Table 2.
Yearly exposure-adjusted subject incidence of adverse events per 10,000 subject-years for long-term denosumab participants where events of interest were <0.1 per 100 subject-years
| FREEDOM (years 1–3) Denosumab |
FREEDOM Extension (years 1–5) Long-term denosumab |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| Denosumab exposure | Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | Year 6 | Year 7 | Year 8 | |
| N = | 3879 | 3682 | 3487 | 2343 | 2244 | 2067 | 1867 | 1742 | |
| Hypocalcemia | 0 | 0 | 0 | 0 | 9.2 | 0 | 5.6 | 0 | |
| Pancreatitis | 5.3 | 5.6 | 8.7 | 0 | 4.6 | 15.6 | 5.6 | 12.2 | |
| Serious cellulitis or erysipelas | 10.6 | 2.8 | 23.3 | 8.7 | 4.6 | 10.4 | 0 | 18.3 | |
| Osteonecrosis of the jaw | 0 | 0 | 0 | 0 | 0 | 20.8 | 5.6 | 0 | |
| Atypical femoral fracture | 0 | 0 | 0 | 0 | 0 | 0 | 5.6 | 0 | |
Analyses were based on the original randomized treatments in FREEDOM. All adverse and serious adverse events were coded using MedDRA v13.0
N number of women who received ≥1 dose of investigational product in FREEDOM or the Extension and were on study at the beginning of the yearly interval