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loanranger

11/25/18 12:41 PM

#249780 RE: PlentyParanoid #249777

"Galera probably wants to see if GC4419 inhibits tumor growth and hence improves survival time and has included survival analysis in secondary measures."

Wouldn't that be mentioned somewhere in the original Study Description or Study Design or Outcome Measures?
All that's shown is a single Preliminary Outcome measure:
1. Cumulative incidence of severe OM [ Time Frame: From the first IMRT fraction through the end of the study treatment period, which is estimated to be 7 weeks. ]

"has included survival analysis in secondary measures"
"Cancer study part"
I know you tossed that "probably" in there for a reason because there is no mention of those things in the clinicaltrials.gov text.

Would you expect a B-OM Phase 3 to included a distant Completion date to allow for a Cancer study part including survival analysis as well?

MinnieM

11/25/18 1:41 PM

#249786 RE: PlentyParanoid #249777

I just sent them a note asking if it is a typo, and, if not, what they'll be looking for.

As LR stated, there are no secondary measures listed and that makes it tough to guess.





In Reply to 'PlentyParanoid'
Can someone explain what is done between the Primary and Study Completion Dates that takes 4 years to do?

The time difference is usually due to secondary measures. Galera probably wants to see if GC4419 inhibits tumor growth and hence improves survival time and has included survival analysis in secondary measures. Waiting sufficient number of people to die takes a long time. Cancer study part does not prevent Galera from filing for SOM after SOM related studies are done.