Table 4.
AE, n (%) | Phase 1 dose escalation (all doses) (N=31) |
Phase 2- Filanesib (N=32) |
Phase 2- Filanesib/Dex (N=55) |
---|---|---|---|
AEs leading to dose reduction | |||
Thrombocytopenia | 1 (3) | 3 (9) | 3 (5) |
Febrile neutropenia | 5 (16) | 1 (3) | 0 (0) |
Mucosal inflammation | 5 (16) | 1 (3) | 0 (0) |
Neutropenia | 2 (6) | 1 (3) | 1 (2) |
Vomiting | 0 (0) | 3 (9) | 0 (0) |
Diarrhea | 0 (0) | 2 (6) | 0 (0) |
Pyrexia | 0 (0) | 2 (6) | 0 (0) |
Lipase increased | 0 (0) | 1 (3) | 1 (2) |
Pneumonia | 1 (3) | 1 (3) | 0 (0) |
Leukopenia | 1 (3) | 0 (0) | 0 (0) |
Corneal disorder | 1 (3) | 0 (0) | 0 (0) |
Vision blurred | 1 (3) | 0 (0) | 0 (0) |
Nausea | 0 (0) | 1 (3) | 0 (0) |
Blood amylase increased | 0 (0) | 0 (0) | 1 (2) |
Bacteremia | 0 (0) | 1 (3) | 0 (0) |
Punctate keratitis | 0 (0) | 1 (3) | 0 (0) |
This table is based on the safety population.
Abbreviations: AE = adverse event(s); Dex = dexamethasone; N or n = number