Table 1.
Baseline Demographics and Patient Characteristics
| Category | Variable | Safety Population | |
|---|---|---|---|
| (n = 1393) | |||
| Age (years) | Mean ± SD | 69.3 ± 8.8 | |
| <75 | 976 | (70.1) | |
| ≥75 | 417 | (29.9) | |
| BPH/LUTS duration (years) | <1 | 439 | (31.5) |
| ≥1–<5 | 518 | (37.2) | |
| ≥5 | 299 | (21.5) | |
| Unknown | 137 | (9.8) | |
| eGFR stage | G1 (≥90) | 52 | (3.7) |
| G2 (≥60–<90) | 410 | (29.4) | |
| G3a (≥45–<60) | 138 | (9.9) | |
| G3b (≥30–<45) | 34 | (2.4) | |
| G4 (≥15–<30) | 3 | (0.2) | |
| Not tested | 756 | (54.3) | |
| Prostate volume (cm3) | <20 | 160 | (11.5) |
| ≥20–<30 | 382 | (27.4) | |
| ≥30–<40 | 324 | (23.3) | |
| ≥40–<50 | 155 | (11.1) | |
| ≥50–<60 | 84 | (6.0) | |
| ≥60 | 113 | (8.1) | |
| Not tested | 175 | (12.6) | |
| Prostate specific antigen (ng/mL) | <4 | 691 | (49.6) |
| ≥4–<10 | 169 | (12.1) | |
| ≥10 | 28 | (2.0) | |
| Not tested | 505 | (36.3) | |
| BPH/LUTS severity (total IPSS) | Mild (≤7) | 131 | (9.4) |
| Moderate (8–19) | 674 | (48.4) | |
| Severe (20–35) | 351 | (25.2) | |
| Not tested | 237 | (17.0) | |
Note: Values are presented as mean ± standard deviation or number (%).
Abbreviations: BPH/LUTS, lower urinary tract symptoms secondary to benign prostatic hyperplasia; eGFR, estimated glomerular filtration rate; IPSS, International Prostate Symptom Score; SD, standard deviation.