An adverse events table categorized by System Organ Class, Dictionary-Derived Term and Greatest intensity.
Usage
aet03_main(adam_db, arm_var = "ACTARM", lbl_overall = NULL, ...)
aet03_pre(adam_db, ...)
aet03_post(tlg, prune_0 = TRUE, ...)
aet03
Arguments
- adam_db
(
list
ofdata.frames
) object containing theADaM
datasets- arm_var
(
string
) variable used for column splitting- lbl_overall
(
string
) label used for overall column, if set toNULL
the overall column is omitted- ...
not used.
- tlg
(
TableTree
,Listing
orggplot
) object typically produced by amain
function.- prune_0
(
flag
) remove 0 count rows
Value
the main function returns an rtables
object.
the preprocessing function returns a list
of data.frame
.
the postprocessing function returns an rtables
object or an ElementaryTable
(null report).
Details
Default Adverse Events by Greatest Intensity table.
Numbers represent absolute numbers of patients and fraction of
N
.Remove zero-count rows unless overridden with
prune_0 = FALSE
.Split columns by arm.
Does not include a total column by default.
Sort by Body System or Organ Class (
SOC
) and Dictionary-Derived Term (PT
).
Examples
run(aet03, syn_data)
#> MedDRA System Organ Class A: Drug X B: Placebo C: Combination
#> MedDRA Preferred Term (N=15) (N=15) (N=15)
#> ————————————————————————————————————————————————————————————————————
#> - Any Intensity - 13 (86.7%) 14 (93.3%) 15 (100%)
#> MILD 0 1 (6.7%) 1 (6.7%)
#> MODERATE 2 (13.3%) 3 (20.0%) 2 (13.3%)
#> SEVERE 11 (73.3%) 10 (66.7%) 12 (80.0%)
#> cl B.2
#> - Any Intensity - 11 (73.3%) 8 (53.3%) 10 (66.7%)
#> MILD 6 (40.0%) 2 (13.3%) 5 (33.3%)
#> MODERATE 5 (33.3%) 6 (40.0%) 5 (33.3%)
#> dcd B.2.2.3.1
#> - Any Intensity - 8 (53.3%) 6 (40.0%) 7 (46.7%)
#> MILD 8 (53.3%) 6 (40.0%) 7 (46.7%)
#> dcd B.2.1.2.1
#> - Any Intensity - 5 (33.3%) 6 (40.0%) 5 (33.3%)
#> MODERATE 5 (33.3%) 6 (40.0%) 5 (33.3%)
#> cl D.1
#> - Any Intensity - 9 (60.0%) 5 (33.3%) 11 (73.3%)
#> MODERATE 5 (33.3%) 1 (6.7%) 4 (26.7%)
#> SEVERE 4 (26.7%) 4 (26.7%) 7 (46.7%)
#> dcd D.1.1.1.1
#> - Any Intensity - 4 (26.7%) 4 (26.7%) 7 (46.7%)
#> SEVERE 4 (26.7%) 4 (26.7%) 7 (46.7%)
#> dcd D.1.1.4.2
#> - Any Intensity - 6 (40.0%) 2 (13.3%) 7 (46.7%)
#> MODERATE 6 (40.0%) 2 (13.3%) 7 (46.7%)
#> cl A.1
#> - Any Intensity - 7 (46.7%) 6 (40.0%) 10 (66.7%)
#> MILD 2 (13.3%) 0 4 (26.7%)
#> MODERATE 5 (33.3%) 6 (40.0%) 6 (40.0%)
#> dcd A.1.1.1.2
#> - Any Intensity - 5 (33.3%) 6 (40.0%) 6 (40.0%)
#> MODERATE 5 (33.3%) 6 (40.0%) 6 (40.0%)
#> dcd A.1.1.1.1
#> - Any Intensity - 3 (20.0%) 1 (6.7%) 6 (40.0%)
#> MILD 3 (20.0%) 1 (6.7%) 6 (40.0%)
#> cl B.1
#> - Any Intensity - 5 (33.3%) 6 (40.0%) 8 (53.3%)
#> SEVERE 5 (33.3%) 6 (40.0%) 8 (53.3%)
#> dcd B.1.1.1.1
#> - Any Intensity - 5 (33.3%) 6 (40.0%) 8 (53.3%)
#> SEVERE 5 (33.3%) 6 (40.0%) 8 (53.3%)
#> cl C.2
#> - Any Intensity - 6 (40.0%) 4 (26.7%) 8 (53.3%)
#> MODERATE 6 (40.0%) 4 (26.7%) 8 (53.3%)
#> dcd C.2.1.2.1
#> - Any Intensity - 6 (40.0%) 4 (26.7%) 8 (53.3%)
#> MODERATE 6 (40.0%) 4 (26.7%) 8 (53.3%)
#> cl D.2
#> - Any Intensity - 2 (13.3%) 5 (33.3%) 7 (46.7%)
#> MILD 2 (13.3%) 5 (33.3%) 7 (46.7%)
#> dcd D.2.1.5.3
#> - Any Intensity - 2 (13.3%) 5 (33.3%) 7 (46.7%)
#> MILD 2 (13.3%) 5 (33.3%) 7 (46.7%)
#> cl C.1
#> - Any Intensity - 4 (26.7%) 4 (26.7%) 5 (33.3%)
#> SEVERE 4 (26.7%) 4 (26.7%) 5 (33.3%)
#> dcd C.1.1.1.3
#> - Any Intensity - 4 (26.7%) 4 (26.7%) 5 (33.3%)
#> SEVERE 4 (26.7%) 4 (26.7%) 5 (33.3%)