Table 1.
Combined data for adverse events from three Phase II registration trials in patients with breast cancer, prostate cancer, and other solid tumors or multiple myeloma38
| Adverse event | Denosumab (n = 2841)a | Zoledronic acid (n = 2836)a |
|---|---|---|
| Adverse events | 2734 (96.2) | 2745 (96.8) |
| Adverse events leading to study discontinuation | 270 (9.5) | 280 (9.9) |
| CTCAE Grade 3, 4, or 5 adverse events | 2000 (70.4) | 2009 (70.8) |
| Serious adverse events | 1599 (56.3) | 1620 (57.1) |
| Adverse events of interest | ||
| Acute phase reactions (first 3 days) | 246 (8.7) | 572 (20.2) |
| Hypocalcemia | 273 (9.6) | 141 (5.0) |
| Osteonecrosis of the jaw | 52 (1.8) | 37 (1.3) |
Note:
a
Patients who received at least one dose of active drug.
Abbreviation: CTCAE, Common Terminology Criteria for Adverse Events.