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 = 2L),
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.- 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) 76.594 (17.889) 69.899 (18.788) 70.492 (18.175)
#> Median 77.531 77.174 74.111
#> Min - Max 46.50 - 106.68 26.42 - 97.69 45.37 - 115.49
#> WEEK 1 DAY 8
#> n 15 15 15 15 15 15
#> Mean (SD) 71.140 (23.441) -5.454 (25.128) 70.958 (14.877) 1.059 (23.345) 67.450 (18.932) -3.043 (23.753)
#> Median 77.210 -2.152 70.033 -8.403 68.471 0.181
#> Min - Max 8.53 - 102.63 -50.97 - 36.54 44.85 - 93.79 -25.34 - 60.50 38.90 - 100.05 -52.20 - 33.13
#> WEEK 2 DAY 15
#> n 15 15 15 15 15 15
#> Mean (SD) 69.350 (16.083) -7.244 (28.960) 76.096 (14.958) 6.198 (29.319) 63.694 (12.920) -6.799 (23.949)
#> Median 65.746 -11.369 75.323 0.255 61.076 -4.954
#> Min - Max 47.22 - 101.44 -49.59 - 42.91 47.50 - 111.40 -37.51 - 69.34 43.25 - 86.13 -52.70 - 40.76
#> WEEK 3 DAY 22
#> n 15 15 15 15 15 15
#> Mean (SD) 73.894 (24.576) -2.700 (32.079) 67.635 (19.114) -2.263 (29.989) 72.054 (19.308) 1.562 (27.494)
#> Median 69.296 5.492 68.468 -2.093 68.686 -5.848
#> Min - Max 44.15 - 131.73 -62.53 - 38.19 31.89 - 108.87 -52.26 - 66.81 32.16 - 109.86 -49.61 - 35.23
#> WEEK 4 DAY 29
#> n 15 15 15 15 15 15
#> Mean (SD) 73.241 (19.256) -3.353 (29.170) 66.524 (25.487) -3.374 (36.024) 66.600 (22.839) -3.892 (24.140)
#> Median 68.689 0.232 66.397 -11.730 64.969 -6.827
#> Min - Max 33.71 - 111.54 -55.14 - 65.04 19.66 - 111.29 -60.39 - 61.00 10.35 - 100.88 -50.72 - 26.77
#> WEEK 5 DAY 36
#> n 15 15 15 15 15 15
#> Mean (SD) 61.690 (22.182) -14.904 (30.330) 60.712 (20.025) -9.187 (24.587) 72.683 (23.495) 2.191 (26.654)
#> Median 57.925 -12.660 60.454 -16.100 77.585 14.635
#> Min - Max 23.89 - 103.74 -60.00 - 57.24 32.53 - 102.02 -52.56 - 50.96 31.21 - 105.05 -42.90 - 34.64
#> QT Duration
#> BASELINE
#> n 15 15 15
#> Mean (SD) 335.294 (123.231) 363.104 (68.160) 347.311 (86.236)
#> Median 372.731 386.316 348.254
#> Min - Max 121.28 - 554.97 214.65 - 445.53 170.80 - 508.54
#> WEEK 1 DAY 8
#> n 15 15 15 15 15 15
#> Mean (SD) 357.361 (85.688) 22.067 (144.166) 415.225 (105.425) 52.121 (144.259) 321.078 (107.553) -26.233 (129.135)
#> Median 344.797 49.432 421.950 62.762 307.962 -17.006
#> Min - Max 241.22 - 517.39 -207.23 - 245.36 234.11 - 604.72 -190.70 - 364.94 118.36 - 480.29 -363.11 - 163.67
#> WEEK 2 DAY 15
#> n 15 15 15 15 15 15
#> Mean (SD) 344.883 (106.793) 9.589 (174.797) 370.548 (80.862) 7.444 (91.301) 354.129 (95.133) 6.818 (142.397)
#> Median 312.236 -9.264 388.515 -9.429 365.292 39.930
#> Min - Max 187.77 - 501.87 -278.91 - 372.71 204.55 - 514.43 -190.58 - 173.87 200.19 - 493.40 -279.46 - 265.56
#> WEEK 3 DAY 22
#> n 15 15 15 15 15 15
#> Mean (SD) 342.062 (92.568) 6.768 (151.505) 326.684 (116.421) -36.420 (145.415) 366.245 (99.106) 18.935 (168.417)
