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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 1 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. © 2012 – Ephicacy All rights reserved 2 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 © 2012 – Ephicacy All rights reserved 3 Summary of Incidence of AE Unleashing potential of Graphs for analysis of AdverEvents © 2012 – Ephicacy All rights reserved 4 Dot Plot Unleashing potential of Graphs for analysis of AdverEvents © 2012 – Ephicacy All rights reserved 5 Forest Plot Unleashing potential of Graphs for analysis of AdverEvents © 2012 – Ephicacy All rights reserved 6 Volcano Plot Unleashing potential of Graphs for analysis of AdverEvents Introduced in the analysis of adverse event data by O’Connell (2006). © 2012 – Ephicacy All rights reserved 7 Adverse Events by Severity Unleashing potential of Graphs for analysis of AdverEvents © 2012 – Ephicacy All rights reserved 8 Butterfly plot Unleashing potential of Graphs for analysis of AdverEvents © 2012 – Ephicacy All rights reserved 9 Heat Map Unleashing potential of Graphs for analysis of AdverEvents © 2012 – Ephicacy All rights reserved 10 Rate of Prevalence of AE Unleashing potential of Graphs for analysis of AdverEvents © 2012 – Ephicacy All rights reserved 11 Line plot Unleashing potential of Graphs for analysis of AdverEvents © 2012 – Ephicacy All rights reserved 12 Failure plot assessing Risk of AE Onset Unleashing potential of Graphs for analysis of AdverEvents © 2012 – Ephicacy All rights reserved 13 Hazard Ratio plot Unleashing potential of Graphs for analysis of AdverEvents © 2012 – Ephicacy All rights reserved 14 Individual Subject AE profile Unleashing potential of Graphs for analysis of AdverEvents © 2012 – Ephicacy All rights reserved 15 Graphical display for individual subject AE Profile Unleashing potential of Graphs for analysis of AdverEvents © 2012 – Ephicacy All rights reserved 16 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 © 2012 – Ephicacy All rights reserved 17 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 © 2012 – Ephicacy All rights reserved 18 Unleashing potential of Graphs for analysis of AdverEvents © 2012 – Ephicacy All rights reserved 19