An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series, two women aged 45 years and 53 years and a woman in her late 50s were described, who developed thyroiditis, hypophysitis, adrenal insufficiency or pneumonitis during treatment with ipilimumab/nivolumab or pembrolizumab [routes and dosages not stated; not all outcomes stated].
Patient 1: A 45-year-old woman, who had stage IIIC serous carcinoma (high-grade) of the right ovary, started receiving neoadjuvant chemotherapy with carboplatin and paclitaxel. Subsequently, she was started receiving pembrolizumab as part of a clinical trial. She completed 3 cycles of combination therapy. She also underwent tumour-reductive surgery. Two weeks after initiation of pembrolizumab therapy, she presented with tachycardia. A physical examination showed thyromegaly and pain on...