Table 3.
Observed toxicities in >10% of pts or observed as grade ≥ 3 using CTCAE criteria.
| CTCAE Term | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 5 | Total | Total Percent |
Grade 3-5 |
Grade 3-5 Percent |
|---|---|---|---|---|---|---|---|---|---|
| Nausea | 11 | 4 | 1 | 0 | 0 | 16 | 88.89 | 1 | 5.56 |
| Anorexia | 9 | 4 | 0 | 0 | 0 | 13 | 72.22 | 0 | 0.00 |
| Constipation | 10 | 2 | 0 | 0 | 0 | 12 | 66.67 | 0 | 0.00 |
| Fatigue | 2 | 8 | 2 | 0 | 0 | 12 | 66.67 | 2 | 11.11 |
| Mucositis oral | 10 | 2 | 0 | 0 | 0 | 12 | 66.67 | 0 | 0.00 |
| Back pain | 6 | 3 | 2 | 0 | 0 | 11 | 61.11 | 2 | 11.11 |
| Dyspnea | 6 | 1 | 3 | 1 | 0 | 11 | 61.11 | 4 | 22.22 |
| Vomiting | 6 | 2 | 3 | 0 | 0 | 11 | 61.11 | 3 | 16.67 |
| Alopecia | 4 | 6 | 0 | 0 | 0 | 10 | 55.56 | 0 | 0.00 |
| Pruritus | 9 | 0 | 0 | 0 | 0 | 9 | 50.00 | 0 | 0.00 |
| Diarrhea | 6 | 1 | 1 | 0 | 0 | 8 | 44.44 | 1 | 5.56 |
| Dyspepsia | 4 | 4 | 0 | 0 | 0 | 8 | 44.44 | 0 | 0.00 |
| Headache | 6 | 2 | 0 | 0 | 0 | 8 | 44.44 | 0 | 0.00 |
| Anemia | 1 | 4 | 2 | 0 | 0 | 7 | 38.89 | 2 | 11.11 |
| Cough | 7 | 0 | 0 | 0 | 0 | 7 | 38.89 | 0 | 0.00 |
| Insomnia | 6 | 1 | 0 | 0 | 0 | 7 | 38.89 | 0 | 0.00 |
| Neutrophil count decreased | 0 | 4 | 1 | 1 | 0 | 6 | 33.33 | 2 | 11.11 |
| Anxiety | 2 | 3 | 0 | 0 | 0 | 5 | 27.78 | 0 | 0.00 |
| Hyperglycemia | 5 | 0 | 0 | 0 | 0 | 5 | 27.78 | 0 | 0.00 |
| Pain | 1 | 2 | 2 | 0 | 0 | 5 | 27.78 | 2 | 11.11 |
| Blurred vision | 4 | 0 | 0 | 0 | 0 | 4 | 22.22 | 0 | 0.00 |
| Dysgeusia | 3 | 1 | 0 | 0 | 0 | 4 | 22.22 | 0 | 0.00 |
| Edema limbs | 4 | 0 | 0 | 0 | 0 | 4 | 22.22 | 0 | 0.00 |
| Hypokalemia | 1 | 2 | 1 | 0 | 0 | 4 | 22.22 | 1 | 5.56 |
| Pain in extremity | 3 | 1 | 0 | 0 | 0 | 4 | 22.22 | 0 | 0.00 |
| Peripheral sensory neuropathy | 2 | 2 | 0 | 0 | 0 | 4 | 22.22 | 0 | 0.00 |
| Aspartate aminotransferase increased | 2 | 1 | 0 | 0 | 0 | 3 | 16.67 | 0 | 0.00 |
| Chest wall pain | 1 | 2 | 0 | 0 | 0 | 3 | 16.67 | 0 | 0.00 |
| Chills | 3 | 0 | 0 | 0 | 0 | 3 | 16.67 | 0 | 0.00 |
| Lung infection | 1 | 0 | 2 | 0 | 0 | 3 | 16.67 | 2 | 11.11 |
| Mucosal infection | 1 | 1 | 1 | 0 | 0 | 3 | 16.67 | 1 | 5.56 |
| Rash acneiform | 3 | 0 | 0 | 0 | 0 | 3 | 16.67 | 0 | 0.00 |
| Rash maculo-papular | 2 | 0 | 1 | 0 | 0 | 3 | 16.67 | 1 | 5.56 |
| Urinary tract pain | 2 | 1 | 0 | 0 | 0 | 3 | 16.67 | 0 | 0.00 |
| Abdominal pain | 1 | 0 | 1 | 0 | 0 | 2 | 11.11 | 1 | 5.56 |
| Alanine aminotransferase increased | 2 | 0 | 0 | 0 | 0 | 2 | 11.11 | 0 | 0.00 |
| Allergic rhinitis | 2 | 0 | 0 | 0 | 0 | 2 | 11.11 | 0 | 0.00 |
| Bone pain | 1 | 1 | 0 | 0 | 0 | 2 | 11.11 | 0 | 0.00 |
| Dry mouth | 2 | 0 | 0 | 0 | 0 | 2 | 11.11 | 0 | 0.00 |
| Infections and infestations - Other, specify | 0 | 2 | 0 | 0 | 0 | 2 | 11.11 | 0 | 0.00 |
| Lymphedema | 2 | 0 | 0 | 0 | 0 | 2 | 11.11 | 0 | 0.00 |
| Nasal congestion | 1 | 1 | 0 | 0 | 0 | 2 | 11.11 | 0 | 0.00 |
| Oral pain | 2 | 0 | 0 | 0 | 0 | 2 | 11.11 | 0 | 0.00 |
| Paresthesia | 2 | 0 | 0 | 0 | 0 | 2 | 11.11 | 0 | 0.00 |
| Skin and subcutaneous tissue disorders - Other, specify | 2 | 0 | 0 | 0 | 0 | 2 | 11.11 | 0 | 0.00 |
| Thromboembolic event | 0 | 2 | 0 | 0 | 0 | 2 | 11.11 | 0 | 0.00 |
| Urinary tract infection | 0 | 2 | 0 | 0 | 0 | 2 | 11.11 | 0 | 0.00 |
| Urinary urgency | 1 | 1 | 0 | 0 | 0 | 2 | 11.11 | 0 | 0.00 |
| Colitis | 0 | 0 | 1 | 0 | 0 | 1 | 5.56 | 1 | 5.56 |
| Dehydration | 0 | 0 | 1 | 0 | 0 | 1 | 5.56 | 1 | 5.56 |
| Investigations - Other, specify | 0 | 0 | 1 | 0 | 0 | 1 | 5.56 | 1 | 5.56 |
| Respiratory failure | 0 | 0 | 0 | 1 | 0 | 1 | 5.56 | 1 | 5.56 |
| Skin infection | 0 | 0 | 1 | 0 | 0 | 1 | 5.56 | 1 | 5.56 |
| White blood cell decreased | 0 | 0 | 1 | 0 | 0 | 1 | 5.56 | 1 | 5.56 |
*
There were no grade 5 events observed