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Create AE Table with Full MedDRA Hierarchy

Source: R/safety_hierarchy.R
create_ae_hierarchy_table.Rd

Creates an adverse event summary table using the full MedDRA hierarchy: System Organ Class (SOC) → High Level Group Term (HLGT) → High Level Term (HLT) → Preferred Term (PT).

Usage

create_ae_hierarchy_table(
  data,
  adsl,
  trt_var = "TRT01P",
  soc_var = "AEBODSYS",
  hlgt_var = "AEHLTGT",
  hlt_var = "AEHLT",
  pt_var = "AEDECOD",
  levels = c("soc", "pt"),
  min_pct = 0,
  sort_by = c("frequency", "alphabetical"),
  title = NULL,
  ...
)

Arguments

data

ADAE dataset (data frame or ADaMData object)

adsl

ADSL dataset for denominators (data frame or ADaMData object)

trt_var

Treatment variable. Default: "TRT01P"

soc_var

SOC variable. Default: "AEBODSYS"

hlgt_var

HLGT variable. Default: "AEHLTGT"

hlt_var

HLT variable. Default: "AEHLT"

pt_var

PT variable. Default: "AEDECOD"

levels

Character vector of hierarchy levels to include. Options: "soc", "hlgt", "hlt", "pt". Default: c("soc", "pt")

min_pct

Numeric. Minimum percentage to display. Default: 0

sort_by

Character. Sort by "alphabetical" or "frequency". Default: "frequency"

title

Character. Table title. Default: NULL (auto-generated)

...

Additional arguments passed to create_clinical_table()

Value

ClinicalTable with hierarchical AE summary

Examples

if (FALSE) { # \dontrun{
# Create AE hierarchy table
table <- create_ae_hierarchy_table(
  data = adae,
  adsl = adsl,
  levels = c("soc", "pt"),
  min_pct = 5
)
table@flextable
} # }