Table 2.

Treatment-related side effects occurring in >5% of patients across primary and continuation treatment phases

Primary treatment phase (n = 40)Optional continuation phase (n = 16)
Total eventsBy grade: n (%)Total eventsBy grade: n (%)
Toxicityn (%)≤G2G3G4n (%)≤G2G3G4
Blood and lymphatic system disorders
 Anemia (decreased hemoglobin)33 (82.5)32 (80)1 (2.5)13 (81)13 (81)
General disorders and administration site conditions
 Chills4 (10)4 (10)1 (6)1 (6)
 Fatigue30 (75)28 (70)2 (5)8 (50)8 (50)
 Fever4 (10)4 (10)0 (0)
 Injection site reaction28 (70)28 (70)12 (75)12 (75)
Gastrointestinal disorders
 Bloating3 (7.5)3 (7.5)0 (0)
 Constipation15 (37.5)15 (37.5)6 (37.5)6 (37.5)
 Diarrhea2 (5)2 (5)2 (12.5)2 (12.5)
 Dyspepsia/GERD3 (7.5)3 (7.5)2 (12.5)2 (12.5)
 Nausea25 (62.5)24 (60)1 (2.5)6 (37.5)6 (37.5)
 Vomiting12 (30)11 (27.5)1 (2.5)1 (6)1 (6)
Infection and infestations
 Urinary tract infection4 (10)4 (10)0 (0)
 Infection, Other1 (2.5)1 (2.5)2 (12.5)1 (6)1 (6)
Investigations
 Neutrophil count decreased20 (50)11 (27.5)7 (17.5)2 (5)7 (44)4 (25)2 (12.5)1 (6)
 Platelet count decreased11 (27.5)11 (27.5)2 (12.5)2 (12.5)
 Weight loss2 (5)2 (5)1 (6)1 (6)
 White blood cell decreased28 (70)20 (50)7 (17.5)1 (2.5)13 (81)11 (69)2 (12.5)
Metabolism and nutrition disorders
 Anorexia10 (25)10 (25)4 (25)4 (25)
 Hypophosphatemia9 (22.5)7 (17.5)2 (5)4 (25)3 (19)1 (6)
Musculoskeletal and connective tissue disorders
 Back pain1 (2.5)1 (2.5)2 (12.5)2 (12.5)
 Bone pain2 (5)2 (5)1 (6)1 (6)
 Pain, NOS2 (5)2 (5)1 (6)1 (6)
 Pain, Other9 (22.5)9 (22.5)4 (25)4 (25)
Nervous system disorders
 Dysgeusia2 (5)2 (5)2 (12.5)2 (12.5)
 Headache10 (25)10 (25)2 (12.5)2 (12.5)
Psychiatric disorders
 Anxiety2 (5)2 (5)1 (6)1 (6)
 Depression2 (5)1 (2.5)1 (2.5)2 (12.5)2 (12.5)
 Insomnia3 (7.5)3 (7.5)0 (0)
Skin and subcutaneous tissue disorders
 Pruritus4 (10)4 (10)1 (6)1 (6)
  • NOTE: Number of worst grade adverse events possibly, probably, or definitely attributed to study drug administration. Toxicities are graded per the NCI CTCAE Version 4 criteria.

  • Abbreviations: ≤G2, grade 1 and 2; G3, grade 3; G4, grade 4; NOS, not otherwise specified.