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of preferred terms that were used for case identification. Primary MACE defined by us

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and custom MACE defined by the Agency had the shortest list of preferred terms

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consisting of 54 and 33 terms, respectively. We identified 41 patients with primary

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MACE and 40 patients with custom MACE. In contrast, SMQ MACE defined by the

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FDA was based upon a list of 148 preferred terms. As expected, this more broadly

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defined endpoint identified a larger number of patients; that is, 141 patients. The

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relationship of these four endpoints is important for the interpretation of the results.

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based on searching for 117 preferred terms in the MedDRA dictionary. We identified 61

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patients with acute CV events. Subsequent to submitting the NDA, we analyzed MACE

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(Major Adverse Cardiovascular Events). MACE was a composite endpoint that

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encompassed CV death, nonfatal myocardial infarction, and nonfatal stroke. Three

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definitions of MACE were initially investigated. For each type of MACE, case

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identification was based upon searching the adverse event database using specific lists of

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preferred terms supplemented by clinical review of all deaths to ensure that each death

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with a CV etiology was counted.

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endpoints using a series of Venn diagrams. The relationship with the two most broadly

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defined endpoints, SMQ MACE and acute CV events, is described at the top of the slide.

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There were 141 patients with SMQ MACE and 61 patients with acute CV events. There

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were 46 patients in the overlap; that is, patients whose events were classified as both

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As can be seen in this slide, the three types of MACE varied in the breadth

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On the next slide I'll explain the relationship of patients with these

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relatively broad endpoint that included both reversible and irreversible ischemic

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events. It also included revascularization procedures.

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Cases of acute CV events were identified in the adverse event database

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