Table 1.

Safety summary.

Double-blind Period,* ABA Group (1 yr; n = 433)Cumulative Period, All ABA-treated Patients (5 yrs; n = 594)
Incidence rate (events/100 patient-yrs)
Adverse events303.4242.32
Serious adverse events17.713.87
Infections90.567.14
Serious infections4.22.84
Malignancies1.71.45
Autoimmune events2.50.99
  • * Data are for patients randomized to abatacept during the double-blind period.

  • Data are for all patients who had received at least 1 dose of abatacept in the double-blind or longterm extension period, regardless of treatment group during the double-blind period. ABA: abatacept.