Table 3.
Adverse event frequency comparison between sorafenib with or without celecoxib
| Adverse events | Sorafenib group (n = 58) | Sorafenib/celecoxib group (n = 58) | P value |
|---|---|---|---|
| Constitutional events | |||
| Fever | 1 (1.7%) | 1 (1.7%) | 1.000c |
| Fatigue | 11 (19.0%) | 2 (3.4%) | 0.008c |
| Weight loss | 10 (17.2%) | 5 (8.5%) | 0.166c |
| Dermatologic events | |||
| Alopecia (Hair loss) | |||
| ≥ Grade 1 | 15 (25.9%) | 5 (8.6%) | 0.014b |
| ≥ Grade 2 | 2 (3.4%) | 0 (0.0%) | 0.476c |
| Hand-foot syndrome | |||
| ≥ Grade 1 | 42 (72.4%) | 33 (68.8%) | 0.680b |
| ≥ Grade 2 | 37 (63.8%) | 17 (29.3%) | < 0.001b |
| ≥ Grade 3 | 11 (19.0%) | 2 (3.4%) | 0.008b |
| Rash | |||
| ≥ Grade 1 | 16 (27.6%) | 3 (5.2%) | 0.001b |
| ≥ Grade 2 | 3 (5.2%) | 1 (1.7%) | 0.611c |
| Gastrointestinal events | |||
| Anorexia | 12 (20.7%) | 6 (10.3%) | 0.124b |
| Diarrhea | |||
| ≥ Grade 1 | 37 (63.8%) | 26 (50.0%) | 0.144b |
| ≥ Grade 2 | 11 (19.0%) | 11 (19.0%) | 1.000b |
| ≥ Grade 3 | 0 (0.0%) | 2 (3.4%) | 0.476c |
| Nausea | 0 (0.0%) | 2 (3.4%) | 0.476c |
| Vomiting | 1 (1.7%) | 1 (1.7%) | 1.000c |
| Voice change | 7 (12.1%) | 2 (3.4%) | 0.165c |
| Hypertension | |||
| ≥ Grade 1 | 16 (27.6%) | 9 (15.5%) | 0.114b |
| ≥ Grade 2 | 6 (10.3%) | 1 (1.7%) | 0.119c |
| ≥ Grade 3 | 3 (5.2%) | 1 (1.7%) | 0.611c |
| Abdominal pain, unspecified | 17 (29.3%) | 7 (12.1%) | 0.022b |
| ECOG performance status score | 0.283c | ||
| 1 | 50 (86.2%) | 55 (94.8%) | |
| 2 | 3 (5.2%) | 1 (1.7%) | |
| Dose reduction/interruption | 27 (46.6%) | 9 (15.5%) | < 0.001b |
| Bone marrow suppression | |||
| Leucopenia | 0.077c | ||
| Grade 1 | 7 (12.1%) | 7 (12.1%) | |
| Grade 2 | 3 (5.2%) | 8 (13.8%) | |
| Grade 3 | 0 (0.0) | 1 (1.7%) | |
| Thrombocytopenia | 0.108c | ||
| Grade 1 | 5 (8.6%) | 11 (19.0%) | |
| Grade 2 | 8 (13.8%) | 6 (10.3%) | |
| Grade 3 | 6 (10.3%) | 3 (5.2%) | |
| Grade 4 | 0 (0.0%) | 1 (1.7%) | |
| Liver dysfunction | |||
| ALT | 32 (55.2%) | 31 (53.4%) | 0.852b |
| AST | 41 (70.7%) | 32 (55.2%) | 0.609a |
| TBIL | 22 (37.9%) | 17 (29.3%) | 0.326a |
| ALB | 25 (43.1%) | 17 (29.3%) | 0.122b |
Values with statistical significance are in bold.
a
T-test.
b
χ2 test.
c
Continuity correction.
ECOG: The Eastern Cooperative Oncology Group.