Table 4.
Yearly exposure-adjusted subject incidence of adverse events per 10,000 subject-years for cross-over denosumab participants where events of interest were <0.1 per 100 subject-years
| 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 | |
| Hypocalcemia | 5.3 | 0 | 3.0 | 23.2 | 4.9 | 0 | 5.9 | 19.1 | |
| Pancreatitis | 5.3 | 2.8 | 0 | 4.6 | 0 | 5.5 | 0 | 0 | |
| Serious cellulitis or erysipelas | 0 | 0 | 3.0 | 0 | 4.9 | 0 | 5.9 | 12.7 | |
| Osteonecrosis of the jaw | 0 | 0 | 0 | 0 | 9.8 | 0 | 5.9 | 0 | |
| Atypical femoral fracture | 0 | 0 | 0 | 0 | 0 | 5.5 | 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