This function builds a System Organ Class (SOC) and Preferred Term (PT)
adverse event summary table, following the AET02 CSR format, using the
tern and rtables packages.
Usage
tern_AET02_table(
adsl,
adae,
patient,
treat,
target = "AEDECOD",
rows_by = "AEBODSYS",
indent = " "
)Arguments
- adsl
Subject-level dataset.
- adae
Adverse event dataset.
- patient
Unique subject identifier variable.
- treat
Treatment arm variable.
- target
Preferred term variable for grouping (default:
"AEDECOD").- rows_by
Higher-level term for nesting (default:
"AEBODSYS").- indent
Ignored (included for compatibility).
Examples
# AE summary by System Organ Class and Preferred Term
tern_AET02_table(
adsl = adsl,
adae = adae,
patient = "USUBJID",
treat = "ARM"
)
#> A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ——————————————————————————————————————————————————————————
#> cl A.1
#> 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.1
#> dcd B.1.1.1.1 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> cl B.2
#> dcd B.2.1.2.1 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> dcd B.2.2.3.1 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> cl C.1
#> dcd C.1.1.1.3 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> cl C.2
#> dcd C.2.1.2.1 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> cl D.1
#> dcd D.1.1.1.1 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> dcd D.1.1.4.2 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> cl D.2
#> dcd D.2.1.5.3 47 (35.1%) 58 (43.3%) 57 (43.2%)
# Nesting at a different level of the MedDRA hierarchy
tern_AET02_table(
adsl = adsl,
adae = adae,
patient = "USUBJID",
treat = "ARM",
target = "AEHLT",
rows_by = "AESOC"
)
#> A: Drug X B: Placebo C: Combination
#> (N=134) (N=134) (N=132)
#> ————————————————————————————————————————————————————————
#> cl A
#> hlt A.1.1.1 78 (58.2%) 75 (56.0%) 89 (67.4%)
#> cl B
#> hlt B.1.1.1 47 (35.1%) 49 (36.6%) 43 (32.6%)
#> hlt B.2.1.2 49 (36.6%) 44 (32.8%) 52 (39.4%)
#> hlt B.2.2.3 48 (35.8%) 54 (40.3%) 51 (38.6%)
#> cl C
#> hlt C.1.1.1 43 (32.1%) 46 (34.3%) 43 (32.6%)
#> hlt C.2.1.2 35 (26.1%) 48 (35.8%) 55 (41.7%)
#> cl D
#> hlt D.1.1.1 50 (37.3%) 42 (31.3%) 51 (38.6%)
#> hlt D.1.1.4 48 (35.8%) 42 (31.3%) 50 (37.9%)
#> hlt D.2.1.5 47 (35.1%) 58 (43.3%) 57 (43.2%)