Table 1.
Patient characteristics
| Levofloxacin group (n=489) | Placebo group (n=488) | ||
|---|---|---|---|
| Age (years) | 67 (59–75) | 67 (61–75) | |
| Sex | |||
| Male | 316 (65%) | 295 (60%) | |
| Female | 173 (35%) | 193 (40%) | |
| Ethnicity | |||
| White | 452 (92%) | 437 (90%) | |
| Mixed | 1 (<1%) | 2 (<1%) | |
| Asian or British Asian | 10 (2%) | 17 (3%) | |
| Black or Black British | 26 (5%) | 28 (6%) | |
| Chinese or other | 0 | 1 (<1%) | |
| Missing | 0 | 3 (1%) | |
| Performance status at randomisation | |||
| 0 | 164 (34%) | 173 (35%) | |
| 1 | 209 (43%) | 188 (39%) | |
| 2 | 80 (16%) | 76 (16%) | |
| 3 | 24 (5%) | 36 (7%) | |
| 4 | 2 (<1%) | 5 (1%) | |
| Missing | 10 (2%) | 10 (2%) | |
| International Staging System | |||
| Stage I | 100 (20%) | 116 (24%) | |
| Stage II | 188 (38%) | 165 (34%) | |
| Stage III | 121 (25%) | 130 (27%) | |
| Missing | 80 (16%) | 77 (16%) | |
| Estimated glomerular filtration rate (mL/min) | |||
| >50 | 369 (75%) | 369 (76%) | |
| 20–50 | 95 (19%) | 93 (19%) | |
| <20 | 25 (5%) | 26 (5%) | |
| High-dose CT with planned autologous stem cell transplantation | |||
| No | 223 (46%) | 222 (45%) | |
| Yes | 266 (54%) | 266 (55%) | |
| Previous infection | |||
| Clostridium difficile | 2 (<1%) | 1 (<1%) | |
| Meticillin-resistant Staphylococcus aureus | 6 (1%) | 7 (1%) | |
| Extended-spectrum β-lactamase coliforms | 3 (1%) | 5 (1%) | |
| Anti-infectives in previous month | |||
| No | 332 (68%) | 331 (68%) | |
| Yes | 75 (15%) | 76 (16%) | |
| Missing | 82 (17%) | 81 (17%) | |
| Steroids 14 days before randomisation | |||
| Yes | 248 (51%) | 246 (50%) | |
| Corticosteroids | |||
| Prednisolone | 24 (5%) | 18 (4%) | |
| Dexamethasone | 226 (46%) | 229 (47%) | |
| Other | .. | 2 (<1%) | |
| Planned anti-myeloma treatment | |||
| Thalidomide-based | 208 (43%) | 216 (44%) | |
| Bortezomib-based | 152 (31%) | 150 (31%) | |
| Lenalidomide-based | 72 (15%) | 69 (14%) | |
| Lenalidomide and carfilzomib-based | 50 (10%) | 43 (9%) | |
| Other | 7 (1%) | 10 (2%) | |
| Bisphosphonate status at randomisation | |||
| Not given | 68 (14%) | 60 (12%) | |
| Given or will be given | 419 (86%) | 419 (86%) | |
| Missing | 2 (<1%) | 9 (2%) | |
| Bisphosphonate | |||
| Zolendronate | 284 (68%) | 280 (67%) | |
| Pamidronate | 111 (26%) | 105 (25%) | |
| Clodronate | 14 (3%) | 23 (5%) | |
| Other | 3 (1%) | 7 (2%) | |
| Missing | 7 (2%) | 4 (1%) | |
| Prophylactic antiviral or antifungal | |||
| No | 170 (35%) | 166 (34%) | |
| Yes | 237 (48%) | 240 (49%) | |
| Missing | 82 (17%) | 82 (17%) | |
| Corrected calcium (μmol/L) | |||
| <2·50 | 340 (69%) | 354 (73%) | |
| 2·50–2·75 | 102 (21%) | 95 (19%) | |
| >2·75 | 29 (6%) | 25 (5%) | |
| Missing | 18 (4%) | 14 (3%) | |
| Evidence of bone disease | |||
| Yes | 338 (69%) | 351 (72%) | |
| Site of bone disease | |||
| Vertebral fracture or collapse | 118 (24%) | 144 (30%) | |
| Lytic lesions | 234 (48%) | 246 (50%) | |
| Fractured rib | 33 (7%) | 24 (5%) | |
| Osteoporosis | 38 (8%) | 37 (8%) | |
| Other fracture | 43 (9%) | 41 (8%) | |
| Serum β-2-microglobulin (mg/L) | |||
| ≤4 | 189 (39%) | 192 (39%) | |
| 4–8 | 148 (30%) | 152 (31%) | |
| >8 | 73 (15%) | 67 (14%) | |
| Missing | 79 (16%) | 77 (16%) | |
| Haemoglobin (g/dL) | |||
| <7·5 | 9 (2%) | 13 (3%) | |
| 7·5–10·0 | 163 (33%) | 166 (34%) | |
| >10·0 | 315 (64%) | 306 (63%) | |
| Missing | 2 (<1%) | 3 (1%) | |
| Platelets (× 109/L) | |||
| ≤150 | 69 (14%) | 79 (16%) | |
| >150 | 418 (85%) | 405 (83%) | |
| Missing | 2 (<1%) | 4 (1%) | |
| Neutrophils (× 109/L) | |||
| <1·8 | 35 (7%) | 55 (11%) | |
| 1·8–3·0 | 138 (28%) | 133 (27%) | |
| >3·0 | 312 (64%) | 296 (61%) | |
| Missing | 4 (1%) | 4 (1%) | |
| Lymphocytes (×109/L) | |||
| <1·2 | 143 (29%) | 147 (30%) | |
| 1·2–1·8 | 165 (34%) | 170 (35%) | |
| >1·8 | 177 (36%) | 167 (34%) | |
| Missing | 4 (1%) | 4 (1%) | |
| Serum creatinine (μmol/L) | |||
| <130 | 387 (79%) | 384 (79%) | |
| 130–199 | 57 (12%) | 54 (11%) | |
| >199 | 42 (9%) | 43 (9%) | |
| Missing | 3 (1%) | 7 (1%) | |
Data are median (IQR) or n (%).