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Overview is an R package designed for the analysis of adverse events (AE) in clinical trials. It operates on ADaM datasets and adheres to the metalite structure. The R package streamlines the process of generating production-ready tables, listings, and figures as outlined in the AE summary chapter and the specific AE chapter of the R for Clinical Study Reports and Submission book. The package encompasses the following components:

AE summary

Specific AE analysis

AE listing

Highlighted features

  • Avoid duplicated input by using metadata structure.
    • For example, define analysis population once to use in all adverse events analysis.
  • Consistent input and output in standard functions.
  • Streamlines mock table generation.


meta_ae_example() |> # Example AE data created using metalite
    population = "apat", # Select population by keywords
    observation = "wk12", # Select observation by keywords
    parameter = "any;rel;ser" # Select AE terms by keywords
  ) |>
  format_ae_summary() |>
    source = "Source:  [CDISCpilot: adam-adsl; adae]", # Define data source
    path_outtable = "ae0summary.rtf" # Define output