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Replies to #49941 on Biotech Values
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DewDiligence

07/20/07 3:11 PM

#49946 RE: p3analyze #49941

>Has DMC mandated cross-over after the interim analysis?<

My understanding is as follows: After the PFS endpoint was hit, the trial was fully unblinded. Patients in the control arm were “encouraged” to continue treatment (i.e. prednisone) until progression. Patients who did not continue in the control arm until progression were ineligible to receive Satraplatin. After progression, any patient who wanted to could cross over.