Table 3. Rates of Toxic Effects, According to Receipt or No Receipt of Bevacizumab.*.
| Toxic Effect | No Bevacizumab (N =596) | Bevacizumab (N =595) | P Value | ||||
|---|---|---|---|---|---|---|---|
| Grade 2 | Grade 3 | Gade 4 | Grade 2 | Grade 3 | Grade 4 | ||
| percent of patients | |||||||
| Overall† | 18 | 49 | 9 | 15 | 61 | 12 | <0.001 |
|
| |||||||
| Leukopenia | 0 | 6 | 1 | 0 | 6 | <1 | 0.47 |
|
| |||||||
| Neutropenia | 0 | 16 | 6 | 0 | 16 | 7 | 1.00 |
|
| |||||||
| Hypertension | 1 | <1 | 0 | 13 | 10 | <1 | <0.001 |
|
| |||||||
| Left ventricular systolic dysfunction | <1 | <1 | 0 | 2 | 1 | <1 | 0.02 |
|
| |||||||
| Fatigue | 0 | 9 | <1 | 0 | 10 | <1 | 0.95 |
|
| |||||||
| Hand–foot syndrome | 11 | 7 | 0 | 15 | 11 | 0 | 0.008 |
|
| |||||||
| Rash | 10 | <1 | <1 | 14 | 1 | <1 | 0.34 |
|
| |||||||
| Diarrhea | 13 | 7 | <1 | 14 | 5 | 0 | 0.67 |
|
| |||||||
| Mucositis | 11 | 1 | 0 | 14 | 4 | <1 | 0.007 |
|
| |||||||
| Nausea | 0 | 4 | <1 | 0 | 5 | 0 | 0.99 |
|
| |||||||
| Vomiting | 0 | 5 | <1 | 0 | 3 | 0 | 0.45 |
|
| |||||||
| Febrile neutropenia | 0 | 6 | <1 | 0 | 10 | <1 | 0.15 |
|
| |||||||
| Infection in wound | 0 | <1 | 0 | 0 | 3 | 0 | 1.00 |
|
| |||||||
| Sensory neuropathy | 11 | 3 | 0 | 12 | 4 | 0 | 0.55 |
|
| |||||||
| Bone pain | 0 | 3 | <1 | 0 | 4 | 0 | 0.39 |
|
| |||||||
| Headache | 0 | <1 | 0 | 0 | 4 | <1 | 0.01 |
|
| |||||||
| Dyspnea | 4 | <1 | 0 | 4 | 1 | <1 | 0.69 |
|
| |||||||
| Thrombosis, thrombus, or embolism | <1 | 1 | <1 | 1 | 2 | 1 | 0.78 |
*
Patients were randomly assigned to receive bevacizumab with each of the first six cycles of chemotherapy.
†
The rate of death in the overall cohort during the treatment period was less than 1% in both groups.