Table 3 Adverse events by group
Grade 3 or 4 AEs | Ineligible (n = 34) | Eligible (n = 169) | Total (n = 203) | P-value* |
|---|---|---|---|---|
Any (%) | 25 (73.5) | 113 (66.9) | 138 (68.0) | 0.547 |
Hematological | ||||
Leukopenia (%) | 13 (38.2) | 67 (39.6) | 80 (39.4) | 1.000 |
Neutropenia (%) | 21 (61.8) | 103 (60.9) | 124 (61.1) | 1.000 |
Thrombocytopenia (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA |
Anemia (%) | 4 (11.8) | 6 (3.6) | 10 (4.9) | 0.066 |
Febrile neutropenia (%) | 4 (11.8) | 14 (8.3) | 18 (8.9) | 0.512 |
Non-hematological | ||||
Fatigue | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA |
Peripheral neuropathy | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA |
Nausea | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA |
Constipation | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA |
Diarrhea | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA |
Total Bilirubin (%) | 1 (2.9) | 0 (0.0) | 1 (0.5) | 0.167 |
AST increased (%) | 1 (2.9) | 5 (3.0) | 6 (3.0) | 1.000 |
ALT increased (%) | 2 (5.9) | 4 (2.4) | 6 (3.0) | 0.264 |
Discontinuation due to AEs (%) | 4 (11.8) | 5 (3.0) | 9 (4.4) | 0.045 |
AEs leading to hospitalization (%) | 2 (5.9) | 11 (6.5) | 13 (6.4) | 1.000 |