Most common AEs during the treatment period
| . | Phase 1, n = 13 . | Phase 2, n = 20 . |
|---|---|---|
| Patients with at least 1 AE (all grades), n (%) | 13 (100) | 20 (100) |
| IRR* | 13 (100) | 19 (95) |
| Hypotension | 10 (77) | 12 (60) |
| Pyrexia | 8 (62) | 13 (65) |
| Chills | 7 (54) | 6 (30) |
| Vomiting | 6 (46) | 11 (55) |
| Neutropenia | 7 (54) | 4 (20) |
| Thrombocytopenia | 4 (31) | 3 (15) |
| Pyrexia | 3 (23) | 4 (20) |
| Lymphopenia | 4 (31) | 2 (10) |
| Anemia | 1 (8) | 5 (25) |
| Febrile neutropenia | 1 (8) | 2 (10) |
| Patients with at least 1 AE (grade 3), n (%) | 8 (62) | 13 (65) |
| IRR | 2 (15) | 5 (25) |
| Neutropenia | 2 (15) | 1 (5) |
| Febrile neutropenia | 0 (0) | 0 (0) |
| Lymphopenia | 2 (15) | 2 (10) |
| Thrombocytopenia | 2 (15) | 0 (0) |
| Leukopenia | 2 (15) | 1 (5) |
| Anemia | 0 (0) | 2 (10) |
| Patients with at least 1 AE (grade 4), n (%) | 6 (46) | 7 (35) |
| Neutropenia | 5 (38) | 3 (15) |
| Febrile neutropenia | 1 (8) | 1 (5) |
| Thrombocytopenia | 0 (0) | 3 (15) |
| . | Phase 1, n = 13 . | Phase 2, n = 20 . |
|---|---|---|
| Patients with at least 1 AE (all grades), n (%) | 13 (100) | 20 (100) |
| IRR* | 13 (100) | 19 (95) |
| Hypotension | 10 (77) | 12 (60) |
| Pyrexia | 8 (62) | 13 (65) |
| Chills | 7 (54) | 6 (30) |
| Vomiting | 6 (46) | 11 (55) |
| Neutropenia | 7 (54) | 4 (20) |
| Thrombocytopenia | 4 (31) | 3 (15) |
| Pyrexia | 3 (23) | 4 (20) |
| Lymphopenia | 4 (31) | 2 (10) |
| Anemia | 1 (8) | 5 (25) |
| Febrile neutropenia | 1 (8) | 2 (10) |
| Patients with at least 1 AE (grade 3), n (%) | 8 (62) | 13 (65) |
| IRR | 2 (15) | 5 (25) |
| Neutropenia | 2 (15) | 1 (5) |
| Febrile neutropenia | 0 (0) | 0 (0) |
| Lymphopenia | 2 (15) | 2 (10) |
| Thrombocytopenia | 2 (15) | 0 (0) |
| Leukopenia | 2 (15) | 1 (5) |
| Anemia | 0 (0) | 2 (10) |
| Patients with at least 1 AE (grade 4), n (%) | 6 (46) | 7 (35) |
| Neutropenia | 5 (38) | 3 (15) |
| Febrile neutropenia | 1 (8) | 1 (5) |
| Thrombocytopenia | 0 (0) | 3 (15) |
Events occurring during or within 24 hours of an infusion for which there was a reasonable suspected causal relationship with that infusion.