EDSS score trends over time by treatment group in TRANSFORMS (a) FAS, (b) CS, and in the FREEDOMS/FREEDOMS II populations (c) FAS, (d) CS.
CS: completer subgroup; EDSS: Expanded Disability Status Scale; FAS: full analysis set; IFNβ-1a: interferon beta-1a.
Comparisons were made using the Mantel–Haenszel χ2 test for trends.
Improving: decreases of ⩾1.0 or ⩾0.5 points from baseline EDSS score if baseline ⩽5.0 or >5.0, respectively, assessed at a scheduled or unscheduled visit, confirmed at 6 months at a scheduled visit in the absence of relapses.
Worsening: increases of ⩾1.0 or ⩾0.5 points from baseline EDSS score if baseline ⩽5.0 or >5.0, respectively, assessed at a scheduled or unscheduled visit, confirmed at 6 months at a scheduled visit in the absence of relapses.
Stable: increases or decreases of 0.5 points from baseline EDSS score if baseline score ⩽5.5, or no change in score if baseline score >5.5.
Fluctuating: all other EDSS patterns not meeting any other definitions.