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MACE than for the broad or inclusive SMQ MACE. Again, this difference between

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custom MACE and SMQ MACE is largely accounted for by including the term, ‘blood

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creatine phosphokinase increase’ in the FDA’s definition for SMQ MACE. We do not

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see evidence of a cardiovascular safety signal for Saxagliptin based on these analyses.

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The risk ratios for primary MACE and acute CV events are summarized on the next slide.

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death at the bottom of the slide. Consistent with our other analyses, we did not see

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evidence for increased risk of death among Saxagliptin exposed patients. The risk ratios

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for custom MACE and SMQ MACE are summarized on the next slide. When the results

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for all three analytic methods for custom MACE and SMQ MACE are depicted together,

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there is a consistent pattern for the upper bound with a 95% confidence interval for risk to

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be well within the FDA defined criterion for approvability.

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Drs. John Alexander and Ken Mahaffey at the Duke Clinical Research Institute to

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perform a blinded review of the clinical data for all patients with SMQ MACE, primary

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MACE in all deaths. They review case report forms, narratives and source documents

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like discharge summaries and ECG’s without knowledge of treatment group assignment.

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They independently identified 40 cases of MACE in this data set. The distribution of

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I want to call your attention to the data for all-cause of death and CV

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The estimates of the risk ratio were lower for the more selected custom

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

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consistent results for these Sponsor defined cardiovascular endpoints. The upper bound

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of the 95% confidence intervals for the risk ratio for the pool analyses were below 1.1 for

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both endpoints.

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The Cox hazard ratio, incidence rate ratio, and incidence ratio all gave

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Again, well within the FDA criterion for approvability. We have asked

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