Table 4.

Overview of adverse events (AE) in the short-term and cumulative analyses from the 8 integrated trials. Data show incidence rates (IR) per 100 patient-years (95% Poisson CI). An AE was defined as any new or worsening illness, sign, symptom, or clinically significant laboratory test abnormality during the course of the trial, regardless of causality. A serious adverse event (SAE) was defined as an AE that was fatal; life-threatening; resulted in or prolonged hospitalization; resulted in persistent or significant disability or incapacity; cancer; a congenital anomaly/birth defect; resulted in an overdose, development of drug dependency or drug abuse; or thought to be an important medical event.

Short-term PeriodCumulative Period, n = 4149
Placebo + Background Therapy Total, n = 1099IV Abatacept + Background Therapy Total, n = 3173
Total SAEPatients with event, n1363991373
IR (95% CI)16.90 (14.18, 19.99)18.10 (16.37, 19.97)14.61 (13.85, 15.41)
Discontinuations due to AEPatients with event, n40158426
IR (95% CI)4.77 (3.41, 6.49)6.84 (5.82, 7.99)3.53 (3.20, 3.88)
DeathsPatients with event, n71273
IR (95% CI)0.82 (0.33, 1.69)0.51 (0.27, 0.90)0.60 (0.47, 0.76)