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:
- Define metadata information using metalite.
- Prepare outdata using
prepare_*()
functions. - Extend outdata using
extend_*()
functions (optional). - Format outdata using
format_*()
functions. - Create TLFs using
tlf_*()
functions.
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.