Table 3.
Adverse events reported on study, regardless of attribution
| Overall population (N = 10) | Any grade, n (%) | Grade 3/4, n (%) | Grade 5, n (%) | |
|---|---|---|---|---|
| Nonhematologic | ||||
| Fatigue | 4 (40) | |||
| Infusion reaction | 2 (20) | |||
| Abdominal pain | 2 (20) | |||
| Anorexia | 2 (20) | |||
| Vomiting | 2 (20) | |||
| Diarrhea | 2 (20) | |||
| Constipation | 2 (20) | |||
| Cough | 2 (20) | |||
| Dyspnea | 2 (20) | |||
| Depression | 2 (20) | |||
| Rash | 1 (10) | 1 (10) | ||
| Peripheral neuropathy | 1 (10)* | |||
| Hematologic | ||||
| Neutropenia | 3 (30)† | |||
| Anemia | 2 (20) | 1 (10) | ||
| Thrombocytopenia | 1 (10) | |||
| Serious adverse events‡ | ||||
| Intracranial hemorrhage | 1 (10)¶ | |||
| Portal vein thrombosis | 1 (10) | |||
| Epiglottitis | 1 (10) | |||
| Pleural effusion | 1 (10) | |||
*
Pretreatment grade 1 neuropathy worsened to grade 2 after 1 cycle of BV, but subsequently returned to baseline without dose modification.
†
All grade 4 events, required dose holds for 1 wk (n = 1) and 3 wk (n = 2); 1 patient required dose reduction of BV for cycle 7 after 2 successive dose holds.
‡
All SAEs were considered unrelated to BV.
¶
Patient died of an intracranial hemorrhage resulting from a mechanical fall during cycle 1 of BV in the setting of thrombocytopenia.