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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
Three men aged 69−83 years were described, who developed tuberculosis (TB) during treatment with prednisolone, cisplatin, paclitaxel, cetuximab or dexamethasone for head and neck cancer [routes and outcomes not stated; not all dosages stated].
Case 1: The 83-year-old man developed TB during treatment with prednisolone. The man was diagnosed with laryngeal squamous cell carcinoma in November 2016. He had been treated for pulmonary TB at the age of 18 years, and at the time of current preservation, his thoracic CT and positron emission tomography (PET) scans were normal. He underwent radiotherapy, however, in April 2017, his carcinoma recurred with laryngeal oedema and cervical lymph node metastasis. While awaiting surgery, he received prednisolone 60mg for the oedema for 1 month,...
- Matsuo M. Development of active tuberculosis during treatment of head and neck carcinoma: A case series. Journal of Medical Case Reports 13: No. 1, May 2019. Available from: URL: http://doi.org/10.1186/s13256-019-2055-2 - Japan