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Message: Re: Amarin 3 or 5 point MACE
2
Feb 13, 2019 07:56AM
4
Feb 13, 2019 09:08AM

Feb 13, 2019 09:24AM

"So if a MACE event takes place with some patients outside the 3 Point MACE, would those patients will simply be discarded and out of the trial and nothing more said."

If a patient has a MACE event outside of the strict 3-point MACE category, the patient will continue dosing in the trial like nothing happened. And if a patient does have a 3-point MACE, they still continue in the trial but subsequent 3-point MACE are not counted towards the primary endpoint. As an example, in EXAMINE most patients who had a 3-point MACE event had a single event. But there were a lot that had 2, and even many that had 3, 4, 5, 6 or more! See Figure 1. But only #1 counts towards the primary endpoint.

BearDownAZ

3
Feb 13, 2019 10:02AM
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