Table 2 Baseline characteristics for patients with at least one SRE during AFFIRM and PREVAIL
Characteristic | PREVAIL (n=587) | AFFIRM (n=421) |
|---|---|---|
Mean (s.d.) age (years) | 70.0 (8.7) | 67.7 (8.3) |
Geographic region, n (%) | ||
Europe | 303 (51.6) | 238 (56.5) |
North America | 162 (27.6) | 140 (33.3) |
Rest of world | 122 (20.8) | 43 (10.2) |
Pain average score, n (%)a | ||
0–1 | 346 (58.9) | 53 (12.6) |
2–3 | 229 (39.0) | 162 (38.5) |
>3 | 9 (1.5) | 157 (37.3) |
Missing | 3 (0.5) | 49 (11.6) |
Fatigue severity, n (%)b | ||
<7 | 525 (92.3) | 296 (70.3) |
⩾7 | 44 (7.7) | 107 (25.4) |
Missing | 0 | 18 (4.3) |
ECOG performance status, n (%) | ||
0 | 195 (33.2) | 131 (31.1) |
1 | 392 (66.8) | 244 (58.0) |
2 | 0 | 46 (10.9) |
Mean (s.d.) time from initial prostate cancer diagnosis to randomization (months) | 71.1 (53.6) | 78.0 (53.4) |
No. of prior chemotherapies, n (%) | ||
1 | NA | 313 (74.3) |
⩾2 | NA | 108 (25.7) |
No. of unique prior hormonal therapies, n (%)c | ||
None | 2 (0.3) | 0 |
1 | 66 (11.2) | 36 (8.6) |
2 | 269 (45.8) | 176 (41.8) |
3 | 161 (27.4) | 123 (29.2) |
⩾4 | 89 (15.2) | 84 (20.0) |
Missing | 0 | 2 (0.5) |
Distant metastasis (M) at diagnosis, n (%) | ||
Mx | 53 (9.0) | 59 (14.0) |
M0 | 282 (48.0) | 151 (25.9) |
M1 | 178 (30.3) | 112 (26.6) |
Unknown | 74 (12.6) | 99 (23.5) |
Disease localization at screening, n (%) | ||
None | 0 | 2 (0.5) |
Bone only | 246 (41.9) | 120 (28.5) |
Soft tissue only | 44 (7.5) | 12 (2.9) |
Both bone and soft tissue | 297 (50.6) | 287 (68.2) |
Visceral disease at screening, n (%) | ||
No | 516 (87.9) | 336 (79.8) |
Yes | 71 (12.1) | 85 (20.2) |
