small MI for sure, let's say I was convinced the patient did in fact have an MI, I am not
sure I would discontinue the patient either from the study. In other words, the fact, I am
not sure how well that speaks to whether the clinician really thought or whether this
really was an MI the fact that it was discontinued, because I don’t think that there was a
high level of concern by the investigators that the experimental drug was likely to cause
MIs. So I am not sure they would discontinue, I don’t know how much that helps me.
DR. BURMAN: Well, why don’t we move on? Thank you very much. I
think Dr. Teerlink, did you have a comment before - a question. Please identify yourself
what you would expect. I agree with all of the comments that we have heard about the
relatively low risk and small numbers of events in the population making it difficult to be
certain that there is not an excess risk.
DR. KONSTAM: That’s not surprising; I don’t find it that surprising.
DR. MELE: I mean, no other event is recorded for them, is what I am
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DR. TEERLINK: You probably would have admitted them, you probably
would have admitted the patient, these are mostly out patient.
DR. KONSTAM: I think we’re on the same wavelength, this is a very
non-specific finding, I agree with that, I just I don’t, you know.
for the record when you speak. Dr. Savage.
DR. MELE: Can I just point out one thing about the CPKs, that most of
these CPKs, these patients did not discontinue. So they continue on the trial.
DR. KONSTAM: Right, but I am not sure, if I thought a patient had a
DR. SAVAGE: I guess, I’m sort of trying to put in perspective the
problem we are facing here. If you really want to look at the effect of a new drug, you