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Re: Thurly post# 54726

Tuesday, 08/03/2010 7:23:36 AM

Tuesday, August 03, 2010 7:23:36 AM

Post# of 347009
How is it possible that the primary and secondary outcome measures both indicate "Designated as safety issue: No" when the endpoint classification is "safety study"?

Pharmacokinetics covers a lot of ground. Yes, it's a phase I evaluation criteria but, it's not necessarily a safety issue.

However, how did you miss the first 3 measures in the primary outcome that were safety issues?

# adverse events [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
# laboratory evaluations [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]
# human anti-chimeric antibody [ Time Frame: Study Completion ] [ Designated as safety issue: Yes ]

Regards,

moby
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