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Re: sushifishman post# 18176

Thursday, 02/07/2019 10:37:11 AM

Thursday, February 07, 2019 10:37:11 AM

Post# of 43784
Dear Sushi
I haven't changed a mere bit in my sheet
I was discussing Lightrock sheet, as I am interested in other angles of study in particular his computation of response rate. I did find some strange things and I did question them.
I am not sure I get still all the substance of it but I think we are approaching.
Still, I am not sure what Lightrock means by 3years OAS as primary endpoint of the study because, as, per CT it is written :

-Primary Outcome Measures :
Overall Survival (OS) in LI + CIZ + SOC vs. SOC [ Time Frame: 3 year ]

>>> Time frame here is an estimate of when data is unblinded : 3 years after Actual Study Completion Date (Dec 2017).

When 298 deaths occur, they build two Kaplan-Meier survival curves (with 298 points on the graph), compare observed survival on one arm VS the other. The logrank test allows to validate statistical significance (need p<0.05) of counted survival benefit regardless of time distribution of events in each group. Both of curves will show OAS from Year zero to Year 8 if it shows a recruited patient in 2011 who survived 8 years.
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