getStats

Compares reference and comparison groups to calculate group-wise metrics and p-values for use in AE volcano plot.

Interactive adverse event (AE) volcano plot for monitoring clinical trial safety. This tool allows users to view the overall distribution of AEs in a clinical trial using standard (e.g. MedDRA preferred term) or custom (e.g. Gender) categories using a volcano plot similar to proposal by Zink et al. (2013) <doi:10.1177/1740774513485311>. This tool provides a stand-along shiny application and flexible shiny modules allowing this tool to be used as a part of more robust safety monitoring framework like the Shiny app from the 'safetyGraphics' R package.

Jeremy Wildfire

volcanoPlot

Volcano Plot for Clinical Trial Adverse Events

Becca Krouse

Natalia Andriychuk

Anh Tran

Isaac Zhao

getStats function

<dl><dt>dfAE</dt>
<dd>Adverse events dataset structured as 1 record per adverse event
per subject</dd>
<dt>dfDemog</dt>
<dd>Subject-level dataset</dd>
<dt>settings</dt>
<dd>Named list of settings (see examples below for standard list)</dd>
<dt>stat</dt>
<dd>Statistic to calculate for AE plot. Options are risk ratio ("RR"
or "Risk Ratio"), risk difference ("RD" or "Risk Difference"). Defaults to
"Risk Ratio".</dd></dl>

Arguments

Get Summary AE Statistics — getStats

<dl>

<dt>dfAE</dt>
<dd>Adverse events dataset structured as 1 record per adverse event
per subject</dd>


<dt>dfDemog</dt>
<dd>Subject-level dataset</dd>


<dt>settings</dt>
<dd>Named list of settings (see examples below for standard list)</dd>


<dt>stat</dt>
<dd>Statistic to calculate for AE plot. Options are risk ratio ("RR"
or "Risk Ratio"), risk difference ("RD" or "Risk Difference"). Defaults to
"Risk Ratio".</dd>

</dl>

getStats: Get Summary AE Statistics

Description

Usage

Value

Arguments

Examples