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Message: Re: Patient Years & MACE rate Question

"Does anyone have a good estimate for how many patient years RVX has accrued so far?"

I don't have a good estimate. My bad estimate is somewhere in the range of 3600 to 4800. BETonMACE was originally designed to yield 3600.

"Also, any pointers on where I can find (posters, press release etc.) the MACE rate for the placebo assumed by RVX before they began the Phase 3 trial?"

An unofficial transcript by from Imtesty from a Sept 2015 Corporate Update presentation reads:

"Where did we come to our sample size? Two-and-a-half thousand patients gives 80% power for a 30% relative risk reduction, which is much less than we saw in our Phase II studies. However, you always anticipate that your Phase III will be less than your Phase II. And the EXAMINE study tells us that we’ll have about a ten-and-a-half percent (10.5%) event rate in the placebo arm at 18 months. And our projections are for about a seven-and-a-half percent (7.47%) rate in the active arm. So we’re well powered for a 30% reduction."

Also, the AHA poster from November 2018 reads:

"With an assumed primary eventr rateof 7 per 100 patient years in the placebo group, the study has 80% powert todetect a 29% reduction in MACE with ABL (or 50% power to detect a 24%r reduction with 2400 patients and an average exposure of 1.5 years."

 A 10.5% event rate at 18 months is 7 per 100 patient years. Because median BETonMACE dosing went past 18 months, the placebo event rate at the actual median dosing period (~24 months?) will likely be greater than 10.5% based on the EXAMINE model. However, a patient's risk of event drops over time (highest risk in first several months of trial), so the actual placebo event rate per 100 patient years will likely fall below 7 per 100 patient years based on the EXAMINE model.

BearDownAZ

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