Most common grade 2 to 4 AEs reported (regardless of attribution)
| Toxicity . | Arm . | Grade 2 . | Grade 3 . | Grade 4 . | Total . |
|---|---|---|---|---|---|
| Anemia | 1 | 10.3% | 10.3% | 0 | 20.5% |
| 2 | 18.4% | 15.8% | 0 | 34.2% | |
| 1 x-over | 19.2% | 11.5% | 0 | 30.8% | |
| Lymphocyte count decrease | 1 | 12.8% | 17.9% | 5.1% | 35.9% |
| 2 | 23.7% | 28.9% | 10.5% | 63.2% | |
| 1 x-over | 0 | 7.7% | 3.8% | 11.5% | |
| Neutrophil count decrease | 1 | 28.2% | 15.4% | 2.6% | 46.2% |
| 2 | 34.2% | 31.6% | 5.3% | 71.1% | |
| 1 x-over | 26.9% | 23.1% | 0 | 50.0% | |
| Platelet count decrease | 1 | 2.6% | 2.6% | 0 | 5.1% |
| 2 | 7.9% | 5.3% | 0 | 13.2% | |
| 1 x-over | 7.7% | 7.7% | 3.8% | 19.2% | |
| White blood cell count decrease | 1 | 23.1% | 2.6% | 0 | 25.6% |
| 2 | 28.9% | 2.6% | 10.5% | 42.1% | |
| 1 x-over | 23.1% | 0 | 0 | 23.1% | |
| Anxiety | 1 | 10.3% | 0 | 0 | 10.3% |
| 2 | 7.9% | 0 | 0 | 7.9% | |
| 1 x-over | 3.8% | 0 | 0 | 3.8% | |
| Atrial fibrillation | 1 | 0 | 0 | 0 | 0 |
| 2 | 7.9% | 2.6% | 0 | 10.5% | |
| 1 x-over | 7.7% | 3.8% | 0 | 11.5% | |
| Back Pain | 1 | 12.8% | 2.6% | 0 | 15.4% |
| 2 | 10.5% | 2.6% | 0 | 13.2% | |
| 1 x-over | 19.2% | 0 | 0 | 19.2% | |
| Chronic kidney disease | 1 | 10.3% | 0 | 0 | 10.3% |
| 2 | 2.6% | 0 | 0 | 2.6% | |
| 1 x-over | 7.7% | 0 | 0 | 7.7% | |
| Constipation | 1 | 15.4% | 0 | 0 | 15.4% |
| 2 | 7.9% | 0 | 0 | 7.9% | |
| 1 x-over | 11.5% | 0 | 0 | 11.5% | |
| Dehydration | 1 | 2.6% | 0 | 0 | 2.6% |
| 2 | 7.9% | 2.6% | 0 | 10.5% | |
| 1 x-over | 0 | 3.8% | 0 | 3.8% | |
| Diarrhea | 1 | 10.3% | 0 | 0 | 10.3% |
| 2 | 18.4% | 2.6% | 0 | 21.1% | |
| 1 x-over | 19.2% | 0 | 0 | 19.2% | |
| Fatigue | 1 | 30.8% | 15.4% | 0 | 46.2% |
| 2 | 34.2% | 15.8% | 0 | 50.0% | |
| 1 x-over | 42.3% | 3.8% | 0 | 46.2% | |
| Generalized muscle weakness | 1 | 10.3% | 2.6% | 0 | 12.8% |
| 2 | 2.6% | 0 | 0 | 2.6% | |
| 1 x-over | 3.8% | 0 | 0 | 3.8% | |
| Hyperglycemia | 1 | 10.3% | 2.6% | 0 | 12.8% |
| 2 | 10.5% | 10.5% | 0 | 21.1% | |
| 1 x-over | 7.7% | 3.8% | 0 | 11.5% | |
| Hypertension | 1 | 2.6% | 7.7% | 0 | 10.3% |
| 2 | 5.3% | 2.6% | 0 | 7.9% | |
