Table 2.
Serious Adverse Events.
| Event | During Chemoradiotherapy | During Adjuvant Treatment | ||||||
|---|---|---|---|---|---|---|---|---|
| Bevacizumab (N = 303) |
Placebo (N = 300) |
Bevacizumab (N = 260) |
Placebo (N = 233) |
|||||
| Grade 3 | Grade 4 | Grade 3 | Grade 4 | Grade 3 | Grade 4 | Grade 3 | Grade 4 | |
| number of patients (percent) | ||||||||
| Anemia | 1 (0.3) | 1 (0.3) | 1 (0.3) | 0 | 4 (1.5) | 2 (0.8) | 3 (1.3) | 0 |
| Leukopenia | 10 (3.3) | 6 (2.0) | 4 (1.3) | 3 (1.0) | 20 (7.7) | 2 (0.8) | 14 (6.0) | 0 |
| Neutropenia | 7 (2.3) | 15 (5.0) | 5 (1.7) | 6 (2.0) | 20 (7.7) | 6 (2.3) | 7 (3.0) | 5 (2.1) |
| Lymphopenia | 24 (7.9) | 8 (2.6) | 22 (7.3) | 5 (1.7) | 27 (10.4) | 7 (2.7) | 23 (10) | 8 (3.4) |
| Thrombocytopenia | 10 (3.3) | 21 (6.9) | 17 (5.7) | 6 (2.0) | 18 (6.9) | 11 (4.2) | 23 (10) | 4 (1.7) |
| Fatigue | 7 (2.3) | 0 | 8 (2.7) | 0 | 32 (12.3) | 2 (0.8) | 21 (9.0) | 0 |
| Nausea and vomiting | 2 (0.7) | 0 | 1 (0.3) | 0 | 11 (4.2) | 0 | 4 (1.7) | 0 |
| Wound dehiscence | 3 (1.0) | 0 | 1 (0.3) | 0 | 3 (1.2) | 1 (0.4) | 2 (0.9) | 0 |
| Hypertension | 4 (1.3) | 0 | 1 (0.3) | 0 | 11 (4.2) | 0 | 2 (0.9) | 0 |
| Thromboembolic disease | 6 (2.0) | 8 (2.6) | 3 (1.0) | 8 (2.7) and 1 grade 5 (0.3) | 11 (4.2) | 8 (3.1) and 1 grade 5 (0.4) | 7 (3.0) | 4 (1.7) |
| Hemorrhage | 0 | 0 | 1 (0.3) | 0 | 3 (1.2) | 1 grade 5 (0.4) | 2 (0.9) | 0 |
| Visceral perforation | 1 (0.3) | 0 | 0 | 1 (0.3) | 2 (0.8) | 1 (0.4) | 1 (0.4) | 0 |