elevated - when they analyze people with elevated CPKs, most of them did not have
another event, if I understood that correctly, which isn’t really directly answering the
question that they have an event when we are analyzing them. It makes a big difference
in the analysis whether you focus on the custom MACE or the broad MACE, or the broad
SMQ. So could you speak a little more about the CPKs and were there any other
evidence that these people actually had heart disease at the time?
understand exactly. I would like a little more discussion of the elevated CPK, because
although other things certainly can elevate, other conditions can elevate CPK, in this
circumstance, usually it's going to be a myocardial infarction or at least some sort of
cardiac damage, so much of the difference between the broad SMQ and a custom MACE
related to people with elevated CPKs.
analyzed or they came in the hospital for chest pain, or how - what were the clinical
circumstances of an elevated CPK?
I believe it was Dr. Mele who presented data that said, if someone had an
I have one question for the FDA, which is a general one. I am not sure I
answer your question that it didn’t have to just be a subsequent event. It's just did they
have an event that was other than just a CPK, but these are first events. So the CPK
would be the first event that was observed and then you would have to look for
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DR. MELE: I just want to clarify about that analysis. Dr. Lowy will
DR. BURMAN: This was an elevated CPK when people just were
DR. LOWY: So, just to reiterate, these trials were not prospectively
designed to pick up these events. So a lot of the information that we had regarding these