routine study visits that were sent to a core lab and had elevated CKs and were sent back
to the investigators asking about whether there were adverse events. In the vast majority
of these, first of all the documentation was limited mostly because the patients were
asymptomatic. A handful of them had some report of some trauma or vigorous exercise
or something, and the majority of them had - the actual electrocardiograms weren’t
available, but reportedly had normal electrocardiograms on multiple occasions after these
events. So that’s the elevated CK samples.
cardiologist from Duke and approximately four weeks ago, BMS approached me and my
colleague, Ken Mahaffy, to review the data that was available on all of these SMQ
MACE events, and I reviewed half of them and Ken Mahaffy reviewed the other half.
We used our standard clinical event committee processes using pretty standard
cardiovascular trial definitions for stroke, myocardial infarction and cardiovascular death.
I think there has been a good discussion about these elevated CK levels.
MACE actually had pretty good documentation in that they were real cardiovascular
events. If we had been doing prospective clinical event adjudication of those events,
virtually all of them, we would have called real clinical events, but the isolated elevated
CK values which again typically actually occurred on multiple occasions in these
My understanding is that there were, protocol mandated blood draws at
The cardiovascular events, the things that went into primary and custom
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primary MACE events in all depths for external review, I think it might be useful to have
Dr. John Alexander define some perspective on the SMQ MACE and the CK increases.
DR. WOLF: Since the Sponsor sent the SMQ MACE events, the
DR. ALEXANDER: Thank you. So I’m John Alexander. I'm a