Table 3.
Adverse events*
| Adverse event | Grade 0 | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
|---|---|---|---|---|---|
| Acute† | |||||
| Leukopenia | 1 (3) | 3 (9) | 9 (26) | 18 (51) | 4 (11) |
| Neutropenia | 6 (17) | 0 (0) | 12 (34) | 16 (46) | 1 (3) |
| Lymphopenia | 0 (0) | 0 (0) | 3 (9) | 24 (69) | 8 (23) |
| Anemia | 2 (6) | 3 (9) | 23 (66) | 7 (20) | 0 (0) |
| Thrombocytopenia | 1 (3) | 16 (46) | 10 (29) | 7 (20) | 1 (3) |
| Fatigue | 0 (0) | 18 (51) | 16 (46) | 1 (3) | 0 (0) |
| Fever | 32 (91) | 2 (6) | 1 (3) | 0 (0) | 0 (0) |
| Sweating/chills | 31 (89) | 4 (11) | 0 (0) | 0 (0) | 0 (0) |
| Diarrhea | 2 (6) | 13 (37) | 13 (37) | 7 (20) | 0 (0) |
| Nausea | 2 (6) | 19 (54) | 12 (34) | 2 (6) | 0 (0) |
| Vomiting/emesis | 18 (51) | 11 (31) | 6 (17) | 0 (0) | 0 (0) |
| Low appetite/weight loss | 6 (17) | 25 (71) | 4 (11) | 0 (0) | 0 (0) |
| Constipation/bloating | 13 (37) | 20 (57) | 2 (6) | 0 (0) | 0 (0) |
| Abdominal/pelvic pain | 6 (17) | 21 (60) | 7 (20) | 1 (3) | 0 (0) |
| Rectal bleeding | 27 (77) | 7 (20) | 0 (0) | 1 (3) | 0 (0) |
| Rectal pain | 20 (57) | 14 (40) | 1 (3) | 0 (0) | 0 (0) |
| Vaginal bleeding/discharge | 13 (37) | 19 (54) | 3 (9) | 0 (0) | 0 (0) |
| Dysuria | 12 (34) | 16 (46) | 7 (20) | 0 (0) | 0 (0) |
| Frequency/urgency | 8 (23) | 23 (66) | 4 (11) | 0 (0) | 0 (0) |
| Incontinence | 20 (57) | 12 (34) | 3 (9) | 0 (0) | 0 (0) |
| Hematuria | 24 (69) | 10 (29) | 1 (3) | 0 (0) | 0 (0) |
| Dyspnea/cough | 30 (86) | 4 (11) | 0 (0) | 1 (3) | 0 (0) |
| Tinnitus | 31 (89) | 4 (11) | 0 (0) | 0 (0) | 0 (0) |
| Neuropathy | 31 (89) | 4 (11) | 0 (0) | 0 (0) | 0 (0) |
| Weakness/dizziness | 28 (80) | 5 (14) | 2 (6) | 0 (0) | 0 (0) |
| Dermatitis/rash | 17 (49) | 16 (46) | 2 (6) | 0 (0) | 0 (0) |
| Late† | |||||
| Rectal bleeding | - | - | 4(11) | 0 (0) | 0 (0) |
| Fistula | - | - | 2 (6) | 0 (0) | 0 (0) |
| Ureteral stricture | - | - | 0 (0) | 2 (6) | 0 (0) |
| Soft tissue necrosis | - | - | 1(3) | 0 (0) | 0 (0) |
| Pelvic fracture | - | - | 0 (0) | 0 (0) | |
| Cystitis | - | - | 1 (3) | 0 (0) |
Other acute grade 1 events (number of patients): headache (4), itching/dryness (3), anxiety (2), insomnia (2), urinary retention (2), dyspareunia (1), dysphagia (1), alopecia (1).
*
Scored with the Common Terminology Criteria for Adverse Events, version 4.0, highest grade recorded, regardless of attribution. Data are presented as number (percentage) of patients unless otherwise indicated.
†
Acute period is from trial registration until 30 d after treatment completion. Late period is 31 or more d after treatment completion.