Review Article
Immune-Mediated Adverse Events Associated with Ipilimumab CTLA-4 Blockade Therapy: The Underlying Mechanisms and Clinical Management
Table 2
Frequency of specific AEs* and irAEs in a pooled analysis of 1498 patients in phase I–III studies of ipilimumab in unresectable stage III or stage IV melanoma [24].
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Regardless of causality. Subjects may have had more than one event. Unknown intensities are included in “Any Grade” column. Grade 5 = death. Results from the following trials were included in the analysis: MDX010-02, -15, -03, -04, -13, -05, -19, -08, -20; CA184-042, -004, -008, -022, -007: These trials ranged from phase I–III, investigated ipilimumab at various doses (0.1–20 mg/kg), as monotherapy or in combination with various agents. All patients included had unresectable stage III or IV melanoma, no prior history or clinical evidence of autoimmune disease or treatment with immunosuppressive drugs, and received at least one dose of ipilimumab. Patient characteristics such as age, prior treatment history and performance status varied among trials. Safety events included in this analysis were those reported between first dose and 70 days after last dose of study therapy. |