DR. KONSTAM: I don’t know if the Agency wants to comment?
DR. FLEGAL: Which estimates are you comparing from that table?
DR. KONSTAM: Well, I am just trying to figure out looking at the broad
to reconcile the data that you presented with what's in the FDA documents and
specifically looking at your, I guess it's slide 62, stratified analysis of FDA defined
MACE, and looking specifically at the SMQ MACE, not the custom MACE. Then I go
back - I go into the FDA document and what I am looking at is on page 37 of the FDA
document table 16, I don't know if that's the best place to look or not, but, I am not - and
maybe these are different analyses and they need to be clarified because your upper
boundaries are lower than the FDA's upper boundaries and I don't know if somebody can
help me reconcile, am I looking at the wrong things or?
their bottom estimate, the incidence ratio which had an upper bound of 1.37 and but the
exact method will generally give you a wider confidence interval, so that explains that
difference of 0.05.
methods. I believe that there were some differences in some of the methologic
procedures. I know that in some cases the agency calculated odds ratios. Our analyses
were primarily based upon risk ratios using the methods that we described.
SMQ MACE definition and so I look at the ST plus LT number I get 1.42 for the upper
boundary, for the odds ratio. So, are these just - and I don't know what they do.
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DR. WOLF: I would ask the Agency to perhaps to comment on their
DR. FLEGAL: Right. So that estimate would be most comparable to
ratio for the FDA defined endpoints. If I could please project slide 3-7, so in this slide, in
DR. KONSTAM: Okay.
DR. WOLF: If I could, we also use an exact method to calculate the risk