EGT01 ECG Parameters and Change from Baseline By Visit Table.
egt01.RdThe 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 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::summarize_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(egt01, syn_data)
#> Analysis Visit 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
#> (N=134) (N=134) (N=134) (N=134) (N=132) (N=132)
#> —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Heart Rate
#> BASELINE
#> n 134 134 132
#> Mean (SD) 71.447 (17.932) 69.829 (20.717) 69.341 (20.948)
#> Median 72.697 73.352 71.956
#> Min - Max 9.09 - 106.91 13.49 - 115.52 11.63 - 115.49
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 70.191 (20.274) -1.257 (25.966) 69.427 (20.799) -0.401 (29.735) 68.654 (18.064) -0.687 (27.807)
#> Median 70.703 -2.197 70.462 -0.520 68.573 -0.760
#> Min - Max 8.53 - 127.50 -50.97 - 89.16 16.85 - 129.14 -68.18 - 88.38 16.87 - 115.60 -68.25 - 67.20
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 70.317 (19.561) -1.130 (26.262) 71.108 (20.556) 1.279 (31.353) 69.193 (18.056) -0.148 (28.606)
#> Median 70.885 -1.105 72.524 -0.311 69.304 -1.548
#> Min - Max 17.14 - 116.32 -85.03 - 67.52 9.22 - 120.54 -73.07 - 81.44 29.62 - 120.50 -67.75 - 66.29
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 68.251 (20.168) -3.196 (28.657) 68.947 (20.558) -0.881 (30.142) 70.884 (20.280) 1.543 (27.285)
#> Median 68.787 -2.167 67.802 1.195 70.124 0.139
#> Min - Max 13.33 - 131.73 -81.20 - 72.57 23.98 - 130.41 -73.03 - 103.31 20.91 - 116.79 -64.51 - 72.52
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 70.063 (18.410) -1.385 (26.595) 71.601 (20.336) 1.772 (30.262) 71.020 (20.591) 1.679 (29.597)
#> Median 69.330 -4.535 72.211 -0.884 70.523 3.811
#> Min - Max 22.30 - 116.51 -58.07 - 77.32 17.53 - 129.06 -64.32 - 85.34 10.35 - 117.30 -65.91 - 105.67
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 66.406 (19.745) -5.041 (27.112) 71.252 (18.923) 1.423 (27.084) 71.257 (18.563) 1.916 (29.591)
#> Median 65.405 -6.827 70.858 0.637 73.292 1.735
#> Min - Max 23.89 - 110.38 -73.26 - 57.24 25.86 - 125.73 -71.15 - 67.37 23.89 - 117.19 -58.23 - 68.86
#> QT Duration
#> BASELINE
#> n 134 134 132
#> Mean (SD) 336.834 (117.958) 351.004 (98.436) 352.598 (105.114)
#> Median 344.414 351.480 347.956
#> Min - Max 86.98 - 665.40 98.90 - 641.92 105.68 - 628.14
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 342.574 (101.093) 5.741 (159.936) 363.946 (102.338) 12.943 (140.729) 359.424 (105.161) 6.826 (147.129)
#> Median 347.264 -1.779 356.539 13.730 363.838 8.685
#> Min - Max 91.63 - 591.42 -346.44 - 452.75 114.92 - 656.45 -317.53 - 416.35 51.91 - 611.88 -473.19 - 358.00
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 353.244 (93.926) 16.410 (162.103) 345.926 (96.783) -5.078 (152.509) 335.689 (98.605) -16.909 (138.448)
#> Median 351.099 16.722 346.831 -9.681 320.957 -22.267
#> Min - Max 138.01 - 587.30 -414.07 - 389.16 146.42 - 556.07 -440.28 - 364.76 104.91 - 562.34 -326.55 - 325.27
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 370.115 (101.568) 33.282 (152.780) 343.412 (102.585) -7.592 (138.803) 346.947 (94.965) -5.652 (144.651)
#> Median 378.209 39.586 335.119 -15.888 352.154 9.113
#> Min - Max 118.14 - 615.18 -391.72 - 520.09 63.37 - 566.51 -311.28 - 293.76 126.09 - 580.81 -412.11 - 410.01
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 345.774 (95.970) 8.941 (145.647) 354.377 (108.286) 3.374 (142.390) 341.358 (106.745) -11.240 (145.648)
#> Median 340.134 5.576 346.699 -17.129 352.295 -11.868
#> Min - Max 110.12 - 616.58 -393.34 - 456.04 80.82 - 687.69 -439.90 - 364.80 4.95 - 570.61 -480.94 - 330.67
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 358.903 (97.693) 22.069 (155.681) 338.648 (99.260) -12.356 (130.457) 349.303 (95.769) -3.296 (135.997)
#> Median 351.959 5.886 344.167 0.405 350.319 12.680
#> Min - Max 88.38 - 661.12 -353.30 - 539.84 31.25 - 563.90 -338.85 - 352.75 119.02 - 581.83 -311.45 - 295.53
#> RR Duration
#> BASELINE
#> n 134 134 132
#> Mean (SD) 1028.419 (286.385) 1027.484 (324.000) 1074.623 (277.328)
#> Median 1041.860 1047.268 1080.866
#> Min - Max 34.33 - 1783.71 5.29 - 1877.19 289.60 - 1617.06
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 990.155 (318.736) -38.264 (446.403) 1061.587 (269.138) 34.103 (401.759) 1039.642 (284.389) -34.981 (406.037)
#> Median 963.881 -86.501 1061.504 66.914 1014.780 -97.826
#> Min - Max 110.82 - 2014.56 -1014.82 - 1389.40 276.83 - 1711.99 -942.16 - 993.82 498.21 - 1937.47 -958.61 - 908.90
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 1013.371 (304.135) -15.047 (425.807) 1109.402 (318.227) 81.918 (453.105) 1045.209 (277.506) -29.414 (380.841)
#> Median 1040.693 40.485 1117.764 69.275 1034.637 -15.331
#> Min - Max 164.19 - 1677.10 -1216.10 - 1053.15 160.73 - 2048.73 -1127.10 - 1148.61 252.84 - 1722.33 -859.27 - 871.54
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 1013.987 (304.990) -14.431 (406.529) 1118.345 (296.527) 90.861 (409.573) 1036.593 (268.521) -38.030 (421.484)
#> Median 1027.232 -50.543 1134.596 52.029 1030.717 -60.720
#> Min - Max 357.04 - 1798.65 -882.94 - 1080.26 97.14 - 1825.43 -887.06 - 1166.15 446.02 - 1713.38 -984.79 - 902.37
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 1033.309 (313.919) 4.890 (483.153) 1079.762 (298.940) 52.278 (429.253) 1027.549 (295.856) -47.074 (378.235)
#> Median 1050.399 5.601 1051.613 69.554 1023.360 -49.519
#> Min - Max 54.33 - 1979.43 -1345.93 - 1195.41 347.94 - 1762.04 -826.43 - 1191.83 341.62 - 2144.86 -1002.03 - 1048.66
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 1072.335 (282.901) 43.916 (379.048) 1058.452 (271.012) 30.968 (436.030) 1029.043 (271.211) -45.580 (405.528)
#> Median 1067.330 55.872 1068.950 33.615 1065.256 -34.395
#> Min - Max 352.97 - 2000.56 -1028.79 - 1418.57 208.83 - 1794.73 -978.97 - 1365.13 436.28 - 1794.07 -962.18 - 1329.88