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Create high-performance clinical reporting tables (TLGs) from ADaM-like inputs. The package provides a consistent, programmatic API to generate common tables such as demographics, adverse event incidence, and laboratory summaries, using ‘data.table’ for fast aggregation over large populations. Functions support flexible target-variable selection, stratification by treatment, and customizable summary statistics, and return tidy, machine-readable results ready to render with downstream table/formatting packages in analysis pipelines.
install.packages("dtlg")Creating an AET01 table:
library(dtlg)
head(adsl[, c("USUBJID", "ARM")])
#> USUBJID ARM
#> 1 AB12345-CHN-3-id-128 A: Drug X
#> 2 AB12345-CHN-15-id-262 C: Combination
#> 3 AB12345-RUS-3-id-378 C: Combination
#> 4 AB12345-CHN-11-id-220 B: Placebo
#> 5 AB12345-CHN-7-id-267 B: Placebo
#> 6 AB12345-CHN-15-id-201 C: Combination
head(aesi[, c("USUBJID", "ARM", "FATAL")])
#> USUBJID ARM FATAL
#> <char> <fctr> <lgcl>
#> 1: AB12345-BRA-1-id-134 A: Drug X FALSE
#> 2: AB12345-BRA-1-id-134 A: Drug X FALSE
#> 3: AB12345-BRA-1-id-134 A: Drug X FALSE
#> 4: AB12345-BRA-1-id-134 A: Drug X TRUE
#> 5: AB12345-BRA-1-id-141 C: Combination FALSE
#> 6: AB12345-BRA-1-id-141 C: Combination FALSE
AET01 <-
AET01_table(
adsl = adsl,
adae = aesi,
patient_var = "USUBJID",
treat_var = "ARM",
aesi_vars = c("FATAL", "SER", "SERWD", "SERDSM", "RELSER",
"WD", "DSM", "REL", "RELWD", "RELDSM", "SEV")
)
AET01[, stats := strtrim(stats, 35)][]
#> stats A: Drug X B: Placebo C: Combination
#> <char> <char> <char> <char>
#> 1: Total number of patients with at le 100 (74.6%) 98 (73.1%) 103 (78.0%)
#> 2: Total number of AEs 502 480 604
#> 3: Total number of deaths 25 (18.7%) 23 (17.2%) 22 (16.7%)
#> 4: Total number of patients withdrawn 3 (2.2%) 6 (4.5%) 5 (3.8%)
#> 5: Total number of patients with at le
#> 6: AE with fatal outcome 5 (3.7%) 5 (3.7%) 6 (4.5%)
#> 7: Serious AE 85 (63.4%) 80 (59.7%) 87 (65.9%)
#> 8: Serious AE leading to withdrawal 6 (4.5%) 12 (9.0%) 9 (6.8%)
#> 9: Serious AE leading to dose modifi 36 (26.9%) 40 (29.9%) 47 (35.6%)
#> 10: Related Serious AE 64 (47.8%) 52 (38.8%) 64 (48.5%)
#> 11: AE leading to withdrawal from tre 20 (14.9%) 24 (17.9%) 26 (19.7%)
#> 12: AE leading to dose modification/i 63 (47.0%) 70 (52.2%) 77 (58.3%)
#> 13: Related AE 86 (64.2%) 85 (63.4%) 92 (69.7%)
#> 14: Related AE leading to withdrawal 10 (7.5%) 9 (6.7%) 12 (9.1%)
#> 15: Related AE leading to dose modifi 44 (32.8%) 44 (32.8%) 51 (38.6%)
#> 16: Severe AE (at greatest intensity) 77 (57.5%) 70 (52.2%) 79 (59.8%)These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.
Health stats visible at Monitor.