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serious adverse events. Five of the six patients who received Saxagliptin and had an

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event of pancreatitis, the past medical history either included a risk factor for pancreatitis

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or a previous history of pancreatitis. There is one case that had no risk factors, the case

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that was deemed to be of moderate intensity and not related by the investigator. In this

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subject, the patient also had concomitant AEs of gastritis and duodenitis in the same

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episode. This patient continued on therapy without interruption and this case resolved

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after 47 days while continuing on Saxagliptin.

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population. There were six cases of pancreatitis in patients who received Saxagliptin

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versus two in the control group. The results are shown for the various Saxagliptin doses,

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all Saxagliptin comparator with the specific cases represented in the left hand column.

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Of the six cases that we are seeing in patients who receive Saxagliptin, two cases were

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considered serious.

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thinking of more things to worry about. So in that spirit, so the business about the

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lymphocytes, I guess I am really unsure whether to worry about it or not or how much to

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be worried about it, and I am also not sure how reassured I am about counting the number

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of infections because I don’t think there were that many in the control group. So I

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One of the two cases, who received control, was considered serious, that is

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DR. BURMAN: You don’t think very much - you don’t have data

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regarding measurement periodically of amylase or lipase in any of these patients?

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DR. CHEN: We did not routinely collect amylase or lipase in the

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program.

DR. BURMAN: Thank you. I think we have one last question before

DR. KONSTAM: Well, the problem with having more time is you start

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lunch.

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