Overall cumulative exposure adjusted event rates for adverse events
| Adverse event | EAE rate on exposure to anakinra* (No of events per 100 patient-years) | |||
|---|---|---|---|---|
| Placebo† | 0 to 1 y | 0 to 2 y | 0 to 3 y | |
| (E = 120.9) | (E = 1041.8) | (E = 1754.8) | (E = 2273.0) | |
| *Cumulative EAE rates in the specified period for 1116 patients randomly assigned to anakinra (873 of whom continued treatment during the open label extension) and 230 patients randomly assigned to placebo who received at least one dose of anakinra during open label. | ||||
| †Cumulative exposure adjusted event rates for patients who received placebo during the randomised, double blind phase. | ||||
| AE, adverse event; E, number of patient-years of exposure; EAE, exposure adjusted event; SAE, serious adverse event; y, years. | ||||
| All AEs | 1029.4 | 990.0 | 779.2 | 689.8 |
| SAEs | 22.3 | 26.5 | 27.7 | 27.1 |
| Serious infections | 1.6 | 5.2 | 5.5 | 5.4 |
| Deaths | 0.8 | 0.6 | 0.6 | 0.7 |