Table 4.
Adverse events and adverse events of interest in patients receiving at least one dose of study treatment
| Zoledronic acid (n=945) |
Denosumab (n=943) |
p value* | |
|---|---|---|---|
| Overall safety summary | |||
| Any adverse event | 918 (97%) | 916 (97%) | 1·00 |
| Adverse events occurring with ≥20% frequency in either treatment group | |||
| Anaemia | 341 (36%) | 337 (36%) | 0·89 |
| Back pain | 287 (30%) | 304 (32%) | 0·40 |
| Decreased appetite | 274 (29%) | 267 (28%) | 0·76 |
| Nausea | 245 (26%) | 272 (29%) | 0·16 |
| Fatigue | 222 (23%) | 257 (27%) | 0·06 |
| Constipation | 251 (27%) | 236 (25%) | 0·46 |
| Bone pain | 245 (26%) | 235 (25%) | 0·63 |
| Asthenia | 239 (25%) | 239 (25%) | 1·00 |
| Arthralgia | 202 (21%) | 194 (21%) | 0·69 |
| Pain in extremity | 196 (21%) | 197 (21%) | 0·95 |
| Peripheral oedema | 174 (18%) | 192 (20%) | 0·30 |
| Adverse events leading to treatment discontinuation | 138 (15%) | 164 (17%) | 0·10 |
| CTCAE grade 3 or 4 adverse events | 628 (66%) | 678 (72%) | 0·01 |
| Serious adverse events | 568 (60%) | 594 (63%) | 0·20 |
| Fatal adverse events | 276 (29%) | 283 (30%) | 0·72 |
| Adverse events of interest | |||
| Infectious adverse events† | 375 (40%) | 402 (43%) | 0·21 |
| Cumulative osteonecrosis of the jaw (total) | 12 (1%) | 22 (2%) | 0·09 |
| Year 1 | 5 (1%) | 10 (1%) | ·· |
| Year 2 | 8 (1%) | 22 (2%) | ·· |
| Hypocalcaemia | 55 (6%) | 121 (13%) | <0·0001 |
| New primary malignant disease | 10 (1%) | 18 (2%) | 0·13 |
Data are number (%). CTCAE=Common Terminology Criteria For Adverse Events (version 3.0).
*
Calculated by Fisher’s exact test.
†
Based on Medical Dictionary for Regulatory Activities (MedDRA; version 12.1) system organ class categorisation of infections and infestations.