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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 retrospective review, 5 patients (3 women and 2 men) aged 62−75 years enrolled in different clinical trials, were described who developed immune-mediated colitis and superimposed Clostridium (C.) difficile infection during treatment with immune checkpoint inhibitors (ICI) tremelimumab, durvalumab, nivolumab for large cell neuroendocrine carcinoma or adenocarcinoma. Levofloxacin also contributed to C. difficile infection in patient number 2 [routes and dosages not stated].
Patient 1: A 75-year-old woman who was enrolled in a study (NCT02000947) developed immune-mediated colitis and superimposed C. difficile infection during treatment with tremelimumab and durvalumab for metastatic large cell neuroendocrine carcinoma of the lung. She had received an unspecified first-line...