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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series, two men aged 79 years and 53 years respectively, were described who developed Pneumocystis jirovecii pneumonia (PJP) during immunosuppressant treatment with carboplatin, cisplatin, ganciclovir, gemcitabine, mycophenolate mofetil, nivolumab, prednisolone or vinorelbine to treat non-small-cell lung cancer (NSCLC). Both the patients died due to respiratory failure out of whom one patient had an off label use of nivolumab and exhibited lack of effect with cotrimoxazole as an anti-infective treatment [routes and dosages not stated for all medications].
Case 1: The 79-year-old man had a medical history of grade-II chronic obstructive pulmonary disease with a smoking history of 50 pack-years. In April 2017, he had been diagnosed with bilateral NSCLC. The left and...
- Schwarz M, et al. Immunosuppression for Immune Checkpoint-related Toxicity Can Cause Pneumocystis Jirovecii Pneumonia (PJP) in Non-small-cell Lung Cancer (NSCLC): A Report of 2 Cases. Clinical Lung Cancer 20: e247-e250, No. 3, May 2019. Available from: URL: http://doi.org/10.1016/j.cllc.2018.12.006 - Austria