Table 6.
Estimated changes from baseline in patient-reported outcomes by treatment arm
| Variable | Placebo | 1 mg/day | 5 mg/day | 15 mg/day | P value (5 mg/day vs Placebo) | P value (any effect) |
|---|---|---|---|---|---|---|
| IPSS | ||||||
| Symptom | −0.07 (−1.01, 0.87) | −1.48 (−2.59, −0.38) | 0.08 (−0.82, 0.99) | 0.13 (−1.31, 1.57) | 0.80 | 0.10 |
| Quality of Life Due to Urinary Symptoms | −0.02 (−0.25, 0.21) | −0.22 (−049, 0.06) | −0.02 (−0.25, 0.20) | −0.17 (−0.53, 0.18) | 0.99 | 0.58 |
| FACIT-F | −0.74 (−2.89, 1.41) | 1.52 (−0.98, 4.03) | −0.11 (−2.17, 1.95) | 0.47 (−2.83, 3.77) | 0.66 | 0.54 |
| PANAS | ||||||
| Positive Affect | 0.79 (−1.12, 2.70) | 0.57 (−1.63, 2.78) | 1.15 (−0.66, 2.95) | −0.45 (−3.36, 2.46) | 0.78 | 0.83 |
| Negative Affect | −1.52 (−2.62, −0.42) | −1.78 (−3.06, −0.50) | −0.14 (−1.19, 0.91) | −2.19 (−3.90, −0.49) | 0.06 | 0.08 |