Table 3.

Adverse events and serious adverse events in the FREEDOM trial34

Type of event	Denosumab (n = 3886)	Placebo (n = 3876)	P value
Adverse events occurring in at least 2% of subjects in either group with P ≤ 0.05
Eczema	118 (3.0%)	65 (1.7%)	<0.001
Falling	175 (4.5%)	219 (5.7%)	0.02
Flatulence	84 (2.2%)	53 (1.4%)	0.008
Serious adverse events occurring in at least 0.1% of subjects in either group with P ≤ 0.01
Cellulitis (including erysipelas)	12 (0.3%)	1 (<0.1%)	0.002
Concussion	1 (<0.1%)	11 (0.3%)	0.004
All adverse events and serious adverse events	3605 (92.8%)	3607 (93.1%)	0.91
All serious adverse events	1004 (25.8%)	972 (25.1%)	0.61

Notes: Five events were identified as being statistically significantly different between subjects treated with denosumab and placebo. Three of these (eczema, flatulence, cellulitis) favored placebo while two (falling, concussions) favored denosumab. There was no difference in total adverse events or serious adverse events.