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Re: None

Friday, 02/13/2015 11:28:03 AM

Friday, February 13, 2015 11:28:03 AM

Post# of 426927
We “know”:
- the 1,612th event will be in Dec 2017
- the 967th event will be in 2016

This means that 645 events should be occur within “22” months (between Feb 2016 and Dec, 17).

The two extrema are app. 4.38% (for both group - means 0% eff.) and 5.2% / placebo - 3.56% / V (31.5% eff.) The 967th event will be in the last (2) week(s) of Feb 2016 in every cases.

If the placebo event rate is not lower than 4.91% (diff. 5.77% vs 5.2%) than the eff.% is minimum 19.5% and it will be enough for p<0,001 at interim and stop the study. (For 99% power we need min. 25% eff. and for this minimum 5.00% placebo event rate was required.)

Just for fun:
for 40% eff. - 5.47% placebo rate
for 50% eff. - 5.84% placebo rate
was required.
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