Table 4.
Grade 2 and 3 adverse events reported at 60 months after randomisation
|
Grade 2 |
Grade 3* |
||||||
|---|---|---|---|---|---|---|---|
| Chemoradiotherapy group (n=201) | Radiotherapy alone group (n=187) | p value† | Chemoradiotherapy group (n=201) | Radiotherapy alone group (n=187) | p value‡ | ||
| Any | 59 (29%) | 33 (18%) | 0·002 | 16 (8%) | 10 (5%) | 0·24 | |
| Allergic reaction or hypersensitivity | 0 | 0 | 0·48 | 0 | 1 (1%) | 0·48 | |
| Auditory or hearing | 4 (2%) | 1 (1%) | 0·29 | 2 (1%) | 1 (1%) | 1·00 | |
| Hypertension | 16 (8%) | 16 (9%) | 0·87 | 4 (2%) | 4 (2%) | 1·00 | |
| Lymphatics (oedema) | 5 (2%) | 0 | 0·06 | 0 | 0 | 1·00 | |
| Gastrointestinal (any) | 16 (8%) | 9 (5%) | 0·19 | 2 (1%) | 1 (1%) | 1·00 | |
| Constipation | 3 (1%) | 1 (1%) | 1·00 | 0 | 1 (1%) | 1·00 | |
| Diarrhoea | 7 (3%) | 7 (4%) | 1·00 | 0 | 0 | 1·00 | |
| Ileus or obstruction | 2 (1%) | 1 (1%) | 0·37 | 2 (1%) | 0 | 0·50 | |
| Haematological (any) | 5 (2%) | 5 (3%) | 1·00 | 0 | 0 | 1·00 | |
| Lymphocytes | 3 (1%) | 4 (2%) | 0·74 | 0 | 0 | 1·00 | |
| Infection (without neutropenia) | 2 (1%) | 0 | 0·12 | 2 (1%) | 0 | 0·50 | |
| Neuropathy (any) | 13 (6%) | 0 | <0·0001 | 1 (<1%) | 0 | 1·01 | |
| Motor neuropathy | 1 (<1%) | 0 | 0·50 | 1 (<1%) | 0 | 1·02 | |
| Sensory neuropathy | 12 (6%) | 0 | <0·0001 | 1 (<1%) | 0 | 1·03 | |
| Neurology (other) | 1 (<1%) | 0 | 0·25 | 2 (1%) | 0 | 0·50 | |
| Pain (any) | 13 (6%) | 5 (3%) | 0·15 | 3 (1%) | 3 (2%) | 1·00 | |
| Joint pain | 7 (3%) | 2 (1%) | 0·14 | 2 (1%) | 1 (1%) | 1·00 | |
| Muscle pain | 1 (<1%) | 1 (1%) | 0·61 | 0 | 1 (1%) | 0·48 | |
| Back/pelvic/limbs | 0 | 2 (1%) | 0·11 | 0 | 1 (1%) | 0·48 | |
| Abdomen/cramps | 2 (1%) | 0 | 0·12 | 2 (1%) | 0 | 0·50 | |
| Other | 2 (1%) | 1 (1%) | 1·00 | 1 (<1%) | 1 (1%) | 1·00 | |
| Musculoskeletal (other) | 0 | 1 (1%) | 1·00 | 1 (<1%) | 0 | 1·00 | |
| Genitourinary | ·· | ·· | ·· | ·· | ·· | ·· | |
| Incontinence | 8 (4%) | 9 (5%) | 1·00 | 0 | 0 | 1·00 | |
| Urinary frequency | 8 (4%) | 2 (1%) | 0·14 | 0 | 1 (1%) | 0·48 | |
| Constitutional | ·· | ·· | ·· | ·· | ·· | ·· | |
| Fatigue | 0 | 3 (2%) | 0·11 | 0 | 0 | 1·00 | |
| Other | 0 | 0 | 1·00 | 1 (<1%) | 0 | 1·00 | |
| Other toxicity | 4 (2%) | 4 (2%) | 1·00 | 3 (1%) | 2 (1%) | 1·00 | |
Data are n (%).
*
Only one grade 4 adverse event was reported 60 months after randomisation for a women treated in the chemoradiotherapy group (ileus or obstruction).
†
Significance level: p<0·01 for grade ≥2 events.
‡
Significance level: p<0·01 for grade ≥3 events. The prevalence of toxicity graded according to the Common Terminology Criteria for Adverse Events version 3.0 was calculated at each timepoint. For each adverse event, the maximum grade per patient was recorded (worst ever by patient).