Table 2.
Most frequent drug-related AEs (≥20 % in any treatment group for all grades): treated patients
| AEs | Ixabepilone + bevacizumab | Paclitaxel + bevacizumab | ||||
|---|---|---|---|---|---|---|
| Arm A (n = 46) | Arm B (n = 45) | Arm C (n = 32) | ||||
| Any | Grade 3 or 4 | Any | Grade 3 or 4 | Any | Grade 3 or 4 | |
| Non-hematologic abnormality, n (%) | ||||||
| Peripheral neuropathy | 34 (75.6) | 8 (17.8)a | 36 (80.0) | 11 (24.4)a | 26 (81.3) | 8 (25.0)a |
| Epistaxis | 22 (48.9) | 0 | 16 (35.6) | 0 | 19 (59.4) | 0 |
| Alopecia | 17 (37.8) | 0 | 22 (48.9) | 0 | 17 (53.1) | 0 |
| Diarrhea | 21 (46.7) | 5 (11.1) | 11 (24.4) | 0 | 17 (53.1) | 1 (3.1) |
| Nausea | 17 (37.8) | 1 (2.2) | 12 (26.7) | 1 (2.2) | 11 (34.4) | 0 |
| Hypertension | 12 (26.7) | 1 (2.2) | 20 (44.4) | 2 (4.4) | 7 (21.9) | 2 (6.3) |
| Asthenia | 14 (31.1) | 1 (2.2) | 16 (35.6) | 6 (13.3) | 9 (28.1) | 0 |
| Headache | 15 (33.3) | 1 (2.2) | 9 (20.0) | 0 | 11 (34.4) | 0 |
| Nail disorder | 10 (22.2) | 0 | 8 (17.8) | 0 | 15 (46.9) | 1 (3.1) |
| Fatigue | 13 (28.9) | 1 (2.2) | 9 (20.0) | 2 (4.4) | 10 (31.3) | 0 |
| Vomiting | 13 (28.9) | 1 (2.2) | 6 (13.3) | 1 (2.2) | 10 (31.3) | 0 |
| Constipation | 13 (28.9) | 0 | 9 (20.0) | 0 | 6 (18.8) | 0 |
| Mucosal inflammation | 7 (15.6) | 0 | 10 (22.2) | 1 (2.2) | 8 (25.0) | 0 |
| Myalgia | 11 (24.4) | 2 (4.4) | 11 (24.4) | 0 | 2 (6.3) | 0 |
| Dysgeusia | 9 (20.0) | 0 | 8 (17.8) | 0 | 4 (12.5) | 0 |
| Stomatitis | 4 (8.9) | 0 | 10 (22.2) | 2 (4.4) | 5 (15.6) | 0 |
| Decreased appetite | 9 (20.0) | 0 | 9 (20.0) | 1 (2.2) | 1 (3.1) | 0 |
| Rash | 7 (15.6) | 0 | 4 (8.9) | 0 | 8 (25.0) | 0 |
| Hematologic abnormality, n (%) | ||||||
| Leukopenia | 28 (62.2) | 3 (6.7) | 42 (93.3) | 18 (40.0) | 26 (81.3) | 3 (9.4) |
| Neutropenia | 26 (57.8) | 7 (15.6) | 41 (91.1) | 27 (60.0) | 26 (81.3) | 7 (21.9) |
| Anemia | 26 (57.8) | 2 (4.4) | 27 (60.0) | 3 (6.7) | 22 (68.8) | 2 (6.3) |
| Thrombocytopenia | 7 (15.6) | 2 (4.4) | 17 (37.8) | 1 (2.2) | 3 (9.4) | 0 |
AEs adverse events
aNo grade 4 event was reported