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Re: p3analyze post# 153800

Monday, 12/10/2012 7:45:32 AM

Monday, December 10, 2012 7:45:32 AM

Post# of 257566

Finally the way the crossover patients were analyzed in both control and cdx011 is a head scratcher. There is the inherent bias only patients who is fit or disease stable get the chance to cross over. The company must have felt it compelling to include such patients in both treatment arm as otherwise the PFS difference would be less pronounced. The correct way would be to censor on last SD visit before crossover and include in only the control arm.


Disagree.

The crossover was after progression. So on the IC arm the PFS data is complete prior to progression. Saying they should censor at that point makes no sense.

As they crossover, they are just like any other patient enterring the trial. Start a new clock at crossover time, and the PFS from there is just another data point.

As to "The company must have felt it compelling to include ...", that is a fairly extreme statement. Why do you not consider it reasonable that this was the SAP?

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