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lymphocyte count in phase 1 and 2b studies of Saxagliptin at higher doses. As the

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consequence, we monitored lymphocyte counts carefully in the phase 3 program. In

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phase 3 we saw a small dose dependent reduction in mean absolute lymphocyte count at

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the 5 mg and 10 mg dose. The decreases were on the order of approximately 100 cells

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per mL relative to placebo from a mean baseline lymphocyte count of approximately

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2,200 cells per mL. The decreases were non-progressive with daily dosing of Saxagliptin

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to 128 weeks. These lymphocyte count decreases were not associated with clinically

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adverse consequences.

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was used to identify events of interest in the phase 3 program for further evaluation. We

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observed that these events were infrequent without imbalance between Saxagliptin in

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control and did not lead to study drug discontinuation. None was considered related to

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study drug as assessed by the investigators. Typically the events appear to be secondary

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to underlying disease or external factors, such as trauma. Overall, the evaluation of

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clinical data has not revealed signals that correlate to the non-clinical monkey skin

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findings.

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were similar to those seen in the general population. That is, without unusual

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opportunistic infections. Further, the frequencies of infection related AEs were

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comparable for the Saxagliptin 5 mg and placebo doses without signal for opportunistic

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events in the overall population.

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In the Saxagliptin development program we noted decreases in

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In patients with low lymphocyte counts, the types of infections we observe

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using special case report forms. We developed a pre-specified list of MedDRA

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preferred terms intended to be potentially correlative to the non-clinical monkey findings.

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The list, which was reflective of ulcerative and necrotic skin conditions,

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