Table III.
Kaplan-Meier incidence proportions of malignancies*
| 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) | |
| All Malignancies | ||||
| Excluding NMSC | ||||
| First year | 7 | 0.0041 (0.0011, 0.0072) | 7 | 0.0033 (0.0004, 0.0061) |
| Second year | 12 | 0.0115 (0.0064, 0.0167) | 8 | 0.0090 (0.0039, 0.0141) |
| Third year | 15 | 0.0208 (0.0139, 0.0277) | 10 | 0.0156 (0.0085, 0.0226) |
| Fourth year | 6 | 0.0244 (0.0169, 0.0319) | 7 | 0.0230 (0.0142, 0.0319) |
| Fifth year | 11 | 0.0321 (0.0234, 0.0408) | 5 | 0.0304 (0.0195, 0.0413) |
| Sixth year | 7 | 0.0475 (0.0332, 0.0617) | 0 | 0.0304 (0.0195, 0.0413) |
| Seventh year | 1 | 0.0509 (0.0352, 0.0666) | 0 | 0.0304 (0.0195, 0.0413) |
| Eighth year | 1 | 0.0574 (0.0373, 0.0775) | 0 | 0.0304 (0.0195, 0.0413) |
| Lymphoma | ||||
| First year | 1 | 0.0006 (0.0000, 0.0018) | 1 | 0.0007 (0.0000, 0.0020) |
| Second year | 0 | 0.0006 (0.0000, 0.0018) | 0 | 0.0007 (0.0000, 0.0020) |
| Third year | 1 | 0.0012 (0.0000, 0.0029) | 1 | 0.0016 (0.0000, 0.0040) |
| Fourth year | 0 | 0.0012 (0.0000, 0.0029) | 0 | 0.0016 (0.0000, 0.0040) |
| Fifth year | 0 | 0.0012 (0.0000, 0.0029) | 0 | 0.0016 (0.0000, 0.0040) |
| Sixth year | 0 | 0.0012 (0.0000, 0.0029) | 0 | 0.0016 (0.0000, 0.0040) |
| Seventh year | 0 | 0.0012 (0.0000, 0.0029) | 0 | 0.0016 (0.0000, 0.0040) |
| NMSC | ||||
| First year | 13 | 0.0075 (0.0035, 0.0116) | 20 | 0.0069 (0.0028, 0.0109) |
| Second year | 14 | 0.0162 (0.0101, 0.0222) | 15 | 0.0158 (0.0092, 0.0223) |
| Third year | 10 | 0.0223 (0.0152, 0.0295) | 12 | 0.0254 (0.0165, 0.0342) |
| Fourth year | 18 | 0.0333 (0.0246, 0.0419) | 9 | 0.0352 (0.0244, 0.0460) |
| Fifth year | 4 | 0.0360 (0.0269, 0.0450) | 0 | 0.0352 (0.0244, 0.0460) |
| Sixth year | 4 | 0.0447 (0.0321, 0.0573) | 0 | 0.0352 (0.0244, 0.0460) |
| Seventh year | 3 | 0.0551 (0.0380, 0.0723) | 0 | 0.0352 (0.0244, 0.0460) |
*
Kaplan-Meier analyses of malignancies included left truncation adjustment for patients with prior etanercept exposure and therefore include follow-up time from etanercept exposure before the registry.
†
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.
NMSC, nonmelanoma skin cancer; CI, confidence interval.