Summary of adverse events
| AEs, n (%) | Placebo (n=224) | Denosumab | |
| 60 mg Q6M (n=221) | 60 mg Q3M (n=222) | ||
| Patients with adverse events | 186 (83.0) | 187 (84.6) | 185 (83.3) |
| Patients with serious adverse events | 13 (5.8) | 19 (8.6) | 19 (8.6) |
| Patients with related adverse events* | 38 (17.0) | 38 (17.2) | 36 (16.2) |
| Patients with related serious adverse events* | 3 (1.3) | 4 (1.8) | 4 (1.8) |
| Death | 0 (0.0) | 0 (0.0) | 1 (0.5) |
| Any adverse events in ≥5% of patients in any treatment group | |||
| Nasopharyngitis | 73 (32.6) | 79 (35.7) | 69 (31.1) |
| Pharyngitis | 16 (7.1) | 13 (5.9) | 16 (7.2) |
| Influenza | 12 (5.4) | 8 (3.6) | 10 (4.5) |
| Stomatitis | 13 (5.8) | 22 (10.0) | 27 (12.2) |
| Dental caries | 9 (4.0) | 12 (5.4) | 7 (3.2) |
| Back pain | 7 (3.1) | 5 (2.3) | 12 (5.4) |
| Upper respiratory tract inflammation | 9 (4.0) | 18 (8.1) | 8 (3.6) |
| Hepatic function abnormal | 20 (8.9) | 14 (6.3) | 13 (5.9) |
| Drug-related serious adverse events* | |||
| Lymphoproliferative disorder | 0 (0.0) | 0 (0.0) | 1 (0.5) |
| Rectal cancer | 0 (0.0) | 0 (0.0) | 1 (0.5) |
| Squamous cell carcinoma of lung | 0 (0.0) | 1 (0.5) | 0 (0.0) |
| Lung neoplasm malignant | 1 (0.4) | 0 (0.0) | 0 (0.0) |
| Interstitial lung disease | 0 (0.0) | 1 (0.5) | 1 (0.5) |
| Abscess jaw | 0 (0.0) | 1 (0.5) | 0 (0.0) |
| Diverticulitis | 1 (0.4) | 0 (0.0) | 0 (0.0) |
| Ventricular tachycardia | 0 (0.0) | 0 (0.0) | 1 (0.5) |
| Platelet count decreased | 0 (0.0) | 0 (0.0) | 1 (0.5) |
| Brain stem infarction | 0 (0.0) | 1 (0.5) | 0 (0.0) |
| Sudden hearing loss | 1 (0.4) | 0 (0.0) | 0 (0.0) |
n=Number of patients who received ≥1 dose of investigational product. Classifications of adverse events are based on the Medical Dictionary for Regulatory Activities. Only includes treatment-emergent adverse events.
*This includes events for which the investigator indicated there was a reasonable possibility they may have been caused by the investigational product.
MACE, major adverse cardiovascular events; Q3M, every 3 months; Q6M, every 6 months.