Table 1. Adverse Events Occurring in > 10% of Patients With Relapsed or Refractory DLBCL and ≥ 5% in the Polatuzumab Vedotin Plus Bendamustine and Rituximab Group.
Polatuzumab vedotin + BR (n = 45) |
BR (n = 39) |
|||
---|---|---|---|---|
Adverse events by body system | All grades, % | Grade 3 or higher, % | All grades, % | Grade 3 or higher, % |
Blood and lymphatic system disorders | ||||
Neutropenia | 49 | 42 | 44 | 36 |
Thrombocytopenia | 49 | 40 | 33 | 26 |
Anemia | 47 | 24 | 28 | 18 |
Lymphopenia | 13 | 13 | 8 | 8 |
Nervous system disorders | ||||
Peripheral neuropathy | 40 | 0 | 8 | 0 |
Dizziness | 13 | 0 | 8 | 0 |
Gastrointestinal disorders | ||||
Diarrhea | 38 | 4.4 | 28 | 5 |
Vomiting | 18 | 2.2 | 13 | 0 |
General disorders | ||||
Infusion-related reaction | 18 | 2.2 | 8 | 0 |
Pyrexia | 33 | 2.2 | 23 | 0 |
Decreased appetite | 27 | 2.2 | 21 | 0 |
Infections | ||||
Pneumonia | 22 | 16a | 15 | 2.6b |
Upper respiratory tract infection | 13 | 0 | 8 | 0 |
Investigations | ||||
Weight decreased | 16 | 2.2 | 8 | 2.6 |
Metabolism and nutrition disorders | ||||
Hypokalemia | 16 | 9 | 10 | 2.6 |
Hypoalbuminemia | 13 | 2.2 | 8 | 0 |
Hypocalcemia | 11 | 2.2 | 5 | 0 |
Note. The table includes a combination of grouped and ungrouped terms. Events were graded using NCI CTCAE version 4. Reprinted with permission from Genentech, Inc. (2019).
aIncludes 2 events with fatal outcome.
bIncludes 1 event with fatal outcome.