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Re: xrymd post# 42372

Thursday, 02/22/2007 2:07:31 PM

Thursday, February 22, 2007 2:07:31 PM

Post# of 257253
> ARTE – Did they break out what the AE's were and were they readily treatable and did they persist?<

Ms. Goostree did not talk about AEs on the webcast except in passing. The 2.1% rate of moderate/severe AEs came from slide #14, which shopws the 5-year follow-up. Based on 145 patients, 8.3% (12 pts) had mild AEs, 1.4% (2 pts) had moderate AEs, and 0.7% (1 patient) had severe AEs.

However, ARTE is cheating by using 145 in the denominator of these calculations because only 119 of the 145 patients were followed for 5 years (#msg-16686689). Using 119 in the denominator, the rate of moderate/severe AEs is 3/119 = 2.5%.

The real rate of moderate/severe AEs is probably even higher than this because the patients who were followed for 5 years constitute a biased subset of the 145-patient pool.

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