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Posted On: 03/14/2021 10:04:25 AM
Post# of 154106
The new trial will have a Primary End Point of Length of Hospital Stay for Ordinal Scale 2.
The reason is obvious, we had very good p-values here.
How many patients are needed ???.
If we make the calculation with a alpha of 0.05 (p-value) and beta of 0.1 (Power 90%) and use the data acquired during the trial, that is, means of 33 (LL) and 38.5 days (SOC) and we use the Standard deviation (SD) of 10.7 obtained in LL arm (the most patients) we obtain 160 patients are required.
Now, the SD of the placebo was smaller (7.6 with less patients). If we assume a SD for the whole population of 10 we have that we will need 138 patients.
This explains to a large extent why we are going for 140 patients.
The reason is obvious, we had very good p-values here.
How many patients are needed ???.
If we make the calculation with a alpha of 0.05 (p-value) and beta of 0.1 (Power 90%) and use the data acquired during the trial, that is, means of 33 (LL) and 38.5 days (SOC) and we use the Standard deviation (SD) of 10.7 obtained in LL arm (the most patients) we obtain 160 patients are required.
Now, the SD of the placebo was smaller (7.6 with less patients). If we assume a SD for the whole population of 10 we have that we will need 138 patients.
This explains to a large extent why we are going for 140 patients.
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