The EGT01 table provides an
overview of the ECG values and its change from baseline of each respective arm
over the course of the trial.
Usage
egt01_main(
adam_db,
dataset = "adeg",
arm_var = "ACTARM",
lbl_overall = NULL,
row_split_var = NULL,
summaryvars = c("AVAL", "CHG"),
visitvar = "AVISIT",
precision = list(default = 0L),
page_var = "PARAMCD",
.stats = c("n", "mean_sd", "median", "range"),
skip = list(CHG = "BASELINE"),
...
)
egt01_pre(adam_db, dataset = "adeg", ...)
egt01Arguments
- 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
run(egt01, 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)
#> ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Heart Rate
#> BASELINE
#> n 15 15 15
#> Mean (SD) 76.6 (17.9) 69.9 (18.8) 70.5 (18.2)
#> Median 77.5 77.2 74.1
#> Min - Max 46 - 107 26 - 98 45 - 115
#> WEEK 1 DAY 8
#> n 15 15 15 15 15 15
#> Mean (SD) 71.1 (23.4) -5.5 (25.1) 71.0 (14.9) 1.1 (23.3) 67.4 (18.9) -3.0 (23.8)
#> Median 77.2 -2.2 70.0 -8.4 68.5 0.2
#> Min - Max 9 - 103 -51 - 37 45 - 94 -25 - 60 39 - 100 -52 - 33
#> WEEK 2 DAY 15
#> n 15 15 15 15 15 15
#> Mean (SD) 69.4 (16.1) -7.2 (29.0) 76.1 (15.0) 6.2 (29.3) 63.7 (12.9) -6.8 (23.9)
#> Median 65.7 -11.4 75.3 0.3 61.1 -5.0
#> Min - Max 47 - 101 -50 - 43 47 - 111 -38 - 69 43 - 86 -53 - 41
#> WEEK 3 DAY 22
#> n 15 15 15 15 15 15
#> Mean (SD) 73.9 (24.6) -2.7 (32.1) 67.6 (19.1) -2.3 (30.0) 72.1 (19.3) 1.6 (27.5)
#> Median 69.3 5.5 68.5 -2.1 68.7 -5.8
#> Min - Max 44 - 132 -63 - 38 32 - 109 -52 - 67 32 - 110 -50 - 35
#> WEEK 4 DAY 29
#> n 15 15 15 15 15 15
#> Mean (SD) 73.2 (19.3) -3.4 (29.2) 66.5 (25.5) -3.4 (36.0) 66.6 (22.8) -3.9 (24.1)
#> Median 68.7 0.2 66.4 -11.7 65.0 -6.8
#> Min - Max 34 - 112 -55 - 65 20 - 111 -60 - 61 10 - 101 -51 - 27
#> WEEK 5 DAY 36
#> n 15 15 15 15 15 15
#> Mean (SD) 61.7 (22.2) -14.9 (30.3) 60.7 (20.0) -9.2 (24.6) 72.7 (23.5) 2.2 (26.7)
#> Median 57.9 -12.7 60.5 -16.1 77.6 14.6
#> Min - Max 24 - 104 -60 - 57 33 - 102 -53 - 51 31 - 105 -43 - 35
#> QT Duration
#> BASELINE
#> n 15 15 15
#> Mean (SD) 335.3 (123.2) 363.1 (68.2) 347.3 (86.2)
#> Median 372.7 386.3 348.3
#> Min - Max 121 - 555 215 - 446 171 - 509
#> WEEK 1 DAY 8
#> n 15 15 15 15 15 15
#> Mean (SD) 357.4 (85.7) 22.1 (144.2) 415.2 (105.4) 52.1 (144.3) 321.1 (107.6) -26.2 (129.1)
#> Median 344.8 49.4 422.0 62.8 308.0 -17.0
#> Min - Max 241 - 517 -207 - 245 234 - 605 -191 - 365 118 - 480 -363 - 164
#> WEEK 2 DAY 15
#> n 15 15 15 15 15 15
