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
 Fatigue4 (40)
 Infusion reaction2 (20)
 Abdominal pain2 (20)
 Anorexia2 (20)
 Vomiting2 (20)
 Diarrhea2 (20)
 Constipation2 (20)
 Cough2 (20)
 Dyspnea2 (20)
 Depression2 (20)
 Rash1 (10)1 (10)
 Peripheral neuropathy1 (10)*
Hematologic
 Neutropenia3 (30)
 Anemia2 (20)1 (10)
 Thrombocytopenia1 (10)
Serious adverse events
 Intracranial hemorrhage1 (10)
 Portal vein thrombosis1 (10)
 Epiglottitis1 (10)
 Pleural effusion1 (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.