Table 3.
SAE and fractures
| Event | USA (N = 632), n (%) | Canada (N = 303), n (%) | Overall (N = 935), n (%) |
|---|---|---|---|
| SAEs | 95 (15.0) | 27 (8.9) | 122 (13.0) |
| Leading to discontinuation of denosumab | 5 (0.8) | 3 (1.0) | 8 (0.9) |
| Leading to withdrawal from the study | 4 (0.6) | 0 (0) | 4 (0.4) |
| Fracturesa | 43 (6.8) | 11 (3.6) | 54 (5.8) |
| Fatal AEsb | 15 (2.4) | 4 (1.3) | 19 (2.0) |
AE adverse event, SAE serious AE
aExcludes fractures not associated with decreased bone mineral density (skull, face, mandible, metacarpals, fingers, toes, and cervical vertebrae), pathologic fractures, and fractures associated with severe trauma (defined as a fall from a height higher than a stool, chair, or first rung of a ladder, or severe trauma other than a fall)
bFatal AEs for the overall patient population were infections (five patients), cardiac disorders (four patients), deaths (three patients), cancer (three patients), respiratory disorders (two patients), lupus (one patient), and arteriosclerosis (one patient)