EGT01 Table 1 (Default) ECG Assessments and Change from Baseline by Visit Table 1.
egt01_1.RdThe EGT01 table 1 summarizes
several electrocardiogram parameters and their evolution throughout the study.
Usage
egt01_1_main(
adam_db,
arm_var = "ACTARM",
summaryvars = list(`Value at Visit` = "AVAL", `Change from \nBaseline` = "CHG"),
visitvar = "AVISIT",
deco = std_deco("EGT01"),
...
)
egt01_1_lyt(
arm_var,
summaryvars,
summaryvars_lbls,
visitvar,
lbl_avisit,
lbl_param,
deco
)
egt01_1_pre(adam_db, ...)
egt01_1_post(tlg, prune_0 = TRUE, ...)
egt01_1Arguments
- adam_db
(
dm) object containing theADaMdatasets- arm_var
(
string) variable used for column splitting- summaryvars
(
character) the variables to be analyzed. For this table,AVALandCHGby default.- visitvar
(
string) typically one of"AVISIT"(Default) or"ATPTN"depending on the type of time point to be displayed.- deco
(
character) decoration withtitle,subtitlesandmain_footercontent- ...
not used.
- summaryvars_lbls
(
character) the label of the variables to be analyzed.- lbl_avisit
(
string) label of thevisitvarvariable.- lbl_param
(
string) label of thePARAMvariable.- tlg
(
TableTree,Listingorggplot) object typically produced by amainfunction.- prune_0
(
flag) remove 0 count rows
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.
Functions
egt01_1_main(): Main TLG functionegt01_1_lyt(): Layoutegt01_1_pre(): Preprocessingegt01_1_post(): Postprocessing
Note
adam_dbobject must contain anadegtable with a"PARAM"column as well as columns specified insummaryvarsandvisitvar.
Examples
db <- syn_data
run(egt01_1, db)
#> Parameter
#> 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
#> ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Heart Rate
#> BASELINE
#> n 134 0 134 0 132 0
#> Mean (SD) 71.4 (17.9) NA 69.8 (20.7) NA 69.3 (20.9) NA
#> Median 72.7 NA 73.4 NA 72.0 NA
#> Min - Max 9.1 - 106.9 NA 13.5 - 115.5 NA 11.6 - 115.5 NA
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 70.2 (20.3) -1.3 (26.0) 69.4 (20.8) -0.4 (29.7) 68.7 (18.1) -0.7 (27.8)
#> Median 70.7 -2.2 70.5 -0.5 68.6 -0.8
#> Min - Max 8.5 - 127.5 -51.0 - 89.2 16.9 - 129.1 -68.2 - 88.4 16.9 - 115.6 -68.2 - 67.2
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 70.3 (19.6) -1.1 (26.3) 71.1 (20.6) 1.3 (31.4) 69.2 (18.1) -0.1 (28.6)
#> Median 70.9 -1.1 72.5 -0.3 69.3 -1.5
#> Min - Max 17.1 - 116.3 -85.0 - 67.5 9.2 - 120.5 -73.1 - 81.4 29.6 - 120.5 -67.7 - 66.3
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 68.3 (20.2) -3.2 (28.7) 68.9 (20.6) -0.9 (30.1) 70.9 (20.3) 1.5 (27.3)
#> Median 68.8 -2.2 67.8 1.2 70.1 0.1
#> Min - Max 13.3 - 131.7 -81.2 - 72.6 24.0 - 130.4 -73.0 - 103.3 20.9 - 116.8 -64.5 - 72.5
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 70.1 (18.4) -1.4 (26.6) 71.6 (20.3) 1.8 (30.3) 71.0 (20.6) 1.7 (29.6)
#> Median 69.3 -4.5 72.2 -0.9 70.5 3.8