#> Mean (SD) 344.9 (106.8) 9.6 (174.8) 370.5 (80.9) 7.4 (91.3) 354.1 (95.1) 6.8 (142.4)
#> Median 312.2 -9.3 388.5 -9.4 365.3 39.9
#> Min - Max 188 - 502 -279 - 373 205 - 514 -191 - 174 200 - 493 -279 - 266
#> WEEK 3 DAY 22
#> n 15 15 15 15 15 15
#> Mean (SD) 342.1 (92.6) 6.8 (151.5) 326.7 (116.4) -36.4 (145.4) 366.2 (99.1) 18.9 (168.4)
#> Median 352.9 -22.8 298.4 -78.4 329.7 -21.6
#> Min - Max 199 - 476 -230 - 303 151 - 561 -205 - 294 249 - 581 -253 - 410
#> WEEK 4 DAY 29
#> n 15 15 15 15 15 15
#> Mean (SD) 371.7 (44.8) 36.4 (139.3) 333.7 (110.4) -29.4 (125.6) 333.2 (96.5) -14.1 (107.6)
#> Median 375.4 59.0 308.0 -41.0 330.9 -25.8
#> Min - Max 302 - 452 -214 - 258 183 - 531 -242 - 134 127 - 489 -235 - 152
#> WEEK 5 DAY 36
#> n 15 15 15 15 15 15
#> Mean (SD) 345.5 (130.5) 10.2 (198.2) 309.9 (84.6) -53.2 (105.7) 322.9 (67.8) -24.4 (117.3)
#> Median 355.7 -23.2 306.2 -12.4 342.0 -27.0
#> Min - Max 88 - 661 -271 - 540 189 - 449 -257 - 92 218 - 427 -291 - 171
#> RR Duration
#> BASELINE
#> n 15 15 15
#> Mean (SD) 1086.9 (363.8) 1050.0 (390.4) 1102.7 (310.4)
#> Median 1116.8 1089.2 1250.0
#> Min - Max 626 - 1653 415 - 1722 386 - 1431
#> WEEK 1 DAY 8
#> n 15 15 15 15 15 15
#> Mean (SD) 968.5 (287.8) -118.4 (546.8) 1041.2 (211.2) -8.8 (435.3) 948.5 (213.7) -154.2 (442.9)
#> Median 961.3 -147.5 1013.8 24.8 965.4 -224.1
#> Min - Max 359 - 1594 -1015 - 912 714 - 1418 -619 - 847 513 - 1229 -737 - 844
#> WEEK 2 DAY 15
#> n 15 15 15 15 15 15
#> Mean (SD) 932.7 (259.6) -154.2 (331.9) 1139.3 (454.2) 89.3 (582.7) 1021.3 (233.5) -81.4 (415.8)
#> Median 950.5 -205.9 1068.0 -5.4 964.6 -142.2
#> Min - Max 410 - 1269 -650 - 473 487 - 2049 -847 - 1149 667 - 1367 -647 - 616
#> WEEK 3 DAY 22
#> n 15 15 15 15 15 15
#> Mean (SD) 1068.9 (319.5) -18.0 (513.4) 1110.9 (259.5) 60.8 (432.7) 1105.9 (306.2) 3.3 (516.7)
#> Median 1202.0 -65.1 1163.7 51.2 1187.1 30.3
#> Min - Max 380 - 1552 -833 - 704 621 - 1453 -887 - 822 446 - 1648 -985 - 816
#> WEEK 4 DAY 29
#> n 15 15 15 15 15 15
#> Mean (SD) 1087.9 (205.9) 1.0 (403.0) 1161.7 (293.3) 111.6 (461.0) 992.1 (283.2) -110.5 (334.9)
#> Median 1084.7 146.6 1055.2 191.0 1029.0 -112.6
#> Min - Max 698 - 1499 -801 - 403 722 - 1762 -528 - 1192 497 - 1382 -598 - 758
#> WEEK 5 DAY 36
#> n 15 15 15 15 15 15
#> Mean (SD) 1016.9 (424.4) -70.0 (505.1) 1135.1 (224.7) 85.1 (497.7) 1089.5 (238.9) -13.1 (362.6)
#> Median 962.6 -142.9 1158.8 -9.6 1081.0 16.7
#> Min - Max 353 - 1844 -895 - 1163 714 - 1437 -843 - 992 700 - 1611 -696 - 562