Summary of AE rates per 100 PY.
| Variables | RTX All-exposure, n = 3595 | RTX Longterm, > 5 Yrs, n = 1246 | Pooled Placebo, n = 818 |
|---|---|---|---|
| Exposure, PY | 14,816 | 8970 | 1107 |
| AE rate (95% CI) | 239.11 (236.63–241.61) | 219.36 (216.31–222.44) | 315.43 (305.14–326.06) |
| SAE rate (95% CI) | 13.82 (13.24–14.43) | 11.88 (11.19–12.62) | 13.82 (11.79–16.19) |
| Infection rate (95% CI) | 75.70 (74.31–77.11) | 70.52 (68.81–72.28) | 90.39 (84.96–96.17) |
| SIE rate (95% CI) | 3.76 (3.46–4.09) | 2.71 (2.39–3.07) | 3.79 (2.80–5.13) |
AE: adverse event; PY: patient-years; RTX: rituximab; SAE: serious adverse events; SIE: serious infection events.