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Saturday, August 12, 2017 4:33:59 PM
Doc, no I did mean Feb 2015. So I my numbers were way off.
May 2014 + 9 months would be Feb 2015. So that would have meant that by Feb 2015 - 248 patients were enrolled.
If they all evented on a blended average of 11.3 months, those 248 patients would have evented by 11 months later.
So that would actually be by January 2016.
Thus, according to looking at the numbers using the hypothesized median instead as an average... if all those 248 patients had evented based on an averages, then the trial would have reached 248 PFS by January 2016.
So I was off - by a year, lol.
Which is actually even better. It certainly can't be said that it fit like a glove - as it took an entire year than I'd originally calculated.
So to be more precise, rather than use an average of 8.68 patients enrolling each month, I found Abeta's chart on enrollment based on Dr. Bs enrollment chart.
May 2014 there were 165.
Looks like by March 15, there were 250 patients enrolled. So I'll work with that.
So starting with April 2015, not Feb 2015, if the blended PFS should have been on average, 11 months, then if all 248 patients had evented based on that 11 month average, they would have done so by February 2016.
Instead, the trial hit 248 events by February 2017. So 23 months after 248 patients were enrolled.
Lol. Well that's even better.
So if those 248 patients that were enrolled by March 2015 were all the 248 patients that evented by February 2017, we would be looking at numbers like this:
82 control x 9 = 738
165 treatment x 30 = 4950
= 5688 / 248 = 22.94
Of course, those 248 patients enrolled by March 2015 were not the same 248 patients that had evented by February 2017. But you can see that if you look at the averages, and consider that most of the pseudoprogressor patients who typically might present with those types of numbers (30 months PFS) were not enrolled in the main arm of this trial, one has to wonder why it took so long to hit 248 PFS events.
And that 30 month average PFS number goes up when you had add more control patients to the mix - but I was just trying to look at it based on how they were enrolled - 1:2.
But let's try that. Let's say that all 110 control patients have evented. And let's go with a pretty high average of 10 months from randomization (which remember, would be 13 months from surgery).
110 control x 10 months = 1100
138 treatment x 33 = 4600
= 5700/248 PFS events = 22.98 months (remember it's 23 months later from March 2015 that we hit 248).
In order to lessen that average treatment number, you'd have to up the number of months it took for the control patients to event.
Let's go back to 82 control patients having evented and revise the number of months it took for them to event. Let's make it so that the control patients all evented on average by 12 months (or 15 from diagnosis).
82 control x 12 = 984
165 treatment x 28.5 = 4703
= 5687 / 248 = 22.93
I guess what becomes obvious, to me anyway, is how it took so long to reach 248 events based on these averages?
But sorry, you were right, I was off on that date. You were so sweet to assume I must have meant the other. Saving me face. Still... it seems my error points out that while I don't know how to add 11 months to February 2015... this trial still should have reached 248 events much sooner than February 2017.
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