RMB. Well on further DD it looks as tho the interim is based on the first 30 adult patients reaching the 90 day endpt . I'm assuming thats 30 patients on the ICU filter ( vs the 50 I assumed previously ) I can't find any data on the trial design ...re stopping thresholds ...but if they are only looking at 30 patients ...stopping is unlikely due to lack of statistical power . Statistical power ...my layman's explanation Flip a coin 10 times and it comes up heads 7 times ...so we assume 70% chance flipping a coin will get you heads each time . Flip a coin 1,000 times ...and its more 50 / 50 .
If the risk reduction is massive ...like they saw in the pediatric trial ....theres a chance it could be stopped ...or perhaps adding a second interim on 60 patients ( 60 on filter / 60 on SOC ) .
Continuation is most likely unless interim shows pediatric level mortality reduction .
There was a 44% absolute risk reduction and relative risk reduction of 62% of mortality in the pediatric trial ...huge benefit JMO Kiwi
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