https://github.com/merck/metalite.ae

An R package for standard adverse events analysis
https://github.com/merck/metalite.ae

cdisc clinical-trials metadata r-package

Last synced: 2 months ago
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An R package for standard adverse events analysis

• Host: GitHub
• URL: https://github.com/merck/metalite.ae
• Owner: Merck
• License: gpl-3.0
• Created: 2022-04-19T16:51:48.000Z (almost 3 years ago)
• Default Branch: main
• Last Pushed: 2024-04-15T04:12:02.000Z (10 months ago)
• Last Synced: 2024-04-22T03:14:51.056Z (9 months ago)
• Topics: cdisc, clinical-trials, metadata, r-package
• Language: R
• Homepage: http://merck.github.io/metalite.ae/
• Size: 7.28 MB
• Stars: 14
• Watchers: 7
• Forks: 3
• Open Issues: 2
• Metadata Files:
  • Readme: README.md
  • License: LICENSE.md

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README

        
# metalite.ae 

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## Installation

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

```r

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:

```r

# 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](https://r4csr.org/tlf-ae-summary.html) and the

[specific AE chapter](https://r4csr.org/tlf-ae-specific.html) 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

```r

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 tutorials](https://merck.github.io/metalite.ae/articles/metalite-ae.html)