Placebo + methotrexate (n = 570) | Rituximab + methotrexate (n = 877) | |
---|---|---|
Total patients (%) with cardiovascular SAE | 7 (1.2) | 11 (1.3) |
Coronary artery disease | 2 (0.4) | 2 (0.2) |
Myocardial infarction | 1 (0.2) | 3 (0.3) |
Angina unstable | 1 (0.2) | 1 (0.1) |
Deep vein thrombosis | 1 (0.2) | 1 (0.1) |
Angina pectoris | 1 (0.2) | 0 |
Atrial fibrillation | 0 | 1 (0.1) |
Cardiac tamponade | 0 | 1 (0.1) |
Hypertension | 0 | 1 (0.1) |
Pericarditis | 1 (0.2) | 0 |
Thromboangiitis obliterans | 0 | 1 (0.1) |
Thrombosis | 0 | 1 (0.1) |
Total patients (%) with ≥ 1 AE infection | 223 (39.1) | 353 (40.3) |
Infections occurring in ≥ 2% of patients | ||
Nasopharyngitis | 43 (7.5) | 63 (7.2) |
Upper respiratory tract infection | 37 (6.5) | 64 (7.3) |
Urinary tract infection | 31 (5.4) | 31 (3.5) |
Bronchitis | 19 (3.3) | 27 (3.1) |
Sinusitis | 20 (3.5) | 25 (2.9) |
Gastroenteritis | 14 (2.5) | 12 (1.4) |
Pharyngitis | 12 (2.1) | 11 (1.3) |
Total patients (%) with a serious infection | 9 (1.6) | 15 (1.7) |
Pneumonia | 2 (0.4) | 2 (0.2) |
Gastroenteritis | 2 (0.4) | 1 (0.1) |
Pyelonephritis | 0 | 3 (0.3) |
Respiratory tract infection | 2 (0.4) | 0 |
Abscess bacterial | 1 (0.2) | 0 |
Abscess intestinal | 1 (0.2) | 0 |
Bronchitis | 0 | 1 (0.1) |
Bronchopneumonia | 1 (0.2) | 0 |
Cellulitis | 0 | 1 (0.1) |
Cellulitis gangrenous | 0 | 1 (0.1) |
SAE: serious adverse event.