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Wednesday, March 05, 2008 9:07:47 AM
Do the 29 women who have successfully tracked through 3 treatment cycles (slide 26 of Pa-zzaz presentation) without problems represent all of the women who have gotten to that point at this time? What happened to the other 40 women in the drug legs of the study (ZPU-003)(.67 * 127 – 16 – 29 = 40). Did they go off drug entirely after the trial? Are they being tracked?
It still seems to me to be the only real data point we don't have in terms of efficacy and safety... does the drug holiday really work over time, for what percentage of patients, and how does dosage bear upon that number? We know factually that during administration it stops bleeding, reduces pain, doesn't significantly increase endometrial thickness, improves QOL and doesn't have any significant AE's... but what happened to the balance of the women who were treated after treatment? Is there data? Were they followed through successive cycles like the 29 mentioned? If so, what happened to them?
TIA
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