Table 1.
Characteristics of patients
| SAF population (n = 1219) | FAS population (n = 1121) | |
|---|---|---|
| Age (years) | ||
| N | 1219 | 1121 |
| Mean (SD) | 65.7 (9.2) | 65.7 (9.2) |
| Age | ||
| <65, n (%) | 559 (45.9) | 509 (45.4) |
| 65–75, n (%) | 433 (35.5) | 404 (36.0) |
| ≥75, n (%) | 227 (18.6) | 208 (18.6) |
| BMI (kg/m2) | ||
| N | 812 | 751 |
| Mean (SD) | 24.4 (2.7) | 24.4 (2.7) |
| Current drinking | ||
| Yes, n (%) | 419 (34.4) | 384 (34.3) |
| No, n (%) | 491 (40.3) | 454 (40.5) |
| Unknown, n (%) | 309 (25.3) | 283 (25.2) |
| Current smoking | ||
| Yes, n (%) | 203 (16.7) | 190 (16.9) |
| No, n (%) | 699 (57.3) | 640 (57.1) |
| Unknown, n (%) | 317 (26.0) | 291 (26.0) |
| IPSS, total | ||
| N | 1219 | 1121 |
| Mean (SD) | 18.1 (6.6) | 18.0 (6.6) |
| IPSS, storage symptoms | ||
| N | 1219 | 1121 |
| Mean (SD) | 10.9 (4.7) | 10.8 (4.7) |
| IPSS, voiding symptoms | ||
| N | 1219 | 1121 |
| Mean (SD) | 7.2 (3.3) | 7.2 (3.3) |
| IPSS, QoL | ||
| N | 1218 | 1120 |
| Mean (SD) | 3.8 (1.1) | 3.8 (1.1) |
| Severity of symptoms | ||
| IPSS total score <20, n (%) | 758 (62.2) | 704 (62.8) |
| IPSS total score ≥20, n (%) | 461 (37.8) | 417 (37.2) |
| Number of voids, nocturnal | ||
| <2, n (%) | 337 (27.6) | 304 (27.1) |
| ≥2, n (%) | 882 (72.4) | 817 (72.9) |
BMI, body mass index; FAS, full analysis set; IPSS, international prostate symptom score; SAF, safety population.