Table 3.
Yearly exposure-adjusted subject incidence of adverse events per 100 subject-years for cross-over denosumab participants
| FREEDOM (years 1–3) Placebo |
FREEDOM Extension (years 1–5) Cross-over denosumaba |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| Denosumab exposure | – | – | – | Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | |
| N = | 3883 | 3687 | 3454 | 2206 | 2105 | 1965 | 1756 | 1646 | |
| All adverse events | 189.5 | 156.3 | 132.8 | 132.1 | 112.3 | 109.8 | 122.5 | 100.1 | |
| Infections | 38.6 | 33.9 | 31.7 | 30.8 | 27.5 | 26.0 | 27.6 | 24.7 | |
| Malignancies | 1.8 | 1.6 | 1.5 | 1.9 | 1.6 | 2.1 | 2.6 | 2.1 | |
| Eczema | 0.8 | 0.5 | 0.6 | 1.0 | 0.9 | 1.1 | 1.2 | 1.0 | |
| Hypocalcemia | <0.1 | 0 | <0.1 | 0.2 | <0.1 | 0 | <0.1 | 0.2 | |
| Pancreatitis | <0.1 | <0.1 | 0 | <0.1 | 0 | <0.1 | 0 | 0 | |
| Serious adverse events | 11.7 | 11.9 | 10.8 | 12.4 | 12.2 | 12.3 | 12.3 | 12.3 | |
| Infections | 1.1 | 1.4 | 1.4 | 1.6 | 1.5 | 1.1 | 1.6 | 1.3 | |
| Cellulitis or erysipelas | 0 | 0 | <0.1 | 0 | <0.1 | 0 | <0.1 | 0.1 | |
| Fatal adverse events | 0.8 | 0.8 | 1.0 | 0.9 | 0.6 | 0.5 | 0.7 | 0.8 | |
| Osteonecrosis of the jaw | 0 | 0 | 0 | 0 | 0.1 | 0 | <0.1 | 0 | |
| Atypical femoral fracture | 0 | 0 | 0 | 0 | 0 | <0.1 | 0 | 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
aOne cross-over subject did not receive investigational product in the Extension and therefore was excluded from the safety analysis