Table 2

Summary of adverse events/100 pt-years

Rituximab+MTX
All Exposure (n=3194)
Rituximab+MTX
>5 years (n=627)
Placebo+MTX (n=818)
Exposure (pt-years)11 96244181107
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.