Table 2.
Treatment-emergent adverse events occurring in at least 20% of patients in either treatment subgroup
| Denosumab 120 mg SC Q4W (N = 102) | Zoledronic acid 4 mg IV Q4W (N = 92) | |
|---|---|---|
| Treatment-emergent AE, n (%) | 102 (100.0) | 92 (100.0) |
| Diarrhea | 52 (51.0) | 47 (51.1) |
| Nausea | 43 (42.2) | 43 (46.7) |
| Pyrexia | 39 (38.2) | 38 (41.3) |
| Upper respiratory tract infection | 38 (37.3) | 37 (40.2) |
| Constipation | 34 (33.3) | 29 (31.5) |
| Neutropenia | 32 (31.4) | 19 (20.7) |
| Decreased appetite | 31 (30.4) | 31 (33.7) |
| Insomnia | 30 (29.4) | 28 (30.4) |
| Cough | 28 (27.5) | 20 (21.7) |
| Anemia | 26 (25.5) | 20 (21.7) |
| Thrombocytopenia | 26 (25.5) | 14 (15.2) |
| Rash | 25 (24.5) | 19 (20.7) |
| Hypokalemia | 23 (22.5) | 22 (23.9) |
| Vomiting | 21 (20.6) | 23 (25.0) |
| Back pain | 19 (18.6) | 21 (22.8) |
| Neuropathy peripheral | 19 (18.6) | 19 (20.7) |
| Herpes zoster | 14 (13.7) | 24 (26.1) |
Preferred terms are sorted by descending order of frequency in the denosumab group and coded using MedDRA version 19.0
AE adverse event, IV intravenously, MedDRA Medical Dictionary for Regulatory Activities, Q4W every 4 weeks, SC subcutaneously