Table 1.
Demographic and disease characteristics at baseline (intention-to-treat population)
|
Intensive pathway |
Non-intensive pathway |
||||
|---|---|---|---|---|---|
| Zoledronic acid (n=555) | Clodronic acid (n=556) | Zoledronic acid (n=426) | Clodronic acid (n=423) | ||
| Age (years; median [range, IQR]) | 59 (31–74, 53–63) | 59 (33–78, 53–63) | 73 (59–89, 70–77) | 73 (57–88, 70–77) | |
| Sex | |||||
| Female | 201 (36%) | 218 (39%) | 191 (45%) | 185 (44%) | |
| Male | 354 (64%) | 338 (61%) | 235 (55%) | 238 (56%) | |
| ISS disease stage | |||||
| I | 129 (23%) | 146 (26%) | 63 (15%) | 47 (11%) | |
| II | 198 (36%) | 182 (33%) | 139 (33%) | 173 (41%) | |
| III | 174 (31%) | 169 (30%) | 173 (41%) | 160 (38%) | |
| Data unavailable | 54 (10%) | 59 (11%) | 51 (12%) | 43 (10%) | |
| β2-microglobulin (mg/L) | 4 (3–7) | 4 (3–7) | 5 (3–8) | 5 (4–8) | |
| Data unavailable | 43 (8%) | 52 (9%) | 47 (11%) | 37 (9%) | |
| Myeloma subtype | |||||
| IgG | 332 (60%) | 328 (59%) | 253 (59%) | 252 (60%) | |
| IgM | 2 (<1%) | 3 (1%) | 1 (<1%) | 2 (<1%) | |
| IgA | 125 (23%) | 116 (21%) | 99 (23%) | 102 (24%) | |
| IgD | 12 (2%) | 13 (2%) | 9 (2%) | 4 (1%) | |
| Light chain or non-expressing | 78 (14%) | 89 (16%) | 58 (14%) | 57 (13%) | |
| Data unavailable | 6 (1%) | 7 (1%) | 6 (1%) | 6 (1%) | |
| Bone disease | |||||
| Yes | 404 (73%) | 411 (74%) | 291 (68%) | 295 (70%) | |
| No | 149 (27%) | 138 (25%) | 130 (31%) | 123 (29%) | |
| Data unavailable | 2 (<1%) | 7 (1%) | 5 (1%) | 5 (1%) | |
| Bone pain | |||||
| Yes | 428 (77%) | 415 (75%) | 275 (65%) | 287 (68%) | |
| No | 120 (22%) | 132 (24%) | 147 (35%) | 131 (31%) | |
| Data unavailable | 7 (1%) | 9 (2%) | 4 (1%) | 5 (1%) | |
| Calcium after hydration (mmol/L) | 2·4 (2·2–2·5) | 2·4 (2·3–2·5) | 2·4 (2·2–2·5) | 2·4 (2·3–2·5) | |
| Data unavailable* | 37 (7%) | 51 (9%) | 37 (9%) | 37 (9%) | |
| Creatinine after hydration (μmol/L) | 100 (84–128) | 96 (79–122) | 101 (82–128) | 105 (88–137) | |
| Data unavailable* | 38 (7%) | 48 (9%) | 32 (8%) | 34 (8%) | |
| Haemoglobin (g/L) | 110 (90–120) | 110 (90–120) | 100 (90–120) | 110 (100–120) | |
| Data unavailable* | 19 (3%) | 20 (4%) | 20 (5%) | 15 (4%) | |
| Platelets (×109/L) | 237 (186–308) | 246 (194–310) | 226 (177–292) | 230 (177–292) | |
| Data unavailable* | 19 (3%) | 20 (4%) | 20 (5%) | 15 (4%) | |
Data are median (IQR) or number of patients (%), unless otherwise indicated. ISS=international staging system.
*
For all variables included in the minimisation algorithm, the stratification category (eg, serum calcium <2·6 vs ≥2·6 mmol/L) was recorded for all patients, even if the exact value was not documented.