Safety assessment
thrombotic, infections, malignancies, hepatic events
HEPATITIS B, VIRUS, ADVERSE EVENTS, INFECTIONS, EVENTS, THROMBOCYTOSIS
All adverse events (AEs) occurring after signing the informed consent form were recorded in the electronic case report form. AEs were classified based on the Medical Dictionary for Regulatory Activities. AE of special interest included infections, myelosuppressive events, thrombocytosis, malignancies, hepatic events, major adverse cardiovascular events, and thrombotic events. Electrocardiograms, physical examinations, vital signs including lung and liver function tests, BK virus plasma and urine screening using quantitative PCR, hepatitis B virus DNA monitoring (only in patients who were positive for HbcAb or HbsAb at Visit 1), and height and weight measurement were performed, and clinically significant findings were reported.