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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 retrospective review between January 2016 and January 2018 described 5 patients, aged 53−83 years, who developed hyperprogression of non small cell lung cancer, leading to various complications in four patients (cases 1, 2, 3 and 5), during treatment with nivolumab for non small cell lung cancer [routes, dosages and durations of treatment to reactions onset not stated].
Case 1: A 69-year-old man underwent concurrent chemoradiotherapy for stage IIIB squamous cell carcinoma from March−May 2015. The primary lung tumour recurred, and nivolumab was started as a second line therapy in May 2016. After nivolumab therapy, he began complaining dyspnoea. Oxygenation status and symptoms began to rapidly deteriorate. On a chest X-ray tumour progression was noted. After two cycles of...