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Re: rafunrafun post# 128686

Tuesday, 05/22/2018 12:20:32 PM

Tuesday, May 22, 2018 12:20:32 PM

Post# of 428912

I mean, by "early", can't they simply mean that they hit their target number of events earlier than expected,


Yes, that's possible. But that would mean they grossly underestimated the event rate. (more often investigators grossly overestimate the event rate)

Hitting the target events with only ~75% planned enrollment is highly unusual.

Below is all I could find about their powering:

Event driven trial
o In the absence of extreme effects, the trial will end after
accrual of at least 530 primary endpoints
o Trial designed to provide 90 percent power to detect a 25
percent relative risk reduction


It is a 3 component hard mace composite endpoint. So, 530 CVD's, MI's or strokes among ~6000 patients (w/slightly more risk than R-IT I think).

Yeah, maybe they hit 530 early.

Here is a good video discussing the rationale of the trial
https://bwhedtech.media.partners.org/programs/cirt/CIRT20121109ridker/main.htm#

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