Table A1.
Patient Demographics and Disease Characteristics by Region
| Characteristic | Europe |
Non-Europe/NA |
NA |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Orteronel Plus Prednisone (n = 394) |
Placebo Plus Prednisone (n = 196) |
Orteronel Plus Prednisone (n = 265) |
Placebo Plus Prednisone (n = 132) |
Orteronel Plus Prednisone (n = 75) |
Placebo Plus Prednisone (n = 37) |
|||||||
| No. of Patients | % | No. of Patients | % | No. of Patients | % | No. of Patients | % | No. of Patients | % | No. of Patients | % | |
| Age, years | ||||||||||||
| Median | 69.0 | 69.0 | 70.0 | 71.0 | 71.0 | 72.0 | ||||||
| Range | 45-89 | 50-86 | 43-87 | 50-87 | 48-84 | 48-85 | ||||||
| ≥ 70 | 187 | 47 | 92 | 47 | 138 | 52 | 75 | 57 | 42 | 56 | 27 | 73 |
| Race | ||||||||||||
| White* | 388 | 98 | 193 | 98 | 169 | 64 | 79 | 60 | 63 | 84 | 33 | 89 |
| Black/African American | 3 | < 1 | 2 | 1 | 8 | 3 | 5 | 4 | 7 | 9 | 2 | 5 |
| Asian* | 1 | < 1 | 1 | < 1 | 72 | 27 | 46 | 35 | 4 | 5 | 1 | 3 |
| American Indian or Alaskan Native | 0 | 0 | 4 | 2 | 1 | < 1 | 0 | 0 | ||||
| Other/not reported | 2 | < 1 | 0 | 12 | 5 | 1 | < 1 | 1 | 1 | 1 | 3 | |
| Time since initial diagnosis, years* | ||||||||||||
| Median | 5.3 | 5.7 | 5.3 | 5.6 | 7.5 | 7.3 | ||||||
| Range | 0-22 | 0.2-28.8 | 0.1-16.8 | 0.1-20.7 | 1.4-19.6 | 1.6-20 | ||||||
| ECOG PS, %† | ||||||||||||
| 0 | 43 | 43 | 41 | 37 | 35 | 35 | ||||||
| 1 | 49 | 52 | 49 | 52 | 57 | 62 | ||||||
| 2 | 7 | 5 | 11 | 11 | 8 | 3 | ||||||
| BPI-SF worst pain score* | ||||||||||||
| Median | 3.0 | 3.0 | 4.0 | 3.5 | 2.0 | 2.5 | ||||||
| Range | 0-10 | 0-10 | 0-10 | 0-10 | 0-10 | 0-10 | ||||||
| PSA at baseline, ng/mL* | ||||||||||||
| Median | 138.0 | 127.5 | 131.0 | 169.0 | 53.6 | 51.6 | ||||||
| Range | 3-7,992 | 3-9,263 | 1-8,456 | 2-19,009 | 0-3,534 | 1-1,164 | ||||||
| Testosterone at baseline, ng/dL | ||||||||||||
| Median | 4.7 | 5.0 | 4.7 | 3.7 | 4.2 | 4.5 | ||||||
| Range | 0.2-99.9 | 0.2-36.1 | 0.2-99.9 | 0.2-138.9 | 0.3-60.7 | 0.4-19.7 | ||||||
| Gleason score at diagnosis | ||||||||||||
| ≤ 6 | 55 | 14 | 39 | 20 | 37 | 14 | 19 | 14 | 10 | 13 | 4 | 11 |
| 7 | 108 | 27 | 56 | 29 | 82 | 31 | 34 | 26 | 23 | 31 | 15 | 41 |
| 8-10 | 191 | 48 | 81 | 41 | 142 | 54 | 74 | 56 | 39 | 52 | 16 | 43 |
| Unknown/missing | 40 | 10 | 20 | 10 | 4 | 2 | 5 | 4 | 3 | 4 | 2 | 5 |
| Extent of disease at baseline | ||||||||||||
| Bone metastases | 379 | 96 | 184 | 94 | 249 | 94 | 123 | 93 | 71 | 95 | 33 | 89 |
| Lymph node metastases | 185 | 47 | 90 | 46 | 126 | 48 | 60 | 45 | 33 | 44 | 21 | 57 |
| Lung metastases | 44 | 11 | 22 | 11 | 36 | 14 | 12 | 9 | 10 | 13 | 5 | 14 |
| Liver metastases | 37 | 9 | 24 | 12 | 19 | 7 | 17 | 13 | 8 | 11 | 3 | 8 |
| Other metastases/missing | 71 | 18 | 36 | 18 | 38 | 14 | 21 | 16‡ | 15 | 20 | 3 | 8 |
| Visceral disease | 106 | 27 | 55 | 28 | 69 | 26 | 35 | 27 | 22 | 29 | 9 | 24 |
| Prior chemotherapy regimens* | ||||||||||||
| 1 | 325 | 82 | 149 | 76 | 179 | 68 | 87 | 66 | 70 | 93 | 27 | 73 |
| ≥ 2 | 69 | 18 | 46 | 23 | 86 | 32 | 45 | 34 | 5 | 7 | 10 | 27 |
| Prior radiation therapy | 257 | 65 | 118 | 60 | 181 | 68 | 82 | 62 | 52 | 69 | 24 | 65 |
| Prior surgery | 184 | 47 | 96 | 49 | 152 | 57 | 75 | 57 | 54 | 72 | 19 | 51 |
| Prior ADT | 380 | 96 | 185 | 94 | 249 | 94 | 126 | 95 | 73 | 97 | 36 | 97 |
Abbreviations: ADT, androgen-deprivation therapy; BPI-SF, Brief Pain Inventory–Short Form; ECOG PS, Eastern Cooperative Oncology Group performance status; NA, North America; PSA, prostate-specific antigen.
*
Differences in baseline characteristics across regions.
†
Percentages may not add up to 100% because of rounding.
‡
One missing.