Table 3.

Treatment-related, grade 3/4 adverse events

Event category and adverse event*10 mg twice daily (n = 51)100 mg twice daily (n = 52)Total (n = 103)
Any adverse event6 (12)4 (8)10 (10)
General
    Anemia1 (2)0 (0)1 (1)
    Injection site urticaria0 (0)1 (2)1 (1)
    Neutrophil count decreased1 (2)0 (0)1 (1)
    Anorexia2 (4)0 (0)2 (2)
    Decreased appetite1 (2)0 (0)1 (1)
Bleeding
    Gastrointestinal hemorrhage0 (0)1 (2)1 (1)
    Intracranial hemorrhage1 (2)0 (0)1 (1)
    Hemoptysis0 (0)1 (2)1 (1)
Thrombosis
    Deep vein thrombosis0 (0)1 (2)1 (1)
  • NOTE: Adverse events are possibly or probably related to study drug based on investigator's assessment of causality. Values in table expressed as n (%).

  • * Adverse events were coded using the Medical Dictionary for Regulatory Activities, version 9.0.

  • Serious adverse event.