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 ]