EXT01 Exposure Summary Table.
ext01.RdThe EXT01 table provides an overview of the of the exposure of the
patients in terms of Total dose administered or missed, and treatment duration.
Usage
ext01_main(
adam_db,
arm_var = "ACTARM",
lbl_overall = NULL,
summaryvars = "AVAL",
row_split_var = "PARCAT2",
page_var = NULL,
map = NULL,
...
)
ext01_pre(adam_db, ...)
ext01_post(tlg, prune_0 = TRUE, ...)
ext01Arguments
- adam_db
(
listofdata.frames) object containing theADaMdatasets- arm_var
(
string) variable used for column splitting- lbl_overall
(
string) label used for overall column, if set toNULLthe overall column is omitted- summaryvars
(
character) variables to be analyzed. The label attribute of the corresponding column inadextable ofadam_dbis used as label.- row_split_var
(
character) additional row split variables.- page_var
(
string) variable name prior to which the row split is by page.- map
(
data.frame) of mapping for split rows.- ...
not used.
- tlg
(
TableTree,Listingorggplot) object typically produced by amainfunction.- prune_0
(
flag) remove 0 count rows
Details
Default Exposure table
The
nrow provides the number of non-missing values. The percentages for categorical variables is based onn. The percentages forTotal number of patients with at least one dose modificationare based on the number of patients in the corresponding analysis population given byN.Split columns by arm, typically
ACTARM.Does not include a total column by default.
Sorted by alphabetic order of the
PARAMvalue. Transform to factor and re-level for custom order.ANL01FLis not relevant subset.
Examples
run(ext01, syn_data)
#> PARCAT2 A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————————
#> Drug A
#> Overall duration (days)
#> n 75 67 75
#> Mean (SD) 121.5 (70.7) 131.2 (78.5) 130.5 (73.1)
#> Median 116.0 127.0 126.0
#> Min - Max 15.0 - 249.0 1.0 - 250.0 1.0 - 246.0
#> Total dose administered
#> n 75 67 75
#> Mean (SD) 6675.2 (1110.9) 6505.1 (1249.3) 6982.4 (1272.5)
#> Median 6720.0 6480.0 7200.0
#> Min - Max 4800.0 - 9360.0 4080.0 - 9360.0 4320.0 - 9360.0
#> Drug B
#> Overall duration (days)
#> n 59 67 57
#> Mean (SD) 111.0 (69.4) 113.7 (68.9) 137.5 (74.4)
#> Median 98.0 104.0 144.0
#> Min - Max 9.0 - 245.0 2.0 - 247.0 15.0 - 250.0
#> Total dose administered
#> n 59 67 57
#> Mean (SD) 6630.5 (1334.0) 6297.3 (1291.1) 6505.3 (1080.7)
#> Median 6720.0 6240.0 6480.0
#> Min - Max 4320.0 - 8880.0 4080.0 - 9120.0 4320.0 - 8640.0
run(ext01, syn_data, summaryvars = c("AVAL", "AVALCAT1"), prune_0 = FALSE)
#> PARCAT2 A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————————
#> Drug A
#> Overall duration (days)
#> n 75 67 75
#> Mean (SD) 121.5 (70.7) 131.2 (78.5) 130.5 (73.1)
#> Median 116.0 127.0 126.0
#> Min - Max 15.0 - 249.0 1.0 - 250.0 1.0 - 246.0
#> n 75 67 75
#> < 1 month 10 (13.3%) 6 (9.0%) 6 (8.0%)
#> 1 to <3 months 17 (22.7%) 18 (26.9%) 20 (26.7%)
#> 3 to <6 months 29 (38.7%) 19 (28.4%) 25 (33.3%)
#> >=6 months 19 (25.3%) 24 (35.8%) 24 (32.0%)
#> <700 0 0 0
#> 700-900 0 0 0
#> 900-1200 0 0 0
#> >1200 0 0 0
#> <5000 0 0 0
#> 5000-7000 0 0 0
#> 7000-9000 0 0 0
#> >9000 0 0 0
#> 7 0 0 0
#> Total dose administered
#> n 75 67 75
#> Mean (SD) 6675.2 (1110.9) 6505.1 (1249.3) 6982.4 (1272.5)
#> Median 6720.0 6480.0 7200.0
#> Min - Max 4800.0 - 9360.0 4080.0 - 9360.0 4320.0 - 9360.0
#> n 75 67 75
#> < 1 month 0 0 0
