Table 4.
Adverse events
| Grade | Standard (N = 16) |
Experimental (N = 14) |
p value | |
|---|---|---|---|---|
| Liver function abnormalities | G I/II | 9 (56.3%) | 9 (64.3%) | 0.72 |
| Grade III/IV | 0 (0.0%) | 2 (14.3%) | 0.21 | |
| Fatigue | G I/II | 8 (50.0%) | 6 (42.9%) | 0.73 |
| Grade III/IV | 0 (0.0%) | 1 (7.1%) | 0.47 | |
| Diarrhea | G I/II | 7 (43.8%) | 7 (50.0%) | 1.00 |
| Neuropathy | G I/II | 3 (18.8%) | 3 (21.4%) | 1.00 |
| Rash | G I/II | 3 (18.8%) | 3 (21.4%) | 1.00 |
| Hypokalemia | G I/II | 5 (31.3%) | 2 (14.3%) | 0.40 |
| Grade III/IV | 1 (6.3%) | 1 (7.1%) | 1.00 | |
| Hypomagnesemia | G I/II | 1 (6.3%) | 0 (0.0%) | 1.00 |
| Mucositis | G I/II | 1 (6.3%) | 1 (7.1%) | 1.00 |
| Nail discoloration | G I/II | 0 (0.0%) | 1 (7.1%) | 0.47 |
| Skin discoloration | G I/II | 0 (0.0%) | 1 (7.1%) | 0.47 |
| Nausea | G I/II | 3 (18.8%) | 0 (0.0%) | 0.23 |
| Constipation | G I/II | 0 (0.0%) | 1 (7.1%) | 0.47 |
| Depression | G I/II | 1 (6.3%) | 1 (7.1%) | 1.00 |
| Anxiety | G I/II | 1 (6.3%) | 0 (0.0%) | 1.00 |
| Epistaxis | G I/II | 0 (0.0%) | 2 (14.3%) | 0.21 |
| Chest pain | G I/II | 1 (6.3%) | 0 (0.0%) | 1.00 |
| Myocardial infarction | G I/II | 0 (0.0% | 0 (0.0%) | 1.00 |
| Grade III/IV/V | 0 (0.0%) | 1 (7.1%) | 0.47 | |
| Musculoskeletal pain | G I/II | 1 (6.3%) | 0 (0.0%) | 1.00 |
| Breast pain | G I/II | 1 (6.3%) | 0 (0.0%) | 1.00 |
| Platelet count decreased | G I/II | 0 (0.0%) | 1 (7.1%) | 0.47 |
| Neutrophil count decreased | G I/II | 0 (0.0%) | 1 (7.1%) | 0.47 |