metalite.sl

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Overview

R package designed for the analysis & reporting of subject baseline characteristics in clinical trials. We assume ADaM datasets are ready for analysis and leverage metalite data structure to define inputs and outputs.

Workflow

The general workflow is:

  1. Define metadata information using metalite.
  2. prepare_sl_summary() prepares datasets for summary of baseline characteristics.
  3. format_base_char() formats output layout.
  4. rtf_base_char() creates TLFs.

Here is a quick example

library("metalite.sl")

metadata_sl <- metalite::meta_adam(
  population = metalite_sl_adsl,
  observation = metalite_sl_adsl
) |>
  metalite::define_plan(metalite::plan(
    analysis = "base_char",
    population = "apat",
    observation = "apat",
    parameter = "age;gender"
  )) |>
  metalite::define_population(
    name = "apat",
    group = "TRTA",
    subset = SAFFL == "Y"
  ) |>
  metalite::define_parameter(
    name = "age",
    var = "AGE",
    label = "Age (years)",
    vargroup = "AGEGR1"
  ) |>
  metalite::define_parameter(
    name = "gender",
    var = "SEX",
    label = "Gender"
  ) |>
  metalite::define_analysis(
    name = "base_char",
    title = "Participant Baseline Characteristics by Treatment Group"
  ) |>
  metalite::meta_build()

metadata_sl |>
  prepare_sl_summary(
    population = "apat",
    analysis = "base_char",
    parameter = "age;gender"
  ) |>
  format_base_char() |>
  rtf_base_char(
    source = "Source: [CDISCpilot: adam-adsl]",
    path_outdata = tempfile(fileext = ".Rdata"),
    path_outtable = tempfile(fileext = ".rtf")
  )

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