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To: Rick Strange who wrote (1450)10/20/1998 5:26:00 PM
From: yosi s  Respond to of 1491
 
The last cohort of the phase 2 trial is split 2:1
In a sense they have lots of placebo patients. By safely increasing the active part, without jeoperdizing the control of a placebo group. Enable to get most information out of treatment group.

This may even get greater significance , and better planning for phase 3.



To: Rick Strange who wrote (1450)10/20/1998 9:37:00 PM
From: Ariella  Read Replies (1) | Respond to of 1491
 
Rick, I thought the split was not 50-50 and that's why more are getting dex in the third cohort.

First two cohorts of Phase II:
dex -- 30 patients..........placebo -- 37 patients

If 20 more are added for part 3, Phase II:
dex ~ 13 patients.........placebo ~ 7 patients

Total for all three (87 patients):
dex ~ 43 patients..........placebo ~ 44 patients
-----------------------------------------------------------------------
If 30 patients are added for part 3:
dex ~ 20 patients............placebo ~ 10 patients

Total for all three (97 patients):
dex ~ 50 patients.............placebo ~ 47 patients

I just figured we needed more headcount on the dex side (and, by the way, why didn't it come out roughly 50-50 to begin with?).

-Ariella