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Posted On: 07/21/2020 4:45:27 PM
Post# of 148984
I'm not sure a binomial p value calculation for the number of patients who had an adverse event is appropriate, but I am going to do it anyway. 
6 out of 28 placebo patients (21.41%) had a SAE
5 out of 56 treatment patients (8.928%) had an SAE.
p value .00788956
Using the other metric, Total SAE (meaning some patients had more than one):
11 SAE in 28 patients on placebo (39.285%)
8 SAE in 56 patients on treatment (14.285%)
p value .00003204
Again, this is not the primary end point of the trial and likely not the correct methodology for analyzing this data, but to me it is a strong indicator.
IF (and that is a big if), the data for the primary endpoint follows this same trend we will have hit a homerun.
6 out of 28 placebo patients (21.41%) had a SAE
5 out of 56 treatment patients (8.928%) had an SAE.
p value .00788956
Using the other metric, Total SAE (meaning some patients had more than one):
11 SAE in 28 patients on placebo (39.285%)
8 SAE in 56 patients on treatment (14.285%)
p value .00003204
Again, this is not the primary end point of the trial and likely not the correct methodology for analyzing this data, but to me it is a strong indicator.
IF (and that is a big if), the data for the primary endpoint follows this same trend we will have hit a homerun.
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