Table 2.

Exposure-Adjusted Subject Incidence of Adverse Events

	Placebo	Denosumab
	FREEDOM, years 1–3 (N = 3883), rate (n)	FREEDOM, years 1–3 (N = 3879), rate (n)	Extension, long-term, years 4–5 (N = 2343), rate (n)	Extension, cross-over, years 1–2 (N = 2206), rate (n)
Adverse events	156.1 (3614)	154.3 (3598)	113.2 (1955)	111.4 (1826)
Infection	30.7 (2113)	29.3 (2052)	25.1 (875)	27.4 (886)
Malignancy	1.6 (167)	1.8 (187)	2.0 (87)	1.6 (68)
Eczema	0.6 (67)	1.1 (119)	1.1 (47)	0.9 (39)
Hypocalcemia	<0.1 (3)	0.0 (0)	<0.1 (1)	0.1 (5)
Pancreatitis	<0.1 (3)	<0.1 (7)	<0.1 (1)	<0.1 (1)
Serious adverse events	10.4 (974)	10.6 (1002)	10.8 (442)	11.1 (428)
Infections	1.3 (134)	1.5 (160)	1.2 (55)	1.5 (63)
Cellulitis or erysipelas	<0.1 (1)	0.1 (12)	<0.1 (3)	<0.1 (1)
Fatal adverse events	0.8 (90)	0.6 (70)	0.6 (26)	0.8 (32)

Treatment groups are based on the original randomized treatments received in FREEDOM. All subjects in the extension are receiving denosumab.

n = total number of subjects with an adverse event; N = number of subjects who received ≥1 dose of investigational product; rate = exposure-adjusted subject incidence per 100 subject-years.