| Responders | Non-responders |
---|
Core Study BL | Extension Study BL | Extension Study EP | Core Study BL | Extension Study BL | Extension Study EP |
---|
 |
N
| 31a
| 31b
| 25c
| 112a
| 112b
| 72c
|
PCS score | Mean Score (SD) | 46.4 (11.4) | 47.4 (10.7) | 48.9 (9.9) | 46.6 (10.4) | 46.0 (9.9) | 48.4 (9.3) |
Change from Core BL (SD) | -- | 0.6 (9.6) | 2.7 (6.7) | -- | −0.5 (8.0) | 2.5 (8.3) |
p-value (between group) | -- | 0.239* | 0.643** | -- | -- | -- |
MCS score | Mean Score (SD) | 38.9 (8.6) | 49.6 (11.5) | 48.5 (9.0) | 42.6 (11.6) | 45.6 (11.0) | 46.9 (9.8) |
Change from Core BL (SD) | -- | 11.3 (10.1) | 10.0 (10.1) | -- | 3.0 (11.3) | 5.0 (10.1) |
p-value (between group) | -- | 0.001* | 0.280** | -- | -- | -- |
-
Note: Extension study BL = 6-week follow-up; extension study BL = end of additional 24 weeks of treatment
-
Abbreviations: BL baseline, EP endpoint, NE Not estimable, MCS Mental Component Summary, PCS Physical Component Summary, SD standard deviation, SF-12 Short Form 12
-
aNumber of patients with SF-12 PCS/MCS scores at core study baseline
-
bNumber of patients with SF-12 PCS/MCS scores at both core study baseline and extension study baseline
-
cNumber of patients with SF-12 PCS/MCS scores at both core study baseline and extension study endpoint
- *P-value comparing mean changes in SF-12 PCS/MCS scores from extension study baseline to core study baseline between responders and non-responders
- **P-value comparing mean changes in SF-12 PCS/MCS scores from extension study endpoint to core study baseline between responders and non-responders