Table 3.
Adverse events during the open-label treatment phase
| Event, n (%) | Breast cancer study | Prostate cancer study | ||
|---|---|---|---|---|
| Denosumab/Denosumab (N = 318)a | Zoledronic acid/Denosumab (N = 334)a | Denosumab/Denosumab (N = 147)a | Zoledronic acid/Denosumab (N = 118)a | |
| All adverse events | 283 (89.0) | 303 (90.7) | 138 (93.9) | 105 (89.0) |
| Serious adverse events | 126 (39.6) | 133 (39.8) | 78 (53.1) | 63 (53.4) |
| Most common adverse events | ||||
| Nausea | 72 (22.6) | 77 (23.1) | 20 (13.6) | 16 (13.6) |
| Anemia | 53 (16.7) | 50 (15.0) | 34 (23.1) | 26 (22.0) |
| Fatigue | 70 (22.0) | 74 (22.2) | 23 (15.6) | 15 (12.7) |
| Back pain | 66 (20.8) | 56 (16.8) | 29 (19.7) | 19 (16.1) |
| Asthenia | 40 (12.6) | 48 (14.4) | 29 (19.7) | 11 (9.3) |
| Arthralgia | 57 (17.9) | 61 (18.3) | 25 (17.0) | 17 (14.4) |
| Adverse events of infectionb | 135 (42.5) | 135 (40.4) | 58 (39.5) | 33 (28.0) |
| Osteonecrosis of the jaw (ONJ)c,d | 20 (6.3) | 18 (5.4) | 12 (8.2) | 7 (5.9) |
| CTCAE, v 3 grade 3 | 2 (0.6) | 6 (1.8) | 3 (2.0) | 1 (0.8) |
| CTCAE, v 3 grade 4 | 0 (0.0) | 1 (0.3) | 0 (0.0) | 1 (0.8) |
| Adverse events of new primary malignancye | 2 (0.6)f | 1 (0.3)g | 1 (0.7)h | 0 (0.0) |
| Adverse events of hypocalcemiai | 12 (3.8) | 9 (2.7) | 8 (5.4) | 5 (4.2) |
| Serious | 3 (0.9) | 0 (0.0) | 1 (0.7) | 1 (0.8) |
CTCAE common terminology criteria for adverse events; version 3
aNumber of patients who received at least one dose of open-label denosumab
bSystem organ class: Infections and Infestations, Medical Dictionary for Regulatory Activities version 14.0 (breast cancer study), 14.1 (prostate cancer study)
cPositively adjudicated by blinded committee of experts. There were no grade 5 ONJ events
dRates not adjusted for patient-years of investigational product exposure and patient follow-up
eNo events were considered by the investigator to be related to denosumab treatment
fRenal cell cancer, squamous cell carcinoma of the skin
gGerm cell cancer
hBladder cancer
iIncludes the preferred terms hypocalcemia and blood calcium decreased