Table 3.
Placebo (N = 3,876)a, n (%) | Denosumab (N = 3,886)a, n (%) | |
---|---|---|
Serious adverse events of infection involving the skin | 3 (<0.1) | 15 (0.4)* |
Cellulitis and erysipelas | 1 (<0.1) | 12 (0.3)b |
Skin bacterial infection | 0 (0) | 2 (<0.1) |
Staphylococcal infection | 1 (<0.1) | 1 (<0.1) |
Infected skin ulcer | 0 (0) | 1 (<0.1)b |
Subcutaneous abscess | 1 (<0.1) | 0 (0) |
*P < 0.05 vs placebo
aNumber of subjects who received ≥1 dose of investigational product
bOne subject in the denosumab group experienced events of cellulitis and erysipelas and infected skin ulcer