Table 3.
Treatment Related Adverse Events*
| All Grades | Grade 1^ | Grade 2^ | Grade 3 | Grade 4 | |
|---|---|---|---|---|---|
| Adverse event | N (%) | N (%) | N (%) | N (%) | N (%) |
| Fatigue | 19 (59%) | 13 (41%) | 6 (19%) | - | - |
| Lymphopenia | 14 (44%) | 1 (3%) | 4 (13%) | 8 (25%) | 1 (3%) |
| Anemia | 12 (38%) | 9 (28%) | 3 (9%) | - | - |
| Diarrhea | 12 (38%) | 8 (25%) | 3 (9%) | 1 (3%) | - |
| Leukopenia | 12 (38%) | 7 (22%) | 4 (13%) | 1 (3%) | - |
| Nausea | 11 (34%) | 11 (34%) | - | - | - |
| Urinary frequency | 8 (25%) | 8 (25%) | - | - | - |
| Cystitis | 7 (22%) | 6 (19%) | 1 (3%) | - | - |
| Hypophosphatemia | 7 (22%) | 2 (6%) | 4 (13%) | 1 (3%) | - |
| Neutropenia | 7 (22%) | 6 (19%) | 1 (3%) | - | - |
| Anorexia | 5 (16%) | 3 (9%) | 2 (6%) | - | - |
| Abdominal pain | 5 (16%) | 4 (13%) | 1 (3%) | - | - |
| Constipation | 5 (16%) | 3 (9%) | 2 (6%) | - | - |
| Thrombocytopenia | 5 (16%) | 5 (16%) | - | - | - |
| Urinary urgency | 5 (16%) | 4 (13%) | 1 (3%) | - | - |
| Hypocalcemia | 4 (13%) | 4 (13%) | - | - | - |
| Hyponatremia | 4 (13%) | 4 (13%) | - | - | - |
| Rectal pain | 4 (13%) | - | 4 (13%) | - | - |
| Urinary tract pain | 4 (13%) | 3 (9%) | 1 (3%) | - | - |
| Alanine aminotransferase increase | 3 (9%) | 2 (6%) | 1 (3%) | - | - |
| Aspartate aminotransferase increase | 3 (9%) | 2 (6%) | 1 (3%) | - | - |
| Hypertension | 3 (9%) | 2 (6%) | 1 (3%) | - | - |
| Hypoalbuminemia | 3 (9%) | 2 (6%) | 1 (3%) | - | - |
| Hypomagnesemia | 3 (9%) | 3 (9%) | - | - | - |
| Radiation dermatitis | 3 (9%) | 1 (3%) | 1 (3%) | 1 (3%) | - |
| Vomiting | 3 (9%) | 3 (9%) | - | - | - |
| Blood bilirubin increased | 2 (6%) | - | 2 (6%) | - | - |
| Dry skin | 2 (6%) | 2 (6%) | - | - | - |
| Hypermagnesemia | 2 (6%) | 2 (6%) | - | - | - |
| Hypokalemia | 2 (6%) | 1 (3%) | 1 (3%) | - | - |
| Palmar-plantar erythrodysesthesia | 2 (6%) | 2 (6%) | - | - | - |
| Rectal hemorrhage | 2 (6%) | 2 (6%) | - | - | - |
| Thrombotic thrombocytopenia purpura | 2 (6%) | 2 (6%) | - | - | - |
| Colitis | 1 (3%) | - | - | 1 (3%) | - |
| Rectal Obstruction | 1 (3%) | - | - | 1 (3%) | - |
*
Events deemed at least possibly related to treatment are reported by the worst grade per patient. There were no grade 5 events.
^
The following grade 1–2 adverse events occurred in a single patient (grade shown in parentheses): alkaline phosphatase increase (1), chills (1), dehydration (2), headache (1), hematuria (1), hemorrhoid (1), gastroesophageal reflux (1), gastrointestinal pain (1), infusion reaction (2), insomnia (1), non-cardiac chest pain (2), pain NOS (1), pain in skin (1), phlebitis (2), proteinuria (1), thromboembolic event (2), urinary disorders other (2), vaginal infection (2), vaginal pain (2), weight loss (1)