Disease progression data for the total cohort (n=313). Comparisons of Kaplan-Meier analyses of “confirmed“ v “sustained“ progression end points, with (A) EDSS point progression and (B) worsening to EDSS 6.0
(A) EDSS point increase | Confirmed progression | Sustained progression | Log rank p value | Positive prediction of confirmed for sustained | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
c(10%) | S(1y) | n (%) | c(10%) | S(1y) | n (%) | ||||||
+1.0-point 3 months | 274 | 0.83 | 101 (32%) | 456 | 0.91 | 48 (15%) | <0.0001 | 0.48 | |||
+1.0-point 6 months | 457 | 0.94 | 67 (21%) | 547 | 0.95 | 44 (14%) | 0.024 | 0.67 | |||
+2.0-points 3 months | 548 | 0.94 | 38 (12%) | NR | 0.97 | 20 (6%) | 0.018 | 0.53 | |||
+2.0-points 6 months | NR | 0.98 | 29 (9%) | NR | 0.98 | 16 (5%) | 0.084 | 0.55 | |||
(B) Worsening to EDSS 6.0 | Confirmed progression | Sustained progression |
Log rank p value | Positive prediction of confirmed for sustained | |||||||
c(5%) | S(1y) | n (%) | c(5%) | S(1y) | n (%) | ||||||
3 months | 526 | 0.96 | 24 (8%) | 637 | 0.97 | 17 (5%) | 0.265 | 0.71 | |||
6 months | 729 | 0.98 | 17 (5%) | NR | 0.98 | 12 (4%) | 0.562 | 0.71 | |||
9 months | NR | 0.99 | 12 (4%) | NR | 0.99 | 10 (3%) | 0.669 | 0.83 | |||
12 months | NR | 1 | 10 (3%) | NR | 1 | 9 (3%) | 1 | 0.90 |
c=Centiles (days); S(1y)=cumulative survival probability at 1 year; n=number (and %) of patients reaching end point; NR=end point not reached.