| 1 x-over | 11.5% | 3.8% | 0 | 15.4% | |
| Hypophosphatemia | 1 | 7.7% | 7.7% | 0 | 15.4% |
| 2 | 7.9% | 10.5% | 0 | 18.4% | |
| 1 x-over | 19.2% | 3.8% | 0 | 23.1% | |
| Insomnia | 1 | 17.9% | 2.6% | 0 | 20.5% |
| 2 | 13.2% | 0 | 0 | 13.2% | |
| 1 x-over | 19.2% | 0 | 0 | 19.2% | |
| Limb edema | 1 | 7.7% | 0 | 0 | 7.7% |
| 2 | 10.5% | 0 | 0 | 10.5% | |
| 1 x-over | 7.7% | 0 | 0 | 7.7% | |
| Lung Infection | 1 | 0 | 7.7% | 0 | 7.7% |
| 2 | 2.6% | 7.9% | 0 | 10.5% | |
| 1 x-over | |||||
| Maculo-papular rash | 1 | 7.7% | 2.6% | 0 | 10.3% |
| 2 | 7.9% | 2.6% | 0 | 10.5% | |
| 1 x-over | |||||
| Nausea | 1 | 5.1% | 0 | 0 | 5.1% |
| 2 | 10.5% | 0 | 0 | 10.5% | |
| 1 x-over | 15.4% | 3.8% | 0 | 19.2% | |
| Peripheral sensory neuropathy | 1 | 17.9% | 0 | 0 | 17.9% |
| 2 | 23.7% | 0 | 0 | 23.7% | |
| 1 x-over | 15.4% | 0 | 0 | 15.4% | |
| Upper respiratory infection | 1 | 20.5% | 0 | 0 | 20.5% |
| 2 | 18.4% | 0 | 0 | 18.4% | |
| 1 x-over | 3.8% | 0 | 3.8% | 7.7% | |
| Weight gain | 1 | 0 | 0 | 0 | 0 |
| 2 | 13.2% | 0 | 0 | 13.2% | |
| 1 x-over | 7.7% | 0 | 0 | 7.7% |
| Toxicity . | Arm . | Grade 2 . | Grade 3 . | Grade 4 . | Total . |
|---|---|---|---|---|---|
| Anemia | 1 | 10.3% | 10.3% | 0 | 20.5% |
| 2 | 18.4% | 15.8% | 0 | 34.2% | |
| 1 x-over | 19.2% | 11.5% | 0 | 30.8% | |
| Lymphocyte count decrease | 1 | 12.8% | 17.9% | 5.1% | 35.9% |
| 2 | 23.7% | 28.9% | 10.5% | 63.2% | |
| 1 x-over | 0 | 7.7% | 3.8% | 11.5% | |
| Neutrophil count decrease | 1 | 28.2% | 15.4% | 2.6% | 46.2% |
| 2 | 34.2% | 31.6% | 5.3% | 71.1% | |
| 1 x-over | 26.9% | 23.1% | 0 | 50.0% | |
| Platelet count decrease | 1 | 2.6% | 2.6% | 0 | 5.1% |
| 2 | 7.9% | 5.3% | 0 | 13.2% | |
| 1 x-over | 7.7% | 7.7% | 3.8% | 19.2% | |
| White blood cell count decrease | 1 | 23.1% | 2.6% | 0 | 25.6% |
| 2 | 28.9% | 2.6% | 10.5% | 42.1% | |
| 1 x-over | 23.1% | 0 | 0 | 23.1% | |
| Anxiety | 1 | 10.3% | 0 | 0 | 10.3% |
| 2 | 7.9% | 0 | 0 | 7.9% | |
| 1 x-over | 3.8% | 0 | 0 | 3.8% | |
| Atrial fibrillation | 1 | 0 | 0 | 0 | 0 |
| 2 | 7.9% | 2.6% | 0 | 10.5% | |
| 1 x-over | 7.7% | 3.8% | 0 | 11.5% | |
