Table 4.
Adverse events according to NCI CTCAE v.4.0.
| Adverse Event | Grade 1–2 n/N (%) |
Grade 3 n/N (%) |
N.a. n/N (%) |
|---|---|---|---|
| Anemia | 71/105 (68) | 1/105 (1) | 6/105 (6) |
| Leucopenia | 44/105 (42) | 1/105 (1) | 6/105 (6) |
| Neutropenia | 6/105 (6) | - | 6/105 (6) |
| Neutropenic fever | - | 1/105 (1) | 6/105 (6) |
| Thrombocytopenia | 38/105 (36) | - | 6/105 (6) |
| Elevated creatinine | 15/105 (14) | - | 6/105 (6) |
| Elevated bilirubine | 12/105 (11) | - | 6/105 (6) |
| Elevated transaminases (AST/ALT) | 41/105 (39) | 2/105 (2) | 6/105 (6) |
| Elevated alkaline phosphatase | 19/105 (18) | - | 6/105 (6) |
| Aconuresis | 4/105 (4) | - | 7/105 (7) |
| Allergic reaction | 11/105 (10) | 2/105 (2) | 7/105 (7) |
| Alopecia | 5/105 (5) | - | 7/105 (7) |
| Anal incontinence | 29/105 (28) | 1/105 (1) | 7/105 (7) |
| Diarrhea | 74/105 (70) | 10/105 (10) | 7/105 (7) |
| Dyspnea | 9/105 (9) | - | 7/105 (7) |
| Emesis | 15/105 (14) | - | 7/105 (7) |
| Erectile dysfunction | 9/82 (11) | 1/82 (1) | 5/82 (6) |
| Fatigue | 67/105 (64) | - | 7/105 (7) |
| Fever | 15/105 (14) | - | 7/105 (7) |
| Hand-foot-syndrome | 7/105 (7) | - | 7/105 (7) |
| Heart disorder | 5/105 (5) | - | 7/105 (7) |
| Hemorrhage | 50/105 (48) | 1/105 (1) | 7/105 (7) |
| Mucositis | 18/105 (17) | 1/105 (1) | 7/105 (7) |
| Nausea | 39/105 (37) | 2/105 (2) | 7/105 (7) |
| Non-infectious cystitis | 53/105 (50) | 2/105 (2) | 7/105 (7) |
| Obstipation | 39/105 (37) | - | 7/105 (7) |
| Pain | 56/105 (53) | 4/105 (4) | 7/105 (7) |
| Peripheral motoric neuropathy | 8/105 (8) | - | 7/105 (7) |
| Peripheral sensoric neuropathy | 64/105 (61) | - | 7/105 (7) |
| Proctitis | 62/105 (59) | 3/105 (3) | 7/105 (7) |
| Radiodermatitis | 71/105 (68) | 7/105 (7) | 7/105 (7) |
| Urge to urinate | 40/105 (38) | - | 7/105 (7) |
| Vaginal stenosis | 3/23 (13) | - | - |
| Weight loss | 23/105 (22) | - | 7/105 (7) |
| Other non-hematological AEs | 20/105 (19) | 7/105 (7) | 6/105 (6) |
N.a.: not available. AEs: adverse events. AST: glutamyl oxaloacetic transaminase/aspartate aminotransferase; ALT: glutamyl pyruvic transaminase/alanine aminotransferase.