Anyone has an explanation as to why the 9902a patients enrolled were much sicker on the average than the 9901 patients enrolled? Other than East coast Vs West coast, I thought the criteria for enrollement were one and the same, so why this anomaly?
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.
Doesn't this make the 9902a three year survival numbers of about 1/3 even more impressive?
Maybe the three year survival numbers for 9901 would have been higher if not for the large imbalance in non-prostate cancer specific death.