Table 4.
AEs regardless of attribution
| Body system | AE* | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Total | Total severe† |
|---|---|---|---|---|---|---|---|---|
| Hematology | 8 | 10 | 9 | 6 | 0 | 33 | 15 | |
| Neutropenia | 3 | 8 | 6 | 4 | 0 | 21 | 10 | |
| Thrombocytopenia | 14 | 3 | 2 | 0 | 0 | 19 | 2 | |
| Anemia | 20 | 10 | 0 | 1 | 0 | 31 | 1 | |
| Constitutional | 7 | 20 | 5 | 1 | 0 | 33 | 6 | |
| Fatigue | 7 | 19 | 5 | 1 | 0 | 32 | 6 | |
| Neurology | 12 | 13 | 3 | 1 | 0 | 29 | 4 | |
| Peripheral sensory neuropathy | 18 | 9 | 1 | 1 | 0 | 29 | 2 | |
| Insomnia | 0 | 3 | 0 | 0 | 0 | 3 | 0 | |
| Confusion/memory impairment | 0 | 3 | 0 | 0 | 0 | 3 | 0 | |
| Agitation/anxiety | 0 | 2 | 0 | 0 | 0 | 2 | 0 | |
| Depression | 0 | 1 | 0 | 0 | 0 | 1 | 0 | |
| Dizziness | 1 | 0 | 0 | 0 | 0 | 1 | 0 | |
| Neuro (mood swings) | 0 | 1 | 0 | 0 | 0 | 1 | 0 | |
| Gastrointestinal | 11 | 6 | 4 | 0 | 0 | 21 | 4 | |
| Nausea | 11 | 2 | 0 | 0 | 0 | 13 | 0 | |
| Diarrhea | 11 | 3 | 2 | 0 | 0 | 16 | 2 | |
| Anorexia | 9 | 2 | 0 | 0 | 0 | 11 | 0 | |
| Vomiting | 4 | 1 | 0 | 0 | 0 | 5 | 0 | |
| Constipation | 0 | 3 | 0 | 0 | 0 | 3 | 0 | |
| Dyspepsia/dysphagia | 0 | 1 | 1 | 0 | 0 | 2 | 1 | |
| Ascites | 0 | 0 | 1 | 0 | 0 | 1 | 1 | |
| Colon/cecum perforation | 0 | 0 | 1 | 0 | 0 | 1 | 1 | |
| Infection/febrile neutropenia | 0 | 7 | 7 | 1 | 1 | 16 | 9 | |
| Pneumonia/bronchitis | 0 | 5 | 5 | 1 | 1 | 12 | 7 | |
| Febrile neutropenia | 0 | 0 | 1 | 0 | 0 | 1 | 1 | |
| Sinus infection | 0 | 1 | 1 | 0 | 0 | 2 | 1 | |
| Infection, no absolute neutrophil count | 0 | 1 | 0 | 0 | 0 | 1 | 0 | |
| Cardiovascular | 0 | 0 | 7 | 3 | 0 | 10 | 10 | |
| Atrial fibrillation/ tachycardia | 0 | 1 | 4 | 0 | 0 | 5 | 4 | |
| QTC internal prolong | 0 | 0 | 1 | 1 | 0 | 2 | 2 | |
| Sinus bradycardia | 0 | 0 | 0 | 1 | 0 | 1 | 1 | |
| Left ventricular failure | 0 | 0 | 1 | 0 | 0 | 1 | 1 | |
| Congestive heart failure | 0 | 0 | 1 | 0 | 0 | 1 | 1 | |
| Syncope vasovagal | 0 | 0 | 3 | 0 | 0 | 3 | 3 | |
| Thrombosis | 0 | 0 | 1 | 1 | 0 | 2 | 2 | |
| Pulmonary | 0 | 4 | 5 | 0 | 0 | 9 | 5 | |
| Dyspnea | 0 | 4 | 4 | 0 | 0 | 8 | 4 | |
| Pleural effusion | 0 | 0 | 1 | 0 | 0 | 1 | 1 | |
| Metabolic/laboratory | 0 | 1 | 4 | 3 | 0 | 8 | 7 | |
| Hyponatremia | 0 | 0 | 3 | 0 | 0 | 3 | 3 | |
| Hyperkalemia | 0 | 0 | 1 | 1 | 0 | 2 | 2 | |
| Hyperglycemia | 0 | 1 | 0 | 0 | 0 | 1 | 0 | |
| Hyperuricemia | 0 | 0 | 0 | 1 | 0 | 1 | 1 | |
| Hypokalemia | 0 | 0 | 0 | 1 | 0 | 1 | 1 | |
| Lymphatics | 1 | 3 | 3 | 0 | 0 | 7 | 3 | |
| Edema in limbs | 1 | 3 | 3 | 0 | 0 | 7 | 3 | |
| Musculoskeletal | 0 | 2 | 3 | 0 | 0 | 5 | 3 | |
| Fracture | 0 | 0 | 1 | 0 | 0 | 1 | 1 | |
| Muscle weakness | 0 | 2 | 2 | 0 | 0 | 4 | 2 | |
| Hepatic | 0 | 1 | 0 | 1 | 0 | 2 | 1 | |
| Alkaline phosphatase increased | 0 | 2 | 0 | 0 | 0 | 2 | 0 | |
| Bilirubin | 0 | 1 | 0 | 0 | 0 | 1 | 0 | |
| Alanine aminotransferase increased | 0 | 0 | 0 | 1 | 0 | 1 | 1 | |
| Ocular/visual | 0 | 3 | 0 | 0 | 0 | 3 | 0 | |
| Blurred or double vision | 0 | 3 | 0 | 0 | 0 | 3 | 0 | |
| Vitreous hemorrhage | 0 | 1 | 0 | 0 | 0 | 1 | 0 | |
| Pain | 0 | 1 | 2 | 0 | 0 | 3 | 2 | |
| Pain in chest | 0 | 0 | 1 | 0 | 0 | 1 | 1 | |
| Myalgia | 0 | 1 | 0 | 0 | 0 | 1 | 0 | |
| Neuralgia | 0 | 1 | 0 | 0 | 0 | 1 | 0 | |
| Pain | 0 | 0 | 2 | 0 | 0 | 2 | 2 | |
| Renal /genitourinary | 0 | 1 | 2 | 0 | 0 | 3 | 2 | |
| Creatinine increased | 0 | 0 | 1 | 0 | 0 | 1 | 1 | |
| Urinary frequency | 0 | 0 | 1 | 0 | 0 | 1 | 1 | |
| Urinary incontinence | 0 | 1 | 0 | 0 | 0 | 1 | 0 | |
| Dermatology/skin | 0 | 2 | 1 | 0 | 0 | 3 | 1 | |
| Bruising | 0 | 1 | 0 | 0 | 0 | 1 | 0 | |
| Decubitus ulcer | 0 | 0 | 1 | 0 | 0 | 1 | 1 | |
| Rash | 0 | 1 | 0 | 0 | 0 | 1 | 0 | |
| Coagulation | 0 | 0 | 2 | 0 | 0 | 2 | 2 | |
| International normalized ratio increased | 0 | 0 | 2 | 0 | 0 | 2 | 2 |
*
Severe is grade 3, 4, or 5.
†
Common Terminology Criteria for Adverse Events Version 3.0