metalite.ae is an R package to analyze adverse events (AE) in clinical trials, including:
The R package simplifies the workflow to create production-ready tables, listings, and figures discussed in the AE summary chapter and the specific AE chapter of the R for Clinical Study Reports and Submission book with full traceability.
The R package is created using the metalite data structure that provides an end-to-end software development lifecycle (SDLC) solution including defining, developing, validating, and finalizing the analysis.
The general workflow covers:
For example, we can create a simple AE summary table as below.
meta_ae_example() |> # Example AE data created using metalite prepare_ae_summary( population = "apat", # Select population by keywords observation = "wk12", # Select observation by keywords parameter = "any;rel;ser" # Select AE terms by keywords |> ) format_ae_summary() |> tlf_ae_summary( source = "Source: [CDISCpilot: adam-adsl; adae]", # Define data source path_outtable = "ae0summary.rtf" # Define output )
Tutorials with additional examples are listed on the package website.