- 31 Downloads
An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective chart review, 5 women and 6 men aged 28−82 years were described, who developed rash, a diffuse erythematous reaction, facial swelling, ocular irritation, whole body rash, nausea, vomiting, fever, pneumonitis, liver enzyme elevation, poor appetite, chills, diarrhoea, weakness, cytokine release syndrome, arthralgia or hypotension during treatment with vemurafenib, dabrafenib, cobimetinib, trametinib, pembrolizumab, ipilimumab or nivolumab [not all routes, dosages and outcomes stated].
Patient 1: A 48-year-old man with BRAFV600E-positive metastatic melanoma was treated with pembrolizumab, but melanoma progressed after the four cycles of pembrolizumab. Thereafter, he received pembrolizumab along with CMP-001. The melanoma again progressed after four cycles....