#> Min - Max 22.3 - 116.5 -58.1 - 77.3 17.5 - 129.1 -64.3 - 85.3 10.4 - 117.3 -65.9 - 105.7
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 66.4 (19.7) -5.0 (27.1) 71.3 (18.9) 1.4 (27.1) 71.3 (18.6) 1.9 (29.6)
#> Median 65.4 -6.8 70.9 0.6 73.3 1.7
#> Min - Max 23.9 - 110.4 -73.3 - 57.2 25.9 - 125.7 -71.2 - 67.4 23.9 - 117.2 -58.2 - 68.9
#> QT Duration
#> BASELINE
#> n 134 0 134 0 132 0
#> Mean (SD) 336.8 (118.0) NA 351.0 (98.4) NA 352.6 (105.1) NA
#> Median 344.4 NA 351.5 NA 348.0 NA
#> Min - Max 87.0 - 665.4 NA 98.9 - 641.9 NA 105.7 - 628.1 NA
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 342.6 (101.1) 5.7 (159.9) 363.9 (102.3) 12.9 (140.7) 359.4 (105.2) 6.8 (147.1)
#> Median 347.3 -1.8 356.5 13.7 363.8 8.7
#> Min - Max 91.6 - 591.4 -346.4 - 452.8 114.9 - 656.5 -317.5 - 416.4 51.9 - 611.9 -473.2 - 358.0
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 353.2 (93.9) 16.4 (162.1) 345.9 (96.8) -5.1 (152.5) 335.7 (98.6) -16.9 (138.4)
#> Median 351.1 16.7 346.8 -9.7 321.0 -22.3
#> Min - Max 138.0 - 587.3 -414.1 - 389.2 146.4 - 556.1 -440.3 - 364.8 104.9 - 562.3 -326.5 - 325.3
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 370.1 (101.6) 33.3 (152.8) 343.4 (102.6) -7.6 (138.8) 346.9 (95.0) -5.7 (144.7)
#> Median 378.2 39.6 335.1 -15.9 352.2 9.1
#> Min - Max 118.1 - 615.2 -391.7 - 520.1 63.4 - 566.5 -311.3 - 293.8 126.1 - 580.8 -412.1 - 410.0
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 345.8 (96.0) 8.9 (145.6) 354.4 (108.3) 3.4 (142.4) 341.4 (106.7) -11.2 (145.6)
#> Median 340.1 5.6 346.7 -17.1 352.3 -11.9
#> Min - Max 110.1 - 616.6 -393.3 - 456.0 80.8 - 687.7 -439.9 - 364.8 4.9 - 570.6 -480.9 - 330.7
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 358.9 (97.7) 22.1 (155.7) 338.6 (99.3) -12.4 (130.5) 349.3 (95.8) -3.3 (136.0)
#> Median 352.0 5.9 344.2 0.4 350.3 12.7
#> Min - Max 88.4 - 661.1 -353.3 - 539.8 31.3 - 563.9 -338.9 - 352.7 119.0 - 581.8 -311.5 - 295.5
#> RR Duration
#> BASELINE
#> n 134 0 134 0 132 0
#> Mean (SD) 1028.4 (286.4) NA 1027.5 (324.0) NA 1074.6 (277.3) NA
#> Median 1041.9 NA 1047.3 NA 1080.9 NA
#> Min - Max 34.3 - 1783.7 NA 5.3 - 1877.2 NA 289.6 - 1617.1 NA
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 990.2 (318.7) -38.3 (446.4) 1061.6 (269.1) 34.1 (401.8) 1039.6 (284.4) -35.0 (406.0)
#> Median 963.9 -86.5 1061.5 66.9 1014.8 -97.8
#> Min - Max 110.8 - 2014.6 -1014.8 - 1389.4 276.8 - 1712.0 -942.2 - 993.8 498.2 - 1937.5 -958.6 - 908.9
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 1013.4 (304.1) -15.0 (425.8) 1109.4 (318.2) 81.9 (453.1) 1045.2 (277.5) -29.4 (380.8)
#> Median 1040.7 40.5 1117.8 69.3 1034.6 -15.3
#> Min - Max 164.2 - 1677.1 -1216.1 - 1053.2 160.7 - 2048.7 -1127.1 - 1148.6 252.8 - 1722.3 -859.3 - 871.5
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 1014.0 (305.0) -14.4 (406.5) 1118.3 (296.5) 90.9 (409.6) 1036.6 (268.5) -38.0 (421.5)
