Table 4.
Grade 3 or 4 adverse events
| N (%) | 80 mg (n=44) | 120 mg (n=65) | 160 mg (n=25) | P-value | |
|---|---|---|---|---|---|
| Dose modification | 0.02 | ||||
| Reduction | 42 (31.3) | 6 (13.6%) | 25 (38.5%) | 11 (44.0%) | |
| Increase | 7 (5.2) | 4 (9.1%) | 3 (4.6%) | 0 (0.0%) | |
| No modification | 85 (63.4) | 34 (77.3%) | 37 (56.9%) | 14 (56.0%) | |
| Grade 3/4 AE | 0.126 | ||||
| No | 117 (87.3) | 41 (93.2%) | 57 (87.7%) | 19 (76.0%) | |
| Yes | 17 (12.7) | 3 (6.8%) | 8 (12.3%) | 6 (24.0%) | |
| Type of grade 3/4 AE | |||||
| HFSR | 9 (6.7) | 1 (2.3%) | 5 (7.6%) | 3 (12.0%) | |
| Mucositis | 2 (1.4) | 0 (0.0%) | 2 (3.1%) | 0 (0.0%) | |
| Bowel perforation | 3 (2.2) | 1 (2.3%) | 1 (1.5%) | 1 (4.0%) | |
| Hepatitis | 1 (0.7) | 1 (2.3%) | 0 (0.0%) | 0 (0.0%) | |
| Diarrhea | 1 (0.7) | 0 (0.0%) | 0 (0.0%) | 1 (4.0%) | |
| Fatigue | 1 (0.7) | 0 (0.0%) | 0 (0.0%) | 1 (4.0%) | |
Abbreviations: AE, adverse event; HFSE, hand-foot skin reaction.