Adverse events
| . | 300 mg (N = 10) . | 500 mg (N = 10) . | 700 mg (N = 10) . | 1000 mg (N = 10) . | Total (N = 40) . | Related . |
|---|---|---|---|---|---|---|
| Total no. | ||||||
| AEs | 80 | 44 | 72 | 78 | 274 | 190 |
| AEs reported on any infusion day | 49 | 30 | 37 | 43 | 159 | 152 |
| AEs on first infusion day | 41 | 24 | 34 | 35 | 134 | 132 |
| SAEs | 3 | 1 | 1 | 2 | 7 | 1 |
| Total no. of AEs ≥ grade 3 (no. of patients)* | 6 (4) | 1 (1) | 3 (3) | 3 (2) | 13 (10) | 8 (7) |
| Dyspnea | 2 | 1 | 3 | 2 | ||
| Hypoxia | 1 | 1 | 1 | |||
| Laryngeal edema | 1 | 1 | 1 | |||
| Throat tightness | 1 | 1 | 1 | |||
| Neutropenic sepsis | 1 | 1 | ||||
| Urinary tract infection | 1 | 1 | ||||
| Pruritus | 1 | 1 | 1 | |||
| Rash | 1 | 1 | 1 | |||
| Abdominal pain | 1 | 1 | 1 | |||
| Ovarian epithelial cancer | 1 | 1 | ||||
| Hydronephrosis | 1 | 1 |
| . | 300 mg (N = 10) . | 500 mg (N = 10) . | 700 mg (N = 10) . | 1000 mg (N = 10) . | Total (N = 40) . | Related . |
|---|---|---|---|---|---|---|
| Total no. | ||||||
| AEs | 80 | 44 | 72 | 78 | 274 | 190 |
| AEs reported on any infusion day | 49 | 30 | 37 | 43 | 159 | 152 |
| AEs on first infusion day | 41 | 24 | 34 | 35 | 134 | 132 |
| SAEs | 3 | 1 | 1 | 2 | 7 | 1 |
| Total no. of AEs ≥ grade 3 (no. of patients)* | 6 (4) | 1 (1) | 3 (3) | 3 (2) | 13 (10) | 8 (7) |
| Dyspnea | 2 | 1 | 3 | 2 | ||
| Hypoxia | 1 | 1 | 1 | |||
| Laryngeal edema | 1 | 1 | 1 | |||
| Throat tightness | 1 | 1 | 1 | |||
| Neutropenic sepsis | 1 | 1 | ||||
| Urinary tract infection | 1 | 1 | ||||
| Pruritus | 1 | 1 | 1 | |||
| Rash | 1 | 1 | 1 | |||
| Abdominal pain | 1 | 1 | 1 | |||
| Ovarian epithelial cancer | 1 | 1 | ||||
| Hydronephrosis | 1 | 1 |
AE indicates adverse event; N, number of subjects exposed to trial drug.
Only treatment-emergent AEs are presented.