Well, they presented 12-month follow-up data last year, should present 24-month follow-up data this year!
As of no frequent occurrences in a few centers, that's expected IMO. There are 68 centers in PACE trial listed, each site probably enrolled very few patients, can't use frequency from a few centers to judge safety profile. Just one SAE from half of centers adds up to a lot overall. The other item I like to see is SAEs from CP patients only. By 12-month follow-up, majority AP/BP patients discontinued from study, thus even though overall SAE rate of increase from 12-month to 24-month seems small, but most likely majority came from CP patients because AP/BP patients would have discontinued more quickly after 12-month on treatment. I think this might be why both ARIA and FDA are more concerned about EPIC, felt the need to make dose modification now rather than let it continue.
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