MS-SMART required sample size/arm by treatment effect size, significance level and statistical power
| MRI measurement times | Baseline–96 weeks | |||
| Two-sided significance level | 0.0167 | 0.05 | ||
| Statistical power (%) | 80 | 90 | 80 | 90 |
| Treatment effect: | 123 | 158 | 92 | 123 |
| 30% | ||||
| 35% | 90 | 116 | 68 | 91 |
| 40% | 69 | 89 | 52 | 70 |
Treatment effect will be expressed as relative mean difference in PBVC under treatment. PBVC assessed using the SIENA registration-based method.
MS-SMART, Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial; PBVC, percentage of brain volume change; SIENA, Structural Image Evaluation, using Normalisation of Atrophy.