Treatment-related AEs in more than 5% of patients overall (MITT population: total N = 34)
| AEs . | No. (%) . |
|---|---|
| No. with any treatment-related AEs | 18 (52.9) |
| Chills | 11 (32.4) |
| Pyrexia | 6 (17.6) |
| Flushing | 4 (11.8) |
| Chest discomfort | 3 (8.8) |
| Fatigue | 3 (8.8) |
| Headache | 3 (8.8) |
| Sinus tachycardia | 3 (8.8) |
| Vomiting | 3 (8.8) |
| Anorexia | 2 (5.9) |
| Dyspnea | 2 (5.9) |
| Serum creatinine increased | 2 (5.9) |
| AEs . | No. (%) . |
|---|---|
| No. with any treatment-related AEs | 18 (52.9) |
| Chills | 11 (32.4) |
| Pyrexia | 6 (17.6) |
| Flushing | 4 (11.8) |
| Chest discomfort | 3 (8.8) |
| Fatigue | 3 (8.8) |
| Headache | 3 (8.8) |
| Sinus tachycardia | 3 (8.8) |
| Vomiting | 3 (8.8) |
| Anorexia | 2 (5.9) |
| Dyspnea | 2 (5.9) |
| Serum creatinine increased | 2 (5.9) |
MITT indicates modified intent to treat.