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Re: iwfal post# 3545

Friday, 02/29/2008 12:13:52 AM

Friday, February 29, 2008 12:13:52 AM

Post# of 8473
iwfal - questions about your question:

<a) What are the differences in the entry criteria for the ph iii vs the ph iib - if any? >

You know in this Anemia trial, the patients are headed to UF surgery later ? Obviously not in the UF Phase iib

<b) For the ph iib subgroup with anemia measurements what were the baseline characteristics relative to the ITT group. >

Hard to know if you are referring to their blood levels at baseline - obviously the main characeristics were UF symptoms.

<c) What, exactly, is the endpoint for the ph iii? >

I believe the measure for Anemia is blood count (now I realize I dont know quite what that is - help - red cell count maybe) - but I beleive the endpoint is basically getting the level back up above the Anemia level (what was it, 11 decalitres or whatever ?)

<d) For that endpoint, what was the observed efficacy in the ph iib? The p value? The arm sizes for the subgroup with anemia data? (Note that this is ordinarily what you would see in a published trial) >

You could look at the presentation in the iBox - I would but I am not sure it is highly relevant.

The very fact that almost all the OTHER patients stopped bleeding makes it intuitive that both the sub-group and the rest count in the decision-making.

<e) What efficacy did you assume in the powering calculation? >

I bet you will give us the numbers any day now ... :o)


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