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Table 1 Baseline demographic and clinical characteristics of the population enrolled in each of the three clinical trials included in the analysis

From: Defining responders to therapies by a statistical modeling approach applied to randomized clinical trial data

  ALLEGRO
N = 1101
BRAVO
N = 881
CONCERTO
N = 1456
p
Age (SD), years 38.69 (9.14) 37.31 (9.39) 36.37 (9.10) < 0.001
Gender, number of males (%) 345 (31.3) 280 (31.8) 465 (31.9) 0.947
Mean number of relapses in the previous year (SD) 1.25 (0.69) 1.30 (0.63) 1.32 (0.55) 0.018
Mean disease duration (SD), years 8.63 (6.79) 6.80 (6.29) 5.81 (4.07) < 0.001
Median EDSS (range) 2.5 (0.0–6.0) 2.5 (0.0–5.5) 2.5 (0.0–5.5) 0.281
Number of patients with baseline Gd+ scan (%) 475 (43.1) 320 (36.3) 578 (39.7) 0.008
Mean T2 lesion volume (SD) (log-transformed cm3) 1.70 (1.26) 1.47 (1.42) 1.60 (1.22) < 0.001
Mean T1 lesion volume (SD) (log-transformed cm3) −0.09 (1.93) 0.02 (1.87) 1.21 (1.31) < 0.001
Mean normalized brain volume (SD), cm3 1581.8 (93.2) 1584.0 (94.4) 1435.0 (93.0) < 0.001
  1. Data reported as mean (standard deviation) and number (percentage) for continuous and categorical variables, respectively (unless otherwise specified)
  2. EDSS Expanded Disability Status Scale, GD+ gadolinium-enhancing