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Engineering_Simple

04/23/21 7:27 PM

#28473 RE: DonDonDonDon #28472

I think you're asking for n (sample size), but I'll take a whack at it...

Assuming:
(1) Both treatment arms had the same # of people
(2) Alpha = Pvalue = 0.05 (since Pvalue must be <= alpha in order to be able to reject it)
(3) Power = 1- Beta (0.8 or 80%)

= at least 1758 Patients total (879 in each arm)

...I took some statistics classes wayyy back when... didn't do the calculations myself, just found an online calculator and filled it out as best as i could ;)


https://clincalc.com/stats/samplesize.aspx

Biotech/scientist/mathematician/clinical people, please feel free to disown me for my assumptions
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CJames22

04/23/21 7:44 PM

#28475 RE: DonDonDonDon #28472

I think it's worth noting the placebo mortality rate (and VFS rate) were incredibly low. I haven't come across placebo rates that low in any study looking at hospitalized COVID patients. I expect both our primary end point and mortality reduction trends would've looked even better if we weren't going up against such strong standard of care