Table 4.
Overall Hematologic and Non-Hematologic Treatment-Emergent Adverse Events in ≥ 5% of Patients
| For All Dose Groups Combined Maximum Toxicity Grade (N = 54) | |||||
|
Adverse Event (Preferred Term) |
Grade 1 n (%) |
Grade 2 n (%) |
Grade 3 n (%) |
Grade 4 n (%) |
Total n (%) |
| Hematologic | |||||
| Anemia | 0 (0) | 3 (5.6) | 11 (20.4) | 4 (7.4) | 18 (33.3) |
| Thrombocytopenia | 0 (0) | 1 (1.9) | 2 (3.7) | 5 (9.3) | 8 (14.8) |
| Neutropenia | 0 (0) | 1 (1.9) | 1 (1.9) | 5 (9.3) | 7 (13.0) |
| Febrile Neutropenia | 0 (0) | 1 (1.9) | 4 (7.4) | 0 (0) | 5 (9.3) |
| Leukopenia | 0 (0) | 0 (0) | 2 (3.7) | 1 (1.9) | 3 (5.6) |
| Non-Hematologic | |||||
| Diarrhea | 13 (24.1) | 6 (11.1) | 3 (5.6) | 0 (0) | 22 (40.7) |
| Nausea | 15 (27.8) | 3 (5.6) | 1 (1.9) | 0 (0) | 19 (35.2) |
| Fatigue | 2 (3.7) | 14 (25.9) | 1 (1.9) | 0 (0) | 17 (31.5) |
| Back Pain | 11 (20.4) | 3 (5.6) | 0 (0) | 1 (1.9) | 15 (27.8) |
| Bone Pain | 6 (11.1) | 5 (9.3) | 3 (5.6) | 0 (0) | 14 (25.9) |
| Headache | 10 (18.5) | 4 (7.4) | 0 (0) | 0 (0) | 14 (25.9) |
| Pain in Extremity | 9 (16.7) | 4 (7.4) | 1 (1.9) | 0 (0) | 14 (25.9) |
| Chills | 7 (13.0) | 6 (11.1) | 0 (0) | 0 (0) | 13 (24.1) |
| Vomiting | 11 (20.4) | 2 (3.7) | 0 (0) | 0 (0) | 13 (24.1) |
| Drug Hypersensitivity | 5 (9.3) | 1 (1.9) | 4 (7.4) | 2 (3.7) | 12 (22.2) |
| Pyrexia | 11 (20.4) | 0 (0) | 0 (0) | 0 (0) | 11 (20.4) |
| Flushing | 10 (18.5) | 0 (0) | 0 (0) | 0 (0) | 10 (18.5) |
| Insomnia | 7 (13.0) | 2 (3.7) | 0 (0) | 0 (0) | 9 (16.7) |
| Oedema Peripheral | 7 (13.0) | 2 (3.7) | 0 (0) | 0 (0) | 9 (16.7) |
| Constipation | 3 (5.6) | 5 (9.3) | 0 (0) | 0 (0) | 8 (14.8) |
| Chest Pain | 3 (5.6) | 2 (3.7) | 2 (3.7) | 1 (1.9) | 8 (14.8) |
| Cough | 5 (9.3) | 2 (3.7) | 1 (1.9) | 0 (0) | 8 (14.8) |
| Dizziness | 7 (13.0) | 0 (0) | 1 (1.9) | 0 (0) | 8 (14.8) |
| Dyspnoea | 5 (9.3) | 2 (3.7) | 0 (0) | 1 (1.9) | 8 (14.8) |
| Arthralgia | 3 (5.6) | 3 (5.6) | 1 (1.9) | 0 (0) | 7 (13.0) |
| Asthenia | 4 (7.4) | 3 (5.6) | 0 (0) | 0 (0) | 7 (13.0) |
| Contusion | 7 (13.0) | 0 (0) | 0 (0) | 0 (0) | 7 (13.0) |
| Decreased Appetite | 4 (7.4) | 2 (3.7) | 1 (1.9) | 0 (0) | 7 (13.0) |
| Dry Mouth | 5 (9.3) | 1 (1.9) | 0 (0) | 0 (0) | 6 (11.1) |
| Epistaxis | 5 (9.3) | 0 (0) | 1 (1.9) | 0 (0) | 6 (11.1) |
| Tachycardia | 5 (9.3) | 1 (1.9) | 0 (0) | 0 (0) | 6 (11.1) |
