Table 3.
AEs in ≥20% of patients by grade following first infusion: mITT population
| Preferred term | No of patients with AEs (N=11) | |||
| Any grade | Grade 3 | Grade 4 | Grade 5 | |
| Patients with any AEs | 11 | 10 | 10 | 2* |
| Lymphopenia /lymphocyte count decreased |
11 | 1 | 10 | 0 |
| Leukopenia/WBC count decreased | 10 | 0 | 10 | 0 |
| Anemia/RBC count decreased | 9 | 6 | 0 | 0 |
| Neutropenia/neutrophil count decreased | 9 | 0 | 8 | 0 |
| Nausea | 7 | 1 | 0 | 0 |
| Pyrexia | 6 | 0 | 0 | 0 |
| Constipation | 5 | 0 | 0 | 0 |
| Hyponatremia | 5 | 5 | 0 | 0 |
| Edema peripheral | 5 | 0 | 0 | 0 |
| Thrombocytopenia /platelet count decreased |
5 | 3 | 2 | 0 |
| Chills | 4 | 0 | 0 | 0 |
| Decreased appetite | 4 | 0 | 0 | 0 |
| Fatigue | 4 | 1 | 0 | 0 |
| Pneumonia | 4 | 1 | 0 | 1 |
| Alopecia | 3 | 0 | 0 | 0 |
| CRS | 3 | 0 | 1 | 0 |
| Diarrhea | 3 | 0 | 0 | 0 |
| Pancytopenia | 3 | 1 | 2 | 0 |
| Sinus tachycardia/tachycardia | 3 | 0 | 0 | 0 |
*There were two grade 5 events: one each of pneumonia and disease progression; neither was considered related to treatment.
AE, adverse event; CRS, cytokine release syndrome; mITT, modified intention-to-treat; RBC, red blood cell; WBC, white blood cell.