Table 6.
Number of Patients with Grade 3–4 Adverse Event occurring Post Surgery and Prior to Chemotherapy or within 60 days of Surgery for Patients who did not have Post-operative Chemotherapy by Category, Term, and Grade Definitely, Probably, or Possibly Related to Protocol Treatment
| Category Term |
Capecitabine/Irinotecan/RT (n=47) Grade |
Capecitabine/Oxaliplatin/RT (n=51) Grade |
||||||
|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | |
| BLOOD/BONE MARROW | 9 | 8 | 1 | 0 | 8 | 9 | 3 | 0 |
| Hemoglobin | 9 | 7 | 0 | 0 | 8 | 8 | 2 | 0 |
| Lymphopenia | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| CARDIAC ARRHYTHMIA | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Atrial fibrillation | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| CONSTITUTIONAL SYMPTOMS | 8 | 6 | 0 | 0 | 5 | 5 | 2 | 0 |
| Fatigue | 6 | 3 | 0 | 0 | 5 | 3 | 1 | 0 |
| Weight decreased | 2 | 3 | 0 | 0 | 3 | 2 | 1 | 0 |
| GASTROINTESTINAL | 8 | 7 | 4 | 0 | 5 | 4 | 5 | 0 |
| Dehydration | 1 | 0 | 1 | 0 | 0 | 2 | 1 | 0 |
| Ileus paralytic | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| Leak (including anastomotic), GI: Small bowel | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Nausea | 2 | 2 | 1 | 0 | 0 | 1 | 0 | 0 |
| Rectal fistula | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Small intestinal stricture NOS | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 0 |
| INFECTION | 0 | 4 | 2 | 0 | 0 | 1 | 3 | 1 |
| Ano-rectal infection NOS | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 1 |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 × 10e9/L): Wound | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Infection with normal ANC or Grade 1 or 2 neutrophils: Pelvis NOS | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Infection with unknown ANC: Rectum | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Peritoneal infection | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| METABOLIC/LABORATORY | 3 | 1 | 3 | 0 | 8 | 3 | 3 | 0 |
| Aspartate aminotransferase increased | 1 | 0 | 1 | 0 | 2 | 0 | 0 | 0 |
| Blood creatinine increased | 0 | 0 | 1 | 0 | 1 | 0 | 2 | 0 |
| Hypoalbuminemia | 1 | 0 | 1 | 0 | 2 | 1 | 1 | 0 |
| Hyponatremia | 2 | 0 | 1 | 0 | 4 | 0 | 0 | 0 |
| Hypophosphatemia | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| NEUROLOGY | 1 | 3 | 0 | 0 | 2 | 1 | 2 | 0 |
| Depression | 0 | 3 | 0 | 0 | 0 | 0 | 1 | 0 |
| Peripheral motor neuropathy | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| PULMONARY/UPPER RESPIRATORY | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 0 |
| Dyspnea | 1 | 0 | 0 | 1 | 1 | 0 | 1 | 0 |
| RENAL/GENITOURINARY | 0 | 2 | 0 | 0 | 0 | 4 | 1 | 0 |
| Renal failure NOS | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Ureteric obstruction | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| VASCULAR | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Thrombosis | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
Adverse events were graded with CTCAE version 3.0.