Table 3.

Adverse events occurring during the 6-month placebo-controlled period. For the placebo + methotrexate group, data pooled from trials: IIa, DANCER, REFLEX, and SERENE studies. Multiple occurrences of the same adverse event in 1 individual counted only once.

Placebo + methotrexate (n = 570)Rituximab + methotrexate (n = 877)
Total patients (%) with cardiovascular SAE7 (1.2)11 (1.3)
  Coronary artery disease2 (0.4)2 (0.2)
  Myocardial infarction1 (0.2)3 (0.3)
  Angina unstable1 (0.2)1 (0.1)
  Deep vein thrombosis1 (0.2)1 (0.1)
  Angina pectoris1 (0.2)0
  Atrial fibrillation01 (0.1)
  Cardiac tamponade01 (0.1)
  Hypertension01 (0.1)
  Pericarditis1 (0.2)0
  Thromboangiitis obliterans01 (0.1)
  Thrombosis01 (0.1)
Total patients (%) with ≥ 1 AE infection223 (39.1)353 (40.3)
Infections occurring in ≥ 2% of patients
  Nasopharyngitis43 (7.5)63 (7.2)
  Upper respiratory tract infection37 (6.5)64 (7.3)
  Urinary tract infection31 (5.4)31 (3.5)
  Bronchitis19 (3.3)27 (3.1)
  Sinusitis20 (3.5)25 (2.9)
  Gastroenteritis14 (2.5)12 (1.4)
  Pharyngitis12 (2.1)11 (1.3)
Total patients (%) with a serious infection9 (1.6)15 (1.7)
  Pneumonia2 (0.4)2 (0.2)
  Gastroenteritis2 (0.4)1 (0.1)
  Pyelonephritis03 (0.3)
  Respiratory tract infection2 (0.4)0
  Abscess bacterial1 (0.2)0
  Abscess intestinal1 (0.2)0
  Bronchitis01 (0.1)
  Bronchopneumonia1 (0.2)0
  Cellulitis01 (0.1)
  Cellulitis gangrenous01 (0.1)
  • SAE: serious adverse event.