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OS and event-free survival are frequent primary endpoints in phase 3 trials.
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The most frequent primary motivator for adding ICHS7 SP endpoints to regulatory toxicology studies was to generate additional data to allow for determination of an integrated risk assessment thereby testing Confidence in Safety (CIS) to better manage and/or mitigate risk.
[14], [15] We classified the type of primary endpoints as hard endpoints, intermediate endpoints and subjective endpoints.
Primary Endpoints.
Two primary endpoints are distinguished.
Both primary endpoints were met.
Primary endpoints occurred in 1804 (18.2%) patients.
The primary endpoints were safety profiles.
Primary endpoints were feasibility and toxicity.
Nonetheless, frequent adaptation in oncology is hampered because the primary endpoint of greatest interest, OS, takes significant time to collect.
The primary endpoint of MACCE was significantly more frequent in anaemic patients than those without anaemia (29.1 vs 19.4%, respectively, p=0.002).
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