - 33
#> WEEK 4 DAY 29
#> n 15 15 15 15 15 15
#> Mean (SD) 103.4 (22.3) 7.3 (30.7) 96.5 (19.5) -11.6 (25.9) 108.3 (18.4) 5.2 (21.9)
#> Median 98.2 2.5 97.4 -16.8 107.6 8.0
#> Min - Max 63 - 148 -38 - 62 63 - 132 -57 - 48 69 - 133 -34 - 42
#> WEEK 5 DAY 36
#> n 15 15 15 15 15 15
#> Mean (SD) 93.2 (18.5) -2.9 (28.9) 97.9 (20.7) -10.2 (27.6) 95.3 (16.4) -7.8 (19.8)
#> Median 90.8 -3.4 99.0 -11.3 93.9 -4.7
#> Min - Max 64 - 139 -49 - 47 69 - 138 -54 - 38 72 - 139 -44 - 29
#> Systolic Blood Pressure
#> SCREENING
#> n 15 0 15 0 15 0
#> Mean (SD) 154.1 (33.5) NE (NE) 157.8 (34.4) NE (NE) 152.4 (22.3) NE (NE)
#> Median 156.2 NE 161.7 NE 149.6 NE
#> Min - Max 78 - 211 NE - NE 80 - 210 NE - NE 108 - 185 NE - NE
#> BASELINE
#> n 15 15 15
#> Mean (SD) 145.9 (28.2) 152.0 (28.7) 154.2 (26.3)
#> Median 142.7 157.7 155.3
#> Min - Max 85 - 196 99 - 195 87 - 193
#> WEEK 1 DAY 8
#> n 15 15 15 15 15 15
#> Mean (SD) 156.5 (21.1) 10.6 (34.6) 147.5 (33.5) -4.5 (48.9) 143.3 (30.8) -10.9 (34.6)
#> Median 160.7 5.8 155.0 2.8 145.5 -5.6
#> Min - Max 127 - 186 -53 - 92 85 - 190 -77 - 91 90 - 192 -66 - 49
#> WEEK 2 DAY 15
#> n 15 15 15 15 15 15
#> Mean (SD) 144.2 (33.7) -1.7 (27.1) 136.9 (30.2) -15.1 (37.8) 148.6 (27.1) -5.6 (44.7)
#> Median 144.3 5.3 142.7 -14.1 147.1 -11.5
#> Min - Max 63 - 204 -54 - 44 70 - 174 -83 - 62 109 - 200 -70 - 114
#> WEEK 3 DAY 22
#> n 15 15 15 15 15 15
#> Mean (SD) 154.9 (35.4) 9.0 (38.5) 149.8 (28.9) -2.2 (44.8) 150.5 (21.4) -3.7 (38.0)
#> Median 158.9 17.2 155.0 -1.8 156.5 -7.6
#> Min - Max 112 - 219 -47 - 96 84 - 193 -110 - 94 95 - 180 -75 - 73
#> WEEK 4 DAY 29
#> n 15 15 15 15 15 15
#> Mean (SD) 150.2 (32.2) 4.2 (33.0) 156.0 (22.9) 4.0 (42.5) 145.7 (23.0) -8.5 (33.2)
#> Median 145.5 3.8 149.1 -10.0 150.8 -14.4
#> Min - Max 69 - 210 -89 - 54 114 - 195 -71 - 78 107 - 188 -42 - 65
#> WEEK 5 DAY 36
#> n 15 15 15 15 15 15
#> Mean (SD) 156.0 (30.9) 10.0 (42.3) 156.4 (35.3) 4.4 (51.8) 143.6 (33.2) -10.6 (44.8)
#> Median 158.1 1.4 164.6 7.1 148.5 -2.4
#> Min - Max 111 - 212 -54 - 90 63 - 199 -131 - 87 92 - 191 -79 - 64