<<I believe the cutoff for interim survival was 6/15/06. At that point there were 112 patients left in active in the study. The breakdown was 90-22 which is much higher than the 2:1 randomization enrollment ratio.>>
I don't think those numbers work, as 463 deaths occurred by that date, and 950 patients enrolled in the trial. [Edit: unless you're saying those numbers are the # of patients still receiving satra or placebo]
I just checked the briefing docs, and I think the 700th death will depend on how back-end loaded the enrollment was. The last patient was enrolled in January 2006, and the median survival at the interim was about 61 weeks satra vs 57 weeks control. I think we'll see the 700th death this year, but perhaps GPCB will try a desperation move and tell the FDA the final unblinding will occur at a higher number of deaths, perhaps 800. Otherwise, I can't see it coming back stat sig at the 700th death. At 463 events, Cox p value was 0.296 and log rank 0.388, with the HR being 0.90.
It sounds like 12-month followup after the 700th death is merely a different desperation method of trying to improve the final p value, instead of just increasing the event trigger to 800 or more.
