Table 4.
Random slopes model results for ALSFRS-R, ALSSQOL-SF, FVC in the OLE period.
| Slope change Points/Month |
Randomisation to Week 48 (12-weeks post OLE Baseline) | 24 Weeks post OLE baseline (Week 60 to Week 120) |
|---|---|---|
| ALSFRS-R Random Slopes Model | ||
| Original Active | −0.796 | −0.447 |
| Original Placebo | −1.166 | −0.843 |
| Slope Difference (SE) | 0.364 (0.149) | 0.397 (0.139) |
| 95% CI of Slope Difference | 0.070 to 0.659 | 0.119 to 0.674 |
| Period Ending Difference (Active Less Placebo) | 2.6 | 6.0 |
| p-value | 0.0159 | 0.0057 |
| FVC (% predicted) Random Slopes Model | ||
| Original Active | −2.05 | −2.2 |
| Original Placebo | −2.05 | −2.2 |
| Slope Difference (SE) | 0 | 0 |
| 95% CI of Slope Difference | NA | NA |
| Period Ending Difference (Active Less Placebo) | 6.9 | 5.3 |
| p-value | NS | NS |
| ALSSQOL-SF Random Slopes Model | ||
| Original Active | −0.010 | 0.124 |
| Original Placebo | −0.136 | −0.006 |
| Slope Difference (SE) | 0.127 (0.035) | 0.119 (0.037) |
| 95% CI of Slope Difference | 0.057 to 0.196 | 0.045 to 0.192 |
| Period Ending Difference (Active Less Placebo) | 1.0 | 2.9 |
| p-value | 0.0004 | 0.0018 |
The random slope models incorporated covariates including delta-FS, time from symptom onset, treatment assignment, and time (days). Backward selection was used to minimise the Akaike information criterion (AIC) to determine final model terms.