Adverse event | Group A (n = 45) | Group B (n = 45) | P value | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
G1 | G2 | G3 | Any grade (%) | G2/G3 (%) | G1 | G2 | G3 | Any grade (%) | G2/G3 (%) | Any grade | G2/G3 | |
Any adverse event | 27 | 8 | 5 | 40 (89%) | 13 (29%) | 15 | 24 | 6 | 45 (100%) | 30 (67%) | 0.056 | 0.001 |
Anemia | 13 | 1 | 0 | 14 (31%) | 1 (2%) | 21 | 2 | 0 | 23 (51%) | 2 (4%) | 0.086 | 1.000 |
Leukopenia | 7 | 2 | 0 | 9 (20%) | 2 (4%) | 12 | 2 | 0 | 14 (31%) | 2 (4%) | 0.334 | 1.000 |
Neutropenia | 9 | 1 | 0 | 10 (22%) | 1 (2%) | 7 | 0 | 0 | 7 (16%) | 0 (0%) | 0.591 | 1.000 |
Thrombocytopenia | 7 | 0 | 0 | 7 (16%) | 0 (0%) | 15 | 0 | 0 | 15 (33%) | 0 (0%) | 0.085 | **** |
Elevation of AST | 12 | 1 | 1 | 14 (31%) | 2 (4%) | 12 | 0 | 0 | 12 (27%) | 0 (0%) | 0.816 | 0.494 |
Elevation of ALT | 12 | 2 | 0 | 14 (31%) | 2 (4%) | 13 | 1 | 0 | 14 (31%) | 1 (2%) | 1.000 | 1.000 |
Elevation of LDH | 5 | 0 | 0 | 5 (11%) | 0 (0%) | 10 | 0 | 0 | 10 (22%) | 0 (0%) | 0.258 | **** |
Elevation of bilirubin | 15 | 1 | 0 | 16 (36%) | 1 (2%) | 14 | 6 | 1 | 21 (47%) | 7 (16%) | 0.392 | 0.058 |
Elevation of creatinine | 3 | 0 | 0 | 3 (7%) | 0 (0%) | 5 | 0 | 0 | 5 (11%) | 0 (0%) | 0.714 | **** |
Anorexia | 8 | 0 | 1 | 9 (20%) | 1 (2%) | 17 | 4 | 1 | 22 (49%) | 5 (11%) | 0.007 | 0.203 |
Nausea | 12 | 0 | 0 | 12 (27%) | 0 (0%) | 13 | 4 | 0 | 17 (38%) | 4 (9%) | 0.367 | 0.117 |
Vomiting | 4 | 0 | 0 | 4 (9%) | 0 (0%) | 6 | 1 | 0 | 7 (16%) | 1 (2%) | 0.522 | 1.000 |
Diarrhea | 5 | 3 | 0 | 8 (18%) | 3 (7%) | 10 | 2 | 1 | 13 (29%) | 3 (7%) | 0.319 | 1.000 |
Stomatitis | 9 | 0 | 0 | 9 (20%) | 0 (0%) | 9 | 2 | 1 | 12 (27%) | 3 (7%) | 0.619 | 0.242 |
Fatigue | 4 | 0 | 0 | 4 (9%) | 0 (0%) | 5 | 1 | 0 | 6 (13%) | 1 (2%) | 0.739 | 1.000 |
Skin symptoms | 4 | 0 | 1 | 5 (11%) | 1 (2%) | 13 | 6 | 1 | 20 (44%) | 7 (16%) | 0.001 | 0.058 |
Keratinitis/conjunctivitis | 0 | 0 | 0 | 0 (0%) | 0 (0%) | 5 | 2 | 0 | 7 (16%) | 2 (4%) | 0.012 | 0.494 |