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Event Analysis Plot of Adverse Events

2025-03-12

Source: vignettes/event_analysis.Rmd
event_analysis.Rmd

1. Introduction

This document details the steps for creating Event Analysis 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
- Report Type as Figure and Report Name as Event Analysis 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 Higher Level Event Term - This variable will help to generate the figure by AEBODSYS or FMQ Name etc., It shows the main bar chart of the percentages of subjects with at least one AE, by AEBODSYS or FMQ Name etc., and treament group.

  • Select Lower Level Event Term - This variable will help to generate the figure by AEDECOD or AELLT etc., It shows the main bar chart of the percentages of subjects with at least one AE, by AEDECOD or AELLT etc., and treatment group.

  • Select Reference Line (%) - Reference lines show how the data in a chart compares to a reference value. This is free text column where you can enter any number as reference value.

Graph Output:

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

  • Select Event Higher Classification - This is related to the Higher Level Event Term variable. It creates a drop down of the variable values selected in the Higher Level Event Term.

  • Select Event Term - This is related to the Lower Level Event Term variable. It creates a drop down of the variable values selected in the Lower Level Event Term.