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Message: Re: BETonMACE top line data
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Jan 16, 2018 12:03AM
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Jan 16, 2018 05:50PM
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Jan 16, 2018 06:26PM
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Jan 16, 2018 08:39PM
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Jan 17, 2018 12:13AM

Golf,

I see what you are saying, but I do have a couple more clarifcations to help avoid overestimating the number of MACE events.

1) In the EXAMINE trial, the 18 month event rate was ~11% and the 12 month event rate was closer to ~9%. You are using the wrong event rate for the 12 month time point.

2) More importantly, based on the EXAMINE trial a MACE event in an individual patient is more likely to occur in the first 9 months of that patient being involved in the study than in the subsequent 15 months (see this post). So it is incorrect to treat cumulative MACE events like compound interest. Once patients get to around the 9 month mark, their risk of experiencing their first MACE is actually lower than new patients entering the trial. See that post for the approximate event rates from EXAMINE at different time points in the trial.

Plus, patients are dosed for up to 24 months.....once patients reach 24 month dosing (might also include the 6 week follow up) they essentially are no longer eligible to contribute MACE evnts to the MACE count. Dosing commenced in first patient(s) on 11/11/2015 and we had our first enrollment update (~600 patients) on 9/12/2016, so patients are already reaching the 24 month dosing point and by 9/12/2018 there will be ~600 patients that have reached 24 month dosing and thus ending their trial participation according to current trial design.

BearDownAZ

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Jan 17, 2018 11:35PM
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