metalite.ae

Overview

metalite.ae is an R package to analyze adverse events (AE) in clinical trials, including:

AE summary.

Specific AE analysis.

AE listing.

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.

Workflow

The general workflow covers:

1. Define metadata information using metalite.
2. Prepare outdata using prepare_*() functions.
3. Extend outdata using extend_*() functions (optional).
4. Format outdata using format_*() functions.
5. Create TLFs using tlf_*() functions.

Tutorials with examples are listed on the package website.

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.