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 events | By grade: n (%) | Total events | By grade: n (%) | |||||
| Toxicity | n (%) | ≤G2 | G3 | G4 | n (%) | ≤G2 | G3 | G4 |
| 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 | ||||||||
| Chills | 4 (10) | 4 (10) | — | — | 1 (6) | 1 (6) | — | — |
| Fatigue | 30 (75) | 28 (70) | 2 (5) | — | 8 (50) | 8 (50) | — | — |
| Fever | 4 (10) | 4 (10) | — | — | 0 (0) | — | — | — |
| Injection site reaction | 28 (70) | 28 (70) | — | — | 12 (75) | 12 (75) | — | — |
| Gastrointestinal disorders | ||||||||
| Bloating | 3 (7.5) | 3 (7.5) | — | — | 0 (0) | |||
| Constipation | 15 (37.5) | 15 (37.5) | — | — | 6 (37.5) | 6 (37.5) | — | — |
| Diarrhea | 2 (5) | 2 (5) | — | — | 2 (12.5) | 2 (12.5) | — | — |
| Dyspepsia/GERD | 3 (7.5) | 3 (7.5) | — | — | 2 (12.5) | 2 (12.5) | — | — |
| Nausea | 25 (62.5) | 24 (60) | 1 (2.5) | — | 6 (37.5) | 6 (37.5) | — | — |
| Vomiting | 12 (30) | 11 (27.5) | 1 (2.5) | — | 1 (6) | 1 (6) | — | — |
| Infection and infestations | ||||||||
| Urinary tract infection | 4 (10) | — | 4 (10) | — | 0 (0) | |||
| Infection, Other | 1 (2.5) | — | 1 (2.5) | — | 2 (12.5) | 1 (6) | 1 (6) | — |
| Investigations | ||||||||
| Neutrophil count decreased | 20 (50) | 11 (27.5) | 7 (17.5) | 2 (5) | 7 (44) | 4 (25) | 2 (12.5) | 1 (6) |
| Platelet count decreased | 11 (27.5) | 11 (27.5) | — | — | 2 (12.5) | 2 (12.5) | — | — |
| Weight loss | 2 (5) | 2 (5) | — | — | 1 (6) | 1 (6) | — | — |
| White blood cell decreased | 28 (70) | 20 (50) | 7 (17.5) | 1 (2.5) | 13 (81) | 11 (69) | 2 (12.5) | — |
| Metabolism and nutrition disorders | ||||||||
| Anorexia | 10 (25) | 10 (25) | — | — | 4 (25) | 4 (25) | — | — |
| Hypophosphatemia | 9 (22.5) | 7 (17.5) | 2 (5) | — | 4 (25) | 3 (19) | 1 (6) | — |
| Musculoskeletal and connective tissue disorders | ||||||||
| Back pain | 1 (2.5) | 1 (2.5) | — | — | 2 (12.5) | 2 (12.5) | — | — |
| Bone pain | 2 (5) | 2 (5) | — | — | 1 (6) | 1 (6) | — | — |
| Pain, NOS | 2 (5) | 2 (5) | — | — | 1 (6) | 1 (6) | — | — |
| Pain, Other | 9 (22.5) | 9 (22.5) | — | — | 4 (25) | 4 (25) | — | — |
| Nervous system disorders | ||||||||
| Dysgeusia | 2 (5) | 2 (5) | — | — | 2 (12.5) | 2 (12.5) | — | — |
| Headache | 10 (25) | 10 (25) | — | — | 2 (12.5) | 2 (12.5) | — | — |
| Psychiatric disorders | ||||||||
| Anxiety | 2 (5) | 2 (5) | — | — | 1 (6) | 1 (6) | — | — |
| Depression | 2 (5) | 1 (2.5) | 1 (2.5) | — | 2 (12.5) | 2 (12.5) | — | — |
| Insomnia | 3 (7.5) | 3 (7.5) | — | — | 0 (0) | — | — | — |
| Skin and subcutaneous tissue disorders | ||||||||
| Pruritus | 4 (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.