The only other definition of MACE that we used was the definition that counted all
deaths, not just cardiovascular deaths, and the reason for doing that is that we were
concerned about any possible bias that might have been introduced by our assessment of
cause of death. So when we included all deaths, not just CV related deaths, we
essentially arrived at the same answer.
filed the NDA and before there was a lot of the discussion surrounding the people who
are gamma agonists, we had to find an endpoint of acute CV events and that endpoint
was defined by a list of preferred terms. When we began to engage with the FDA on
focusing on MACE like events, what we did is we selected a subset of the preferred terms
and defined acute CV events and these were preferred terms that focused on acute
myocardial infarction, stroke, and cardiovascular causes of mortality. We did not do
iterative definitions of events.
understand the data and maybe the statistical folks in the room can help me with this
because we are being asked to look at upper boundaries of confidence limits and I'm
trying to reconcile, and I know we are going to have an FDA presentation, but I am trying
We selected that particular definition of MACE as our primary definition.
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list of preferred terms that defined acute CV events, we subsetted those events to really
focus on the events that were more consequential like MI and stroke.
DR. WOLF: The way that we arrived at that definition is before we
DR. KONSTAM: All right. My last question relates to just making sure I
DR. KONSTAM: So the primary MACE definition is something you
constructed and that was your first shot at it without any preconception about how the
data was going to come out, is that what I hear?