Safety summary and TEAE profile
| n (%) . | All patients, N = 60 . |
|---|---|
| Patients with any TEAE | 60 (100.0) |
| Patients with any treatment-related TEAE | 54 (90.0) |
| TEAEs occurring in ≥15% of all patients | |
| CRS | 29 (48.3) |
| Fatigue | 21 (35.0) |
| Pyrexia | 19 (31.7) |
| Anemia | 18 (30.0) |
| Hypotension | 15 (25.0) |
| Cough | 15 (25.0) |
| Thrombocytopenia | 14 (23.3) |
| Diarrhea | 13 (21.7) |
| Nausea | 12 (20.0) |
| Hypophosphatemia | 11 (18.3) |
| Neutropenia | 11 (18.3) |
| Chills | 10 (16.7) |
| Insomnia | 10 (16.7) |
| Neutrophil count decreased | 10 (16.7) |
| Decreased appetite | 10 (16.7) |
| Peripheral edema | 9 (15.0) |
| Hypomagnesemia | 9 (15.0) |
| Abdominal pain | 9 (15.0) |
| Dyspnea | 9 (15.0) |
| Grade ≥3 TEAE | 46 (76.7) |
| Treatment-related grade ≥3 TEAE | 31 (51.7) |
| Serious TEAE | 33 (55.0) |
| Treatment-related serious TEAE | 24 (40.0) |
| TEAE leading to treatment discontinuation | 8 (13.3) |
| Treatment-related TEAE leading to treatment discontinuation | 5 (8.3) |
| TEAE leading to dose interruption/delay | 35 (58.3) |
| Treatment-related TEAE leading to dose interruption/delay | 28 (46.7) |
| TEAE leading to death | 2 (3.3) |
| Treatment-related TEAE leading to death | 1 (1.7) |
| n (%) . | All patients, N = 60 . |
|---|---|
| Patients with any TEAE | 60 (100.0) |
| Patients with any treatment-related TEAE | 54 (90.0) |
| TEAEs occurring in ≥15% of all patients | |
| CRS | 29 (48.3) |
| Fatigue | 21 (35.0) |
| Pyrexia | 19 (31.7) |
| Anemia | 18 (30.0) |
| Hypotension | 15 (25.0) |
| Cough | 15 (25.0) |
| Thrombocytopenia | 14 (23.3) |
| Diarrhea | 13 (21.7) |
| Nausea | 12 (20.0) |
| Hypophosphatemia | 11 (18.3) |
| Neutropenia | 11 (18.3) |
| Chills | 10 (16.7) |
| Insomnia | 10 (16.7) |
| Neutrophil count decreased | 10 (16.7) |
| Decreased appetite | 10 (16.7) |
| Peripheral edema | 9 (15.0) |
| Hypomagnesemia | 9 (15.0) |
| Abdominal pain | 9 (15.0) |
| Dyspnea | 9 (15.0) |
| Grade ≥3 TEAE | 46 (76.7) |
| Treatment-related grade ≥3 TEAE | 31 (51.7) |
| Serious TEAE | 33 (55.0) |
| Treatment-related serious TEAE | 24 (40.0) |
| TEAE leading to treatment discontinuation | 8 (13.3) |
| Treatment-related TEAE leading to treatment discontinuation | 5 (8.3) |
| TEAE leading to dose interruption/delay | 35 (58.3) |
| Treatment-related TEAE leading to dose interruption/delay | 28 (46.7) |
| TEAE leading to death | 2 (3.3) |
| Treatment-related TEAE leading to death | 1 (1.7) |
Treatment-related TEAEs led to hospitalization in 5 patients (device-related infection, pneumonia, encephalopathy, epilepsy, and acute pancreatitis; n = 1 each).