these endpoints in the post-hoc analysis permit a reliable assessment of cardiovascular
safety and given the limitations of the data, it seems like they might. Actually it’s
unknown because there is no real adjudication. All of us have participated in clinical
trials where you may comment on an individual patient but adjudication, which is more
strict, may or may not be accurate. So the real question is, how accurate is this post-hoc
adjudication? Is it enough to then have these custom MACE and broad MACE to base
the decision on at this point in time? Any comments? Dr. Veltri?
suggestions on how to analyze the data. There is one more way to handle data that has a
small number of events and that is, instead of conditioning on the number of events, the
total number of events across both groups, you don’t do that. You say, is there any
common event probabilities? Suppose the event probability is the same in the two
groups. Is there any probability that would be consistent with the data shown? So there
is just one more test, Statistic Bernard’s test, which might be done in addition.
done a wonderful job in looking at this custom MACE concept. If you have a database
where these CV death and mild stroke have been adjudicated, then you have that same
database where you have investigative reports looking at specific MedDRA preferred
terms, you can actually possibly compare the actual CEC adjudicated in these clinical
trials versus the customized approach. I suspect that is going to be very close. I think
that’s one way of trying to validate this when you don’t have the CEC adjudication.
DR. PROSCHAN: Yes, there is just one more thing in terms of
DR. BURMAN: Thank you. One statement is, please discuss whether
DR. VELTRI: It’s the same comment I had before. I think the FDA has
DR. BURMAN: Thank you. Other comments?
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