serious adverse events. Five of the six patients who received Saxagliptin and had an
event of pancreatitis, the past medical history either included a risk factor for pancreatitis
or a previous history of pancreatitis. There is one case that had no risk factors, the case
that was deemed to be of moderate intensity and not related by the investigator. In this
subject, the patient also had concomitant AEs of gastritis and duodenitis in the same
episode. This patient continued on therapy without interruption and this case resolved
after 47 days while continuing on Saxagliptin.
population. There were six cases of pancreatitis in patients who received Saxagliptin
versus two in the control group. The results are shown for the various Saxagliptin doses,
all Saxagliptin comparator with the specific cases represented in the left hand column.
Of the six cases that we are seeing in patients who receive Saxagliptin, two cases were
thinking of more things to worry about. So in that spirit, so the business about the
lymphocytes, I guess I am really unsure whether to worry about it or not or how much to
be worried about it, and I am also not sure how reassured I am about counting the number
of infections because I don’t think there were that many in the control group. So I
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
regarding measurement periodically of amylase or lipase in any of these patients?
DR. CHEN: We did not routinely collect amylase or lipase in the
DR. BURMAN: Thank you. I think we have one last question before
DR. KONSTAM: Well, the problem with having more time is you start