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CytoDyn Inc CYDY
(Total Views: 675)
Posted On: 08/05/2020 5:43:48 AM
Post# of 153903
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Posted By: lorbas
Re: Coocooburra #47143
Great find, thanks!

One would assume/hope that if the DSMB sees great stat sig in one of the secondary endpoints at n=195, that they would recommend a similar change... I think it could be attractive to change the PE to the following SE at Day 14:

Change in clinical status of subject at Day 14 (on a 7 point ordinal scale) [ Time Frame: Day 14 ]
A 7-category ordinal scale of patient health status ranges from: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.

I could see that if mortality is at 30% or slightly below in placebo group that it will be difficult to get a halt even if there is a 50% mortality risk reduction, especially if DSMB follows a conservative boundary (0.001).

Mortality rate (Pl vs L) n=195
40% vs 20% 0.002183
40% vs 25% 0.01577
40% vs 15% 0.0001635
35% vs 20% 0.01279
35% vs 25% 0.0628
35% vs 15% 0.001464
30% vs 20% 0.05436
30% vs 15% 0.00936















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