Table 3.
Adverse events during treatment
NDP group (n = 78) |
DDP group (n = 79) |
P value | |||||||
---|---|---|---|---|---|---|---|---|---|
Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 1 | Grade 2 | Grade 3 | Grade 4 | ||
Hematological | |||||||||
Leukopenia | 30 (38.46) | 18 (23.08) | 4 (5.13) | 0 | 31 (39.24) | 26 (32.91) | 6 (7.59) | 0 | 0.247 |
Neutropenia | 13 (16.67) | 10 (12.82) | 3 (3.85) | 1 (1.28) | 22 (27.84) | 6 (7.59) | 2 (2.53) | 1 (1.27) | 0.463 |
Anemia | 35 (44.87) | 4 (5.13) | 0 | 0 | 34 (43.04) | 1 (1.27) | 0 | 0 | 0.350 |
Thrombocytopenia | 3 (3.85) | 1 (1.28) | 0 | 0 | 4 (5.06) | 1 (1.27) | 0 | 0 | 0.934 |
Lymphopenia | 7 (8.97) | 27 (34.62) | 41 (52.56) | 0 | 4 (5.06) | 25 (31.65) | 47 (59.49) | 3 | 0.192 |
Non-hematological | |||||||||
Vomiting | 20 (25.64) | 16 (20.51) | 4 (5.13) | 0 | 30 (37.97) | 22 (27.84) | 9 (11.39) | 0 | 0.021∗ |
Nausea | 21 (26.92) | 18 (23.08) | 5 (6.41) | 0 | 32 (40.51) | 24 (30.38) | 11 (13.92) | 0 | 0.009∗ |
Anorexia | 23 (29.49) | 22 (28.21) | 7 (8.97) | 0 | 33 (41.77) | 25 (31.65) | 13 (16.46) | 0 | 0.011∗ |
Constipation | 10 (12.82) | 5 (6.41) | 0 | 0 | 12 (15.19) | 7 (8.87) | 0 | 0 | 0.473 |
Diarrhea | 22 (28.21) | 8 (10.26) | 0 | 0 | 23 (29.11) | 9 (11.39) | 0 | 0 | 0.387 |
Hiccups | 2 (2.56) | 0 | 0 | 0 | 2 (2.53) | 0 | 0 | 0 | 0.942 |
Weight loss | 30 (38.46) | 12 (15.38) | 1 (1.28) | 0 | 34 (43.04) | 14 (17.72) | 3 | 0 | 0.041∗ |
Fatigue | 7 (8.97) | 6 (7.69) | 0 | 0 | 7 (8.86) | 7 (8.86) | 0 | 0 | 0.849 |
Fever | 2 (2.56) | 1 (1.28) | 0 | 0 | 3 (3.80) | 0 | 0 | 0 | 0.904 |
Total bilirubin | 6 (7.69) | 1 (1.28) | 0 | 0 | 2 (2.53) | 1 (1.27) | 0 | 0 | 0.034∗ |
ALT increase | 6 (7.69) | 1 (1.28) | 0 | 0 | 1 (1.27) | 1 (1.27) | 0 | 0 | 0.044∗ |
AST increase | 5 (6.41) | 1 (1.28) | 0 | 0 | 1 (1.27) | 1 (1.27) | 0 | 0 | 0.046∗ |
Creatinine increase | 0 | 0 | 0 | 0 | 4 (5.06) | 0 | 0 | 0 | <0.001∗ |
Data are n (%). No grade 5 adverse events occurred during treatment. As prespecified by protocol, differences in adverse events were analyzed using χ2 test.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; DDP, cisplatin; NDP, nedaplatin.
P < 0.05 is considered significant.