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Re: sts66 post# 29689

Tuesday, 06/24/2014 3:44:00 AM

Tuesday, June 24, 2014 3:44:00 AM

Post# of 426268
I could not say no, but in the previous 2 rounds were not delay.

R-IT:
- with 'updated' enrollment data: 50-50% splitt of the period enrollment between begining and end of the period (assumung linear enrollment during the period) and
- with 'updated' event rate: 5,00% - the design change (TG min. 150 increased to min 200 in May 2013) was due to lower than expected event rate
- eff. 22%: assuming 1:1 relation between TG and eff. ('based' on studies and ANCHOR data)

YTD: 418 events
For 90% power: we need 725 events / May 2015
interim analysis (60%, 967 events): Jan 2016
100%, 1612 events: Nov 2017

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