Adverse Event/Toxicity Data

Hi All

 

Do any of you have methods by which you group adverse event or toxicity data for analysis, either by coding or assigning a “preferred term”?

Does anyone apply MedDRA coding to their data? What sort of resource does that entail? If not do other CTUs group terms any other ways? E.g. numerical coding of terms for analysis.

Does anyone also collect system, organ and class data with their AEs or is this retrospectively collected if an event needs expedited reporting to the MHRA or is required for a DSUR?

We have tried a couple of methods by either forcing assessment of toxicities/AEs against pre-specified CTCAE terms on the CRF or recording as a free text field on a log CRF page and then getting a medic to review and provide a single common term for variations in event descriptions (for example grouping lethargy, tiredness, fatigue as one single term).

Thanks for any help or discussion on this.

Gareth

MAHSC-CTU

[Author]

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