An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 73-year-old man experienced acute cellular rejection (ACR) of liver leading to chronic cellular rejection mediated liver graft loss following treatment with nivolumab for non-melanoma skin cancers and a conjunctival squamous cell carcinoma [route and dosage not stated].
The man had undergone a deceased donor liver transplantation 12 years previously due to cryptogenic cirrhosis complicated by hepatocellular carcinoma, was hospitalised for abnormal liver tests. Since the transplantation, he had over 25 skin lesions diagnosed as non-melanoma skin cancer. In 2016, he developed conjunctival lesions that were subsequently removed and confirmed to be squamous cell carcinoma. In 2017, another fungating tumour was found to involve the left scalp, and he underwent wide local excision,...