Table 3 Detailed AEs and bivalirudin-related ADRs in System Organ Class (SOC)
Items | AEs, No. (%) | Bivalirudin-related ADRs, No. (%) | ||||||
|---|---|---|---|---|---|---|---|---|
Total | Mild | Moderate | Severe | Total | Mild | Moderate | Severe | |
Total | 120 (13.1) | 110 (12.0) | 4 (0.4) | 6 (0.7) | 40 (4.4) | 38 (4.1) | 2 (0.2) | 0 (0.0) |
Gastrointestinal disorders | 38 (4.1) | 35 (3.8) | 2 (0.2) | 1 (0.1) | 10 (1.1) | 8 (0.9) | 2 (0.2) | 0 (0.0) |
Blood and lymphatic system disorders | 28 (3.1) | 28 (3.1) | 0 (0.0) | 0 (0.0) | 28 (3.1) | 28 (3.1) | 0 (0.0) | 0 (0.0) |
General disorders and administration site conditions | 27 (2.9) | 27 (2.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Respiratory, thoracic, and mediastinal disorders | 24 (2.6) | 22 (2.4) | 1 (0.1) | 1 (0.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Nervous system disorders | 15 (1.6) | 11 (1.2) | 2 (0.2) | 2 (0.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Investigations | 14 (1.5) | 12 (1.3) | 1 (0.1) | 1 (0.1) | 2 (0.2) | 2 (0.2) | 0 (0.0) | 0 (0.0) |
Cardiac disorders | 12 (1.3) | 10 (1.1) | 0 (0.0) | 2 (0.2) | 1 (0.1) | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Skin and subcutaneous tissue disorders | 8 (0.9) | 8 (0.9) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Renal and urinary disorders | 7 (0.8) | 7 (0.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Infections and infestations | 6 (0.7) | 6 (0.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Metabolism and nutrition disorders | 5 (0.5) | 5 (0.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Hepatobiliary disorders | 5 (0.5) | 5 (0.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Psychiatric disorders | 5 (0.5) | 5 (0.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Vascular disorders | 4 (0.4) | 4 (0.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Musculoskeletal and connective tissue disorders | 3 (0.3) | 3 (0.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Injury, poisoning and procedural complications | 2 (0.2) | 2 (0.2) | 0 (0.0) | 0 (0.0) | 1 (0.1) | 1 (0.1) | 0 (0.0) | 0 (0.0) |
Immune system disorders | 1 (0.1) | 1 (0.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |