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Posted On: 12/22/2020 8:34:32 AM
Post# of 153886
Can someone help me understand please. I'm wondering where the 42 day readout went.
"The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14."
So the 42 day mortality was only supposed to happen had we gone for the DSMC-suggested readout at 3 quarters enrollment? We are no longer bound to that as we blew past that and hit full enrollment? Is that why 42 day isn't mentioned above?
Also, wondering if a 42 day readout on the final enrollment would actually be advantageous anyway for us?
"The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14."
So the 42 day mortality was only supposed to happen had we gone for the DSMC-suggested readout at 3 quarters enrollment? We are no longer bound to that as we blew past that and hit full enrollment? Is that why 42 day isn't mentioned above?
Also, wondering if a 42 day readout on the final enrollment would actually be advantageous anyway for us?
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