Table 3.

Frequency of patients with bleeding events

Below MTD (n = 12)At MTD (n = 12)Above MTD (n = 2)Total (n = 26)
Patients with any bleeding events* [n (%)]7 (58.3)3 (25.0)1 (50.0)11 (42.3)
CTCAE grade of most intense bleeding event [n (%)]
    CTCAE grade 16 (50.0)2 (16.7)1 (50.0)9 (34.6)
    CTCAE grade 21 (8.3)1 (8.3)0 (0.0)2 (7.7)
Patients with drug-related bleeding event [n (%)]4 (33.3)0 (0.0)0 (0.0)4 (15.4)
Patients with any bleeding event determined to be DLT [n (%)]0 (0.0)0 (0.0)0 (0.0)0 (0.0)
  • *Bleeding events include the MedDRA PT of “epistaxis,” “hematuria,” “hemoptysis,” and “rectal hemorrhage.”