Table 3.
Grade ≥3 AEs stratified by treatment
| Grade ≥3 AEs | 5-FU/RT n=132 |
mFOLFOX-6 n=80 |
|---|---|---|
| Patients with Grade ≥3 AEs | 24 (18%) | 9 (11%) |
| Most common Grade ≥3 AEs | ||
| Gastrointestinal | 10 (8%) | 0 (0%) |
| Abdominal/Rectal pain | 6 (5%) | 1 (1%) |
| Vascular | 0 (0%) | 2 (3%) |
| Infection | 2 (2%) | 0 (0%) |
| Hematologic | 3 (2%) | 4 (5%) |
| Constitutional symptoms | 3 (2%) | 0 (0%) |
| Cardiac event | 0 (0%) | 1 (1%) |
| Other (Allergy/skin/rash) | 8 (6%) | 3 (4%) |
AE: Adverse event; 5-FU: 5-fluorouracil; RT: radiation therapy; mFOLFOX-6: modified FOLFOX-6 chemotherapy.