EGT01
ECG Assessments and Change from Baseline by Visit Table.
egt01.Rd
The EGT01
table summarizes
several electrocardiogram parameters and their evolution throughout the study.
Arguments
- adam_db
(
list
ofdata.frames
) object containing theADaM
datasets- arm_var
(
string
) variable used for column splitting- summaryvars
(
character
) variables to be analyzed. The label attribute of the corresponding column inadeg
table ofadam_db
is used as label.- visitvar
(
string
) typically one of"AVISIT"
(Default) or"ATPTN"
depending on the type of time point to be displayed- precision
(named
list
ofinteger
) where names are values found in thePARAMCD
column and the the values indicate the number of digits that should be represented formin
,max
andmedian
.Mean
andsd
are represented with one more decimal of precision.- default_precision
(
integer
) the default number of digits.- ...
not used.
- tlg
(
TableTree
,Listing
orggplot
) object typically produced by amain
function.- prune_0
(
flag
) remove 0 count rows
Details
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 byAVISIT
. Re-level to customize order.
Note
adam_db
object must contain anadeg
table with a"PARAM"
column as well as columns specified insummaryvars
andvisitvar
.
Examples
run(egt01, syn_data, precision = list(
"HR" = 1,
"QT" = 1,
"RR" = 0
))
#> Parameter A: Drug X B: Placebo C: Combination
#> Analysis Visit Change from Change from Change from
#> Value at Visit Baseline Value at Visit Baseline Value at Visit Baseline
#> (N=3216) (N=3216) (N=3216) (N=3216) (N=3168) (N=3168)
#> ———————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Heart Rate
#> BASELINE
#> n 134 134 132
#> Mean (SD) 71.45 (17.93) 69.83 (20.72) 69.34 (20.95)
#> Median 72.70 73.35 71.96
#> Min - Max 9.1 - 106.9 13.5 - 115.5 11.6 - 115.5
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 70.19 (20.27) -1.26 (25.97) 69.43 (20.80) -0.40 (29.73) 68.65 (18.06) -0.69 (27.81)
#> Median 70.70 -2.20 70.46 -0.52 68.57 -0.76
#> 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) 70.32 (19.56) -1.13 (26.26) 71.11 (20.56) 1.28 (31.35) 69.19 (18.06) -0.15 (28.61)
#> Median 70.88 -1.10 72.52 -0.31 69.30 -1.55
#> 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) 68.25 (20.17) -3.20 (28.66) 68.95 (20.56) -0.88 (30.14) 70.88 (20.28) 1.54 (27.28)
#> Median 68.79 -2.17 67.80 1.19 70.12 0.14
#> 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) 70.06 (18.41) -1.38 (26.59) 71.60 (20.34) 1.77 (30.26) 71.02 (20.59) 1.68 (29.60)
#> Median 69.33 -4.54 72.21 -0.88 70.52 3.81
#> 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) 66.41 (19.74) -5.04 (27.11) 71.25 (18.92) 1.42 (27.08) 71.26 (18.56) 1.92 (29.59)
#> Median 65.40 -6.83 70.86 0.64 73.29 1.74
#> 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 134 134 132
#> Mean (SD) 336.83 (117.96) 351.00 (98.44) 352.60 (105.11)
#> Median 344.41 351.48 347.96
#> Min - Max 87.0 - 665.4 98.9 - 641.9 105.7 - 628.1
#> WEEK 1 DAY 8
#> n 134 134 134 134 132 132
#> Mean (SD) 342.57 (101.09) 5.74 (159.94) 363.95 (102.34) 12.94 (140.73) 359.42 (105.16) 6.83 (147.13)
#> Median 347.26 -1.78 356.54 13.73 363.84 8.69
#> 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) 353.24 (93.93) 16.41 (162.10) 345.93 (96.78) -5.08 (152.51) 335.69 (98.61) -16.91 (138.45)
#> Median 351.10 16.72 346.83 -9.68 320.96 -22.27
#> 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) 370.12 (101.57) 33.28 (152.78) 343.41 (102.58) -7.59 (138.80) 346.95 (94.96) -5.65 (144.65)
#> Median 378.21 39.59 335.12 -15.89 352.15 9.11
#> 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) 345.77 (95.97) 8.94 (145.65) 354.38 (108.29) 3.37 (142.39) 341.36 (106.75) -11.24 (145.65)
#> Median 340.13 5.58 346.70 -17.13 352.30 -11.87
#> 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) 358.90 (97.69) 22.07 (155.68) 338.65 (99.26) -12.36 (130.46) 349.30 (95.77) -3.30 (136.00)
#> Median 351.96 5.89 344.17 0.40 350.32 12.68
#> 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 134 134 132
#> Mean (SD) 1028.4 (286.4) 1027.5 (324.0) 1074.6 (277.3)
#> Median 1041.9 1047.3 1080.9
#> Min - Max 34 - 1784 5 - 1877 290 - 1617
#> 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 111 - 2015 -1015 - 1389 277 - 1712 -942 - 994 498 - 1937 -959 - 909
#> 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 - 1677 -1216 - 1053 161 - 2049 -1127 - 1149 253 - 1722 -859 - 872
#> 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 - 1799 -883 - 1080 97 - 1825 -887 - 1166 446 - 1713 -985 - 902
#> 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 - 1979 -1346 - 1195 348 - 1762 -826 - 1192 342 - 2145 -1002 - 1049
#> 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 - 2001 -1029 - 1419 209 - 1795 -979 - 1365 436 - 1794 -962 - 1330