Table 2.
Change in BPH Symptom Score (IPSS) from baseline to long-term follow-up
| Visit | Statistic | NX02-0017 | NX02-0018 | Pooled studies NX02-0017 and NX02-0018 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| FT 2.5 mg | Placebo | p valueb | FT 2.5 mg | Placebo | p valueb | FT 2.5 mg | Placebo | p valueb | ||
| N = 292 | N = 196 | N = 290 | N = 195 | N = 582 | N = 391 | |||||
| Baselinea | n | 292 | 196 | – | 290 | 195 | – | 582 | 391 | – |
| Mean (SD) | 23.3(4.93) | 23.1(5.04) | – | 23.7 (4.98) | 23.2 (5.13) | – | 23.5 (4.96) | 23.2 (5.08) | – | |
| Median | 23.0 | 23.0 | – | 24.0 | 23.0 | – | 23.5 | 23.0 | – | |
| Min–max | 12.0–35.0 | 15.0–35.0 | – | 15.0 to 35.0 | 15.0 to 35.0 | – | 12.0 to 35.0 | 15.0 to 35.0 | – | |
| Change from Baseline (Visit 10) | n | 292 | 196 | – | 290 | 195 | – | 582 | 391 | – |
| Mean (SD) | − 5.3(6.81) | − 6.1(7.35) | – | − 6.6 (6.41) | − 6.3 (6.83) | – | − 6.0 (6.64) | − 6.2 (7.09) | – | |
| Median | − 5.0 | − 5.2 | 0.1871 | − 5.0 | − 6.0 | 0.5402 | − 5.0 | − 5.8 | 0.5760 | |
| Min–max | − 27–9.0 | − 29–14.0 | – | − 26 to 10.0 | − 28 to 9.0 | – | − 27 to 10.0 | − 29 to 14.0 | – | |
| Change from Baseline (Follow-up) | n | 292 | 196 | – | 290 | 195 | – | 582 | 391 | – |
| Mean (SD) | − 5.1(6.23) | − 3.8(5.98) | – | − 6.4 (5.78) | − 4.2 (6.09) | – | − 5.7 (6.05) | − 4.0 (6.03) | – | |
| Median | − 4.0 | − 3.5 | 0.0378 | − 6.3 | − 3.0 | < 0.0001 | − 5.2 | − 3.0 | < 0.0001 | |
| Min–max | − 33–6.0 | − 25 to 16.0 | – | − 25 to 8.0 | − 27 to 13.0 | – | − 33 to 8.0 | − 27 to 16.0 | – | |
N number of patients within the population and treatment group based on the available observations
n number of available observations
aBaseline = Last available value before treatment
bNormality assumption not met and p value was based on non-parametric Wilcoxon rank sum test