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Volcano plot for Risk Ratio of Any Adverse Events

2025-03-12

Source: vignettes/volcano_plot.Rmd
volcano_plot.Rmd

1. Introduction

This document details the steps for creating Volcano Plot using carver application which is a graph report. The required input ADaM data for this is an ADAE dataset.

1.1 Report Inputs in App

Upon loading/selecting ADAE data and clicking the Report Inputs tab, report inputs can be added.

  • Report Type as Figure and Report Name as Volcano Plot for the graph

Treatment/Population
Required

  • Under Treatment and Population Selection, select appropriate Treatment Variable:
    For table, Treatment Variable determines the columns and for Figure, determines how to differentiate groups by color.

  • Select appropriate Treatment Sort Variable which will give the order for sorting Treatment variable.

  • To subset entire data based on population flags, select Population Filter. eg. Overall, Safety (SAFFL).

Processing Data:

  • Add or Edit the default Analysis Subset Condition and Denominator Subset Condition to filter input data (for calculating categorical counts alone or for entire data respectively)

  • Select Adverse Event Filter(s) - To filter input data

  • Select Period - To generate the figure by either Overall Duration or Other.

  • Select Summary By - It helps to select either Participants if the plot is to based on subject count or Events if the plot is to based on AE counts.

  • Select Lower Level Event Term - This variable will help to generate the figure by AEBODSYS or FMQ Name etc., It is a type of scatterplot that shows statistical significance (P-value) versus magnitude of change (fold change).

  • Select Lower Level Event Term - This variable will help to generate the figure by AEDECOD or AELLT etc., It is a type of scatterplot that shows statistical significance (P-value) versus magnitude of change (fold change).

  • select Measure of Association - To generate the plot by either Risk Ratio or Risk Difference.

  • Select Control Group - To choose the control treatment to compare with treatment

  • Select Treatment Group - To choose the treatment to compare with control

  • Update the p Value Cutoff, Alpha Value(CI), Risk Reference Lines and Cutoff of Incidence (%) as desired to generate the plot.

Graph Output:

  • Click Process Report Input button and switch to Graph Output tab to generate the graph.