Table 1.
Yearly exposure-adjusted subject incidence of adverse events per 100 subject-years for long-term denosumab participants
| 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 | |
| All adverse events | 188.5 | 154.9 | 131.6 | 134.8 | 116.9 | 114.2 | 120.8 | 106.3 | |
| Infections | 37.7 | 31.9 | 31.0 | 30.3 | 26.8 | 27.5 | 28.9 | 26.9 | |
| Malignancies | 1.8 | 1.5 | 2.2 | 2.0 | 2.4 | 2.0 | 2.7 | 1.7 | |
| Eczema | 1.6 | 1.1 | 0.9 | 1.0 | 1.3 | 1.0 | 0.7 | 0.7 | |
| Hypocalcemia | 0 | 0 | 0 | 0 | <0.1 | 0 | <0.1 | 0 | |
| Pancreatitis | <0.1 | <0.1 | <0.1 | 0 | <0.1 | 0.2 | <0.1 | 0.1 | |
| Serious adverse events | 11.8 | 11.2 | 12.0 | 10.8 | 13.0 | 12.3 | 15.4 | 11.3 | |
| Infections | 1.5 | 1.6 | 1.6 | 1.3 | 1.2 | 1.7 | 2.4 | 1.2 | |
| Cellulitis or erysipelas | 0.1 | <0.1 | 0.2 | <0.1 | <0.1 | 0.1 | 0 | 0.2 | |
| Fatal adverse events | 0.6 | 0.6 | 0.7 | 0.4 | 0.8 | 0.9 | 1.3 | 0.7 | |
| Osteonecrosis of the jaw | 0 | 0 | 0 | 0 | 0 | 0.2 | <0.1 | 0 | |
| Atypical femoral fracture | 0 | 0 | 0 | 0 | 0 | 0 | <0.1 | 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