Table 3. Analysis of safety in full analysis Set.
| No. (%) | ||||
|---|---|---|---|---|
| UFT group (n = 29) | OBS group (n = 29) | |||
| Adverse Event | Any grade | Grade 3 or 4 | Any grade | Grade 3 or 4 |
| Hematologic | ||||
| Leucopenia | 7 (24.1) | 0 | 2 (6.9) | 0 |
| Neutropenia | 4 (13.8) | 0 | 1 (3.4) | 0 |
| Anemia | 12 (41.4) | 1 (3.4) | 2 (6.9) | 0 |
| thrombocytopenia | 3 (10.3) | 1 (3.4) | 1 (3.4) | 0 |
| Non-hematologic | ||||
| Hyperbilirubinemia | 3 (10.3) | 0 | 0 | 0 |
| Fatigue | 3 (10.3) | 0 | 0 | 0 |
| Increased ALP | 7 (24.1) | 0 | 0 | 0 |
| Elevated GGT | 2 (6.9) | 0 | 1 (3.4) | 0 |
| Decreased appetite | 6 (20.7) | 0 | 2 (6.9) | 0 |
| Diarrhea | 2 (6.9) | 2 (6.9) | 0 | 0 |
| Abdominal distension | 4 (13.8) | 0 | 1 (3.4) | 0 |
Abbreviations: ALP, alkaline phosphatase; GGT, γ-glutamyltransferase