During the combination phase, 9 patients (15.8%) displayed at least 1 TEAE that led to withdrawal of study medication (24 events): bile duct stenosis (3 events); jaundice, tricuspid valve incompetence (2 events each); arthralgia, asthenia, blood bilirubin increase, cardiac failure, cholangitis, congestive cardiomyopathy, C-reactive protein increase, depression, diabetes mellitus, edema, hyperbilirubinemia, ileus, leucocytosis, myalgia, nausea, seronegative arthritis, and vomiting (1 event each). Here, CRP is linked to heart failure.