Table 4.
Adverse events*.
| Toxicity category | All (N = 91) | Treatment naïve |
Relapsed or ≥second line |
||||||
|---|---|---|---|---|---|---|---|---|---|
| Bendamustine monotherapy (n = 10) |
Bendamustine + rituximab combination therapy (n = 6) |
Bendamustine monotherapy (n = 20) |
Bendamustine + rituximab combination therapy (n = 55) |
||||||
| Total AEs (all grades) | All grades (n) | Grade 3/4 (n) | All grades (n) | Grade 3/4 (n) | All grades (n) | Grade 3/4 (n) | All grades (n) | Grade 3/4 (n) | |
| Weight loss | 10 | 1 (grade 0) | 0 | 0 | 0 | 2 (grade 0) | 0 | 7 (grade 0) | 0 |
| Pulmonary | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 1 |
| URI (1) | URI (1)$ | URI (1)$ | |||||||
| Dyspnea (2) | Dyspnea (2) | ||||||||
| Pleural effusion (1) Worsened pulmonary function (1) | Pleural effusion (1) Worsened pulmonary function (1) | ||||||||
| Other (1) | Other (1) | ||||||||
| Cardiac | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Mild CHF | Mild CHF | ||||||||
| Blood/bone marrow | 37 | 5 | 2 | 2 | 1 | 13 | 6 | 17 | 13 |
| Hematologic (1) | Thrombocytopenia (1)$ | Thrombocytopenia (1)$ | Cytopenia (1) | Hematologic (1)$ | Thrombocytopenia (1)$ Cytopenia (3) | Thrombocytopenia (1)$ | Thrombocytopenia (2) Cytopenia (6) | Thrombocytopenia (1)$Cytopenia (5)$Neutropenia (5)$Myelosuppression(1)$Hemolysis (1)$ | |
| Thrombocytopenia (4)Cytopenia (13)Anemia (4)Neutropenia (10)Pancytopenia (2)Myelosuppression (1)Hemolysis (2) | Cytopenia (3)Anemia (1) | Cytopenia (1)$ | Hematologic (1)$ | Anemia (2)Neutropenia (4)Pancytopenia (2)Hemolysis (1)$ | Neutropenia (3)$ | Anemia (1) Neutropenia (6) | |||
| Pancytopenia (1)$ | Myelosuppression (1)$ | ||||||||
| Hemolysis (1)$ | Hemolysis (1)$ | ||||||||
| Skin | 5 | 2 | 1 | 0 | 0 | 1 | 1 | 2 | 0 |
| Rash (5) | Rash (2) | Rash (1)$ | Rash (1)$ | Rash (1)$ | Rash (2) | ||||
| Fever (no infection) | 8 | 2 | 0 | 0 | 0 | 1 | 0 | 5 | 0 |
| Gastrointestinal | 8 | 0 | 0 | 1 | 0 | 2 | 0 | 5 | 1 |
| Nausea/vomiting (4)Constipation (1) | Nausea/vomiting (1) | Nausea/vomiting (2) | Nausea/vomiting (1)Constipation (1) | Abdominal pain (1)$ | |||||
| Abdominal pain (1) | Mucositis (1) | ||||||||
| Mucositis (1) | Diarrhea (1) | ||||||||
| Diarrhea (1) | Abdominal pain (1)$ | ||||||||
| Neurologic | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Blood pressure | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 |
| Hypertension (4) | Hypertension (4) | ||||||||
| Hemorrhage | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Infection | 9 | 1 | 1 | 0 | 0 | 2 | 0 | 6 | 1 |
| Herpes zoster (2) | Klebsiella | Klebsiella sepsis (1) | Other (2) | Herpes zoster (2) | Cryptococcal sepsis (1) | ||||
| Cryptococcal | sepsis (1) | Cryptococcal | |||||||
| sepsis (1) | sepsis (1) | ||||||||
| Klebsiella sepsis (1) | Pneumonia (1) | ||||||||
| Pneumonia (1) | |||||||||
| Other (4) | Other (2) | ||||||||
| General | 34 | 3 | 0 | 1 | 0 | 9 | 0 | 21 | 0 |
| Fatigue (30) | Fatigue (3) | Fatigue (1) | Fatigue (6) | Fatigue (20) | |||||
| Weakness (3) | Weakness (2) | Weakness (1) | |||||||
| Anorexia (1) | Anorexia (1) | ||||||||
AE, adverse event; CHF, congestive heart failure; URI, upper respiratory infection.
*
Frequency is counted by type of events; each patient may have had multiple events.
$
Adverse event(s) led to dose reduction/delay or discontinuation of bendamustine.