Pharmacovigilance (PV)
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Dear PV forum members
We are increasingly coming across situations where by the MedDRA preferred terms do not match with the RSI.
A lot, of the time our reviewers are responding that the event is expected as either they feel the terms are synonymous or the same in terms of review.
The one particular issue we are increasingly coming across is with neutropenia, neutropenic sepsis and febrile neutropenia. Often our reviewers feel the three terms are the same (I won’t say synonyms as I believe they refer to different medical concepts), i.e. neutropenic fever, neutropenic sepsis and febrile neutropenia should be treated in the same way when assessing if the event is an SAE . However direct guidance from the MHRA states neutropenia, neutropenic sepsis and febrile neutropenia are distinct terms and reflect different clinical scenarios. Therefore if the RSI states neutropenia, they should report SUSARS for any febrile neutropenia or neutropenic sepsis.
Is this something you have come across before? We are wondering if its more of a broader issue or if its just linked to blood cancer trials?
Any thoughts welcome
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