Table 4.
Number of Patients with Grade 3–4 Adverse Event occurring Prior to Surgery by Category, Term, and Grade Definitely, Probably, or Possibly Related to Protocol Treatment
| Category Term |
Capecitabine/Irinotecan/RT (n=52) Grade |
Capecitabine/Oxaliplatin/RT (n=52) Grade |
||||||
|---|---|---|---|---|---|---|---|---|
| 1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | |
| BLOOD/BONE MARROW | 13 | 14 | 5 | 0 | 18 | 11 | 2 | 0 |
| Hemoglobin | 18 | 3 | 0 | 0 | 13 | 4 | 1 | 0 |
| Leukopenia NOS | 13 | 11 | 4 | 0 | 9 | 3 | 2 | 0 |
| Lymphopenia | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 0 |
| Neutrophil count | 10 | 4 | 3 | 0 | 2 | 3 | 1 | 0 |
| CONSTITUTIONAL SYMPTOMS | 26 | 7 | 1 | 0 | 17 | 12 | 4 | 0 |
| Fatigue | 20 | 7 | 1 | 0 | 17 | 10 | 4 | 0 |
| DERMATOLOGY/SKIN | 11 | 10 | 1 | 0 | 12 | 15 | 0 | 0 |
| Dermatitis radiation NOS | 4 | 7 | 1 | 0 | 5 | 4 | 0 | 0 |
| GASTROINTESTINAL | 17 | 21 | 6 | 0 | 18 | 20 | 9 | 1 |
| Anorexia | 7 | 2 | 1 | 0 | 1 | 7 | 1 | 0 |
| Colitis NOS | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 |
| Dehydration | 0 | 2 | 1 | 0 | 0 | 3 | 4 | 0 |
| Diarrhea NOS | 17 | 14 | 4 | 0 | 18 | 14 | 9 | 0 |
| Dry mouth | 2 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Enteritis | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 1 |
| Nausea | 14 | 6 | 0 | 0 | 16 | 8 | 1 | 0 |
| Proctitis NOS | 4 | 1 | 0 | 0 | 6 | 6 | 1 | 0 |
| Small intestinal stricture NOS | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Tooth development disorder | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Vomiting NOS | 2 | 4 | 0 | 0 | 4 | 4 | 1 | 0 |
| INFECTION | 0 | 1 | 0 | 0 | 0 | 1 | 2 | 0 |
| Febrile neutropenia | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Infection with Grade 3 or 4 neutrophils (ANC <1.0 × 10e9/L): Urinary tract NOS | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| METABOLIC/LABORATORY | 14 | 6 | 3 | 0 | 12 | 7 | 4 | 1 |
| Aspartate aminotransferase increased | 3 | 0 | 1 | 0 | 6 | 2 | 0 | 0 |
| Hyperglycemia NOS | 6 | 2 | 1 | 0 | 4 | 1 | 0 | 0 |
| Hypoalbuminemia | 5 | 2 | 0 | 0 | 2 | 3 | 2 | 0 |
| Hypocalcemia | 4 | 0 | 0 | 0 | 4 | 2 | 1 | 0 |
| Hypokalemia | 7 | 0 | 0 | 0 | 6 | 0 | 1 | 1 |
| Hyponatremia | 4 | 0 | 1 | 0 | 4 | 0 | 2 | 0 |
| NEUROLOGY | 2 | 3 | 0 | 0 | 13 | 5 | 1 | 0 |
| Depression | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| PAIN | 8 | 7 | 3 | 0 | 11 | 11 | 2 | 0 |
| Abdominal pain NOS | 3 | 5 | 1 | 0 | 1 | 4 | 1 | 0 |
| Penile pain | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Proctalgia | 4 | 2 | 2 | 0 | 5 | 7 | 1 | 0 |
| PULMONARY/UPPER RESPIRATORY | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 0 |
| Hiccups | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 0 |
Includes adverse events where relationship to protocol treatment is missing.
Adverse events were graded with CTCAE version 3.0.