How to avoid the use of the word "exceedance"?

Question

From my translation from Russian:

The following safety information that may suggest changes in the benefit-risk ratio of the drug product is subject to expedited reporting to the regulatory bodies within 15 calendar days:

1. imposition of restrictions on the drug product’s distribution; market withdrawal; non-renewal, revocation or suspension of marketing authorization in the territory of other countries for safety- or efficacy-related reasons;

2. exceedance of the expected frequency of serious adverse reactions;

I feel that exceedance is stylistically wrong, it's a rare quaint word. What could be the alternative phrasing of this item in the list?

I thought of exceesive frequency but where to put the word expected, which is present in the Russian original?

So is there an alternative to the word "exceedance", a word or phrase with a noun function that has the same approximate meaning?

Maybe "violation of the upper limit of the expected frequency of serious adverse reactions?"

Answer 1

Maybe "exceeding the expected frequency of serious reactions."

But it still has a problem, as it doesn't specify a threshold to trigger the requirement. Maybe that's true of the original in Russian.

Maybe "frequency of serious reactions [exceeding/higher than] the expected level by []"