Table 2.
Summary of Adverse Events
| Adverse event | Double blind |
Open label |
|
|---|---|---|---|
| Denosumab (n = 475), n, % | Placebo (n = 481), n, % | Alendronate (n = 242), n, % | |
| All | 448 (94.3) | 446 (92.7) | 229 (94.6) |
| Serious | 66 (13.9) | 68 (14.1) | 30 (12.4) |
| Fatal | 5 (1.1) | 5 (1.0) | 0 (0.0) |
| Leading to study discontinuation | 5 (1.1) | 2 (0.4) | 2 (0.8) |
| Leading to discontinuation of IP | 23 (4.8) | 31 (6.4) | 18 (7.4) |
| AEs of interest | |||
| Hypocalcemia | 2 (0.4) | 0 (0.0) | 2 (0.8) |
| Bacterial cellulitis | 6 (1.3) | 3 (0.6) | 0 (0.0) |
| Infection | 286 (60.2) | 269 (55.9) | 131 (54.1) |
| Eczema | 70 (14.7) | 81 (16.8) | 31 (12.8) |
| Potentially related to hypersensitivity | 90 (18.9) | 105 (21.8) | 45 (18.6) |
| Cardiovascular disorder | 68 (14.3) | 63 (13.1) | 21 (8.7) |
| Malignant or unspecified tumors | 9 (1.9) | 11 (2.3) | 2 (0.8) |
| Fracture healing complication | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| ONJ | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Atypical femoral fracture | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Serious AEs of interest | |||
| Hypocalcemia | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Bacterial cellulitis | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Infection | 5 (1.1) | 7 (1.5) | 3 (1.2) |
| Eczema | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Potentially related to hypersensitivity | 0 (0.0) | 0 (0.0) | 1 (0.4) |
| Cardiovascular disorder | 6 (1.3) | 7 (1.5) | 2 (0.8) |
| Malignant or unspecified tumors | 7 (1.5) | 10 (2.1) | 2 (0.8) |
The analysis of AEs included those of all subjects who received at least one dose of IP. Reported AEs were coded by using Medical Dictionary for Regulatory Activities, version 14.0.