Table 2. Grade 3–4 adverse events occurring during and up to 4 weeks following completion of CRT (based on 81 patients that had some treatment).
| Grade 3 | Grade 4 | |
|---|---|---|
| No. of patients (%) | No. of patients (%) | |
|
Haematological adverse events | ||
| Anaemia | 1 (1%) | 1 (1%) |
| Leucopoenia | 5 (6%) | 1 (1%) |
| Thrombocytopenia | 0 (0%) | 1 (1%) |
| Neutropenia | 4 (5%) | 1 (1%) |
| Febrile neutropenia | 1 (1%) | 1 (1%) |
| Any haematological AE | 10 (12%) | 4 (5%) |
|
Non-haematological adverse events | ||
| Diarrhoea | 20 (25%) | 0 (0%) |
| Acneiform rash | 7 (9%) | 0 (0%) |
| Fatigue | 6 (8%) | 0 (0%) |
| Dehydration | 1 (1%) | 0 (0%) |
| Pyrexia/Fever | 1 (1%) | 0 (0%) |
| Headache | 1 (1%) | 0 (0%) |
| Insomnia | 1 (1%) | 0 (0%) |
| Taste disturbance | 1 (1%) | 0 (0%) |
| Nausea | 1 (1%) | 0 (0%) |
| Vomiting | 1 (1%) | 0 (0%) |
| Urticaria | 1 (1%) | 0 (0%) |
| Other rash/skin reactionsa | 7 (9%) | 0 (0%) |
| Anal/rectal/bowel complicationsb | 6 (7%) | 0 (0%) |
| Thrombotic eventc | 1 (1%) | 5 (6%) |
| Otherd | 4 (5%) | 1 (1%) |
| Any non-haematological adverse event | 36 (44%) | 6 (7%) |
| Any adverse event | 38 (47%) | 10 (12%) |
Abbreviations: AE=adverse event; CRT=chemoradiation.
a
Skin related toxicity (2); rash (1); radiotherapy skin reaction (1); papular rash (1); shingles (1); perineal desquamation (1).
b
Rectal pain (1); bowel obstruction (1); tenesmus (1); sore anal verge (1); pain passing stools/rectal pain (1); perianal abscess (1).
c
Grade 3: deep vein thrombosis (1). Grade 4: pulmonary embolism (3); thrombosis/embolism (2).
d
Grade 3: pulmonary infection(1); vasovagal attack(1); urinary tract problems (1); dry cracked heels (1). Grade 4: urinary tract infection (1).