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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 report, a man in his 60s developed subacute cutaneous lupus erythematosus (SCLE) and dermatomyositis during treatment with nivolumab for metastatic small cell lung cancer, and a woman in her 60s developed SCLE during treatment with infliximab and pembrolizumab for metastatic non-small cell lung cancer [exact ages not stated; ].
Case 1: The man, who had been diagnosed with metastatic small cell lung cancer, presented to the dermatology department with a 6-week history of severely pruritic, photodistributed, erythematous macules and scaly papules, which coalesced into annular plaques. He had received two nivolumab infusions 3 mg/kg every 2 weeks with a favourable response. He developed the cutaneous eruptions shortly after the second dose of nivolumab. His cutaneous eruptions...