Table 4.
IPSS, total at each visit and change from baseline in the FAS population after stratification according to age and severity of symptoms
| Age group (years) |
Severity of symptoms |
||||
|---|---|---|---|---|---|
| ≤64 | 65–74 | ≥75 | IPSS < 20 | IPSS ≥ 20 | |
| Baseline | |||||
| N | 509 | 404 | 208 | 704 | 418 |
| Mean (SD) | 17.7 (6.1) | 18.3 (7.0) | 18.1 (6.8) | 13.8 (3.3) | 25.2 (4.1) |
| 3 months | |||||
| N | 505 | 397 | 206 | 695 | 413 |
| Mean (SD) | 13.0 (6.7) | 13.9 (7.0) | 14.3 (7.4) | 11.2 (5.5) | 17.5 (7.3) |
| Change from baseline at 3 months | |||||
| N | 505 | 397 | 1108 | 695 | 413 |
| Mean (SD) | −4.7 (6.4) | −4.5 (7.3) | −3.9 (7.1) | −2.6 (5.6) | −7.7 (7.5) |
| P∗ | <0.01 | <0.01 | <0.01 | <0.01 | <0.01 |
| 6 months | |||||
| N | 392 | 332 | 163 | 571 | 316 |
| Mean (SD) | 12.5 (7.0) | 13.1 (7.3) | 13.0 (7.2) | 11.2 (6.2) | 15.7 (7.9) |
| Change from baseline at 6 months | |||||
| N | 392 | 332 | 163 | 571 | 316 |
| Mean (SD) | −5.0 (7.1) | −5.0 (8.2) | −5.0 (7.8) | −2.6 (6.4) | −9.4 (7.7) |
| P∗ | <0.01 | <0.01 | <0.01 | <0.01 | <0.01 |
FAS, full analysis set; IPSS, international prostate symptom score.
∗
Paired t test.