AEs during treatment according to category
| . | Grade ≥3 AEs∗ n = 248 . | Grade ≥3 SAEs† n = 102 . |
|---|---|---|
| Infection | 84 | 41 |
| Febrile neutropenia | 12 | 8 |
| Neutropenia | 40 | 6 |
| Thrombocytopenia | 8 | 2 |
| Lymphopenia | 32 | 1 |
| Infusion-related events‡ | 11 | 8 |
| Tumor lysis syndrome | 4 | 3 |
| Pyrexia | 6 | 0 |
| Anemia | 4 | 2 |
| Constitutional/musculoskeletal | 3 | 1 |
| Cardiac event | 5 | 4 |
| CNS (CVA, TIA, syncope, etc) | 2 | 1§ |
| MDS | 5 | 4 |
| Gastrointestinal symptoms | 9 | 5 |
| Gastrointestinal perforation | 2 | 1 |
| Respiratory (dyspnea, cough, etc) | 6 | 2 |
| Hemorrhagic event | 1 | 1 |
| Nonmelanoma skin cancer | 1 | 1 |
| Skin rash | 2 | 2 |
| Hypogammaglobulinemia | 3 | 3 |
| Thromboembolic event | 4 | 2 |
| Progressive multifocal encephalopathy | 1 | 1 |
| Other | 3 | 3 |
| . | Grade ≥3 AEs∗ n = 248 . | Grade ≥3 SAEs† n = 102 . |
|---|---|---|
| Infection | 84 | 41 |
| Febrile neutropenia | 12 | 8 |
| Neutropenia | 40 | 6 |
| Thrombocytopenia | 8 | 2 |
| Lymphopenia | 32 | 1 |
| Infusion-related events‡ | 11 | 8 |
| Tumor lysis syndrome | 4 | 3 |
| Pyrexia | 6 | 0 |
| Anemia | 4 | 2 |
| Constitutional/musculoskeletal | 3 | 1 |
| Cardiac event | 5 | 4 |
| CNS (CVA, TIA, syncope, etc) | 2 | 1§ |
| MDS | 5 | 4 |
| Gastrointestinal symptoms | 9 | 5 |
| Gastrointestinal perforation | 2 | 1 |
| Respiratory (dyspnea, cough, etc) | 6 | 2 |
| Hemorrhagic event | 1 | 1 |
| Nonmelanoma skin cancer | 1 | 1 |
| Skin rash | 2 | 2 |
| Hypogammaglobulinemia | 3 | 3 |
| Thromboembolic event | 4 | 2 |
| Progressive multifocal encephalopathy | 1 | 1 |
| Other | 3 | 3 |
CNS, central nervous system; CVA, cerebrovascular accident; PML, progressive multifocal leukoencephalopathy; TIA, transient ischaemic attack.
AEs of grade 3, 4, and 5 indicate severe, life-threatening, and fatal AEs.
SAEs include fatal or life-threating events or events that caused (prolonged) hospital admission or substantial disability.
Infusion reactions were attributed to rituximab in 9 patients and to bendamustine in 2 patients (grade 3, n = 1, grade 4, n = 1, which resulted in treatment discontinuation).
One patient died from PML due to JC virus during follow-up.