Table 3.
Incidence of AEs in the safety analysis set.
| Disorders of different system | SAS (N=1751) |
Total | |||
|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | ||
| AEs (one at least) | 637 (36•4%) | 209 (11•9%) | 54 (3•1%) | 6 (0•3%) | 906 (51•7%) |
| Abnormal laboratory examinations | 377 (21•5%) | 67 (3•8%) | 6 (0•3%) | 2 (0•1%) | 452 (25•8%) |
| ALT increased | 166 (9•5%) | 32 (1•8%) | 3 (0•2%) | 0 | 201 (11•5%) |
| Whole blood cell decreased | 1 (0•05%) | 0 | 0 | 2 (0•1%) | 3 (0•2%) |
| Gastrointestinal system | 305 (17•4%) | 79 (4•5%) | 9 (0•5%) | 0 | 393 (22•4%) |
| Diarrhea | 59 (3•4%) | 13 (0•7%) | 2 (0•1%) | 0 | 74 (4•2%) |
| Gastric ulcer | 1 (0•05%) | 2 (0•1%) | 3 (0•2%) | 0 | 6 (0•3%) |
| Nervous system | 148 (8•5%) | 17 (1•0%) | 3 (0•2%) | 1 (0•05%) | 169 (9•7%) |
| Dizzy | 83 (4•7%) | 7 (0•4%) | 2 (0•1%) | 0 | 92 (5•3%) |
| Brain infarction | 0 | 0 | 0 | 1 (0•05%) | 1 (0•05%) |
| Skin and subcutaneous tissue | 134 (7•7%) | 22 (1•3%) | 4 (0•2%) | 1 (0•05%) | 161 (9•2%) |
| Rash | 34 (1•9%) | 7 (0•4%) | 0 | 1 (0•05%) | 42 (2•4%) |
| Facial edema | 25 (1•4%) | 3 (0•2%) | 2 (0•1%) | 0 | 30 (1•7%) |
| Infectious diseases | 107 (6•1%) | 23 (1•3%) | 10 (0•6%) | 0 | 140 (8•0%) |
| Urinary tract infection | 15 (0•9%) | 2 (0•1%) | 2 (0•1%) | 0 | 19 (1•1%) |
| Pulmonary infection | 0 | 0 | 4 (0•2%) | 0 | 4 (0•2%) |
| Systemic diseases and various reactions of administration site | 95 (5•4%) | 19 (1•1%) | 1 (0•05%) | 1 (0•05%) | 116 (6•6%) |
| Death | 0 | 0 | 0 | 1 (0•05%) | 1 (0•05%) |
| Respiratory system, chest and mediastinum | 64 (3•7%) | 13 (0•7%) | 2 (0•1%) | 0 | 79 (4•5%) |
| Musculoskeletal and connective tissue | 13 (0•7%) | 12 (0•7%) | 19 (1•1%) | 0 | 44 (2•5%) |
| Rheumatoid arthritis | 0 | 5 (0•3%) | 7 (0•4%) | 0 | 12 (0•7%) |
| Fracture | 0 | 3 (0•2%) | 7 (0•4%) | 0 | 10 (0•6%) |
| Eyes disorders | 35 (2•0%) | 1 (0•1%) | 1 (0•05%) | 0 | 37 (2•1%) |
| Circulatory system | 29 (1•7%) | 5 (0•3%) | 1 (0•05%) | 1 (0•05%) | 36 (2•1%) |
| Acute myocardial infarction | 0 | 0 | 0 | 1 (0•05%) | 1 (0•05%) |
| Metabolic and nutritional system | 26 (1•5%) | 6 (0•3%) | 0 | 0 | 32 (1•8%) |
| Blood and lymphatic system | 16 (0•9%) | 6 (0•3%) | 0 | 0 | 22 (1•3%) |
| Kidney and urinary system | 18 (1•0%) | 0 | 2 (0•1%) | 0 | 20 (1•1%) |
| Ear and labyrinth | 16 (0•9%) | 0 | 0 | 0 | 16 (0•9%) |
| Reproductive system and breast diseases | 10 (0•6%) | 3 (0•2%) | 0 | 0 | 13 (0•7%) |
| Immune system diseases | 2 (0•1%) | 4 (0•2%) | 1 (0•05%) | 0 | 7 (0•4%) |
| Blood vessels and lymphatic vessels | 7 (0•4%) | 0 | 0 | 0 | 7 (0•4%) |
| Hepatobiliary system | 1 (0•05%) | 2 (0•1%) | 1 (0•05%) | 1 (0•05%) | 5 (0•3%) |
| Hepatitis E | 0 | 0 | 0 | 1 (0•05%) | 1 (0•05%) |
| Injury, poisoning and surgical complications | 2 (0•1%) | 3 (0•2%) | 0 | 0 | 5 (0•3%) |
| Operations | 0 | 3 (0•2%) | 1 (0•05%) | 0 | 4 (0•2%) |
| Tumors (benign, malignant, or unknown) | 0 | 2 (0•1%) | 0 | 0 | 2 (0•1%) |
| Endocrine system | 1 (0•05%) | 0 | 0 | 0 | 1 (0•05%) |
| Pregnancy, puerperium and perinatal period | 0 | 0 | 1 (0•05%) | 0 | 1 (0•05%) |