Table 3

Summary of safety events

Patients with event, n (%)Placebo+MTX (n=63)Rituximab
500 mg+MTX (n=62)
Rituximab
1000 mg+MTX (n=60)
Any TEAE41 (65.1)35 (56.5)36 (60.0)
 Mild20 (31.7)17 (27.4)13 (21.7)
 Moderate17 (27.0)18 (29.0)19 (31.7)
 Severe4 (6.3)4 (6.7)
 Treatment-related14 (22.2)13 (21.0)9 (15.0)
Any serious TEAE5 (7.9)3 (4.8)4 (6.7)
 Events/100 PY12.04.96.9
Any infection16 (25.4)25 (40.3)27 (45.0)
Any serious infection1 (1.6)3 (5.0)
 Events/100 PY0.01.63.4
Death on study
  • MTX, methotrexate; PY, patient-year; TEAE, treatment-emergent adverse event.