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the incidence rate ratio and the incidence ratio. The FDA permitted us to use other

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methods of analyses, so we also calculated hazard ratios based on the Cox proportional

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hazard regression method. These methods were consistently applied to our pooled

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assessment of risk ratio. For the sake of simplicity, I will initially focus on the four major

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CV endpoints that were analyzed. These endpoints are listed on this slide in the

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approximate order in which we analyzed them. Identification of CV endpoints was

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primarily based upon searching our adverse event database for events that coded to

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particular preferred terms in the MedDRA dictionary as described by Dr. Joffe.

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long-term experience in our program. I will present data from the short-term plus long-

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term phase of our studies assessed until the time of the day 120 safety update, as this

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provides the most comprehensive longitudinal description of CV events in our program.

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This experience reflects 5,000 patient-years of exposure including 3,700 patient-years of

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exposure on Saxagliptin. All pooled analyses of CV events were stratified by study in

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recognition of the fact that CV risk profile may have varied across individual trials.

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the middle column. While the number of patients identified with each endpoint is listed

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in the last column highlighted in light blue. Our initial assessment of CV safety initiated

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prior to submission of the NDA was based upon the endpoint acute cardiovascular events.

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This endpoint targeted CV events that were acute, ischemic and consequential. It was a

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The FDA requested that we calculate risk ratios for CV events based on

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The number of preferred terms used to identify each endpoint is listed in

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randomized control data from approximately 4,600 patients enrolled in phase 2b and

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phase 3 studies. Approximately 3,300 of these patients were exposed to Saxagliptin.

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The FDA requested analyses of both the short-term and a short-term plus

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