Tuesday, September 02, 2014 9:39:57 PM
1.) More than 2.000 (app. 5.000) was enrolled before criteria change in May 2013 (due to low event rate). However the 150 (and 200) mg /dl was the minimum level and not the real level. I am not remember exactly where (maybe GS conference) Thero said that the median and the mean TG are north 200 mg / dl.
2.) The planned Power is 90% (at 15% eff.) and total event is 1.612, however if eff.% is higher the same Power could be reached (see: #28220) with less event. The enrollment is totally as planned originally, it was not slow down after AdCom. Current enrollment is over 7.000 and will be 100% in Q1-2 2015.
3.) Timing of result (both interim and final): It depends on the real event rate vs planned and real eff.% vs planned. We do not know any of them, but it is "funny" that higher eff.% will be lead to later result.
Interim definitely will not reached before 2016 Q1 and final before 2017 Q3. It is just the "date" of the last event and analysis will take - at least - additional 6 months.
So if real (placebo) event rate is lower than planned and / or eff.% is excellent 2018/19 is possible as final.
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