01 January 2016 3 2K Report

Hello all. I have a small question. Assume a one arm clinical trial, with the primary endpoint being safety related: 1 = A subject had AE (at least one), 0 = the subject did not have any AE. In addition assume that the sample size is small, say 30 subjects, as this is a preliminary pilot study. The time for the primary endpoint is up to 4 weeks, i.e. if subject had AE's within the first 4 weeks, he is  a failure. Now, assume that a particular subject drops out after 3 weeks. How would you handle this, assuming that your analysis should be done on the ITT analysis set ? Clearly, if this subject already had an AE prior dropping out, he is a failure. But what if he didn't, and we do not know if he would have had AE after dropping out. Thank you for your opinions.

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