General safety and tolerability.
fatigue, treatment-emergent adverse, toxicities, nausea and vomiting, TEAEs, dizziness, headache
DISORDERS, NERVOUS SYSTEM DISORDERS, GASTROINTESTINAL DISORDERS, ADMINISTRATION SITE REACTIONS
All single and multiple i.v. and p.o. doses of FMGX were well tolerated. There were no severe treatment-emergent adverse events (TEAEs), serious AEs (SAEs), or withdrawals due to treatment-related TEAEs reported. No TEAEs or laboratory safety test results met any of the predefined rules that prevented dose escalation. There were no dose-limiting toxicities observed, and the maximum tolerated dose was not determined or reached in these studies. The most frequently reported drug-related TEAEs across all treatment groups were gastrointestinal disorders (nausea and vomiting), nervous system disorders (headache and dizziness), and general disorders and administration site reactions (fatigue) (Table S1), which generally were more frequent in the highest-dose groups. Tolerability of FMGX after p.o. administration generally improved under 