Table 6 Incidence rate of selected adverse events by rituximab indication
| Â | Incidence rate [95% CI] | ||||
|---|---|---|---|---|---|
| Â | Total | RA | CTD | Vasculitis | Other |
SAE/100 patient-years | 23.3 [19.8, 27.3] | 21.8 [17.5, 26.8] | 15.3 [10.5, 21.6] | 106.9 [71.1, 154.5] | 28.6 [9.3, 66.7] |
SIE/100 patient-years | 8.4 [6.4, 10.9] | 8.7 [6.1, 12.1] | 4.8 [2.3, 8.8] | 34.4 [15.7, 65.2] | 5.7 [0.1, 31.8] |
IRR/100 patient-years | 4.2 [2.8, 6.1] | 3.3 [1.9, 5.7] | 2.9 [1.1, 6.2] | 15.3 [4.2, 39.1] | 22.9 [6.2, 58.5] |
Malignancies/100 patient-years | 0.8 [0.2, 1.8] | 0.7 [0.1, 2.1] | 1.0 [0.1, 3.5] | 0 | 0 |
Deaths/100 patient-years | 1.50 [0.81, 2.79] | 0.97 [0.36, 2.58] | 0.96 [0.24, 3.83] | 11.5 [3.70, 35.5] | 5.71 [0.80, 40.6] |
Observation time, patient-years | 665.2 | 412.5 | 209.0 | 26.2 | 17.5 |