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Re: threefoot post# 57769

Monday, 03/28/2016 3:27:45 PM

Monday, March 28, 2016 3:27:45 PM

Post# of 704399
There is a lot of information on when and if researchers can change endpoints. After the first interim analysis, it is basically not allowed. Hard to say what the powering was for the pure pseudoprogressor group -- I do not believe it was mentioned on clinical trials.gov.

However, this would lead one to believe subtype analysis was planned.

http://www.tandfonline.com/doi/full/10.4161/hv.29276

In case the primary and secondary endpoints are not achieved, it is planned for the data to be analyzed further based on sub-classification of the trial population. Finally, three interim analyses have been scheduled to take place for data evaluation while the trial is ongoing.


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