Table 2.
Summary of Adverse Events.*
| Event | Denosumab (N = 731) |
Placebo (N = 725) |
|---|---|---|
| no. (%) | ||
| Adverse event | 638 (87.3) | 627 (86.5) |
| Most common: ≥5% in either group | ||
| Arthralgia | 92 (12.6) | 80 (11.0) |
| Back pain | 81 (11.1) | 74 (10.2) |
| Constipation | 73 (10.0) | 75 (10.3) |
| Pain in extremity | 66 (9.0) | 51 (7.0) |
| Hypertension | 57 (7.8) | 51 (7.0) |
| Peripheral edema | 53 (7.3) | 48 (6.6) |
| Nasopharyngitis | 47 (6.4) | 45 (6.2) |
| Fatigue | 44 (6.0) | 45 (6.2) |
| Dizziness | 41 (5.6) | 31 (4.3) |
| Musculoskeletal pain | 41 (5.6) | 26 (3.6) |
| Diarrhea | 40 (5.5) | 39 (4.4) |
| Hot flush | 38 (5.2) | 32 (4.4) |
| Urinary tract infection | 37 (5.1) | 32 (4.4) |
| Possibly treatment-related | 62 (8.5) | 65 (9.0) |
| CTC grade 3, 4, or 5 | 269 (36.8) | 244 (33.7) |
| Serious adverse event | 253 (34.6) | 222 (30.6) |
| Adjudicated cardiovascular | 80 (10.9) | 80 (11.0) |
| Cardiovascular death | 19 (2.6) | 21 (2.9) |
| Acute coronary syndrome | 18 (2.5) | 27 (3.7) |
| Stroke or transient ischemic attack | 21 (2.9) | 17 (2.3) |
| Congestive heart failure | 8 (1.1) | 11 (1.5) |
| Other vascular | 18 (2.5) | 12 (1.7) |
| Arrhythmia | 19 (2.6) | 15 (2.1) |
| Most common other serious adverse event: ≥1% in either group | ||
| Pneumonia | 11 (1.5) | 11 (1.5) |
| Syncope | 8 (1.1) | 5 (0.7) |
| Dyspnea | 8 (1.1) | 3 (0.4) |
| Metastasis to bone | 3 (0.4) | 10 (1.4) |
| Possibly treatment-related | 3 (0.4) | 4 (0.6) |
| Death | 44 (6.0) | 46 (6.3) |
*
CTC denotes Common Terminology Criteria of the National Cancer Institute (version 3).