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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 34-year-old woman developed autoimmune hepatitis while receiving treatment with ipilimumab and nivolumab for stage IV metastatic melanoma during pregnancy.
The woman, who was 7 weeks pregnant, presented for evaluation of a mass in the left breast in May 2016. She was diagnosed with mutated BRAF codon V600E stage IV metastatic melanoma with hepatic, pulmonary, bone, ipsilateral axillary and retro-pectoral lymph nodes involvement, and elevated LDH. She started receiving treatment with ipilimumab and nivolumab at FDA-approved doses during week 9 of pregnancy [routes and dosages not stated]. Two weeks into the ipilimumab and nivolumab treatment, she experienced pain in the left rib cage, which was due to a non-displaced pathologic bone fracture. She was then treated with...
- Burotto M, et al. Viable Pregnancy in a patient with metastatic melanoma treated with double checkpoint immunotherapy. Seminars in Oncology 45: 164-169, No. 3, Jun 2018. Available from: URL: http://doi.org/10.1053/j.seminoncol.2018.03.003 - Chile