8. Drug-related adverse events.
| Adverse events | NPCT (n=129) [n (%)] | PBCT (n=91) [n (%)] | |||||
| Grade 1−2 | Grade 3 | Grade 4 | Grade 1−2 | Grade 3 | Grade 4 | ||
| ALT, alanine aminotransferase; AST, aspartate aminotransferase; PPE, palmar-plantar erythrodysesthesia; NPCT, non-platinum-based chemotherapy; PBCT, platinum-based chemotherapy; NA, not applicable. No grade 5 adverse events were observed. | |||||||
| Hematological | |||||||
| Leucopenia | 38 (29.5) | 14 (10.9) | 5 (3.9) | 24 (26.4) | 11 (12.1) | 3 (3.3) | |
| Neutropenia | 11 (8.5) | 13 (10.1) | 2 (1.6) | 15 (16.5) | 6 (6.6) | 3 (3.3) | |
| Febrile neutropenia | NA | 2 (1.6) | 0 (0) | NA | 2 (2.2) | 0 (0) | |
| Anemia | 4 (3.1) | 0 (0) | 0 (0) | 3 (3.3) | 4 (4.4) | 1 (1.1) | |
| Thrombocytopenia | 2 (1.6) | 0 (0) | 0 (0) | 3 (3.3) | 5 (5.5) | 3 (3.3) | |
| Laboratory-assessed items | |||||||
| Increased ALT/AST | 6 (4.7) | 0 (0) | 0 (0) | 9 (9.9) | 0 (0) | 0 (0) | |
| Increased bilirubin | 3 (2.3) | 0 (0) | 0 (0) | 3 (3.3) | 0 (0) | 0 (0) | |
| Non-hematological | |||||||
| Nausea | 16 (12.4) | 1 (0.8) | NA | 14 (15.4) | 0 (0) | NA | |
| Vomiting | 9 (7.0) | 1 (0.8) | 0 (0) | 4 (4.4) | 1 (1.1) | 0 (0) | |
| Anorexic | 19 (14.7) | 0 (0) | 0 (0) | 6 (6.6) | 0 (0) | 0 (0) | |
| Diarrhea | 5 (3.9) | 0 (0) | 0 (0) | 4 (4.4) | 0 (0) | 0 (0) | |
| Abdominal distension | 3 (2.3) | 0 (0) | NA | 5 (5.5) | 0 (0) | NA | |
| Constipation | 5 (3.9) | 0 (0) | 0 (0) | 3 (3.3) | 0 (0) | 0 (0) | |
| Fatigue | 27 (20.9) | 2 (1.6) | NA | 13 (14.3) | 1 (1.1) | NA | |
| Hyperhidrosis | 15 (11.6) | 0 (0) | NA | 9 (9.9) | 0 (0) | NA | |
| Weight loss | 3 (2.3) | 0 (0) | NA | 1 (1.1) | 0 (0) | NA | |
| Insomnia | 13 (10.1) | 1 (0.8) | NA | 10 (11.0) | 0 (0) | NA | |
| Pain | 13 (10.1) | 0 (0) | NA | 5 (5.5) | 0 (0) | NA | |
| Alopecia | 17 (13.2) | NA | NA | 10 (11.0) | NA | NA | |
| PPE | 16 (12.4) | 0 (0) | NA | 0 (0) | 0 (0) | NA | |
| Pruritus | 8 (6.2) | 0 (0) | NA | 4 (4.4) | 0 (0) | NA | |
| Hyperpigmentation | 7 (5.4) | NA | NA | 5 (5.5) | NA | NA | |
| Dyspnea | 1 (0.8) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
| Palpitations | 3 (2.3) | NA | NA | 0 (0) | NA | NA | |
| Stomatitis | 8 (6.2) | 0 (0) | 0 (0) | 2 (2.2) | 0 (0) | 0 (0) | |
| Peripheral neuropathy | 10 (7.8) | 1 (0.8) | 0 (0) | 1 (1.1) | 0 (0) | 0 (0) | |
| Headache | 1 (0.8) | 0 (0) | NA | 0 (0) | 0 (0) | NA | |
| Dizziness | 2 (1.6) | 0 (0) | NA | 1 (1.1) | 0 (0) | NA | |