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what actual events had occurred, and then they regrouped, compared their custom lists

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and reached unanimous agreement on which term should and should not be included in

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the custom MACE. It’s important to realize though that this custom MACE is not the

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same as post-hoc adjudication. The reviewers looked at preferred terms, not at the data

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behind the preferred terms. In a few slides later I will explain why post-hoc adjudication

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was not conducted for these clinical programs.

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that is considered more likely to represent events of myocardial infarction and stroke, as

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reported by investigators. How do we come up with a custom MACE? Well, a panel of

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three FDA clinical reviewers independently reviewed all the preferred terms in the SMQ

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MACE and they did so with the following question in mind. If I had a patient who

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actually had a myocardial infarction or stroke, is this a preferred term that I might

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actually have chosen for such an event?

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full list of the preferred terms in both endpoints is included in your briefing packets. As

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you can see all the terms on this slide are in the SMQ MACE, but only three are in the

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custom MACE. Take, for example, coronary artery occlusion. This may simply

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represent a stable fixed coronary defect, and doesn’t necessarily imply an acute event, for

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that reason it’s not included in custom MACE. Whereas coronary artery thrombosis does

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imply an acute event and is included in custom MACE. The preferred term infarction

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could be anywhere in the body, could be in the bowel, could be in the legs, and so

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The three reviewers did this independently, they didn’t take into account

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Let’s give you an example of SMQ MACE versus custom MACE and the

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terms from the myocardial infarction SMQ, and preferred terms from the central

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nervous system hemorrhages and cerebrovascular accidents SMQ.

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Custom MACE refers to a subset of preferred terms from SMQ MACE

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