Table 3. Treatment-related adverse events (N = 155)†.
Nimotuzumab+Gefitinib (n=78) | Gefitinib (n=75) | P-value | |||||
---|---|---|---|---|---|---|---|
Adverse event | All grades | Grade 1-2 | Grade≥3 | All grades | Grade 1-2 | Grade≥3 | |
N (%) | N (%) | ||||||
Acneiform rash | 37(47.4%) | 35(44.9%) | 2 (2.6%) | 34(44.2%) | 33(42.9%) | 1 (1.3%) | 0.40 |
Diarrhea | 28 (35.9%) | 26 (33.3%) | 2 (2.6%) | 27 (35.1%) | 26 (33.8%) | 1 (1.3%) | 0.52 |
Anorexia | 27 (34.6%) | 25 (32.1%) | 2 (2.6%) | 21 (27.3%) | 18 (23.4%) | 3 (3.9%) | 0.28 |
Stomatitis | 18 (23.1%) | 18 (23.1%) | 0 (0%) | 20 (26.0%) | 20 (26.0%) | 0 (0%) | 0.40 |
Dry skin | 16 (20.5%) | 16 (20.5%) | 0 (0%) | 16 (20.5%) | 16 (20.5%) | 0 (0%) | 0.40 |
Pruritus | 16 (20.5%) | 16 (20.5%) | 0 (0%) | 16 (20.8%) | 16 (20.8%) | 0 (0%) | 0.56 |
Paronychia | 12 (15.4%) | 12 (15.4%) | 0 (0%) | 13 (16.9%) | 13 (16.9%) | 0 (0%) | 0.48 |
AST elevation | 11(14.1%) | 9 (11.5%) | 2 (2.6%) | 8 (10.4%) | 6 (7.8%) | 2 (2.6%) | 0.32 |
ALT elevation | 10 (12.8%) | 8 (10.3%) | 2 (2.6%) | 8 (10.4%) | 5 (6.5%) | 3 (3.9%) | 0.29 |
Myalgia | 9 (11.6%) | 9 (11.6%) | 0 (0%) | 7 (9.1%) | 7 (9.1%) | 0 (0%) | 0.60 |
Nausea | 8 (10.3%) | 8 (10.3%) | 0 (0%) | 10 (13.0%) | 8 (10.4%) | 2 (2.6%) | 0.39 |
Vomiting | 5 (6.4%) | 5 (6.4%) | 0 (0%) | 4 (5.2%) | 4 (5.2%) | 0 (0%) | 0.50 |
Thrombocytopenia | 5 (6.4%) | 5 (6.4%) | 1 (1.3%) | 3 (3.9%) | 3 (3.9%) | 0 (0%) | 0.56 |
Neutropenia | 4 (5.1%) | 4 (5.1%) | 0 (0%) | 2 (3.9%) | 2 (3.9%) | 0 (0%) | 0.50 |
Anemia | 3 (3.8%) | 3 (3.8%) | 0 (0%) | 4(5.2%) | 4(5.2%) | 0 (0%) | 0.49 |
Pneumonitis | 3 (3.8%) | 3 (3.8%) | 0 (0%) | 3 (3.9%) | 2 (2.6%) | 1 (1.3%) | 0.65 |
Toxic-effect grades are based on the National Cancer Institute Common Terminology Criteria (version 3.0).