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kris_kade

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kris_kade

Re: DewDiligence post# 4683

Thursday, 08/16/2007 10:15:06 PM

Thursday, August 16, 2007 10:15:06 PM

Post# of 19309
Dew,

Per information posted on the govt. clinical trial site,

http://www.clinicaltrials.gov/ct/show/NCT00506519;jsessionid=A2E3DEF0A70B56B59173DF6D7219AAC9?order=...

Further study details as provided by LEO Pharma:

Primary Outcome Measures:
Patients alive on day 28 having had an improvement in DIC score and having had no worsening on organ failure score.

Secondary Outcome Measures:
Mortality at 28 and 90 days. Change in organ failure score and DIC score. Pharmacokinetic (PK) parameters.


The Primary Outcome clearly says the Patients need to be alive on Day 28 while only improvement is needed in DIC score.

Is this not considered as Survival benefit (that needs to be met) ?

TIA

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