TABLE 2.
Characteristics of 1,629 adverse events.
| Adverse events classified by system organ class | n (%) |
|---|---|
| Gastrointestinal disorders | 467 (28.7) |
| Skin and subcutaneous tissue disorders | 327 (20.1) |
| Nervous system disorders | 185 (11.4) |
| General disorders and administration site conditions | 146 (9.0) |
| Psychiatric disorders | 110 (6.8) |
| Investigations a | 81 (5.0) |
| Respiratory, thoracic, and mediastinal disorders | 64 (3.9) |
| Cardiac disorders | 44 (2.7) |
| Eye disorders | 35 (2.1) |
| Musculoskeletal and connective tissue disorders | 32 (2.0) |
| Infections and infestations | 23 (1.4) |
| Vascular disorders | 23 (1.4) |
| Immune system disorders | 19 (1.2) |
| Injury, poisoning, and procedural complications | 18 (1.1) |
| Metabolism and nutrition disorders | 17 (1.0) |
| Renal and urinary disorders | 13 (0.8) |
| Reproductive system and breast disorders | 8 (0.5) |
| Ear and labyrinth disorders | 6 (0.4) |
| Hepatobiliary disorders | 5 (0.3) |
| Blood and lymphatic system disorders | 3 (0.2) |
| Product issues | 3 (0.2) |
| Duration of adverse events | |
| −1 day | 110 (6.8) |
| 2–5 days | 69 (4.2) |
| 6–10 days | 40 (2.5) |
| 11–50 days | 55 (3.4) |
| 50 days ∼ | 8 (0.5) |
| (Missing) | 1,347 (82.7) |
| Results of adverse events | |
| Recovered or resolved | 569 (34.9) |
| Recovering or resolving | 108 (6.6) |
| Not Recovered or not resolved | 75 (4.6) |
| Recovered or resolved with sequelae | 59 (3.6) |
| Fetal | 9 (0.6) |
| Unknown | 809 (49.7) |
a
81 adverse events under the SOC, of Investigation included hepatobiliary investigations (48 cases); physical examination and organ system status topics (15 cases); cardiac and vascular investigations (9 cases); metabolic, nutritional, and blood gas investigations (4 cases); renal and urinary tract investigations and urinalyses (3 cases); and neurological, special senses, and psychiatric investigations (2 cases).