Table 5.

Serious adverse events and fractures

Event, patient incidence, n (%)	Overall	US	Canada
	N = 935	N = 632	N = 303
All SAEs	66 (7.1)	51 (8.1)	15 (5.0)
SAEs leading to discontinuation of denosumab	5 (0.5)	3 (0.5)	2 (0.7)
SAEs leading to withdrawal from the study	3 (0.3)	3 (0.5)	0 (0.0)
Fatal adverse eventsa	9 (1.0)	7 (1.1)	2 (0.7)
Osteoporotic fracturesb, c	19 (2.0)	18 (2.8)	1 (0.7)

SAE serious adverse event, US United States

^aOne death, which occurred after the data cut-off for this analysis, resulted from an SAE that began during the interim data analysis period

^bAny fracture recorded on the case report form, excluding skull, facial bones, mandible, metacarpus, finger phalanges, toe phalanges, and cervical vertebrae and not associated with known severe trauma (fall from higher than the height of stool, chair, first rung on a ladder or equivalent [>20 in] or severe trauma other than a fall) or pathological fractures

^cOn-study osteoporotic fractures were as follows: 1 carpus, 2 fibula, 2 humerus, 5 spine, 5 metatarsus, 2 patella, 1 pubis, 2 radius, 1 rib, 5 tarsus, 1 tibia