Saturday, December 10, 2022 5:25:01 PM
You have to click on where it says sample 1 summary and then enter the mean and SD and n
The SEM of 0.51 for pooled treated and 0.86 for placebo have to be converted to SD by multiplying by sqrt (n)
So whether you use n=301 and n=161 (maintenance dose cohorts) or n=280 and n= 154 (accounting for the additional dropouts due to adverse events plus a few more non-AE dropouts in each group and still getting Odds ratio exactly as in slide) you will get a one-sided p-value of 0.033 and a two sided p value of 0.065 (smaller n) or 0.066 (maintenance cohort n). I believe two sided is more appropriate. Anavex can counter-argue that they were only looking for improvement so one sided is appropriate. Regulatory agencies might differ.
Depending on the n you can enter:
mean 4.11 SD=10.67 n=154 and mean 2.26, SD= 8.53 and n=280
or
mean = 4.11 SD = 10.91 n=161 and mean = 2.26, SD = 8.85 and n=301
Regardless of the above, the 95% CI for relative reduction in decline is wrong. The difference of the mean is -1.85 (2.26-4.11). CI of the difference of the mean is -(0.004, 3.696) so CI of the relative reduction in decline % would be (0.0, 99)
The SEM of 0.51 for pooled treated and 0.86 for placebo have to be converted to SD by multiplying by sqrt (n)
So whether you use n=301 and n=161 (maintenance dose cohorts) or n=280 and n= 154 (accounting for the additional dropouts due to adverse events plus a few more non-AE dropouts in each group and still getting Odds ratio exactly as in slide) you will get a one-sided p-value of 0.033 and a two sided p value of 0.065 (smaller n) or 0.066 (maintenance cohort n). I believe two sided is more appropriate. Anavex can counter-argue that they were only looking for improvement so one sided is appropriate. Regulatory agencies might differ.
Depending on the n you can enter:
mean 4.11 SD=10.67 n=154 and mean 2.26, SD= 8.53 and n=280
or
mean = 4.11 SD = 10.91 n=161 and mean = 2.26, SD = 8.85 and n=301
Regardless of the above, the 95% CI for relative reduction in decline is wrong. The difference of the mean is -1.85 (2.26-4.11). CI of the difference of the mean is -(0.004, 3.696) so CI of the relative reduction in decline % would be (0.0, 99)
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