The exact number of therapy arm trial patients who died
The exact number of therapy arm trial patients who died is:
(42%-12%)*25.6=7.56 pateints.
This number assumes mortality probability of an over 65 patient is 42% as occurred in CD12.
Also assumes mortality probability of an under 65 patient is 12% as occurred in CD12.
As reported, 33% of therapy arm patients were over 65.
As reported, 23% of placebo arm patients were over 65.
This means that 10% of the therapy arm patients, 25.6, were over age 65 and should have been under 65 in order to match the placebo arm of the trial.
So, then question becomes: How many excess deaths will occurr in a group of over 65 patients in CD12 compared to the number of deaths that would have occurred if the 25.6 patients were less than 65?
The answer is 7.56 patients.
7.56 patients moves the primary endpoint mortality reduction of LL vs. placebo from 18.5% to 31.2%.
As many statistic experts have reported on this message board, the goalpost on mortality reduction to achieve p value less than 0.05 is somewhere in the vicinity of 30%.
If indeed these numbers are correct, namely that approximately 25 extra patients over 65 were in the therapy arm compared to the placebo arm, then CD12 would have either hit or barely missed its p value goal.
This strikes me as a conclusive, EUA-earning result, let alone the urgency of a pandemic, the SOC impact of dexamethasone on CD12, the impact of SOC on moving placebo deaths outside of 28 days, and the safety of leronlimab. How can anyone in their right mind not approve this?
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