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Message: Re: MACE Event rate,....
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Feb 28, 2019 10:58AM
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Feb 28, 2019 01:35PM
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Feb 28, 2019 01:50PM

Bear, I am curious about this.

As you stated:The trial was originally designed/statistically powered assuming that apbetalone (ABL) would elicit a 30% relative risk reduction (RRR).

However the actual primary endpoint is: Time to first occurrence of adjudication-confirmed narrowly-defined MACE (cardio-vascular death, non-fatal MI or stroke).

Therefore, I assume that a successful topline result is achieved if a statistically-significant reduction in time-to-first-occurrence is achieved, regardless of the overall %RRR.  I understand that the trial design had to based on assumptions about overall number of MACE (and when they occurred) in the placebo and ABL groups, but the specified endpoint is time to MACE (not number of MACE) and I assumed that would be the parameter tested for significance.  

Is this correct?

Jupe  

 

 

 

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