In the updated analysis, 147 (60%) of patients in the combination arm and 128 (52%) of patients in the control arm experienced a grade 3 or 4 treatment-related event.r
In the combination arm, the most common grade 3 and 4 toxicities were rash (17%), y-glutamyltransferase concentration rise (15%), blood creatine phosphokinase rise (12%) and alanine aminotransferase concentration rise (11%). In the control arm, the most common grade 3 and 4 toxicities were rash (16%), cutaneous squamous cell carcinoma (13%) and y-glutamyltransferase concentration rise (10%).r
Adverse events r
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52 patients (11%) discontinued treatment due to treatment related adverse events, including 35 (14%) in the combination arm and 17 (7%) in the vemurafenib arm. The most common reason for discontinuation was liver function test derangement.
8 patients (2%) died during the study. 5 patients died in the combination arm due to pneumonia, Clostridium difficile colitis, coma, cardiac arrest and death (unspecified). 3 patients in the vemurafenib group died due to cardiac failure, atelectasis and death (unspecified).r