Table 2.
Treatment-related AEs by dose level and symptom
| Rigosertib twice daily dosing (mg) | 70 | 140 | 280 | 560 | 700 | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Evaluable patients | 3 | 2 | 3 | 33 | 6 | 47 | ||||||
| Patients with a DLT | 0 |
0 |
0 |
1 |
1 |
2 |
||||||
| Grade | 2 | 3 | 2 | 3 | 2 | 3 | 2 | 3 | 2 | 3 | 2 | 3 |
| Dysuria | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 2a | 4 | 0 | 17 | 2 |
| Cystitis | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 4 | 0 |
| Micturition urgency | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 4 | 0 |
| Hematuria | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1a | 1 | 1b | 2 | 2 |
| Urinary hesitancy | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| Abdominal discomfort | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Abdominal distension | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Abdominal pain | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Nausea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Fatigue | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 |
| Hypertonic bladder | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| Pelvic pain | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 1 |
| Hyponatremia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
a
DLT (grade 3 hematuria and dysuria week 3).
b
DLT (grade 3 hematuria week 2).