Table 2.
Summary of adverse events
| Denosumab | ||||
|---|---|---|---|---|
| Placebo (N=88) | 60 mg Q6M (N=86) | 60 mg Q3M (N=85) | 60 mg Q2M (N=87) | |
| All adverse events | 73 (83.0%) | 69 (80.2%) | 65 (76.5%) | 82 (94.3%) |
| Serious adverse events | 9 (10.2%) | 4 (4.7%) | 6 (7.1%) | 8 (9.2%) |
| Treatment-related adverse events | 16 (18.2%) | 16 (18.6%) | 12 (14.1%) | 18 (20.7%) |
| Treatment-related serious adverse events | 2 (2.3%) | 1 (1.2%) | 2 (2.4%) | 0 |
| Death | 0 | 0 | 0 | 0 |
| Any adverse event in ≥5% of patients in any treatment group | ||||
| Nasopharyngitis | 23 (26.1%) | 21 (24.4%) | 20 (23.5%) | 28 (32.2%) |
| Hepatic function abnormal | 14 (15.9%) | 7 (8.1%) | 9 (10.6%) | 17 (19.5%) |
| Stomatitis | 5 (5.7%) | 6 (7.0%) | 5 (5.9%) | 9 (10.3%) |
| Upper respiratory tract inflammation | 5 (5.7%) | 4 (4.7%) | 10 (11.8%) | 6 (6.9%) |
| Pharyngitis | 7 (8.0%) | 7 (8.1%) | 4 (4.7%) | 5 (5.7%) |
| Back pain | 2 (2.3%) | 5 (5.8%) | 3 (3.5%) | 6 (6.9%) |
| Bronchitis | 3 (3.4%) | 2 (2.3%) | 5 (5.9%) | 5 (5.7%) |
| Dental caries | 3 (3.4%) | 3 (3.5%) | 5 (5.9%) | 4 (4.6%) |
| Eczema | 2 (2.3%) | 2 (2.3%) | 3 (3.5%) | 6 (6.9%) |
| Constipation | 3 (3.4%) | 5 (5.8%) | 1 (1.2%) | 3 (3.4%) |
| Periodontitis | 5 (5.7%) | 1 (1.2%) | 5 (5.9%) | 2 (2.3%) |
| Gastritis | 2 (2.3%) | 0 | 5 (5.9%) | 2 (2.3%) |
| Hypertension | 5 (5.7%) | 1 (1.2%) | 1 (1.2%) | 1 (1.1%) |
Data are number or number (%). 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. Preferred terms are sorted by descending order of pooled frequency in the denosumab groups.
Q2M, every 2 months; Q3M, every 3 months; Q6M, every 6 months.