EGT01 Table 1 (Default) ECG Assessments and Change from Baseline by Visit Table 1egt01_1.RdThe EGT01 table 1 summarizes several electrocardiogram parameters and their evolution throughout the study.
egt01_1(
adam_db,
armvar = .study$actualarm,
summaryvars = .study$evo_vars,
summaryvars_lbls = var_labels_for(adam_db$adeg, summaryvars),
visitvar = "AVISIT",
prune_0 = TRUE,
deco = std_deco("EGT01"),
.study = list(actualarm = "ACTARM", evo_vars = c("AVAL", "CHG"))
)
egt01_1_lyt(
armvar = .study$actualarm,
summaryvars = .study$evo_vars,
summaryvars_lbls = .study$evo_vars_lbls,
visitvar = .study$visitvar,
lbl_avisit = "",
lbl_param = "",
deco = std_deco("EGT01"),
.study = list(actualarm = "ACTARM", evo_vars = c("AVAL", "CHG"), evo_vars_lbls =
c("Analysis \nValue", "Change from \nBaseline"), visitvar = "AVISIT")
)
egt01_1_pre(adam_db)(dm) object containing the ADaM datasets
(character) variable used for column splitting
(vector of character) the variables to be analyzed. For this table, AVAL and CHG by default.
(vector of character) the label of the variables to be analyzed.
(character) typically one of "AVISIT" (Default) or "ATPTN" depending on the type of time point
to be displayed.
(logical) remove 0 count rows
(character) decoration with title, subtitles and main_footer content
(list) with default values for the arguments of the function
(character) label of the visitvar variable.
(character) label of the PARAM variable.
The Analysis Value column, displays the number of patients, the mean, standard deviation, median and range of
the analysis value for each visit.
The Change from Baseline column, 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 PARAM labels in alphabetic order then by chronological time point given
by AVISIT. Re-level to customize order
egt01_1_lyt: egt01_1 Layout
egt01_1_pre: egt01_1 Preprocessing
library(dm)
db <- syn_test_data() %>%
egt01_1_pre()
egt01_1(db)
#> Main Title
#> Protocol: {{protocol}}
#>
#> ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Parameter
#> Analysis Visit A: Drug X B: Placebo C: Combination
#> Analysis Value Absolute Change from Baseline Analysis Value Absolute Change from Baseline Analysis Value Absolute Change from Baseline
#> ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Heart Rate
#> BASELINE
#> n 134 0 134 0 132 0
#> Mean (SD) 71.4 (17.9) NA (NA) 69.8 (20.7) NA (NA) 69.3 (20.9) NA (NA)
#> Median 72.7 NA 73.4 NA 72.0 NA
#> Min - Max 9.1 - 106.9 NA - NA 13.5 - 115.5 NA - NA 11.6 - 115.5 NA - 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 (NA) 351.0 (98.4) NA (NA) 352.6 (105.1) NA (NA)
#> Median 344.4 NA 351.5 NA 348.0 NA
#> Min - Max 87.0 - 665.4 NA - NA 98.9 - 641.9 NA - NA 105.7 - 628.1 NA - 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 (NA) 1027.5 (324.0) NA (NA) 1074.6 (277.3) NA (NA)
#> Median 1041.9 NA 1047.3 NA 1080.9 NA
#> Min - Max 34.3 - 1783.7 NA - NA 5.3 - 1877.2 NA - NA 289.6 - 1617.1 NA - 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
#> ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#>
#> Footnotes go here
egt01_1(db, summaryvars_lbls = c("Value at Visit", "Change from Baseline"))
#> Main Title
#> Protocol: {{protocol}}
#>
#> ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Parameter
#> Analysis Visit A: Drug X B: Placebo C: Combination
#> Value at Visit Change from Baseline Value at Visit Change from Baseline Value at Visit Change from Baseline
#> ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Heart Rate
#> BASELINE
#> n 134 0 134 0 132 0
#> Mean (SD) 71.4 (17.9) NA (NA) 69.8 (20.7) NA (NA) 69.3 (20.9) NA (NA)
#> Median 72.7 NA 73.4 NA 72.0 NA
#> Min - Max 9.1 - 106.9 NA - NA 13.5 - 115.5 NA - NA 11.6 - 115.5 NA - 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 (NA) 351.0 (98.4) NA (NA) 352.6 (105.1) NA (NA)
#> Median 344.4 NA 351.5 NA 348.0 NA
#> Min - Max 87.0 - 665.4 NA - NA 98.9 - 641.9 NA - NA 105.7 - 628.1 NA - 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 (NA) 1027.5 (324.0) NA (NA) 1074.6 (277.3) NA (NA)
#> Median 1041.9 NA 1047.3 NA 1080.9 NA
#> Min - Max 34.3 - 1783.7 NA - NA 5.3 - 1877.2 NA - NA 289.6 - 1617.1 NA - 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
#> ————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#>
#> Footnotes go here
syn_test_data() %>%
egt01_1_pre()
#> ── Metadata ────────────────────────────────────────────────────────────────────
#> Tables: `adsl`, `adae`, `adaette`, `adcm`, `addv`, … (15 total)
#> Columns: 846
#> Primary keys: 2
#> Foreign keys: 1