Re: Patient Years & MACE rate Question

...We Welcome You To The Resverlogix HUB withIn The AGORACOM COMMUNITY!

Dear Agoracom Family,

I want to thank all of you for your patience with us over the past 48 hours and apologize for what was admittedly a botched launch of our new site.

As you can see, we have reverted back to the previous version of the site while we address multiple forum functionality flaws that inexplicably made their way into the launch.

To this end:

1.We have identified 8 fundamental but easily fixable flaws that will be corrected in the coming week, so that you can continue to use the forums exactly as you've been accustomed to.

2.Additionally we will also be implementing a couple of design improvements to "tighten up" the look and feel of the forums.

Have a great Sunday, especially those of you like me that are celebrating Orthodox Easter ... As well as those of you who are also like me and mourning another Maple Leafs Game 7 exit ... Ugggh!

Sincerely,

George et al

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BearDownAZ

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Re: Patient Years & MACE rate Question

in response to

Re: Patient Years & MACE rate Question

KOO-KOO2

posted on Jul 11, 2019 10:23AM

It's fun to play with numbers. But keep in mind that:

1) The placebo event rate is unknown. EXAMINE provides the best example but that is just one trial and its event rate may not be reproducible. BETonMACE has additional low-HDL requirement that may affect the placebo event rate to an uncertain degree.

2) The apabetalone effect size is unknown. Could be 0% RRR. Could be 50% RRR. BETonMACE was modeled for a 30% RRR but we don't know what the actual %RRR will be.

3) Discontinuations/Dropouts are unknown. This greatly impacts patient year estimates.

4) Enrollment updates are vague. Because patient enrollment is reported in "waves", one does not know how many patient were added towards the beginning of the wave or towards the end of the wave. One could over- or under-estimate enrollment and patient years based on assumptions.

5) Total MACE events are unknown. We know it will be 250 or greater. We don't know much beyond that.

So have fun with numbers, but keep the limitations of your assumptions in mind.