Table 3.
Mean Change and the Difference (ONO‐4474 − Placebo) in Mean Change From Baseline to Week 4 in VAS24, WOMAC, and PGA Scales
| ONO‐4474 | Placebo | |
|---|---|---|
| VAS24, mm | ||
| N | 49 | 50 |
| Posterior mean change (posterior SD) | −25.5 (3.1) | −19.8 (3.1) |
| Difference in posterior mean change (posterior SD) | −5.8 (4.4) | |
| 95%CI for difference in posterior mean | −14.3 to 2.8 | |
| Bayesian posterior probability with the difference <0 mm | 90.6% | |
| Bayesian posterior probability with the difference <−8.2 mm | 29.2% | |
| WOMAC, mm | ||
| N | 50 | 51 |
| LS mean change (SD) | −20.4 (2.4) | −16.8 (2.5) |
| Difference in LS mean change (SD) | −3.6 (3.5) | |
| 95%CI for difference in LS mean change | −10.5 to 3.3 | |
| WOMAC (pain), mm | ||
| N | 50 | 51 |
| LS mean change (SD) | −22.4 (2.7) | −18.3 (2.7) |
| Difference in LS mean change (SD) | −4.1 (3.8) | |
| 95%CI for difference in LS mean change | −11.7 to 3.5 | |
| PGA, mm | ||
| N | 50 | 52 |
| LS mean change (SD) | −27.9 (3.2) | −21.4 (3.2) |
| Difference in LS mean change (SD) | −6.4 (4.5) | |
| 95%CI for difference in LS mean change | −15.4 to 2.6 | |
CI, confidence interval; LS, least squares; PGA, Patient Global Assessment; SD, standard deviation; VAS24, visual analog scale over 24 hours; WOMAC, Western Ontario and McMaster Universities OA Index.
Covariance analysis was performed for repeated measures data with treatment groups, time points, and the interaction between time points and treatment groups as factors, and baseline values as the covariate. Nonstructural covariance was assumed for correlation among repeated measures data.