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Re: jessellivermore post# 31239

Monday, 07/28/2014 9:10:19 AM

Monday, July 28, 2014 9:10:19 AM

Post# of 426074
JL,

Please check / comment this:

We - including myself - used the 5,2% as the event rate of placebo arm, however I could find it only as the overall event rate for the study (ie.: Amarin Presentations for the October 16, 2013 Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee page 73). If this is the case, then the planned placebo rate is 5,62% and the Vascepa arm is 4,78% (avg. 5,2% with 15% eff.).

The lower than expected total events rate (resulted in design modification in May 2013) due to:
a.) lower event rate in placebo: assuming that “number is calculated by actuaries and takes into account whether they are primary or secondary interventions” it’s not the case
b.) Vascepa is significantly better than 15%.

We don’t know the exact difference, however if the actual rate was (before May 2013, for the total trial and assuming that placebo arm was 5,62% as planned)
5,00% (96% of 5,2%) = 22% eff.
4,94% (95% of 5,2%) = 24% eff.
4,68% (90% of 5,2%) = 34% eff.
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