#> Median 1027.2 -50.5 1134.6 52.0 1030.7 -60.7
#> Min - Max 357.0 - 1798.7 -882.9 - 1080.3 97.1 - 1825.4 -887.1 - 1166.2 446.0 - 1713.4 -984.8 - 902.4
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 1033.3 (313.9) 4.9 (483.2) 1079.8 (298.9) 52.3 (429.3) 1027.5 (295.9) -47.1 (378.2)
#> Median 1050.4 5.6 1051.6 69.6 1023.4 -49.5
#> Min - Max 54.3 - 1979.4 -1345.9 - 1195.4 347.9 - 1762.0 -826.4 - 1191.8 341.6 - 2144.9 -1002.0 - 1048.7
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 1072.3 (282.9) 43.9 (379.0) 1058.5 (271.0) 31.0 (436.0) 1029.0 (271.2) -45.6 (405.5)
#> Median 1067.3 55.9 1068.9 33.6 1065.3 -34.4
#> Min - Max 353.0 - 2000.6 -1028.8 - 1418.6 208.8 - 1794.7 -979.0 - 1365.1 436.3 - 1794.1 -962.2 - 1329.9
run(egt01_1, db, summaryvars = list("AVAL", "Change" = "CHG"))
#> Parameter
#> Analysis Visit A: Drug X B: Placebo C: Combination
#> Analysis Value Change Analysis Value Change Analysis Value Change
#> ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Heart Rate
#> BASELINE
#> n 134 0 134 0 132 0
#> Mean (SD) 71.4 (17.9) NA 69.8 (20.7) NA 69.3 (20.9) NA
#> Median 72.7 NA 73.4 NA 72.0 NA
#> Min - Max 9.1 - 106.9 NA 13.5 - 115.5 NA 11.6 - 115.5 NA
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 70.2 (20.3) -1.3 (26.0) 69.4 (20.8) -0.4 (29.7) 68.7 (18.1) -0.7 (27.8)
#> Median 70.7 -2.2 70.5 -0.5 68.6 -0.8
#> Min - Max 8.5 - 127.5 -51.0 - 89.2 16.9 - 129.1 -68.2 - 88.4 16.9 - 115.6 -68.2 - 67.2
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 70.3 (19.6) -1.1 (26.3) 71.1 (20.6) 1.3 (31.4) 69.2 (18.1) -0.1 (28.6)
#> Median 70.9 -1.1 72.5 -0.3 69.3 -1.5
#> Min - Max 17.1 - 116.3 -85.0 - 67.5 9.2 - 120.5 -73.1 - 81.4 29.6 - 120.5 -67.7 - 66.3
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 68.3 (20.2) -3.2 (28.7) 68.9 (20.6) -0.9 (30.1) 70.9 (20.3) 1.5 (27.3)
#> Median 68.8 -2.2 67.8 1.2 70.1 0.1
#> Min - Max 13.3 - 131.7 -81.2 - 72.6 24.0 - 130.4 -73.0 - 103.3 20.9 - 116.8 -64.5 - 72.5
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 70.1 (18.4) -1.4 (26.6) 71.6 (20.3) 1.8 (30.3) 71.0 (20.6) 1.7 (29.6)
#> Median 69.3 -4.5 72.2 -0.9 70.5 3.8
#> Min - Max 22.3 - 116.5 -58.1 - 77.3 17.5 - 129.1 -64.3 - 85.3 10.4 - 117.3 -65.9 - 105.7
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 66.4 (19.7) -5.0 (27.1) 71.3 (18.9) 1.4 (27.1) 71.3 (18.6) 1.9 (29.6)
#> Median 65.4 -6.8 70.9 0.6 73.3 1.7
#> Min - Max 23.9 - 110.4 -73.3 - 57.2 25.9 - 125.7 -71.2 - 67.4 23.9 - 117.2 -58.2 - 68.9
#> QT Duration
#> BASELINE
#> n 134 0 134 0 132 0
#> Mean (SD) 336.8 (118.0) NA 351.0 (98.4) NA 352.6 (105.1) NA
#> Median 344.4 NA 351.5 NA 348.0 NA
#> Min - Max 87.0 - 665.4 NA 98.9 - 641.9 NA 105.7 - 628.1 NA
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 342.6 (101.1) 5.7 (159.9) 363.9 (102.3) 12.9 (140.7) 359.4 (105.2) 6.8 (147.1)
#> Median 347.3 -1.8 356.5 13.7 363.8 8.7
