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Re: io_io post# 12069

Monday, 06/13/2005 2:34:35 AM

Monday, June 13, 2005 2:34:35 AM

Post# of 253596
Re: GTCB

>>I don't see where the EMEA trial actual results were discussed (I do see where there were 2 DVTs - was that the only end-point ?)<<

Avoidance of DVT was indeed the efficacy endpoint in the European trial. The two cases were only suspected DVT based on ultrasound scans – not actual clinical cases of DVT.

>>Also, what is the historical rate of DVTs (or other endpoint events or occurrence) - meaning how does the "control arm" typically fare?<<

For individuals with hereditary AT deficiency undergoing surgery or childbirth without antithrombin augmentation, the rate of clinical DVT is 30%+.

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