Table 2.
Treatment-emergent AEs observed in more than 10% of patients and all grade 3 or 4 AEs
| AE | Grade 1, n | % | Grade 2, n | % | Grade 3, n | % | Grade 4, n | % | All grade, n | % |
|---|---|---|---|---|---|---|---|---|---|---|
| Neutropenia | 0 | 0 | 2 | 7 | 1 | 3 | 25 | 83 | 28 | 93 |
| Anemia | 18 | 60 | 8 | 27 | 2 | 7 | 0 | 0 | 28 | 93 |
| Constipation | 21 | 70 | 2 | 7 | 0 | 0 | 0 | 0 | 23 | 77 |
| Nausea | 16 | 53 | 4 | 13 | 0 | 0 | 0 | 0 | 20 | 67 |
| ALT elevation | 15 | 50 | 2 | 7 | 2 | 7 | 1 | 3 | 20 | 67 |
| Fatigue | 12 | 40 | 1 | 3 | 0 | 0 | 0 | 0 | 13 | 43 |
| Rash | 10 | 33 | 2 | 7 | 1 | 3 | 0 | 0 | 13 | 43 |
| Peripheral sensory neuropathy | 9 | 30 | 1 | 3 | 0 | 0 | 0 | 0 | 10 | 33 |
| AST elevation | 8 | 27 | 1 | 3 | 0 | 0 | 1 | 3 | 10 | 33 |
| Dyspepsia | 6 | 20 | 3 | 10 | 0 | 0 | 0 | 0 | 9 | 30 |
| Oral pain | 8 | 27 | 1 | 3 | 0 | 0 | 0 | 0 | 9 | 30 |
| Headache | 7 | 23 | 1 | 3 | 0 | 0 | 0 | 0 | 8 | 27 |
| Insomnia | 7 | 23 | 1 | 3 | 0 | 0 | 0 | 0 | 8 | 27 |
| Diarrhea | 8 | 27 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 27 |
| Pain | 8 | 27 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 27 |
| Night sweats | 8 | 27 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 27 |
| Myalgia | 7 | 23 | 1 | 3 | 0 | 0 | 0 | 0 | 8 | 27 |
| Vomiting | 5 | 17 | 2 | 7 | 1 | 3 | 0 | 0 | 8 | 27 |
| Dyspnea | 6 | 20 | 1 | 3 | 0 | 0 | 0 | 0 | 7 | 23 |
| Alopecia | 5 | 17 | 1 | 3 | 0 | 0 | 0 | 0 | 6 | 20 |
| Hypokalemia | 6 | 20 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 20 |
| Upper respiratory tract infection | 0 | 0 | 5 | 17 | 1 | 3 | 0 | 0 | 6 | 20 |
| Thrombocytopenia | 4 | 13 | 2 | 7 | 0 | 0 | 0 | 0 | 6 | 20 |
| Bone pain | 4 | 13 | 1 | 3 | 0 | 0 | 0 | 0 | 5 | 17 |
| Back pain | 5 | 17 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 17 |
| Mucositis oral | 5 | 17 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 17 |
| Febrile neutropenia | 0 | 0 | 0 | 0 | 5 | 17 | 0 | 0 | 5 | 17 |
| Cough | 3 | 10 | 1 | 3 | 0 | 0 | 0 | 0 | 4 | 13 |
| Anxiety | 3 | 10 | 1 | 3 | 0 | 0 | 0 | 0 | 4 | 13 |
| Chills | 4 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 13 |
| Dry mouth | 4 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 13 |
| Arthralgia | 4 | 13 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 13 |
| Hyponatremia | 0 | 0 | 0 | 0 | 3 | 10 | 0 | 0 | 3 | 10 |
| Syncope | 0 | 0 | 0 | 0 | 3 | 10 | 0 | 0 | 3 | 10 |
| Sepsis | 0 | 0 | 0 | 0 | 1 | 3 | 1 | 3 | 2 | 7 |
| Colonic obstruction | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 1 | 3 |
| Colon abscess | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 1 | 3 |
| Conjunctivitis | 0 | 0 | 0 | 0 | 1 | 3 | 0 | 0 | 1 | 3 |
| Total | 30 | 100 | 23 | 77 | 13 | 43 | 25 | 83 | 30 | 100 |