know, there aren’t that many events and there are a lot of different analyses done. That I
see is actually an advantage. The first one is not an advantage; not having too many
events is not an advantage. Analyzing it in many different ways is an advantage and I
think it showed that the results don’t change very much as you change your methodology,
which is important. Of course, you know, it’s true that there are not a lot of events. In
particular, that causes problems, you know, when you are looking at the more specific
cardiovascular outcome because some trials have no events and, you know, how do you
include them? I mean the traditional method of analyzing that kind of data when you
have a small number of events is too conditioned on the total number of events you have
in a given trial.
clinical trials permits a reliable assessment of cardiovascular safety. We have had some
discussion of this but I would like to open it up for further clarification and discussion.
probability that they would be as lopsided as they are, in terms of treatment - the control
versus the treatment? If you do that type of analysis the natural thing to use is the odds
ratio. It just so happens that when you look at the distribution of that kind of statistic,
what comes out naturally is that it depends on the odds ratio. Here we have relatively
small event rates so the odds ratio and the relative risk are about the same thing. So, you
know, I found it reassuring that the different analyses came out with similar conclusions
by and large.
DR. PROSCHAN: Yeah. You know, as mentioned earlier about, you
Say, okay, given that we have had five of these events, what’s the
Question No. 1:
Please discuss whether the low cardiovascular event rate in the Saxagliptin
DR. BURMAN: Thank you. Dr. Konstam?
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