Table 2.
Regional differences of propacetamol-related adverse events according to system organ class terms.
| System organ class (SOC) | Asia | Europe | ||
|---|---|---|---|---|
| Report (N) | Serious (N, %) | Report (N) | Serious (N, %) | |
| Blood and lymphatic system disorders | 42 | 16 (38.1) | 107 | 12 (11.2) |
| Cardiac disorders | 162 | 32 (19.8) | 15 | 7 (46.7) |
| Congenital, familial and genetic disorders | 1 | 0 (0.0) | 2 | 0 (0.0) |
| Ear and labyrinth disorders | 10 | 0 (0.0) | 3 | 1 (33.3) |
| Endocrine disorders | 1 | 1 (100.0) | 0 | 0 (0.0) |
| Eye disorders | 38 | 5 (13.2) | 10 | 1 (10.0) |
| Gastrointestinal disorders | 2500 | 25 (1.0) | 43 | 5 (11.6) |
| General disorders and administration site conditions | 1226 | 53 (4.3) | 158 | 30 (19.0) |
| Hepatobiliary disorders | 32 | 19 (59.4) | 68 | 12 (17.7) |
| Immune system disorders | 61 | 39 (63.9) | 35 | 6 (17.1) |
| Infections and infestations | 6 | 4 (66.7) | 19 | 5 (26.3) |
| Injury, poisoning and procedural complications | 1 | 1 (100.0) | 5 | 1 (20.0) |
| Investigations | 244 | 48 (19.7) | 68 | 5 (7.4) |
| Metabolism and nutrition disorders | 25 | 1 (4.0) | 8 | 3 (37.5) |
| Musculoskeletal and connective tissue disorders | 65 | 2 (3.1) | 11 | 2 (18.2) |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 | 1 (50.0) | 1 | 0 (0.0) |
| Nervous system disorders | 1084 | 54 (5.0) | 49 | 8 (16.3) |
| Psychiatric disorders | 44 | 4 (9.1) | 12 | 1 (8.3) |
| Renal and urinary disorders | 9 | 2 (22.2) | 17 | 7 (41.2) |
| Reproductive system and breast disorders | 2 | 0 (0.0) | 1 | 0 (0.0) |
| Respiratory, thoracic and mediastinal disorders | 183 | 35 (19.1) | 23 | 7 (30.4) |
| Skin and subcutaneous tissue disorders | 1111 | 75 (6.8) | 361 | 23 (6.4) |
| Vascular disorders | 2721 | 801 (29.4) | 95 | 33 (34.7) |
| Social circumstances | 0 | 0 (0.0) | 1 | 0 (0.0) |