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Posted On: 12/22/2020 8:48:24 AM
Post# of 148942
Re: Lionel_Joseph #69191
Lionel,
42 days analysis was added, as it appears that placebo patients died 29-42 day window, adding to the evidence supporting leronlimab. This would have been a mechanism to support early trial termination, rather than waiting for complete enrollment.
I believe this was only a DSMC recommendation, not a change in FDA approved trial endpoint. I believe that is why the 42 day analysis not listed on clinicaltrials.gov
The trial results, 28 days mortality, plus the numerous secondary endpoints are the metrics by which leronlimab will be judged.
42 days analysis was added, as it appears that placebo patients died 29-42 day window, adding to the evidence supporting leronlimab. This would have been a mechanism to support early trial termination, rather than waiting for complete enrollment.
I believe this was only a DSMC recommendation, not a change in FDA approved trial endpoint. I believe that is why the 42 day analysis not listed on clinicaltrials.gov
The trial results, 28 days mortality, plus the numerous secondary endpoints are the metrics by which leronlimab will be judged.
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