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Re: walldiver post# 2115

Tuesday, 02/27/2007 7:40:04 AM

Tuesday, February 27, 2007 7:40:04 AM

Post# of 12660
Baseline bone lesion count > 10 was significantly imbalanced against the treatment arm in D9902a. That might have been the strongest factor contributing to the poor p value. So yes, adding a few more patients properly randomized would not have changed that imbalance enough to make a difference to the p value.

Also the same bone lesions counts were much worse in D9902a than in D9901 over the entire ITT. This is one of the strong indicators of advanced disease state since PC has a preference to metastasize to bones. This would imply a faster progression time, earlier death, and a more exaggerated delay effect when comparing the KM curves for TTP and survival. For TTP in D9902a, the delay effect essentially wiped out any difference between the curves.
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