Power Calculation

#1
Hi, I have a power calculation question.

I have an initial study that has 6 subjects (all treatment group) and a follow-up study with 60 subjects (randomized into treatment and placebo 1:1).

Can I find the probability of any of the 60 subjects experiencing an Adverse event, if >=33% of the 6 subjects develops an Adverse event. I was going to try to use PROC POWER in SAS for this, but was unsure where to start.

Thank you!
 

fed2

Active Member
#2
I think what you got to do here is
1) get exact confidence interval on prob of AE in you 6 people.
2) prob of any AE in 30 = 1 - (1 - prob of AE)^30, 30 = 60/2
3) take upper and lower limits from part 1 and plug into 'prob of AE' in 2

You made a 95% Confidence limit on the prob of any AE in follow-up trial.