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, ...)
aet03Arguments
- 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- ...
not used.
- tlg
(
TableTree,Listingorggplot) object typically produced by amainfunction.- 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%)