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Tuesday, December 15, 2015 11:40:08 AM
The question is whether it is the total number of patients enrolled or that number minus censored patients
OK, one last try on this.
The final analysis with be planned for when some defined (but not made public) number of events is reached. It will not be exactly that because they might well get a few extra events before they actually cutoff the dataset.
That nunber is not 582, as that could take a decade. So in order to get the data in a rational amount of time they predetermine to cut it off at some number of events.
About 500-530 might be a reasonable guess, but all we can do is guess.
And it is 1/3 of this number for the first look.
As far as censors, this is a mistaken way of looking at it. At any moment in time, it is always the case that events + censors = enrolled. So technically it is true that the "final event number" is 582 - censors. But censors does not drive the "final event number", the "final event number" drives the censors in the final analysis.
BTW: Good job on realizing that one can not just plug in events at the median, and you must use a guestimated event curve applied against the enrollment.
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