AET02 Table 2 (Supplementary) Adverse Events by System Organ Class, High Level Term and Preferred Term Table 2.
aet02_2.RdThe AET02_2 table provides an overview of the number of patients experiencing adverse events and the number of
adverse events categorized by Body System, High Level Term and Dictionary-Derived Term.
Usage
aet02_2_main(
adam_db,
arm_var = "ACTARM",
lbl_overall = NULL,
lbl_aebodsys = "MedDRA System Organ Class",
lbl_aedecod = "MedDRA Preferred Term",
lbl_aehlt = "MedDRA High-Level Term",
deco = std_deco("AET02"),
...
)
aet02_2_lyt(
arm_var,
lbl_overall = NULL,
lbl_aebodsys,
lbl_aedecod,
lbl_aehlt,
deco
)
aet02_2_pre(adam_db, ...)
aet02_2_post(tlg, prune_0 = TRUE, ...)
aet02_2
aet02_3_main(
adam_db,
arm_var = "ACTARM",
lbl_overall = NULL,
lbl_aedecod = "MedDRA Preferred Term",
deco = std_deco("AET02"),
...
)Arguments
- adam_db
(
dm) 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- lbl_aebodsys
(
character) text label forAEBODSYS.- lbl_aedecod
(
character) text label forAEDECOD.- lbl_aehlt
(
character) text label forAEHLT.- deco
(
character) decoration withtitle,subtitlesandmain_footercontent- ...
not used.
- tlg
(
TableTree,Listingorggplot) object typically produced by amainfunction.- prune_0
(
flag) remove 0 count rows
Details
Numbers represent absolute numbers of patients and fraction of
N, or absolute number of event when specified.Remove zero-count rows unless overridden with
prune_0 = FALSE.Split columns by arm.
Does not include a total column by default.
Sort Body System or Organ Class, High Level Term and Dictionary-Derived Term hierarchically by highest overall frequencies.
Missing values of
AEBODSYS,AEHLTandAEDECODinadaeare labeled byNo Coding available.
Numbers represent absolute numbers of patients and fraction of
N, or absolute number of event when specified.Remove zero-count rows unless overridden with
prune_0 = FALSE.Split columns by arm.
Does not include a total column by default.
Sort Dictionary-Derived Code by highest overall frequencies.
Missing values of
AEDECODinaeadare labeled byNo Coding available.
Functions
aet02_2_main(): Main TLG functionaet02_2_lyt(): Layoutaet02_2_pre(): Preprocessingaet02_2_post(): Postprocessingaet02_3_main(): Main TLG function
Note
adam_dbobject must contain anadaetable with the columns"AEBODSYS","AEHLT"and"AEDECOD".
adam_dbobject must contain anadaetable with the column"AEDECOD".
Examples
run(aet02_2, syn_data)
#> MedDRA System Organ Class
#> MedDRA High-Level Term A: Drug X B: Placebo C: Combination
#> MedDRA Preferred Term (N=134) (N=134) (N=132)
#> —————————————————————————————————————————————————————————————————————————————————————————————————————————
#> Total number of patients with at least one adverse event 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> Overall total number of events 609 622 703
#> cl A.1
#> Total number of patients with at least one adverse event 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> Total number of events 132 130 160
#> hlt A.1.1.1
#> Total number of patients with at least one adverse event 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> Total number of events 132 130 160
#> dcd A.1.1.1.1 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> dcd A.1.1.1.2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> cl B.2
#> Total number of patients with at least one adverse event 79 (59.0%) 74 (55.2%) 85 (64.4%)
#> Total number of events 129 138 143
#> hlt B.2.2.3
#> Total number of patients with at least one adverse event 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> Total number of events 64 76 77
#> dcd B.2.2.3.1 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> hlt B.2.1.2
#> Total number of patients with at least one adverse event 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> Total number of events 65 62 66
#> dcd B.2.1.2.1 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> cl D.1
#> Total number of patients with at least one adverse event 79 (59.0%) 67 (50.0%) 80 (60.6%)
#> Total number of events 127 106 135
#> hlt D.1.1.1
#> Total number of patients with at least one adverse event 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> Total number of events 61 51 71
#> dcd D.1.1.1.1 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> hlt D.1.1.4
#> Total number of patients with at least one adverse event 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> Total number of events 66 55 64
#> dcd D.1.1.4.2 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> cl D.2
#> Total number of patients with at least one adverse event 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> Total number of events 62 72 74
#> hlt D.2.1.5
#> Total number of patients with at least one adverse event 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> Total number of events 62 72 74
#> dcd D.2.1.5.3 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> cl B.1
#> Total number of patients with at least one adverse event 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> Total number of events 56 60 62
#> hlt B.1.1.1
#> Total number of patients with at least one adverse event 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> Total number of events 56 60 62
#> dcd B.1.1.1.1 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> cl C.2
#> Total number of patients with at least one adverse event 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Total number of events 48 53 65
#> hlt C.2.1.2
#> Total number of patients with at least one adverse event 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Total number of events 48 53 65
#> dcd C.2.1.2.1 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> cl C.1
#> Total number of patients with at least one adverse event 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> Total number of events 55 63 64
#> hlt C.1.1.1
#> Total number of patients with at least one adverse event 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> Total number of events 55 63 64
#> dcd C.1.1.1.3 43 (32.1%) 46 (34.3%) 43 (32.6%)