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Posted On: 09/13/2020 5:19:15 PM
Post# of 153907
In reviewing some literature it would seem that the number of survivals once patients require mechanical ventilation is still rather low:
https://www.medscape.com/viewarticle/936689#vp_2
For our CD12 trial I foresee a rather large number of deaths. Let's assume in overall a 50% death rate for S/C patients (33). How many could we have in the LL group and still demonstrate statistical significance??
With 45 deaths in LL group our p-value would be 0.0252 (one tailed test). With 48 deaths this would be 0.0505.
If FDA decided to use a two-tailed test we can "afford" maximum 45 deaths (provided 33 perish in the placebo group).
We are getting close to the day we know what our numbers are
https://www.medscape.com/viewarticle/936689#vp_2
Quote:
They examined hospital chargemaster data and ICD-10 codes for COVID-19 inpatients between February 15 and April 20.
Among the nearly 2000 hospitalized adults requiring mechanical ventilation in the current report, only 27% were discharged alive . "The outcomes of people who are mechanically ventilated are really quite sobering," Brown said.
People who ever required mechanical ventilation were 32 times more likely to die compared with others whose highest level of oxygenation was low-flow, high-flow, or no oxygen therapy in an analysis that controlled for demographics and comorbidities.
For our CD12 trial I foresee a rather large number of deaths. Let's assume in overall a 50% death rate for S/C patients (33). How many could we have in the LL group and still demonstrate statistical significance??
With 45 deaths in LL group our p-value would be 0.0252 (one tailed test). With 48 deaths this would be 0.0505.
If FDA decided to use a two-tailed test we can "afford" maximum 45 deaths (provided 33 perish in the placebo group).
We are getting close to the day we know what our numbers are
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