Re: You're right 10bagr, you didn't sway me....
in response to
by
posted on
Feb 02, 2019 05:06PM
I don't think adjudication will neccessarily be done when 250 events are announced....
I see it like this....there are 3 piles so to speak. In one pile are those patients who are still dosing, either eith 208 or Placebo. Then when a suspected MACE occurs they move into Pile #2, which I'll call Suspected MACE. If the event is confirmed after adjudication, then that's added to the number in Pile #3 which I will call #3 Confirmed MACE.
I don't have any idea what happens though if a patient who's had a suspected MACE, but later its determined to have been something else. Do they go back to taking the drug/placebo? I would suspect they would but I don't know. Bear would probably have the best idea.
So just spitballing, right now we might be sitting at 235 confirmed MACE in Pile #3. In pile #2 there might be 40 events that are in the process of being adjudicated....but I imagine that with adjudication being something that is on going, that the number in Pile #2 is constantly changing, going down when an event is either confirmed or not, and up as suspected events get in line for adjudication.
When the 250 events is reached, I imagine there will still be suspected MACE in pile #2....and that, while dosing will stop, those events in Pile #2 would continue being evaluated meaning after 250 another, 5, 10....15 or 20....whatever, that more events will be added to the 250 number.