Table 4. Treatment-related serious adverse events affecting ⩾5% of patients during the local treatment perioda and follow-up phase.
|
Number of patients (%)
|
|||
|---|---|---|---|
| Toxicity NCI-CTC grade | Induction chemotherapy only (n=21) | Chemoradiotherapy (n=41)b | Radiotherapy alone (n=46) |
| Oesophagitis/dysphagia | — | 7 (17) | — |
| Infection without neutropenia grade 4 | — | 4 (10) | 2 (4) |
| Fever without infection or neutropenia grade 4 | 1 (5) | 3 (7) | 4 (9) |
| Pneumonitis | — | 2 (5) | — |
| Dyspnoea | — | 2 (5) | 2 (4) |
| Infection with neutropenia grade 4 | 1 (5) | 2 (5) | 1 (2) |
| Anaemia | 1 (5) | — | — |
| Cardiac dysrhythmia | 1 (5) | — | — |
| Reduced performance status | 1 (5) | — | — |
| Vomiting | 1 (5) | — | — |
a
Local treatment period includes the 30 days after the last infusion for nonhaematological toxicities and the 7 days after the last infusion for haematological toxicities.
b
Two patients were excluded owing to being randomised to local treatment but not receiving their randomised therapy.