Population | n | Mean years | Mean | EDSS | Utility | |||
At risk | On treatment | Baseline EDSS | Absolute treatment effect | Relative rate of progression | Absolute treatment effect | Relative rate of progression | ||
Primary analysis population | 4862 | 8.7 | 7.0 | 3.18 | 0.12 (0.07, 0.17) | 93% (90%, 96%) | 0.039 (0.034, 0.044) | 76% (73%, 79%) |
One-way analyses | ||||||||
On treatment throughout | 2855 | 8.7 | 8.7 | 3.02 | 0.46 (0.39, 0.53) | 73% (69%, 77%) | 0.073 (0.067, 0.079) | 55% (51%, 58%) |
Ever off-treatment | 2007 | 8.8 | 4.6 | 3.40 | −0.36 (−0.44, −0.28) | 123% (118%, 128%) | −0.010 (−0.018, −0.001) | 106% (101%, 111%) |
By gender | ||||||||
Male | 1224 | 8.6 | 6.8 | 3.19 | −0.12 (−0.23, 0.00) | 107% (100%, 114%) | 0.013 (0.002, 0.024) | 92% (85%, 99%) |
Female | 3638 | 8.8 | 7.0 | 3.17 | 0.20 (0.14, 0.26) | 88% (84%, 92%) | 0.048 (0.042, 0.053) | 71% (67%, 74%) |
Baseline at or before 28 February 2003 | 997 | 8.7 | 7.0 | 3.35 | 0.03 (−0.09, 0.14) | 98% (91%, 106%) | 0.035 (0.024, 0.046) | 78% (71%, 85%) |
Baseline after 28 February 2003 | 3865 | 8.8 | 7.0 | 3.13 | 0.14 (0.09, 0.20) | 91% (88%, 95%) | 0.040 (0.034, 0.045) | 75% (72%, 79%) |
Baseline at or before 31 August 2003 | 2351 | 8.7 | 6.9 | 3.32 | 0.02 (−0.06, 0.10) | 99% (94%, 103%) | 0.033 (0.025, 0.040) | 79% (75%, 84%) |
Baseline after 31 August 2003 | 2511 | 8.8 | 7.0 | 3.05 | 0.21 (0.14, 0.29) | 88% (83%, 92%) | 0.044 (0.037, 0.052) | 73% (69%, 77%) |
Disease duration at baseline | ||||||||
≤3 years | 1251 | 8.8 | 7.3 | 2.46 | 0.45 (0.33, 0.57) | 77% (71%, 83%) | 0.060 (0.050, 0.070) | 65% (59%, 71%) |
>3 years | 3611 | 8.7 | 6.9 | 3.43 | 0.00 (−0.05, 0.06) | 100% (96%, 103%) | 0.032 (0.026, 0.037) | 80% (76%, 84%) |
≤6 years | 2295 | 8.8 | 7.2 | 2.67 | 0.32 (0.24, 0.40) | 83% (78%, 87%) | 0.051 (0.043, 0.058) | 70% (65%, 74%) |
>6 years | 2567 | 8.7 | 6.8 | 3.64 | −0.06 (−0.12, 0.01) | 104% (99%, 108%) | 0.028 (0.022, 0.035) | 82% (78%, 86%) |
Two-way analyses | ||||||||
Disease duration ≤3 years and: | ||||||||
Baseline EDSS ≤3.5 | 981 | 8.9 | 7.5 | 1.80 | 0.60 (0.47, 0.73) | 73% (67%, 79%) | 0.068 (0.058, 0.079) | 61% (55%, 67%) |
Baseline EDSS 4–5.5 | 199 | 8.4 | 6.7 | 4.41 | 0.00 (−0.29, 0.28) | 100% (74%, 127%) | 0.039 (0.009, 0.068) | 74% (56%, 94%) |
Baseline ≥EDSS 6 | 71 | 8.0 | 5.7 | 6 | −0.35 (−0.76, 0.05) | 209% (83%, 338%) | 0.001 (−0.050, 0.051) | 100% (65%, 135%) |
Disease duration >3 years and: | ||||||||
Baseline EDSS ≤3.5 | 1959 | 9.0 | 7.4 | 2.12 | 0.23 (0.14, 0.31) | 90% (85%, 94%) | 0.044 (0.036, 0.051) | 73% (69%, 78%) |
Baseline EDSS 4–5.5 | 1076 | 8.6 | 6.7 | 4.43 | −0.14 (−0.23, −0.04) | 112% (104%, 121%) | 0.038 (0.027, 0.048) | 76% (69%, 82%) |
Baseline ≥EDSS 6 | 576 | 8.0 | 5.4 | 6 | −0.48 (−0.59, −0.37) | 236% (204%, 268%) | −0.021 (−0.038, −0.004) | 114% (103%, 125%) |
EDSS, Expanded Disability Status Scale.