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Abstract

The Medical Dictionary for Regulatory Activities (MedDRA) will be the standard coding dictionary for adverse events in the future. We will report our experience with MedDRA Version 2.1 in coding and analysis of adverse events from two cancer trials. We will highlight differences between MedDRA and conventional dictionaries such as Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART), and we will summarize our experience with licensing, installation, and browsing and coding software for this novel dictionary. We will focus on our experience with MedDRA's extreme specificity: Slightly different verbatim terms are prone to be coded to different preferred terms and even entirely different system organ classes. This can have serious implications for statistical analysis that will also be discussed. We will develop recommendations on how these issues can be avoided by appropriate steps from clinical trial monitoring through data management to the statistical analysis plan.

Keywords

MedDRA Coding conventions Incidence rates Cancer trials Special search categories

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References

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Using Meddra for Adverse Events in Cancer Trials: Experience,Caveats,and Advice

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