Table II.

Kaplan-Meier incidence proportions of SAEs and SIEs

Registry Year	Based on Observation Time*		Based on Exposure Time†
	Patients With Event, n	Cumulative Incidence, Q (95% CI)	Patients With Event, n	Cumulative Incidence, Q (95% CI)
SAEs
First year	139	0.0633 (0.0531, 0.0735)	121	0.0581 (0.0480, 0.0682)
Second year	103	0.1163 (0.1024, 0.1301)	75	0.1070 (0.0926, 0.1215)
Third year	70	0.1557 (0.1397, 0.1718)	37	0.1386 (0.1215, 0.1558)
Fourth year	53	0.1878 (0.1703, 0.2054)	35	0.1771 (0.1565, 0.1977)
Fifth year	51	0.2224 (0.2031, 0.2417)	19	0.2029 (0.1799, 0.2260
SIEs
First year	45	0.0204 (0.0145, 0.0263)	39	0.0184 (0.0127, 0.0242)
Second year	25	0.0334 (0.0257, 0.0411)	18	0.0301 (0.0222, 0.0379)
Third year	17	0.0432 (0.0343, 0.0521)	12	0.0408 (0.0310, 0.0506)
Fourth year	13	0.0514 (0.0415, 0.0613)	5	0.0467 (0.0356, 0.0577)
Fifth year	20	0.0650 (0.0536, 0.0765)	8	0.0581 (0.0447, 0.0716)

^*Includes all events and exposure days that occurred since the first day of treatment with etanercept.

^†Includes only events that occurred during etanercept exposure plus a 30-day risk window after each dosing interval.

SAEs, serious adverse events; SIEs, serious infectious events; CI, confidence interval.