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io_io

08/17/06 6:41 PM

#715 RE: alizumo #714

re: P-11

Nice work. The distribution looks conservative. Do we have any "interim" enrollment numbers at any milestone, or we just got the beginning and end dates ?


"if we suppose the trial is to be unblinded today"

Maybe this is the problem as I see it. On what basis would you expect the trial to be un-blinded ? For sure it would not be 100% of the patients have "evented". It might be as low as two-thirds.


"I use theoretical survival curves"

Now these you should keep secret !
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iwfal

08/18/06 12:52 AM

#725 RE: alizumo #714

Alizumo - Inre enrollment curves:

a) There were actually 175 enrollees (per the 10K)

b) You look like you used something less than an R^2 enrollment curve (which is optimistic since it has patients enrolling earlier). A more normal enrollment pattern is r^2. However I used r^4 as a conservative assumption since GTOP, for instance, enrolled 40% of their patients in the last 6 months of 36 months. r^4 is a little more conservative than even GTOP.