Table 1.
Patient Characteristics
| Characteristic | Cases(n = 293) |
Controls(n = 585) |
Wilcoxon Rank Sum P | Fisher's Exact P | ||
|---|---|---|---|---|---|---|
| No. | % | No. | % | |||
| Age, years | ||||||
| Median | 63.3 | 64.1 | .61 | |||
| Q1 | 57.8 | 58.1 | ||||
| Q3 | 70.2 | 70.2 | ||||
| Range | 46.1-86.9 | 45.1-84.8 | ||||
| Treatment arm (blinded) | ||||||
| A | 163 | 56 | 326 | 56 | 1.00 | |
| B | 130 | 44 | 259 | 44 | ||
| Celecoxib (blinded) | ||||||
| C | 221 | 75 | 426 | 73 | .42 | |
| D | 72 | 25 | 159 | 27 | ||
| Prior chemotherapy | ||||||
| No | 200 | 68 | 405 | 69 | .82 | |
| Yes | 93 | 32 | 180 | 31 | ||
| Prior taxane | ||||||
| No | 244 | 84 | 490 | 84 | .92 | |
| Yes | 48 | 16 | 94 | 16 | ||
| Unknown/missing | 1 | 1 | ||||
| Prior radiation therapy | ||||||
| No | 100 | 34 | 175 | 30 | .22 | |
| Yes | 192 | 66 | 407 | 70 | ||
| Unknown/missing | 1 | 3 | ||||
| Prior HRT | ||||||
| No | 94 | 35 | 289 | 53 | < .001 | |
| Yes | 178 | 65 | 258 | 47 | ||
| Unknown/missing | 21 | 38 | ||||
| Fracture in past 10 years | ||||||
| No | 255 | 87 | 534 | 91 | .06 | |
| Yes | 38 | 13 | 51 | 9 | ||
| BMI at baseline | ||||||
| Missing | 2 | 0.7 | 8 | 1 | ||
| Known | 291 | 577 | ||||
| Median | 28.2 | 27.9 | .51 | |||
| Q1 | 25.0 | 24.4 | ||||
| Q3 | 33.1 | 32.4 | ||||
| Range | 17.7-56.8 | 16.9-50.8 | ||||
| ECOG PS at baseline | ||||||
| 0 | 237 | 80.9 | 491 | 84 | .24 | |
| 1 | 55 | 18.8 | 88 | 15 | ||
| 2 | 1 | 0.3 | 6 | 1 | ||
| Bisphosphonate use | ||||||
| No | 249 | 95 | 473 | 87 | .66 | |
| Yes | 12 | 5 | 72 | 13 | ||
| Unknown/missing | 10 | 40 | ||||
| MS-AEs withdrew from therapy | ||||||
| Yes | ||||||
| Grade 1 | 17 | 6 | 0 | |||
| Grade 2 | 108 | 37 | 0 | |||
| Grade 3 | 101 | 34 | 0 | |||
| Grade 4 | 6 | 2 | 0 | |||
| No | ||||||
| Grade 3 | 58 | 20 | 0 | |||
| Grade 4 | 3 | 1 | 0 | |||
Abbreviations: Q1, first quartile; Q3, third quartile; HRT, hormone replacement therapy; BMI, body mass index; ECOG, Eastern Cooperative Oncology Group; PS, performance status; MS-AE, musculoskeletal adverse event.