| Back Pain | 1 | 12.8% | 2.6% | 0 | 15.4% |
| 2 | 10.5% | 2.6% | 0 | 13.2% | |
| 1 x-over | 19.2% | 0 | 0 | 19.2% | |
| Chronic kidney disease | 1 | 10.3% | 0 | 0 | 10.3% |
| 2 | 2.6% | 0 | 0 | 2.6% | |
| 1 x-over | 7.7% | 0 | 0 | 7.7% | |
| Constipation | 1 | 15.4% | 0 | 0 | 15.4% |
| 2 | 7.9% | 0 | 0 | 7.9% | |
| 1 x-over | 11.5% | 0 | 0 | 11.5% | |
| Dehydration | 1 | 2.6% | 0 | 0 | 2.6% |
| 2 | 7.9% | 2.6% | 0 | 10.5% | |
| 1 x-over | 0 | 3.8% | 0 | 3.8% | |
| Diarrhea | 1 | 10.3% | 0 | 0 | 10.3% |
| 2 | 18.4% | 2.6% | 0 | 21.1% | |
| 1 x-over | 19.2% | 0 | 0 | 19.2% | |
| Fatigue | 1 | 30.8% | 15.4% | 0 | 46.2% |
| 2 | 34.2% | 15.8% | 0 | 50.0% | |
| 1 x-over | 42.3% | 3.8% | 0 | 46.2% | |
| Generalized muscle weakness | 1 | 10.3% | 2.6% | 0 | 12.8% |
| 2 | 2.6% | 0 | 0 | 2.6% | |
| 1 x-over | 3.8% | 0 | 0 | 3.8% | |
| Hyperglycemia | 1 | 10.3% | 2.6% | 0 | 12.8% |
| 2 | 10.5% | 10.5% | 0 | 21.1% | |
| 1 x-over | 7.7% | 3.8% | 0 | 11.5% | |
| Hypertension | 1 | 2.6% | 7.7% | 0 | 10.3% |
| 2 | 5.3% | 2.6% | 0 | 7.9% | |
| 1 x-over | 11.5% | 3.8% | 0 | 15.4% | |
| Hypophosphatemia | 1 | 7.7% | 7.7% | 0 | 15.4% |
| 2 | 7.9% | 10.5% | 0 | 18.4% | |
| 1 x-over | 19.2% | 3.8% | 0 | 23.1% | |
| Insomnia | 1 | 17.9% | 2.6% | 0 | 20.5% |
| 2 | 13.2% | 0 | 0 | 13.2% | |
| 1 x-over | 19.2% | 0 | 0 | 19.2% | |
| Limb edema | 1 | 7.7% | 0 | 0 | 7.7% |
| 2 | 10.5% | 0 | 0 | 10.5% | |
| 1 x-over | 7.7% | 0 | 0 | 7.7% | |
| Lung Infection | 1 | 0 | 7.7% | 0 | 7.7% |
| 2 | 2.6% | 7.9% | 0 | 10.5% | |
| 1 x-over | |||||
| Maculo-papular rash | 1 | 7.7% | 2.6% | 0 | 10.3% |
| 2 | 7.9% | 2.6% | 0 | 10.5% | |
| 1 x-over | |||||
| Nausea | 1 | 5.1% | 0 | 0 | 5.1% |
| 2 | 10.5% | 0 | 0 | 10.5% | |
| 1 x-over | 15.4% | 3.8% | 0 | 19.2% | |
| Peripheral sensory neuropathy | 1 | 17.9% | 0 | 0 | 17.9% |
| 2 | 23.7% | 0 | 0 | 23.7% | |
| 1 x-over | 15.4% | 0 | 0 | 15.4% | |
| Upper respiratory infection | 1 | 20.5% | 0 | 0 | 20.5% |
| 2 | 18.4% | 0 | 0 | 18.4% | |
| 1 x-over | 3.8% | 0 | 3.8% | 7.7% | |
| Weight gain | 1 | 0 | 0 | 0 | 0 |
| 2 | 13.2% | 0 | 0 | 13.2% | |
| 1 x-over | 7.7% | 0 | 0 | 7.7% |