The incidence of ADRs was 8.6% (63/732); serious ADRs, 3.4% (25/732); and bleeding AEs, 6.4% (Electronic Supplement 2). The most common ADRs were gastrointestinal disorders (e.g., gastrointestinal hemorrhage) [3.3% (24/732)]. The most common serious ADRs were also gastrointestinal disorders [2.0% (15/732)]. Table 2 summarizes the breakdown of bleeding AEs. Bleeding AEs occurred in 6.4% of patients. The most common bleeding AE was gastrointestinal disorders (2.7%), followed by general disorders and administration site conditions (1.0%). Regarding puncture site bleeding (puncture site hemorrhage or vessel puncture site hematoma), the puncture site locations were femoral (three patients), radial (two patients), femoral + radial (one patient), and brachial (one patient). The incidence of major bleeding [thrombolysis in myocardial infarction (TIMI) criteria] AEs was 1.6%. Approximately 60% (7/12) of all major bleeding AEs were gastrointestinal disorders.Table 2Incidence of bleeding adverse events by severity and siteItemResultNo. of patients in the safety analysis set732No. of patients with bleeding AEs47No. of bleeding AEs52Incidence of patients with bleeding AEs (%)6.4No. of patients with major bleeding AEs12Incidence of patients with major bleeding AEs (%)1.6Type of bleeding AENo. of patients with bleeding AEs; No. of bleeding AEsa (%)Classification of bleeding (TIMI)Major bleeding (N = 12)Minor bleeding (N = 15)Clinically relevant (N = 12)Other (N = 10)Blood and lymphatic system disorders5 (0.7)13–1 Anemia5  (0.7)13–1Eye disorders1 (0.1)–––1 Conjunctiva hemorrhage1  (0.1)–––1Cardiac disorder3 (0.4)––3– Cardiac tamponade1  (0.1)––1– Myocardial hemorrhage2  (0.3)––2–Vascular disorders2 (0.3)–1–1 Hematoma1  (0.1)–––1 Bleeding1 (0.1)–1––Respiratory, thoracic and mediastinal disorders3 (0.4)12 Epistaxis1 (0.1)––1– Hemoptysis1 (0.1)––1– Pulmonary hemorrhage1  (0.1)1–––Gastrointestinal disorders20 (2.7)7662 Hemorrhagic intestinal diverticulum1 (0.1)––1– Gastrointestinal hemorrhage6  (0.8)312– Gingival bleeding1 (0.1)–––1 Hematemesis1 (0.1)–1–– Hematochezia1 (0.1)––1– Mallory-Weiss syndrome1 (0.1)–1–– Melena4  (0.5)–121 Rectal hemorrhage2  (0.3)2––– Upper gastrointestinal hemorrhage1  (0.1)1––– Large intestinal hemorrhage1  (0.1)–1–– Duodenal hemorrhage1  (0.1)1––– Hemorrhoidal bleeding1 (0.1)–1––Skin and subcutaneous tissue disorders4 (0.5)–4–– Subcutaneous hemorrhage4 (0.5)–4––Renal and urinary disorders3 (0.4)111– Hematuria3  (0.4)111–General disorders and administration site conditions7 (1.0)22–3 Puncture site hemorrhage6  (0.8)12–3 Vessel puncture site hematoma1 (0.1)1–––Injury, poisoning and procedural complications3 (0.4)–––3 Subcutaneous hematoma2 (0.3)–––2 Wounds1 (0.1)–––1For SOC, the number of patients with bleeding AEs was tabulated, and for preferred term, the number of bleeding AEs (i.e., the number of patients for each preferred term) was tabulated. MedDRA/J version 18.1 AEs adverse events, SOC system organ class, TIMI thrombolysis in myocardial infarction aThe number of patients for SOC and the number of bleeding AEs for each preferred term were tabulated. The number of serious bleeding AEs is specified in square brackets in the applicable cells