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routine study visits that were sent to a core lab and had elevated CKs and were sent back

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to the investigators asking about whether there were adverse events. In the vast majority

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of these, first of all the documentation was limited mostly because the patients were

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asymptomatic. A handful of them had some report of some trauma or vigorous exercise

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or something, and the majority of them had - the actual electrocardiograms weren’t

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available, but reportedly had normal electrocardiograms on multiple occasions after these

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events. So that’s the elevated CK samples.

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cardiologist from Duke and approximately four weeks ago, BMS approached me and my

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colleague, Ken Mahaffy, to review the data that was available on all of these SMQ

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MACE events, and I reviewed half of them and Ken Mahaffy reviewed the other half.

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We used our standard clinical event committee processes using pretty standard

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cardiovascular trial definitions for stroke, myocardial infarction and cardiovascular death.

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I think there has been a good discussion about these elevated CK levels.

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MACE actually had pretty good documentation in that they were real cardiovascular

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events. If we had been doing prospective clinical event adjudication of those events,

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virtually all of them, we would have called real clinical events, but the isolated elevated

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CK values which again typically actually occurred on multiple occasions in these

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My understanding is that there were, protocol mandated blood draws at

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The cardiovascular events, the things that went into primary and custom

Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com

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primary MACE events in all depths for external review, I think it might be useful to have

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Dr. John Alexander define some perspective on the SMQ MACE and the CK increases.

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DR. WOLF: Since the Sponsor sent the SMQ MACE events, the

DR. ALEXANDER: Thank you. So I’m John Alexander. I'm a

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