Suspected AESIs (thrombotic events and/or thrombocytopenia) were reported by the investigator in 2.1% (8/382) of participants in the Coad_SD group and 3.1% (12/384) in the Control_SD group and included the following verbatim terms; deep vein thrombosis, pulmonary embolism, heparin-induced thrombocytopenia (positive anti-platelet factor 4 test result encoded by MedDRA as heparin-induced thrombocytopenia), pulmonary embolism, thrombocytopenia, and platelet count decreased. The gene discussed is PF4; the disease is deep vein thrombosis.