the incidence rate ratio and the incidence ratio. The FDA permitted us to use other
methods of analyses, so we also calculated hazard ratios based on the Cox proportional
hazard regression method. These methods were consistently applied to our pooled
assessment of risk ratio. For the sake of simplicity, I will initially focus on the four major
CV endpoints that were analyzed. These endpoints are listed on this slide in the
approximate order in which we analyzed them. Identification of CV endpoints was
primarily based upon searching our adverse event database for events that coded to
particular preferred terms in the MedDRA dictionary as described by Dr. Joffe.
long-term experience in our program. I will present data from the short-term plus long-
term phase of our studies assessed until the time of the day 120 safety update, as this
provides the most comprehensive longitudinal description of CV events in our program.
This experience reflects 5,000 patient-years of exposure including 3,700 patient-years of
exposure on Saxagliptin. All pooled analyses of CV events were stratified by study in
recognition of the fact that CV risk profile may have varied across individual trials.
the middle column. While the number of patients identified with each endpoint is listed
in the last column highlighted in light blue. Our initial assessment of CV safety initiated
prior to submission of the NDA was based upon the endpoint acute cardiovascular events.
This endpoint targeted CV events that were acute, ischemic and consequential. It was a
The FDA requested that we calculate risk ratios for CV events based on
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
phase 3 studies. Approximately 3,300 of these patients were exposed to Saxagliptin.
The FDA requested analyses of both the short-term and a short-term plus