600 patients....doing the math
posted on
Aug 29, 2016 08:49PM
Okay...so we have 600 patients so far, 25% of the total forecasted participants. and that took we'll say 10 months. At this rate it will take 30 more months before BETonMACE is fully enrolled, 2 and a half years.
The events based trial will be completed, as I understand it, when 250 MAC events have occured....with the futility analysis slated to occur after 125 events. According to wiki 75% of Diabetes Mellitus patients can expect to suffer from a MAC event....
So of the currently enrolled patients a total of 450 MACE would be the statistcal average. But of course we have a placebo group which I will assume to be half of the 600....so I'm guessing we have 300 patients dosed with Apelbetalone + Statin, and half to be dosed with a placebo in place of Apelbetalone.
Obviously the goal of the trial is to prove that RVX 000222, or RVX 208 or Apelbetalone...or whatever...the goal is to show RRR so hopefully there will be zero or very few MAC events with the dosed arm.
75% of 300 is 225....not enough to get us to trial completion, but enough to reach the futility analysis. I am operating under the assumption that if the futility analysis is positive that RVX could take off....
From my understanding it takes years for the damage that Diabetes does to blood vessells...it can take 10+ years to manifest into a MAC event....so I'm guessing a lot will depend on how long trial patients have been suffering from the disease.
Okay....I'm going back to the chart, this medical science makes my head hurt.