#> Min - Max 91.6 - 591.4 -346.4 - 452.8 114.9 - 656.5 -317.5 - 416.4 51.9 - 611.9 -473.2 - 358.0
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 353.2 (93.9) 16.4 (162.1) 345.9 (96.8) -5.1 (152.5) 335.7 (98.6) -16.9 (138.4)
#> Median 351.1 16.7 346.8 -9.7 321.0 -22.3
#> Min - Max 138.0 - 587.3 -414.1 - 389.2 146.4 - 556.1 -440.3 - 364.8 104.9 - 562.3 -326.5 - 325.3
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 370.1 (101.6) 33.3 (152.8) 343.4 (102.6) -7.6 (138.8) 346.9 (95.0) -5.7 (144.7)
#> Median 378.2 39.6 335.1 -15.9 352.2 9.1
#> Min - Max 118.1 - 615.2 -391.7 - 520.1 63.4 - 566.5 -311.3 - 293.8 126.1 - 580.8 -412.1 - 410.0
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 345.8 (96.0) 8.9 (145.6) 354.4 (108.3) 3.4 (142.4) 341.4 (106.7) -11.2 (145.6)
#> Median 340.1 5.6 346.7 -17.1 352.3 -11.9
#> Min - Max 110.1 - 616.6 -393.3 - 456.0 80.8 - 687.7 -439.9 - 364.8 4.9 - 570.6 -480.9 - 330.7
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 358.9 (97.7) 22.1 (155.7) 338.6 (99.3) -12.4 (130.5) 349.3 (95.8) -3.3 (136.0)
#> Median 352.0 5.9 344.2 0.4 350.3 12.7
#> Min - Max 88.4 - 661.1 -353.3 - 539.8 31.3 - 563.9 -338.9 - 352.7 119.0 - 581.8 -311.5 - 295.5
#> RR Duration
#> BASELINE
#> n 134 0 134 0 132 0
#> Mean (SD) 1028.4 (286.4) NA 1027.5 (324.0) NA 1074.6 (277.3) NA
#> Median 1041.9 NA 1047.3 NA 1080.9 NA
#> Min - Max 34.3 - 1783.7 NA 5.3 - 1877.2 NA 289.6 - 1617.1 NA
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 990.2 (318.7) -38.3 (446.4) 1061.6 (269.1) 34.1 (401.8) 1039.6 (284.4) -35.0 (406.0)
#> Median 963.9 -86.5 1061.5 66.9 1014.8 -97.8
#> Min - Max 110.8 - 2014.6 -1014.8 - 1389.4 276.8 - 1712.0 -942.2 - 993.8 498.2 - 1937.5 -958.6 - 908.9
#> WEEK 2 DAY 15
#> n 134 134 134 134 132 132
#> Mean (SD) 1013.4 (304.1) -15.0 (425.8) 1109.4 (318.2) 81.9 (453.1) 1045.2 (277.5) -29.4 (380.8)
#> Median 1040.7 40.5 1117.8 69.3 1034.6 -15.3
#> Min - Max 164.2 - 1677.1 -1216.1 - 1053.2 160.7 - 2048.7 -1127.1 - 1148.6 252.8 - 1722.3 -859.3 - 871.5
#> WEEK 3 DAY 22
#> n 134 134 134 134 132 132
#> Mean (SD) 1014.0 (305.0) -14.4 (406.5) 1118.3 (296.5) 90.9 (409.6) 1036.6 (268.5) -38.0 (421.5)
#> Median 1027.2 -50.5 1134.6 52.0 1030.7 -60.7
#> Min - Max 357.0 - 1798.7 -882.9 - 1080.3 97.1 - 1825.4 -887.1 - 1166.2 446.0 - 1713.4 -984.8 - 902.4
#> WEEK 4 DAY 29
#> n 134 134 134 134 132 132
#> Mean (SD) 1033.3 (313.9) 4.9 (483.2) 1079.8 (298.9) 52.3 (429.3) 1027.5 (295.9) -47.1 (378.2)
#> Median 1050.4 5.6 1051.6 69.6 1023.4 -49.5
#> Min - Max 54.3 - 1979.4 -1345.9 - 1195.4 347.9 - 1762.0 -826.4 - 1191.8 341.6 - 2144.9 -1002.0 - 1048.7
#> WEEK 5 DAY 36
#> n 134 134 134 134 132 132
#> Mean (SD) 1072.3 (282.9) 43.9 (379.0) 1058.5 (271.0) 31.0 (436.0) 1029.0 (271.2) -45.6 (405.5)
#> Median 1067.3 55.9 1068.9 33.6 1065.3 -34.4
#> Min - Max 353.0 - 2000.6 -1028.8 - 1418.6 208.8 - 1794.7 -979.0 - 1365.1 436.3 - 1794.1 -962.2 - 1329.9