Table 3.
Summary of treatment-related grade 3 or 4 adverse events in the intention-to-treat population
| Adverse events (grade 3 or 4) | Total patients [cases (%)] (N = 123) | Treatment groups | P value# | |
|---|---|---|---|---|
| Irinotecan plus S-1 group [cases (%)] (n = 61) | S-1 monotherapy group [cases (%)] (n = 62) | |||
| Anemia | 3 (2.4) | 2 (3.3) | 1 (1.6) | 0.619 |
| Leukopenia | 10 (8.1) | 10 (16.4) | 0 (0) | 0.001 |
| Neutropenia | 10 (8.1) | 9 (14.8) | 1 (1.6) | 0.008 |
| Thrombocytopenia | 2 (1.6) | 2 (3.3) | 0 (0) | 0.496 |
| Diarrhea | 3 (2.4) | 2 (3.3) | 1 (1.6) | 0.619 |
| Nausea | 3 (2.4) | 3 (4.9) | 0 (0) | 0.119 |
| Vomiting | 2 (1.6) | 1 (1.6) | 1 (1.6) | 0.748 |
| Fatigue | 3 (2.4) | 2 (3.3) | 1 (1.6) | 0.619 |
| Anorexia | 1 (0.8) | 0 (0) | 1 (1.6) | 1.000 |
| Elevated bilirubin | 1 (0.8) | 1 (1.6) | 0 (0) | 1.000 |
#Tested by Fisher’s exact test