#> 1 to <3 months 0 0 0
#> 3 to <6 months 0 0 0
#> >=6 months 0 0 0
#> <700 0 0 0
#> 700-900 0 0 0
#> 900-1200 0 0 0
#> >1200 0 0 0
#> <5000 2 (2.7%) 6 (9.0%) 3 (4.0%)
#> 5000-7000 44 (58.7%) 34 (50.7%) 34 (45.3%)
#> 7000-9000 27 (36.0%) 25 (37.3%) 35 (46.7%)
#> >9000 2 (2.7%) 2 (3.0%) 3 (4.0%)
#> 7 0 0 0
#> Drug B
#> Overall duration (days)
#> n 59 67 57
#> Mean (SD) 111.0 (69.4) 113.7 (68.9) 137.5 (74.4)
#> Median 98.0 104.0 144.0
#> Min - Max 9.0 - 245.0 2.0 - 247.0 15.0 - 250.0
#> n 59 67 57
#> < 1 month 5 (8.5%) 7 (10.4%) 5 (8.8%)
#> 1 to <3 months 22 (37.3%) 20 (29.9%) 14 (24.6%)
#> 3 to <6 months 18 (30.5%) 28 (41.8%) 17 (29.8%)
#> >=6 months 14 (23.7%) 12 (17.9%) 21 (36.8%)
#> <700 0 0 0
#> 700-900 0 0 0
#> 900-1200 0 0 0
#> >1200 0 0 0
#> <5000 0 0 0
#> 5000-7000 0 0 0
#> 7000-9000 0 0 0
#> >9000 0 0 0
#> 7 0 0 0
#> Total dose administered
#> n 59 67 57
#> Mean (SD) 6630.5 (1334.0) 6297.3 (1291.1) 6505.3 (1080.7)
#> Median 6720.0 6240.0 6480.0
#> Min - Max 4320.0 - 8880.0 4080.0 - 9120.0 4320.0 - 8640.0
#> n 59 67 57
#> < 1 month 0 0 0
#> 1 to <3 months 0 0 0
#> 3 to <6 months 0 0 0
#> >=6 months 0 0 0
#> <700 0 0 0
#> 700-900 0 0 0
#> 900-1200 0 0 0
#> >1200 0 0 0
#> <5000 8 (13.6%) 12 (17.9%) 4 (7.0%)
#> 5000-7000 28 (47.5%) 37 (55.2%) 37 (64.9%)
#> 7000-9000 23 (39.0%) 17 (25.4%) 16 (28.1%)
#> >9000 0 1 (1.5%) 0
#> 7 0 0 0
levels(syn_data$adex$AVALCAT1) <- c(levels(syn_data$adex$AVALCAT1), "12 months")
map <- data.frame(
PARAMCD = "TDURD",
AVALCAT1 = c("< 1 month", "1 to <3 months", ">=6 months", "3 to <6 months", "12 months")
)
run(ext01, syn_data, summaryvars = c("AVAL", "AVALCAT1"), prune_0 = FALSE, map = map)
#> PARCAT2 A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ———————————————————————————————————————————————————————————————————————————————
#> Drug A
#> Overall duration (days)
#> n 75 67 75
#> Mean (SD) 121.5 (70.7) 131.2 (78.5) 130.5 (73.1)
#> Median 116.0 127.0 126.0
#> Min - Max 15.0 - 249.0 1.0 - 250.0 1.0 - 246.0
#> n 75 67 75
#> < 1 month 10 (13.3%) 6 (9.0%) 6 (8.0%)
#> 1 to <3 months 17 (22.7%) 18 (26.9%) 20 (26.7%)
#> >=6 months 19 (25.3%) 24 (35.8%) 24 (32.0%)
#> 3 to <6 months 29 (38.7%) 19 (28.4%) 25 (33.3%)
#> 12 months 0 0 0
#> Total dose administered
#> n 75 67 75
#> Mean (SD) 6675.2 (1110.9) 6505.1 (1249.3) 6982.4 (1272.5)
#> Median 6720.0 6480.0 7200.0
#> Min - Max 4800.0 - 9360.0 4080.0 - 9360.0 4320.0 - 9360.0
#> n 75 67 75
#> <5000 2 (2.7%) 6 (9.0%) 3 (4.0%)
#> 5000-7000 44 (58.7%) 34 (50.7%) 34 (45.3%)
#> 7000-9000 27 (36.0%) 25 (37.3%) 35 (46.7%)
#> >9000 2 (2.7%) 2 (3.0%) 3 (4.0%)
#> Drug B
#> Overall duration (days)
#> n 59 67 57
#> Mean (SD) 111.0 (69.4) 113.7 (68.9) 137.5 (74.4)
#> Median 98.0 104.0 144.0
#> Min - Max 9.0 - 245.0 2.0 - 247.0 15.0 - 250.0
#> n 59 67 57
#> < 1 month 5 (8.5%) 7 (10.4%) 5 (8.8%)
#> 1 to <3 months 22 (37.3%) 20 (29.9%) 14 (24.6%)
#> >=6 months 14 (23.7%) 12 (17.9%) 21 (36.8%)
#> 3 to <6 months 18 (30.5%) 28 (41.8%) 17 (29.8%)
#> 12 months 0 0 0
#> Total dose administered
#> n 59 67 57
#> Mean (SD) 6630.5 (1334.0) 6297.3 (1291.1) 6505.3 (1080.7)
#> Median 6720.0 6240.0 6480.0
#> Min - Max 4320.0 - 8880.0 4080.0 - 9120.0 4320.0 - 8640.0
#> n 59 67 57
#> <5000 8 (13.6%) 12 (17.9%) 4 (7.0%)
#> 5000-7000 28 (47.5%) 37 (55.2%) 37 (64.9%)
#> 7000-9000 23 (39.0%) 17 (25.4%) 16 (28.1%)
#> >9000 0 1 (1.5%) 0