Create AET02-style AE summary table
AET02_table.Rd
Summarises adverse events in a format similar to the AET02 table from a CSR, showing total AE counts, patients with AEs, and a breakdown by System Organ Class (SOC) and Preferred Term (PT).
Usage
AET02_table(
adsl,
adae,
patient,
treat,
target = "AEDECOD",
rows_by = "AEBODSYS",
indent = nbsp(n = 4L)
)
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
Character or string to indent nested rows (default: 4 non-breaking spaces).
Examples
# Create a AET02 table
AET02_table(
adsl = adsl,
adae = aesi,
patient = "USUBJID",
treat = "ARM",
target = "AEDECOD",
rows_by = "AEBODSYS",
indent = " "
)
#> stats A: Drug X B: Placebo
#> <char> <char> <char>
#> 1: Total number of patients with at least one AE 100 (74.6%) 98 (73.1%)
#> 2: Total number of AEs 502 480
#> 3: cl B.2
#> 4: dcd B.2.1.2.1 52 (38.8%) 51 (38.1%)
#> 5: dcd B.2.2.3.1 50 (37.3%) 55 (41.0%)
#> 6: Total number of events 102 106
#> 7: Total number of patients with at least one event 62 (46.3%) 56 (41.8%)
#> 8: cl D.1
#> 9: dcd D.1.1.1.1 52 (38.8%) 40 (29.9%)
#> 10: dcd D.1.1.4.2 54 (40.3%) 44 (32.8%)
#> 11: Total number of events 106 84
#> 12: Total number of patients with at least one event 64 (47.8%) 54 (40.3%)
#> 13: cl A.1
#> 14: dcd A.1.1.1.1 57 (42.5%) 43 (32.1%)
#> 15: dcd A.1.1.1.2 58 (43.3%) 56 (41.8%)
#> 16: Total number of events 115 99
#> 17: Total number of patients with at least one event 68 (50.7%) 58 (43.3%)
#> 18: cl D.2
#> 19: dcd D.2.1.5.3 49 (36.6%) 57 (42.5%)
#> 20: Total number of events 49 57
#> 21: Total number of patients with at least one event 37 (27.6%) 46 (34.3%)
#> 22: cl B.1
#> 23: dcd B.1.1.1.1 44 (32.8%) 43 (32.1%)
#> 24: Total number of events 44 43
#> 25: Total number of patients with at least one event 38 (28.4%) 37 (27.6%)
#> 26: cl C.2
#> 27: dcd C.2.1.2.1 39 (29.1%) 40 (29.9%)
#> 28: Total number of events 39 40
#> 29: Total number of patients with at least one event 28 (20.9%) 36 (26.9%)
#> 30: cl C.1
#> 31: dcd C.1.1.1.3 47 (35.1%) 51 (38.1%)
#> 32: Total number of events 47 51
#> 33: Total number of patients with at least one event 36 (26.9%) 34 (25.4%)
#> stats A: Drug X B: Placebo
#> C: Combination
#> <char>
#> 1: 103 (78.0%)
#> 2: 604
#> 3:
#> 4: 59 (44.7%)
#> 5: 68 (51.5%)
#> 6: 127
#> 7: 74 (56.1%)
#> 8:
#> 9: 64 (48.5%)
#> 10: 50 (37.9%)
#> 11: 114
#> 12: 68 (51.5%)
#> 13:
#> 14: 74 (56.1%)
#> 15: 63 (47.7%)
#> 16: 137
#> 17: 76 (57.6%)
#> 18:
#> 19: 65 (49.2%)
#> 20: 65
#> 21: 50 (37.9%)
#> 22:
#> 23: 50 (37.9%)
#> 24: 50
#> 25: 36 (27.3%)
#> 26:
#> 27: 57 (43.2%)
#> 28: 57
#> 29: 48 (36.4%)
#> 30:
#> 31: 54 (40.9%)
#> 32: 54
#> 33: 36 (27.3%)
#> C: Combination