Table 3.
Grade 3–4 adverse events
| RealFLOT: Preoperative (n = 206) |
RealFLOT: Postoperative (n = 142a) |
Patients ≥ 65 in the preoperative phase (n = 89) |
Patients < 65 in the preoperative phase (n = 117) |
Patients ≥ 65 in the postoperative phase (n = 56a) |
Patients < 65 in the postoperative phase (n = 86a) |
|
|---|---|---|---|---|---|---|
| Hematologic AEs | ||||||
| Neutropenia | 19.9% | 16.9% | 18.0% | 21.4% | 14.3% | 18.6% |
| Febrile neutropenia | 4.4% | 1.4% | 4.5% | 4.3% | 1.8% | 1.2% |
| Anemia | 0.5% | 0.7% | 0% | 0.8% | 0% | 1.2% |
| Gastrointestinal AEs | ||||||
| Diarrhea | 1.5% | 3.5% | 2.2% | 0.8% | 3.6% | 3.4% |
| Stomatitis | 0.5% | 1.4% | 1.1% | 0% | 1.8% | 1.2% |
| Nausea | 2.4% | 5.6% | 3.4% | 1.7% | 1.8% | 8.1% |
| Vomiting | 1.9% | 3.5% | 4.5% | 0.8% | 1.8% | 4.6% |
| Increases in ALT/AST | 0.5% | 0% | 0% | 0.8% | 0% | 0% |
| Infective events (any G) | 5.8% | 3.5% | 5.6% | 6.0% | 5.4% | 2.3% |
| Neurotoxic effects | 1% | 2.8% | 2.2% | 0% | 1.8% | 3.5% |
| Cardiac complications | 0.5% | 0% | 1.1% | 0% | 0% | 0% |
| Thromboembolic events (any G) | 2.4% | 1.4% | 0% | 4.3% | 1.8% | 1.2% |
a At the time of the interim analysis, 4 patients were still under postoperative treatment
Abbreviations: AE adverse event; G grade