Great find, thanks! One would assume/hope that
Post# of 148173
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