Table 5.
AEs leading to treatment discontinuation
| AE, n (%) | Phase 1 dose escalation (all doses) (N=31) |
Phase 2- Filanesib (N=32) |
Phase 2- Filanesib/Dex (N=55) |
|---|---|---|---|
| Death | 0 (0) | 1 (3) | 1 (2) |
| Fatigue | 0 (0) | 2 (6) | 0 (0) |
| Arthritis bacterial | 0 (0) | 0 (0) | 1 (2) |
| Pneumonia | 0 (0) | 0 (0) | 1 (2) |
| Sepsis | 1 (3) | 0 (0) | 1 (2) |
| Septic shock | 0 (0) | 0 (0) | 1 (2) |
| Thrombocytopenia | 1 (3) | 0 (0) | 2 (4) |
| Febrile neutropenia | 0 (0) | 0 (0) | 1 (2) |
| Hypercalcemia | 0 (0) | 0 (0) | 2 (4) |
| Dehydration | 0 (0) | 0 (0) | 1 (2) |
| Fluid overload | 0 (0) | 1 (3) | 0 (0) |
| Acute respiratory distress syndrome | 0 (0) | 0 (0) | 1 (2) |
| Dyspnea | 0 (0) | 0 (0) | 1 (2) |
| Cardiac failure congestive | 0 (0) | 0 (0) | 1 (2) |
| Renal failure acute | 0 (0) | 0 (0) | 1 (2) |
| Blister | 0 (0) | 1 (3) | 0 (0) |
| Leukopenia | 1 (3) | 0 (0) | 0 (0) |
| Neutropenia | 1 (3) | 0 (0) | 0 (0) |
| Atrial fibrillation | 1 (3) | 0 (0) | 0 (0) |
| Vision blurred | 1 (3) | 0 (0) | 0 (0) |
This table is based on the safety population.
Abbreviations: AE = adverse event(s); Dex = dexamethasone; N or n = number