Incidence of adverse events and adverse reactions by system organ class (safety population)
| Total (n=241) | Group A (n=96) | Group B (n=95) | Group C (n=50) | |
| Febuxostat dose increasing stepwise from 10 to 40 mg | Febuxostat 40mg+colchicine | Febuxostat 40 mg | ||
| Patients (events) % | Patients (events) % | Patients (events) % | Patients (events) % | |
| Adverse events | 51 (74) 21.2 | 21 (35) 21.9 | 19 (23) 20.0 | 11 (16) 22.0 |
| Infections and infestations | 25 (35) 10.4 | 9 (15) 9.4 | 11 (13) 11.6 | 5 (7) 10.0 |
| Neoplasms benign, malignant and unspecified | 1 (1) 0.4 | 1 (1) 1.0 | – | – |
| Metabolism and nutrition disorders | 2 (2) 0.8 | 2 (2) 2.1 | – | – |
| Vascular disorders | 1 (1) 0.4 | 1 (1) 1.0 | – | – |
| Respiratory, thoracic and mediastinal disorders | 4 (6) 1.7 | 2 (4) 2.1 | 1 (1) 1.1 | 1 (1) 2.0 |
| Gastrointestinal disorders | 1 (1) 0.4 | – | 1 (1) 1.1 | – |
| Hepatobiliary disorders | 5 (5) 2.1 | 4 (4) 4.2 | – | 1 (1) 2.0 |
| Skin and subcutaneous tissue disorders | 2 (2) 0.8 | 1 (1) 1.0 | 1 (1) 1.1 | – |
| Musculoskeletal and connective tissue disorders | 9 (10) 3.7 | 4 (5) 4.2 | 3 (3) 3.2 | 2 (2) 4.0 |
| Renal and urinary disorders | 2 (2) 0.8 | 1 (1) 1.0 | 1 (1) 1.1 | – |
| Investigations | 4 (4) 1.7 | – | 3 (3) 3.2 | 1 (1) 2.0 |
| Injury, poisoning and procedural complications | 4 (4) 1.7 | 1 (1) 1.0 | – | 3 (3) 6.0 |
| Surgical and medical procedures | 1 (1) 0.4 | – | – | 1 (1) 2.0 |
| Adverse reactions | 21 (24) 8.7 | 7 (9) 7.3 | 9 (10) 9.5 | 5 (5) 10.0 |
| Infections and infestations | 7 (8) 2.9 | – | 6 (7) 6.3 | 1 (1) 2.0 |
| Metabolism and nutrition disorders | 1 (1) 0.4 | 1 (1) 1.0 | – | – |
| Respiratory, thoracic and mediastinal disorders | 1 (1) 0.4 | – | 1 (1) 1.1 | – |
| Hepatobiliary disorders | 4 (4) 1.7 | 3 (3) 3.1 | – | 1 (1) 2.0 |
| Skin and subcutaneous tissue disorders | 2 (2) 0.8 | 1 (1) 1.0 | 1 (1) 1.1 | – |
| Musculoskeletal and connective tissue disorders | 3 (4) 1.2 | 2 (3) 2.1 | – | 1 (1) 2.0 |
| Renal and urinary disorders | 2 (2) 0.8 | 1 (1) 1.0 | 1 (1) 1.1 | – |
| Investigations | 1 (1) 0.4 | – | – | 1 (1) 2.0 |
| Injury, poisoning and procedural complications | 1 (1) 0.4 | – | – | 1 (1) 2.0 |
Number of events, tabulated by system organ class (SOC, MedDRA 17.1).