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DrBengtP

10/30/06 4:21 PM

#1409 RE: ocyanblue #1406

D9901 was not backloaded at all.

I know that this statement is a bit of a long shot, but I think that an impression of the enrollment pattern can be obtained by looking at the time points at which the non-PCa-deaths were censored (Dr. Small's presentation from 10/20). These patients were censored because their deaths were unrelated to PCa, therefore, the timing and number of these deaths - together with the likelyhood of being alive at the time of censoring - can give an indication of the enrollment pattern.

I made some rough estimates, and to me it appears as if the last half of the patients were enrolled at a constant rate.

Please have a look at the graph, and let me know if you see my point.

Br.
Bengt
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croumagnon

10/30/06 4:34 PM

#1410 RE: ocyanblue #1406

"With sicker patients, the median OS will not be as robust as in 9901, assuming some benefit for cross-over, probably around 16 months for placebos"

I am not sure you can draw that conclusion because for a time 9902b was strictly enrolling less sick patients with Gleason scores <=7. Therefore, I am not sure if the final patient make-up would actually be sicker than the 9901/9902a population or actually less sick, in which case your 16 months may actually be 25 months or more...

This back and forth with 9902b enrollment criteria has always confused me and bothered me. First it was all Gleason but asymptomatic; then it was Gleason <=7; then it was all Gleason and "minimal" symptoms. We went from same as 9901, to less sick, to more sick... What the final outcome will be is anyone's guess...