AET04 Table 1 (Default) Adverse Events by Highest NCI CTACAE AE Grade Table 1.
aet04_1.RdThe AET04 table provides an
overview of adverse event with the highest NCI CTCAE grade per individual.
Usage
aet04_1_main(
adam_db,
arm_var = "ACTARM",
lbl_overall = NULL,
lbl_aebodsys = "MedDRA System Organ Class",
lbl_aedecod = "MedDRA Preferred Term",
grade_groups = NULL,
deco = std_deco("AET04"),
...
)
aet04_1_lyt(
arm_var,
lbl_overall,
lbl_aebodsys,
lbl_aedecod,
toxicity_grade,
grade_groups,
deco
)
aet04_1_pre(adam_db, ...)
aet04_1_post(tlg, prune_0 = TRUE, ...)
aet04_1Arguments
- adam_db
(
dm) object containing theADaMdatasets- arm_var
(
character) variable used for column splitting- lbl_overall
(
character) label used for overall column, if set toNULLthe overall column is omitted- lbl_aebodsys
(
character) text label forAEBODSYS.- lbl_aedecod
(
character) text label forAEDECOD.- grade_groups
(
list) putting in correspondence toxicity grades and labels.- deco
(
character) decoration withtitle,subtitlesandmain_footercontent- ...
not used.
- toxicity_grade
(
vector of character) putting in correspondence toxicity levels.- tlg
(
TableTree,Listingorggplot) object typically produced by amainfunction.- prune_0
(
logical) 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.Events with missing grading values are excluded.
Split columns by arm, typically
ACTARM.Does not include a total column by default.
Sort Body System or Organ Class and Dictionary-Derived Term by highest overall frequencies. Analysis Toxicity Grade is sorted by severity.
Functions
aet04_1_main(): Main TLG functionaet04_1_lyt(): Layoutaet04_1_pre(): Preprocessingaet04_1_post(): Postprocessing
Examples
grade_groups <- list(
"Grade 1-2" = c("1", "2"),
"Grade 3-4" = c("3", "4"),
"Grade 5" = c("5")
)
grade_groups <- list(
"Grade 1-2" = c("1", "2"),
"Grade 3-5" = c("3", "4", "5")
)
run(aet04_1, syn_data, grade_groups = grade_groups)
#> MedDRA System Organ Class
#> MedDRA Preferred Term A: Drug X B: Placebo C: Combination
#> Grade (N=134) (N=134) (N=132)
#> ——————————————————————————————————————————————————————————————————————————————————————
#> - Any adverse events -
#> - Any Grade - 122 (91.0%) 123 (91.8%) 120 (90.9%)
#> Grade 1-2 13 (9.7%) 19 (14.2%) 11 (8.3%)
#> 1 7 (5.2%) 9 (6.7%) 4 (3.0%)
#> 2 6 (4.5%) 10 (7.5%) 7 (5.3%)
#> Grade 3-5 109 (81.3%) 104 (77.6%) 109 (82.6%)
#> 3 18 (13.4%) 14 (10.4%) 16 (12.1%)
#> 4 15 (11.2%) 20 (14.9%) 18 (13.6%)
#> 5 76 (56.7%) 70 (52.2%) 75 (56.8%)
#> cl A.1
#> - Overall -
#> - Any Grade - 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> Grade 1-2 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> 1 30 (22.4%) 27 (20.1%) 39 (29.5%)
#> 2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> dcd A.1.1.1.1
#> - Any Grade - 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> Grade 1-2 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> 1 50 (37.3%) 45 (33.6%) 63 (47.7%)
#> dcd A.1.1.1.2
#> - Any Grade - 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> Grade 1-2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> 2 48 (35.8%) 48 (35.8%) 50 (37.9%)
#> cl B.2
#> - Overall -
#> - Any Grade - 79 (59.0%) 74 (55.2%) 85 (64.4%)
#> Grade 1-2 30 (22.4%) 30 (22.4%) 33 (25.0%)
#> 1 30 (22.4%) 30 (22.4%) 33 (25.0%)
#> Grade 3-5 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> 3 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> dcd B.2.2.3.1
#> - Any Grade - 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> Grade 1-2 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> 1 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> dcd B.2.1.2.1
#> - Any Grade - 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> Grade 3-5 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> 3 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> cl D.1
#> - Overall -
#> - Any Grade - 79 (59.0%) 67 (50.0%) 80 (60.6%)
#> Grade 3-5 79 (59.0%) 67 (50.0%) 80 (60.6%)
#> 3 29 (21.6%) 25 (18.7%) 29 (22.0%)
#> 5 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> dcd D.1.1.1.1
#> - Any Grade - 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> Grade 3-5 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> 5 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> dcd D.1.1.4.2
#> - Any Grade - 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> Grade 3-5 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> 3 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> cl D.2
#> - Overall -
#> - Any Grade - 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> Grade 1-2 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> 1 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> dcd D.2.1.5.3
#> - Any Grade - 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> Grade 1-2 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> 1 47 (35.1%) 58 (43.3%) 57 (43.2%)
#> cl B.1
#> - Overall -
#> - Any Grade - 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> Grade 3-5 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> 5 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> dcd B.1.1.1.1
#> - Any Grade - 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> Grade 3-5 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> 5 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> cl C.2
#> - Overall -
#> - Any Grade - 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Grade 1-2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> 2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> dcd C.2.1.2.1
#> - Any Grade - 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> Grade 1-2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> 2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> cl C.1
#> - Overall -
#> - Any Grade - 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> Grade 3-5 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> 4 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> dcd C.1.1.1.3
#> - Any Grade - 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> Grade 3-5 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> 4 43 (32.1%) 46 (34.3%) 43 (32.6%)