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 Period | Cumulative Period, n = 4149 | |||
|---|---|---|---|---|
| Placebo + Background Therapy Total, n = 1099 | IV Abatacept + Background Therapy Total, n = 3173 | |||
| Total SAE | Patients with event, n | 136 | 399 | 1373 |
| IR (95% CI) | 16.90 (14.18, 19.99) | 18.10 (16.37, 19.97) | 14.61 (13.85, 15.41) | |
| Discontinuations due to AE | Patients with event, n | 40 | 158 | 426 |
| IR (95% CI) | 4.77 (3.41, 6.49) | 6.84 (5.82, 7.99) | 3.53 (3.20, 3.88) | |
| Deaths | Patients with event, n | 7 | 12 | 73 |
| IR (95% CI) | 0.82 (0.33, 1.69) | 0.51 (0.27, 0.90) | 0.60 (0.47, 0.76) | |