| Anorexia | 3 (5.6) | 1 (1.9) | 1 (1.9) | 0 (0) | 5 (9.3) |
| Chest Discomfort | 4 (7.4) | 1 (1.9) | 0 (0) | 0 (0) | 5 (9.3) |
| Dyspepsia | 4 (7.4) | 1 (1.9) | 0 (0) | 0 (0) | 5 (9.3) |
| Dyspnoea Exertional | 1 (1.9) | 4 (7.4) | 0 (0) | 0 (0) | 5 (9.3) |
| Ecchymosis | 5 (9.3) | 0 (0) | 0 (0) | 0 (0) | 5 (9.3) |
| Musculoskeletal Discomfort | 5 (9.3) | 0 (0) | 0 (0) | 0 (0) | 5 (9.3) |
| Somnolence | 4 (7.4) | 0 (0) | 1 (1.9) | 0 (0) | 5 (9.3) |
| Urinary Tract Infection | 1 (1.9) | 4 (7.4) | 0 (0) | 0 (0) | 5 (9.3) |
| Abdominal Pain Upper | 2 (3.7) | 2 (3.7) | 0 (0) | 0 (0) | 4 (7.4) |
| Depression | 3 (5.6) | 1 (1.9) | 0 (0) | 0 (0) | 4 (7.4) |
| Dry Skin | 4 (7.4) | 0 (0) | 0 (0) | 0 (0) | 4 (7.4) |
| Infusion Site Bruising | 4 (7.4) | 0 (0) | 0 (0) | 0 (0) | 4 (7.4) |
| Infusion Site Reaction | 3 (5.6) | 0 (0) | 1 (1.9) | 0 (0) | 4 (7.4) |
| Neck Pain | 3 (5.6) | 0 (0) | 1 (1.9) | 0 (0) | 4 (7.4) |
| Pneumonia | 1 (1.9) | 1 (1.9) | 2 (3.7) | 0 (0) | 4 (7.4) |
| Pruritus | 4 (7.4) | 0 (0) | 0 (0) | 0 (0) | 4 (7.4) |
| Rash | 4 (7.4) | 0 (0) | 0 (0) | 0 (0) | 4 (7.4) |
| Anxiety | 2 (3.7) | 1 (1.9) | 0 (0) | 0 (0) | 3 (5.6) |
| Conjunctival Hemorrhage | 3 (5.6) | 0 (0) | 0 (0) | 0 (0) | 3 (5.6) |
| Dehydration | 1 (1.9) | 0 (0) | 1 (1.9) | 1 (1.9) | 3 (5.6) |
| Dysgeusia | 3 (5.6) | 0 (0) | 0 (0) | 0 (0) | 3 (5.6) |
| Hematuria | 2 (3.7) | 0 (0) | 1 (1.9) | 0 (0) | 3 (5.6) |
| Hyperhidrosis | 2 (3.7) | 0 (0) | 1 (1.9) | 0 (0) | 3 (5.6) |
| Hypertension | 1 (1.9) | 2 (3.7) | 0 (0) | 0 (0) | 3 (5.6) |
| Hypokalemia | 2 (3.7) | 0 (0) | 1 (1.9) | 0 (0) | 3 (5.6) |
| Hypotension | 1 (1.9) | 1 (1.9) | 1 (1.9) | 0 (0) | 3 (5.6) |
| Infusion Site Erythema | 2 (3.7) | 1 (1.9) | 0 (0) | 0 (0) | 3 (5.6) |
| Infusion Site Pain | 3 (5.6) | 0 (0) | 0 (0) | 0 (0) | 3 (5.6) |
| Lung Infiltration | 1 (1.9) | 1 (1.9) | 0 (0) | 1 (1.9) | 3 (5.6) |
| Mouth Ulceration | 3 (5.6) | 0 (0) | 0 (0) | 0 (0) | 3 (5.6) |
| Musculoskeletal Stiffness | 2 (3.7) | 1 (1.9) | 0 (0) | 0 (0) | 3 (5.6) |
| Oedema | 2 (3.7) | 0 (0) | 1 (1.9) | 0 (0) | 3 (5.6) |
| Pharyngolaryngeal Pain | 2 (3.7) | 1 (1.9) | 0 (0) | 0 (0) | 3 (5.6) |
| Upper Respiratory Tract Infection | 1 (1.9) | 2 (3.7) | 0 (0) | 0 (0) | 3 (5.6) |
| Vision Blurred | 2 (3.7) | 1 (1.9) | 0 (0) | 0 (0) | 3 (5.6) |