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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, a 50-year-old woman developed colitis during treatment with ipilimumab and nivolumab for metastatic urothelial carcinoma, and a 78-year-old man developed colitis during treatment with ipilimumab for prostate cancer [routes and dosages not stated].
Patient 1: The 50-year-old woman, who was diagnosed with high-grade metastatic urothelial carcinoma, started receiving treatment with immune checkpoint inhibitors nivolumab and ipilimumab in clinical trial (NCT1928394). Two weeks following the treatment initiation, she was admitted with grade ≥2 bloody diarrhoea and diagnosed with colitis clinically. Endoscopy revealed multiple large ulcers and diffuse inflammatory exudate. Analysis of immune infiltrates in the colonic mucosa revealed a dense inflammatory...