TABLE 3.
Tofacitinib All | Predominant-dose Tofacitinib 5 mg Twice Daily | Predominant-dose Tofacitinib 10 mg Twice Daily | |
---|---|---|---|
Total number of patients | 1124 | 198 | 926 |
Primary analysis | |||
Total PY of exposure | 2576.4 | 664.1 | 1912.2 |
Patients with events, n (%) | 20 (1.8) | 3 (1.5) | 17 (1.8) |
IR (95% CI) | 0.75 (0.46–1.16) | 0.44 (0.09–1.29) | 0.86 (0.50–1.38) |
Colorectal cancer | |||
Total PY of exposure | 2661.70 | 677.87 | 1983.83 |
Patients with events, n (%) | 2 (0.2) | 0 (0.0) | 2 (0.2) |
IR (95% CI) | 0.08 (0.01–0.27) | 0.00 (0.00–0.54) | 0.10 (0.01–0.36) |
Lymphoma and lymphoproliferative disease | |||
Total PY of exposure | 2661.76 | 677.76 | 1984.00 |
Patients with events, n (%) | 2 (0.2) | 1 (0.5) | 1 (0.1) |
IR (95% CI) | 0.08 (0.01–0.27) | 0.15 (0.00–0.82) | 0.05 (0.00–0.28) |
Abbreviations: CI, confidence interval; IR, incidence rate (unique patients with event per 100 PY of exposure); n, number of patients with the event; PY, patient-years.
aAll events, including those that are outside the 28-day risk period, are included.