Table 3.

Nonhematological adverse events in >10% of patients, regardless of attribution

Adverse event* by armn (%)
Grade 3Grade 4Grade 5Total
Fatigue
 A12 (14.8)0012 (14.8)
 B16 (20)0016 (20)
Infections and infestations
 A10 (12.3)1 (1.2)1 (1.2)12 (14.7)
 B10 (12.5)01 (1.3)11 (13.8)
Sepsis
 A011 (13.6)5 (6.2)16 (19.8)
 B05 (6.3)6 (7.5)11 (13.8)
Lung infection
 A16 (19.8)2 (2.5)2 (2.5)20 (24.8)
 B20 (25)02 (2.5)22 (27.5)
Hyperglycemia
 A10 (12.3)3 (3.7)013 (16)
 B13 (16.3)0013 (16.3)
Hypoalbuminemia
 A16 (19.8)0016 (19.8)
 B10 (12.5)0010 (12.5)
Hypocalcemia
 A7 (8.6)3 (3.7)010 (12.3)
 B3 (3.8)1 (1.3)04 (5.1)
Hypokalemia
 A10 (12.3)3 (3.7)013 (16)
 B12 (15)1 (1.3)013 (16.3)
Hypophosphatemia
 A9 (11.1)009 (11.1)
 B6 (7.5)006 (7.5)
Peripheral sensory neuropathy
 A0000
 B8 (10)2 (2.5)010 (12.5)
Dyspnea
 A9 (11.1)009 (11.1)
 B10 (12.5)1 (1.3)011 (13.8)
Hypoxia
 A6 (7.4)1 (1.2)07 (8.6)
 B8 (10)01 (1.3)9 (11.3)
Hypertension
 A6 (7.4)006 (7.4)
 B14 (17.5)0014 (17.5)
Hypotension
 A11 (13.6)3 (3.7)014 (17.3)
 B10 (12.5)4 (5)014 (17.5)
  • Excludes hematological toxicity and febrile neutropenia, which were observed in all patients.

  • * Regardless of attribution, per National Cancer Institute Common Toxicity Criteria (version 4.0).

  • 161 patients were evaluated for adverse events: arm A (decitabine), n = 81; arm B (decitabine + bortezomib), n = 80.