Table 2.
Adverse Events by Treatment Arm (Pre- and Post Addendum)
| Adverse Event (%) | CPB | CPBE | ||
|---|---|---|---|---|
| Pre-addendum 5 | Post-Addendum 5 | |||
| Neutropenia | ||||
| Grade 3+ | 28.2 | 50 | 51 | |
| Grade 4+ | 7 | 5 | 7.8 | |
|
| ||||
| Leukopenia | ||||
| Grade 3+ | 15.5 | 35 | 19.6 | |
| Grade 4+ | 1.4 | 0 | 2 | |
|
| ||||
| Anemia | ||||
| Grade 3+ | 9.9 | 10 | 5.9 | |
| Grade 4+ | 0 | 0 | 0 | |
|
| ||||
| Thrombocytopenia | ||||
| Grade 3+ | 1.4 | 10 | 3.9 | |
| Grade 4+ | 2.8 | 0 | 5.9 | |
|
| ||||
| Fatigue | ||||
| Grade 3+ | 12.7 | 15 | 17.6 | |
| Grade 4+ | 0 | 0 | 0 | |
|
| ||||
| Anorexia | ||||
| Grade 3+ | 2.8 | 10 | 5.9 | |
| Grade 4+ | 0 | 0 | 0 | |
|
| ||||
| Hypertension | ||||
| Grade 3+ | 12.7 | 20 | 21.6 | |
| Grade 4+ | 0 | 0 | 0 | |
|
| ||||
| Nausea | ||||
| Grade 3+ | 4.2 | 0 | 11.8 | |
| Grade 4+ | 0 | 0 | 0 | |
|
| ||||
| Vomiting | ||||
| Grade 3+ | 2.8 | 0 | 5.9 | |
| Grade 4+ | 0 | 0 | 0 | |
|
| ||||
| Thromboembolism | ||||
| Grade 3+ | 2.8 | 10 | 3.9 | |
| Grade 4+ | 0 | 0 | 0 | |
|
| ||||
| Sensory Neuropathy | Grade 3+ | 2.8 | 0 | 2 |
| Grade 4+ | 0 | 0 | 0 | |
|
| ||||
| Diarrhea | ||||
| Grade 3+ | 5.6 | 5 | 5.9 | |
| Grade 4+ | 0 | 0 | 2 | |
|
| ||||
| Generalized Muscle Weakness | ||||
| Grade 3+ | 2.8 | 5 | 3.9 | |
| Grade 4+ | 0 | 0 | 0 | |
|
| ||||
| Abdominal Pain | ||||
| Grade 3+ | 7 | 0 | 11.8 | |
| Grade 4+ | 0 | 0 | 0 | |