Table 3.
Dataset | Measurement | 33% reduction | 50% reduction | 90% reduction |
---|---|---|---|---|
RRMS1 | GMV | 328 | 147 | 46 |
WMV | 3859 | 1712 | 527 | |
BPV | 603 | 269 | 84 | |
RRMS2 | GMV | 1127 | 503 | 157 |
WMV | 18944 | 8425 | 2605 | |
BPV | 724 | 323 | 100 | |
RRMS3 | GMV | 419 | 187 | 59 |
WMV | 1414 | 627 | 193 | |
BPV | 2391 | 1064 | 329 |
Each sample size calculation assumes a 1:1 allocation of patients to treatment and placebo, 80% power and a two sided significance level of 0.05. Sample sizes are totals for both arms.
BPV, brain parenchymal volume; GMV, gray matter volume; RRMS, relapsing–remitting multiple sclerosis; RRMS1, untreated cohort of RRMS patients observed monthly for 9 months14; RRMS2, untreated cohort of RRMS patients observed every 3 months for 1.5 years17; RRMS3, treated cohort of RRMS patients observed monthly for 9 months14; WMV, white matter volume.