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Re: DonDonDonDon post# 33365

Monday, 09/13/2021 2:29:46 PM

Monday, September 13, 2021 2:29:46 PM

Post# of 42553

The clinical trials website says "Subjects in ordinal scores 5 or 6 at baseline with a CRP<150 mg/L at baseline and age<85 years" so it has been updated to exclude patients with a CRP>150mg/L or >85yo.



That was a change to the primary endpoint made on July 22nd. That is not a change to inclusion/exclusion criteria. If their aim was to exclude CRP > 150 they would have done so then but it still hasn't been changed. The only change to inclusion/exclusion criteria made at the time is those who have used prednisone in the last 7 days are not excluded. Also ordinal scale category 5, 6, or 7 is now referred to as ordinal score 5, 6, or 7.

For eligibility there is no longer any maximum age which had been set to 99. If lenzilumab has a hard time saving the lives of those 85+ just imagine the struggle with centenarians.