Table 3.
Adverse events in at least 25% of patients
| EBd (n = 75) | Bd (n = 75) | |||
|---|---|---|---|---|
| Events* | Any grade† | Grade 3-4 | Any grade† | Grade 3-4 |
| All AEs | 75 (100) | 53 (71) | 72 (96) | 45 (60) |
| Infections | 50 (67) | 16 (21) | 40 (53) | 10 (13) |
| Diarrhea | 33 (44) | 6 (8) | 25 (33) | 3 (4) |
| Constipation | 30 (40) | 1 (1) | 22 (29) | 0 |
| Cough | 33 (44) | 1 (1) | 18 (24) | 0 |
| Anemia | 28 (37) | 5 (7) | 22 (29) | 5 (7) |
| Peripheral neuropathy | 27 (36) | 7 (9) | 27 (36) | 9 (12) |
| Pyrexia | 28 (37) | 0 | 21 (28) | 3 (4) |
| Peripheral edema | 22 (29) | 3 (4) | 18 (24) | 0 |
| Insomnia | 22 (29) | 1 (1) | 14 (19) | 1 (1) |
| Asthenia | 21 (28) | 3 (4) | 22 (29) | 2 (3) |
| Fatigue | 22 (29) | 3 (4) | 19 (25) | 1 (1) |
| Paresthesia | 20 (27) | 0 | 14 (19) | 4 (5) |
| Nausea | 20 (27) | 1 (1) | 16 (21) | 1 (1) |
| Thrombocytopenia | 12 (16) | 7 (9) | 20 (27) | 13 (17) |
Data are n (%) of patients. Data cutoff: August 10, 2015.
*
AEs were categorized using the Medical Dictionary for Regulatory Activities and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3).12
†
Grade 5 AEs occurred in 4 patients in the EBd group and 6 patients in the Bd group.