Table 4. Cardiac and most common adverse events reported as possibly, probably, or definitely related to treatment in the mITT population.
| Arm A (N = 38) | Arm B (N = 41) | |||||||
|---|---|---|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Hematological toxicity | ||||||||
| Anemia | 3 (7.9%) | 3 (7.9%) | 2 (5.3%) | 0 (0.0%) | 2 (4.9%) | 4 (9.8%) | 0 (0.0%) | 0 (0.0%) |
| Thrombocytopenia | 0 (0.0%) | 0 (0.0%) | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Leukopenia | 3 (7.9%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 3 (7.3%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Neutropenia | 2 (5.3%) | 4 (10.5%) | 5 (13.2%) | 2 (5.3%) | 4 (9.8%) | 2 (4.9%) | 4 (9.8%) | 1 (2.4%) |
| Febrile Neutropenia | 0 (0.0%) | 0 (0.0%) | 1 (2.6%) | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 2 (4.9%) | 0 (0.0%) |
| Gastrointestinal disorders | ||||||||
| Diarrhea | 18 (47.4%) | 5 (13.2%) | 5 (13.2%) | 0 (0.0%) | 12 (29.3%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Constipation | 4 (10.5%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (4.9%) | 1 (2.4%) | 0 (0.0%) | 0 (0.0%) |
| Nausea | 14 (36.8%) | 4 (10.5%) | 1 (2.6%) | 0 (0.0%) | 12 (29.3%) | 4 (9.8%) | 1 (2.4%) | 0 (0.0%) |
| Vomiting | 12 (31.6%) | 5 (13.2%) | 0 (0.0%) | 0 (0.0%) | 4 (9.8%) | 1 (2.4%) | 1 (2.4%) | 0 (0.0%) |
| Mucositis | 13 (34.2%) | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 12 (29.3%) | 5 (12.2%) | 0 (0.0%) | 0 (0.0%) |
| Dyspepsia | 2 (5.3%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (4.9%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Pyrosis | 3 (7.9%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 6 (14.6%) | 1 (2.4%) | 0 (0.0%) | 0 (0.0%) |
| Epigastric Pain | 6 (15.8%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 5 (12.2%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| General disorders | ||||||||
| Fatigue | 22 (57.9%) | 8 (21.1%) | 1 (2.6%) | 0 (0.0%) | 23 (56.1%) | 11 (26.8%) | 0 (0.0%) | 0 (0.0%) |
| Headache | 2 (5.3%) | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 4 (9.8%) | 2 (4.9%) | 0 (0.0%) | 0 (0.0%) |
| Fever | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (4.9%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Vascular disorders | ||||||||
| Edema | 2 (5.3%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 4 (9.8%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Hypertension | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (4.9%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Skin disorders | ||||||||
| Alopecia | 5 (13.2%) | 12 (31.6) | 0 (0.0%) | 0 (0.0%) | 9 (22.0%) | 9 (22.0%) | 0 (0.0%) | 0 (0.0%) |
| Rash | 7 (18.4%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 4 (9.8%) | 2 (4.9%) | 0 (0.0%) | 0 (0.0%) |
| Erythema | 2 (5.3%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 4 (9.8%) | 0 (0.0%) | 1 (2.4%) | 0 (0.0%) |
| Pruritus | 4 (10.5%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (4.9%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Nail changes | 3 (7.9%) | 2 (5.3%) | 0 (0.0%) | 0 (0.0%) | 4 (9.8%) | 2 (4.9%) | 0 (0.0%) | 0 (0.0%) |
| Toxicodermic reaction to chemotherapy | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (2.4%) | 0 (0.0%) |
| Rosacea | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (2.4%) | 0 (0.0%) |
| Skin toxicity | 2 (5.3%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 3 (7.3%) | 2 (4.9%) | 0 (0.0%) | 0 (0.0%) |
| Metabolism disorders | ||||||||
| Anorexia | 4 (10.5%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 2 (4.9%) | 1 (2.4%) | 0 (0.0%) | 0 (0.0%) |
| Hypercalcemia | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Hypercholesterolemia | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (2.4%) | 1 (2.4%) | 0 (0.0%) | 0 (0.0%) |
| Hypertriglyceridemia | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (2.4%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Metabolism disorders | ||||||||
| AST/ALT increased | 8 (21.1%) | 3 (7.9%) | 2 (5.3%) | 0 (0.0%) | 7 (17.1%) | 1 (2.4%) | 0 (0.0%) | 0 (0.0%) |
| Musculoskeletal disorders | ||||||||
| Arthralgia | 3 (7.9%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 6 (14.6%) | 2 (4.9%) | 0 (0.0%) | 0 (0.0%) |
| Myalgia | 8 (21.1%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 7 (17.1%) | 2 (4.9%) | 0 (0.0%) | 0 (0.0%) |
| Septic arthritis | 0 (0.0%) | 0 (0.0%) | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Nervous system disorders | ||||||||
| Sensory Neuropathy | 10 (26.3%) | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 19 (46.3%) | 5 (12.2%) | 0 (0.0%) | 0 (0.0%) |
| Dizziness | 1 (2.6%) | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 1 (2.4%) | 1 (2.4%) | 0 (0.0%) | 0 (0.0%) |
| Dysgeusia | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 4 (9.8%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Respiratory disorders | ||||||||
| Epistaxis | 3 (7.9%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 9 (22.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Dyspnea | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 3 (7.3%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Reproductive system | ||||||||
| Amenorrhea | 1 (2.6%) | 3 (7.9%) | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 1 (2.4%) | 0 (0.0%) | 0 (0.0%) |
| Cardiac disorders | ||||||||
| Left ventricular systolic dysfunction | 0 (0.0%) | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (2.4%) | 1 (2.4%) | 0 (0.0%) |
| Dilated aortic root | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
Data are N (%).