Table 5.
Late TRAE (N = 157) | Grade 1 and 2 n (%) |
Grade 3 n (%) |
Grade 4 n (%) |
---|---|---|---|
Dysphagia | 4 (2.6) | 3 (1.9) | 0 |
Thirst *1 | 4 (2.6) | 0 | 0 |
Skin disorder *2 | 1 (0.6) | 2 (1.3) | 0 |
Soft tissue infection | 0 | 2 (1.3) | 0 |
Hyperamylasemia | 0 | 2 (1.3) | 0 |
Papilloedema | 0 | 2 (1.3) | 0 |
Visual acuity reduced | 2 (1.3) | 0 | 0 |
Radiation necrosis (site unknown) | 2 (1.3) | 0 | 0 |
Decreased appetite *3 | 2 (1.3) | 0 | 0 |
Pneumonia aspiration | 0 | 0 | 1 (0.6) |
Abscess bacterial (site unknown) | 0 | 1 (0.6) | 0 |
Brain abscess | 0 | 1 (0.6) | 0 |
Infected neoplasm | 0 | 1 (0.6) | 0 |
Cranial nerve paralysis | 0 | 1 (0.6) | 0 |
Cataract | 0 | 1 (0.6) | 0 |
Pneumonitis | 0 | 1 (0.6) | 0 |
Oroantral fistula | 0 | 1 (0.6) | 0 |
Ulcer haemorrhage | 0 | 1 (0.6) | 0 |
Radiation retinopathy | 0 | 1 (0.6) | 0 |
Osteoradionecrosis | 0 | 1 (0.6) | 0 |
*1 Including the description “dry mouth”. *2 Including the descriptions “skin exfoliation” and “skin ulcer”. *3 Including the description “hypophagia”. All notations conform to MedDRA/J version 25.1. Abbreviations: TRAEs, treatment-related adverse events; MedDRA, Medical Dictionary for Regulatory Activities.