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Re: Lykiri post# 214989

Monday, 02/18/2019 3:32:36 PM

Monday, February 18, 2019 3:32:36 PM

Post# of 704556

NWBO speaks of "documented disease progression".

Can you make something of that?


Yes, there are pre-specified censoring rules.

I don't recall the details here, but, for example, if a patients stops dcvax therapy (or placebo) but doesn't have an MRI showing progression he is censored (it doesn't count as an event). So, with PFS as the primary, documenting progression is important.

You can see the different censoring rules in the FDA guidelines about endpoints in oncology trials. there is an appendix that discusses it (and sensitivity analysis as well)
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