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Message: Re: You're right 10bagr, you didn't sway me....
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Jan 31, 2019 08:03PM
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Jan 31, 2019 08:11PM
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Jan 31, 2019 09:06PM
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Jan 31, 2019 09:27PM

RVXoldtimer has it right. And Growacet, your pile analogy is spot on.

Koo, I posted on the probable order of events last night in this post. I will paste the list again below. I think the main debate in the most recent few posts here has been on 1, 2a and 2b  below. Maybe having it explained in a different way will help you understand.

Unconfirmed (not yet adjudicated) MACE events happen and they are being adjudicated on an ongoing basis to move them into the confirmed pile (as Growacet referred to). Once 250 adjudicated events occur, this is the trigger to stop dosing (#1 below). But when dosing ends, there will still be unconfirmed events left to be adjudicated (#2a below). This is why they are expecting 250+ adjudicated events in the final total and why there will be an additional 2-3 month adjudication period after dosing ends. So while they are adjudicated the final events beyond 250 (that occured before dosing ended) they can also concurrently do the 4-16 week safety follow ups (#2b below).  

1) 250 adjudicated events achieved, triggering end of dosing.

2a) Completion of adjudication to evaluate remaining unconfirmed events and possibly move more into the confirmed/adjudicated category. 

2b) Last patient follow up safety visits.

3) Database lock (might occur prior to completion of 2a and/or 2b)

4) Crunching and analyzing the data

5) Top-line data release for primary outcome (possibly CKD and cognition sub-study results too if available).

6) More crunching and analyzing the data

7) Full primary outcome data presented and published

8) CKD and cognition sub-study results reported if not done earlier

9) More data analysis

10) Pre-specified comparisons for primary outcome reported

The other point to clarify is about patients still dosing after a MACE event. Unless the patient dies or chooses to leave the trial, they will keep dosing even if they have already had a 3-point MACE event. In the EXAMINE trial, many individual patients had 2 or more MACE events. But only the first adjudicated/confirmed 3-point MACE event will count towards the 250 total. 

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