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Unleashing Potential of Graphs for Analysis of
Adverse Events
Unleashing potential of Graphs for analysis of AdverEvents
Abhinav Jain
Ephicacy Lifescience Analytics Pvt. Ltd. Bangalore
© 2012 – Ephicacy All rights reserved
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Introduction: Graphs for Analysis
of Clinical Data
 Graphs are always instrumental in the analysis and
interpretation of complex clinical drug development data.
 Compared to tabular presentation of analysis results graphs
provides “Accuracy-of-Data-Presentation” and “Speed-ofInterpretation” enabling accurate and reliable interpretation of
Unleashing potentialdata.
of Graphs for analysis of AdverEvents
the multifaceted
 Graphs are always employed for presenting results of efficacy
endpoints but are seldom used in safety analysis.
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Graphs for Analysis of Adverse
Events
 Adverse Events (AEs) are integral part of safety profile in any
clinical trial. Traditionally results from analysis of AE data are
summarized using tabular methods of tables and listings.
 Graphical presentations of AE data can help in detecting
potential safety signals and can aid in concise, precise analysis
of AE data.
Unleashing potential of Graphs for analysis of AdverEvents
 In this presentation we will cover how graphs can be used to
present results from following 4 aspects of AE analysis:
 Incidence of AE
 Prevalence of AE
 Risk of AE Onset
 AE profile of individual subject
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Summary of Incidence of AE
Unleashing potential of Graphs for analysis of AdverEvents
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Dot Plot
Unleashing potential of Graphs for analysis of AdverEvents
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Forest Plot
Unleashing potential of Graphs for analysis of AdverEvents
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Volcano Plot
Unleashing potential of Graphs for analysis of AdverEvents
Introduced in the analysis of adverse event data by O’Connell (2006).
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Adverse Events by Severity
Unleashing potential of Graphs for analysis of AdverEvents
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Butterfly plot
Unleashing potential of Graphs for analysis of AdverEvents
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Heat Map
Unleashing potential of Graphs for analysis of AdverEvents
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Rate of Prevalence of AE
Unleashing potential of Graphs for analysis of AdverEvents
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Line plot
Unleashing potential of Graphs for analysis of AdverEvents
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Failure plot assessing Risk of AE
Onset
Unleashing potential of Graphs for analysis of AdverEvents
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Hazard Ratio plot
Unleashing potential of Graphs for analysis of AdverEvents
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Individual Subject AE profile
Unleashing potential of Graphs for analysis of AdverEvents
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Graphical display for individual
subject AE Profile
Unleashing potential of Graphs for analysis of AdverEvents
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Ways to enhance AE graphs
 Apply appropriate Sub-groups: Most frequent, Leading to
discontinuation, SAEs, Special interest AEs
 Apply appropriate sorting order: AE terms, RR, Time of Onset
 Perform formatting based upon regulatory reporting or
exploratory analysis
Unleashing potential of Graphs for analysis of AdverEvents
 Integrate graphics and tabular display of results to provide
concise and precise information
 Use proper color scheme to enable easy interpretation
 Use grid lines and reference lines as appropriate
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References
•
“Graphical Approaches to the Analysis of Safety Data from Clinical Trials”
by Ohad Amit, Richard M. Heiberger and Peter W. Lane in Pharmaceutical
Statistics 2008; 7:20-35
•
“Clinical Adverse Events Data Analysis and Visualization” by Shi-Tao Yeh
www.lexjansen.com/pharmasug/2007/po/po10.pdf
•
“Statistical Graphics and Reporting in Drug Development” by Michael
O’Connell,Unleashing
Sven potential
Knudsen
www.lexjansen.com/phuse/2006/ts/ts04.pdf
of Graphs for
analysis of AdverEvents
•
“Drug Safety Reporting- now and then” by David J. Garbutt
www.phuse.eu/download.aspx?type=cms&docID=2855
•
“Clinical Trial Reporting Using SAS/GRAPH® SG Procedures” by Susan
Schwartz
http://support.sas.com/resources/papers/proceedings09/1742009.pdf
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Unleashing potential of Graphs for analysis of AdverEvents
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