Table 2.

Subject Incidence of Adverse Events

	Placebo N = 705	Denosumab N = 720
Any adverse event, n (%)	655 (93)	676 (94)
Most common adverse events, n (%)
Back pain	156 (22)	168 (23)
Constipation	119 (17)	127 (18)
Arthralgia	112 (16)	123 (17)
Diarrhea	102 (14)	111 (15)
Urinary tract infection	96 (14)	108 (15)
Serious adverse events, n (%)	323 (46)	329 (46)
Most common serious adverse events, n (%)
Urinary retention	31 (4)	54 (8)
Hematuria	24 (3)	35 (5)
Prostate cancer	21 (3)	15 (2)
Anemia	12 (2)	22 (5)
Urinary tract infection	14 (2)	15 (2)
Grade 3, 4, or 5 adverse events, n (%)	353 (50)	381 (53)
Adjudicated positive osteonecrosis of the jaw	0	33 (5)
Hypocalcemia	2 (<1)	12 (2)