Mr Dog
I want to know exactly what the geographic anomaly is . Seems other have been briefed with more detailed information. Is it eastern Europe high or low PFS as compared to what other geographic region. Is it a specific large center or country ? Australia, UK, Russia, Ukraine, Serbia, Poland & Bulgaria ???
Did participants in Australia for instance perform as expected in line with 4.2 to 4.7 PFS for control. What was HA-I PFS in aussie trial center? I ask as we know care system and way trial site is run in Australia and ACL have access to full data quickly in Australia . I understand it is a small % of the overall trial.
Of the 350 progressions how many were on HA-I?
How many people remain on treatment in the trial ? How many of them on HA-I
How many patients dropped out?
Did patients on HA-I have less side affects?
It's late but what I can't get my head around . I'm missing something obvious.
With Median PFS of 5.5 months both arms I don't understand why the trial took so long to complete.
Lets assume all 415 patients enrolled on March 2013( yep last day of our enrollments) .
175 of the 350 progress by oct 2013 5.5 months. later
further 12 months later ( data lock) the other 175 progress?
Now consider we started the trial with gradual enrollment when? December 2011 14 months earlier.
Tired and not making a lot of sense
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