Table 5.
Worst adverse event (grade) reported over entire time on trial
| Standard of care (n=1184) | Standard of care plus zoledronic acid (n=593) | Standard of care plus docetaxel (n=592) | Standard of care plus zoledronic acid and docetaxel (n=593) | ||
|---|---|---|---|---|---|
| Safety population | |||||
| Number of patients included in analysis* | 1228 | 608 | 550 | 516 | |
| Grade 1–5 adverse event | 1213 (99%) | 604 (99%) | 550 (100%) | 515 (100%) | |
| Grade 3–5 adverse event | 399 (32%) | 197 (32%) | 288 (52%) | 269 (52%) | |
| Grade 5 adverse event | 5 | 1 | 4 | 6 | |
| Most frequent adverse events reported as grade 3–5 | |||||
| Endocrine disorder (including impotence, hot flushes) | 145 (12%) | 74 (12%) | 57 (10%) | 64 (12%) | |
| Febrile neutropenia | 15 (1%) | 5 (<1%) | 84 (15%) | 74 (14%) | |
| Neutropenia (neutrophils) | 6 (0%) | 3 (<1%) | 66 (12%) | 62 (12%) | |
| General disorder (including lethargy, fever, asthenia) | 46 (4%) | 28 (5%) | 34 (7%) | 56 (11%) | |
| Musculoskeletal (including bone pain, generalised pain) | 69 (6%) | 35 (6%) | 32 (6%) | 44 (9%) | |
| Gastrointestinal disorder (including diarrhoea, abdominal pain, constipation, vomiting) | 36 (3%) | 19 (3%) | 45 (8%) | 37 (7%) | |
| Renal (including renal impairment, urinary-tract infection) | 71 (6%) | 30 (5%) | 23 (4%) | 25 (5%) | |
| Notable adverse events | |||||
| Respiratory disorder (including dyspnoea, upper respiratory-tract infection) | 27 (2%) | 13 (2%) | 29 (5%) | 23 (4%) | |
| Cardiac disorder (including hypertension, myocardial infarction) | 35 (3%) | 19 (3%) | 16 (3%) | 19 (4%) | |
| Osteonecrosis of the jaw | 0 (0%) | 10 (2%) | 0 (0%) | 21 (4%) | |
| Nervous system other (including peripheral neuropathy) | 20 (2%) | 8 (1%) | 19 (3%) | 19 (4%) | |
| Nail changes | 0 (0%) | 0 (0%) | 5 (1%) | 4 (1%) | |
| ITT population | |||||
| Number of patients included in analysis† | 1173 | 587 | 579 | 563 | |
| Grade 1–5 adverse event | 1160 (99%) | 583 (99%) | 577 (100%) | 562 (100%) | |
| Grade 3–5 adverse event | 375 (32%) | 184 (31%) | 298 (51%) | 296 (53%) | |
| Grade 5 adverse event | 4 | 1 | 4 | 7 | |
Grade 5 adverse events were not necessarily treatment-related; similarly treatment-related deaths were not always grade 5 adverse events. ITT=intention-to-treat.
*
Analysis by actual treatment initiated (irrespective of assigned study arm) in patients who underwent adverse event assessment.
†
Analysis by assigned study arm in patients who underwent adverse event assessment.