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Posted On: 12/22/2020 10:06:21 PM
Post# of 148902
For the noobs, just a reminder we completed enrollment 390 pts in our severe/critical trial.
We must have been very close at 50% interim analysis for the DSMC to recommend continuing trial unchanged and KNOW per Nader deaths ~ 45 at 195.
So estimating around 25L to 20P for a p-value near 0.10 at 50% (195) and if continued at this mortality rate we would get 50L and 40P for a p-value of 0.01 = stat. sig on PE!!!!
However, mortality rate is improving:
https://jamanetwork.com/journals/jamainternal...erm=122220
so lets say we continue to next 195 at 15% mortality in placebo...but keeping with death rate in L arm (0.15x65 = 9.75 round to 10 so 30P) same reduction rate in L arm (25/40) = 37.5 % reduction...so (9.75x.375) about 4 in L-arm.
Thus 29L to 30P = (2:1 study) = 29-30:60 = roughly 50% mortality reduction = STAT SIG MORTALITY REDUCTION!
statisticians please comment.
We must have been very close at 50% interim analysis for the DSMC to recommend continuing trial unchanged and KNOW per Nader deaths ~ 45 at 195.
So estimating around 25L to 20P for a p-value near 0.10 at 50% (195) and if continued at this mortality rate we would get 50L and 40P for a p-value of 0.01 = stat. sig on PE!!!!
However, mortality rate is improving:
https://jamanetwork.com/journals/jamainternal...erm=122220
so lets say we continue to next 195 at 15% mortality in placebo...but keeping with death rate in L arm (0.15x65 = 9.75 round to 10 so 30P) same reduction rate in L arm (25/40) = 37.5 % reduction...so (9.75x.375) about 4 in L-arm.
Thus 29L to 30P = (2:1 study) = 29-30:60 = roughly 50% mortality reduction = STAT SIG MORTALITY REDUCTION!
statisticians please comment.
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