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Re: tjguy post# 499

Tuesday, 07/11/2017 7:02:24 PM

Tuesday, July 11, 2017 7:02:24 PM

Post# of 1408
I think we will gEt zalviso results before we have to worry about that. Any thoughts on endpoints?

Primary Outcome Measures:
Device Functionality: Proportion of patients who experience at least one system-generated error [ Time Frame: Up to 72 hours ]???this will be determine from investigator notes?
How is this different than the below endpoint? Other than your using device logs...

Proportion of patients who experience at least one system-generated error based on the Controller data while using the Zalviso System ???this will be measured by the device and needs to be less than %5?

Device Usability: Proportion of patients with misplaced tablets [ Time Frame: Up to 72 hours ]
Proportion of patients with misplaced tablets
??this needs to be less than 5%

Would have been nice to list the quantitative values we need to meet.
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