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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 75-year-old man developed pulmonary tuberculosis, hypoalbuminaemia, anaemia and lymphopenia during treatment with nivolumab for lung adenocarcinoma and metastasis to left adrenal gland. Additionally, he developed a paradoxical response following treatment with nivolumab, isoniazid, rifampicin, pyrazinamide and ethambutol for pulmonary tuberculosis [routes not stated; not all dosages and outcomes stated].
The man was diagnosed with a stage IV (T3N2M1b) lung adenocarcinoma in 2015. He received three lines of chemotherapy with various medications and palliative radiation therapy. A progression of the lung adenocarcinoma with a metastatic adrenal lesion was observed after three cycles of third-line chemotherapy. On 17 February, he started receiving fourth-line therapy with...
- Takata S, et al. Paradoxical response in a patient with non-small cell lung cancer who received nivolumab followed by anti-Mycobacterium tuberculosis agents. Journal of Infection and Chemotherapy 25: 54-58, No. 1, Jan 2019. Available from: URL: http://doi.org/10.1016/j.jiac.2018.06.016 - JapanCrossRefPubMedGoogle Scholar