Introduction to metalite.aeSource:
metalite.ae 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 package encompasses the following components:
Specific AE analysis.
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. It ensures complete traceability throughout the development lifecycle, leveraging the metalite data structure.
This R package offers a comprehensive software development lifecycle (SDLC) solution, encompassing activities such as definition, development, validation, and finalization of the analysis.
- 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.
The overall workflow includes the following steps:
- Define metadata information using metalite R package.
- Prepare outdata using
- Extend outdata using
- Format outdata using
- Create TLFs using
For instance, we can illustrate the creation of a straightforward AE summary table as shown 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 )
Additional examples and tutorials can be found on the package website, offering further guidance and illustrations.