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metalite.ae

Installation

The easiest way to get metalite.ae is to install from CRAN:

install.packages("metalite.ae")

Alternatively, to use a new feature or get a bug fix, you can install the development version of metalite.ae from GitHub:

# install.packages("remotes")
remotes::install_github("Merck/metalite.ae")

Overview

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 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.

Example

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
  )

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Version

Install

install.packages('metalite.ae')

Monthly Downloads

700

Version

0.1.2

License

GPL-3

Issues

Pull Requests

Stars

Forks

Maintainer

Yujie Zhao

Last Published

April 16th, 2024

Functions in metalite.ae (0.1.2)

fmt_ci

Format confidence interval
format_ae_summary

Format AE summary analysis
meta_ae_example

Create an example meta_adam object
format_ae_specific

Format AE specific analysis
format_ae_specific_subgroup

Format AE specific subgroup analysis
rate_compare

Unstratified and stratified Miettinen and Nurminen test
rate_compare_sum

Unstratified and stratified Miettinen and Nurminen test in aggregate data level
prepare_ae_listing

Prepare datasets for AE listing
tlf_ae_specific

Specific adverse events table
metalite.ae-package

metalite.ae: Adverse Events Analysis Using 'metalite'
prepare_ae_specific

Prepare datasets for AE specific analysis
tlf_ae_specific_subgroup

Specific adverse events table for subgroup analysis
prepare_ae_specific_subgroup

Prepare datasets for AE specific subgroup analysis
metalite_ae_adex

ADEX dataset
prepare_ae_summary

Prepare datasets for AE summary
tlf_ae_summary

AE summary table
tlf_ae_exp_adj

Exposure-adjusted AE summary table
tlf_ae_listing

Generate AE listing
fmt_pval

Format p-value
extend_ae_summary_eaer

Add exposure-adjusted rate information for AE summary analysis
format_ae_exp_adj

Format exposure-adjusted AE summary
extend_ae_specific_duration

Add average duration information for AE specific analysis
extend_ae_specific_subgroup

Add subgroup analysis in AE specific analysis
extend_ae_specific_inference

Add inference information for AE specific analysis
extend_ae_specific_events

Add average number of events information for AE specific analysis
fmt_pct

Format percentage
fmt_est

Format model estimator