Table 2.
Baseline demographics and disease characteristics in the completer and non-completer subgroups of TRANSFORMS and of the combined FREEDOMS populations.
| TRANSFORMS | FREEDOMS and FREEDOMS II combined | |||
|---|---|---|---|---|
| CS (n = 544) | NCS (n = 736) | CS (n = 505) | NCS (n = 1051) | |
| Participant demographics | ||||
| Women, n (%) | 354 (65.1) | 507 (68.9) | 357 (70.7) | 800 (76.1) |
| p value a | 0.151 | 0.022 | ||
| Age, years | ||||
| Mean ± SD | 35.9 ± 8.16 | 36.3 ± 8.76 | 37.9 ± 8.39 | 38.8 ± 8.87 |
| Median (range) | 36 (18–55) | 37 (18–55) | 38 (18–55) | 39 (18–55) |
| p value a | 0.424 | 0.064 | ||
| Prior MS treatment, n (%) | ||||
| Yes | 294 (54.0) | 451 (61.3) | 215 (42.6) | 658 (62.6) |
| p value a | 0.01 | <0.0001 | ||
| Duration of MS since first symptom, years | ||||
| Mean ± SD | 7.2 ± 5.97 | 7.5 ± 6.31 | 8.3 ± 6.71 | 9.6 ± 7.50 |
| Median (range) | 5.8 (0–33) | 6.0 (0–40) | 6.7 (0–32) | 7.9 (0–49) |
| p value a | 0.577 | 0.001 | ||
| Clinical disease characteristics | ||||
| Relapses in the 2 years before baseline, n | ||||
| Mean ± SD | 2.2 ± 1.99 | 2.3 ± 1.25 | 2.1 ± 1.20 | 2.2 ± 1.34 |
| Median (range) | 2 (1–40) | 2 (1–12) | 2 (1–11) | 2 (1–14) |
| p value a | 0.266 | 0.976 | ||
| EDSS score | ||||
| Mean ± SD | 2.10 ± 1.275 | 2.29 ± 1.311 | 2.31 ± 1.205 | 2.43 ± 1.346 |
| Median (range) | 2.00 (0.0–5.5) | 2.00 (0.0–5.5) | 2.00 (0.0–5.5) | 2.00 (0.0–6.5) |
| p value a | 0.008 | 0.068 | ||
| MRI disease characteristics | ||||
| Gadolinium-enhancing lesions, n | ||||
| Mean ± SD | 1.0 ± 3.54 | 1.3 ± 3.60 | 1.3 ± 3.19 | 1.4 ± 4.30 |
| Median (range) | 0.0 (0–66) | 0.0 (0–36) | 0.0 (0–37) | 0.0 (0–84) |
| p value a | 0.468 | 0.672 | ||
| T2 lesion volume, mm3 | ||||
| Mean ± SD | 4806.5 ± 5847.24 | 5253.2 ± 6322.96 | 6115.5 ± 7537.45 | 5710.2 ± 7646.82 |
| Median (range) | 2640.7 (0–46 020) | 2932.7 (0–46 280) | 3136.0 (0–47 148) | 2941.4 (0–69 203) |
| p value a | 0.333 | 0.065 | ||
| Normalized brain volume, cm3 | ||||
| Mean ± SD | 1527.8 ± 71.30 | 1524.3 ± 85.19 | 1520.6 ± 80.83 | 1519.9 ± 85.85 |
| Median (range) | 1533.4 (1245–1716) | 1526.7 (1185–1862) | 1525.6 (1171–1733) | 1527.7 (1144–1756) |
| p value a | 0.397 | 0.291 | ||
CS: completer subgroup; EDSS: Expanded Disability Status Scale; NCS: non-completer subgroup; SD: standard deviation.
a
Comparison of the completer and non-completer subgroups. p values for binary outcomes were obtained using a chi-square test; p values for ordinal outcomes were obtained using a Mantel–Haenszel chi-square test; p values for quantitative variables were obtained using a Wilcoxon rank-sum test.