Rituximab+MTX All Exposure (n=3194) | Rituximab+MTX >5 years (n=627) | Placebo+MTX (n=818) | |
---|---|---|---|
Exposure (pt-years) | 11 962 | 4418 | 1107 |
AEs/100 pt-years (95% CI) | 263.10 (260.21 to 266.02) | 254.12 (249.46 to 258.86) | 315.43 (305.14 to 326.06) |
SAEs/100 pt-years (95% CI) | 14.40 (13.73 to 15.09) | 14.30 (13.23 to 15.46) | 13.82 (11.79 to 16.19) |
Infections/100 pt-years (95% CI) | 81.64 (80.04 to 83.27) | 75.41 (72.89 to 78.02) | 90.39 (84.96 to 96.17) |
SIEs/100 pt-years (95% CI) | 3.94 (3.60 to 4.31) | 3.26 (2.77 to 3.84) | 3.79 (2.80 to 5.13) |
AE, adverse event; MTX, methotrexate; pt-year, patient-year; SAE, serious adverse event; SIE, serious infection event.