#> Median 352.930 -22.771 298.353 -78.409 329.688 -21.584
#> Min - Max 199.40 - 476.04 -230.25 - 303.00 151.05 - 561.23 -205.30 - 293.76 249.42 - 580.81 -252.73 - 410.01
#> WEEK 4 DAY 29
#> n 15 15 15 15 15 15
#> Mean (SD) 371.650 (44.805) 36.356 (139.308) 333.697 (110.377) -29.407 (125.592) 333.181 (96.466) -14.130 (107.622)
#> Median 375.412 58.958 308.020 -40.987 330.911 -25.820
#> Min - Max 302.32 - 451.62 -214.07 - 258.04 183.09 - 531.08 -241.72 - 134.12 126.95 - 488.57 -234.92 - 152.49
#> WEEK 5 DAY 36
#> n 15 15 15 15 15 15
#> Mean (SD) 345.504 (130.543) 10.210 (198.224) 309.919 (84.624) -53.185 (105.730) 322.931 (67.801) -24.380 (117.331)
#> Median 355.730 -23.213 306.219 -12.373 341.988 -26.952
#> Min - Max 88.38 - 661.12 -271.06 - 539.84 189.01 - 448.58 -256.52 - 91.57 217.51 - 427.16 -291.03 - 171.19
#> RR Duration
#> BASELINE
#> n 15 15 15
#> Mean (SD) 1086.908 (363.811) 1050.034 (390.444) 1102.659 (310.359)
#> Median 1116.849 1089.193 1250.037
#> Min - Max 626.19 - 1653.12 414.61 - 1721.89 385.51 - 1430.81
#> WEEK 1 DAY 8
#> n 15 15 15 15 15 15
#> Mean (SD) 968.499 (287.811) -118.409 (546.796) 1041.186 (211.201) -8.848 (435.281) 948.491 (213.746) -154.168 (442.882)
#> Median 961.296 -147.460 1013.786 24.754 965.429 -224.054
#> Min - Max 358.92 - 1593.51 -1014.82 - 911.82 714.44 - 1417.52 -618.80 - 847.31 513.35 - 1229.09 -736.69 - 843.58
#> WEEK 2 DAY 15
#> n 15 15 15 15 15 15
#> Mean (SD) 932.717 (259.634) -154.191 (331.884) 1139.332 (454.231) 89.298 (582.750) 1021.283 (233.529) -81.376 (415.781)
#> Median 950.533 -205.949 1068.007 -5.449 964.616 -142.180
#> Min - Max 409.68 - 1269.35 -649.69 - 473.09 486.51 - 2048.73 -846.72 - 1148.61 667.36 - 1367.25 -647.47 - 616.15
#> WEEK 3 DAY 22
#> n 15 15 15 15 15 15
#> Mean (SD) 1068.865 (319.540) -18.043 (513.412) 1110.882 (259.523) 60.848 (432.700) 1105.918 (306.185) 3.259 (516.734)
#> Median 1201.998 -65.085 1163.690 51.200 1187.130 30.318
#> Min - Max 380.49 - 1551.65 -832.86 - 703.74 621.41 - 1453.29 -887.06 - 822.18 446.02 - 1648.32 -984.79 - 816.30
#> WEEK 4 DAY 29
#> n 15 15 15 15 15 15
#> Mean (SD) 1087.915 (205.940) 1.008 (403.039) 1161.681 (293.257) 111.647 (460.979) 992.134 (283.177) -110.525 (334.932)
#> Median 1084.658 146.611 1055.223 191.008 1028.997 -112.599
#> Min - Max 697.59 - 1499.17 -801.16 - 402.97 722.35 - 1762.04 -528.27 - 1191.83 497.14 - 1382.12 -597.95 - 757.99
#> WEEK 5 DAY 36
#> n 15 15 15 15 15 15
#> Mean (SD) 1016.880 (424.428) -70.027 (505.078) 1135.131 (224.684) 85.097 (497.679) 1089.527 (238.909) -13.132 (362.606)
#> Median 962.584 -142.925 1158.815 -9.553 1081.015 16.706
#> Min - Max 352.97 - 1843.86 -894.83 - 1162.79 714.34 - 1436.68 -843.41 - 992.34 699.72 - 1611.38 -696.03 - 561.53