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Table 4 Baseline demographic and clinical characteristics of responders and non-responders in the three trials

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

  ALLEGRO BRAVO CONCERTO
  NR
N = 426
R
N = 675
NR
N = 367
R
N = 514
NR
N = 1015
R
N = 441
Mean age (SD), years 37.1 (8.5) 39.7 (9.4) 36.6 (8.8) 37.8 (9.8) 36.0 (8.8) 37.3 (9.7)
Gender, males (%) 299 (70.2) 46 (6.8) 260 (70.8) 20 (3.9) 465 (45.8) 0 (0.0)
Mean number of relapses in the previous year (SD) 1.60 (0.80) 1.03 (0.49) 1.55 (0.75) 1.13 (0.45) 1.44 (0.61) 1.04 (0.20)
Mean disease duration (SD), years 8.22 (6.66) 8.89 (6.87) 6.62 (5.94) 6.92 (6.53) 5.94 (4.23) 5.51 (3.66)
Median EDSS (range) 2.5 (0–5.5) 2.5 (0–6) 3 (0–5.5) 2.5 (0–5.5) 2.5 (0–5.5) 2.5 (0–5.5)
Number of patients with Gd+ baseline scans (%) 159 (37.3) 316 (46.8) 123 (33.5) 197 (38.3) 352 (34.7) 226 (51.3)
Mean T2 lesion volume (SD), log-transformed cm3 1.97 (1.16) 1.53 (1.29) 1.72 (1.35) 1.29 (1.45) 1.68 (1.22) 1.41 (1.19)
Mean T1 lesion volume (SD), log-transformed cm3 0.31 (1.80) −0.33 (1.96) 0.42 (1.76) − 0.27 (1.90) 1.31 (1.31) 0.97 (1.29)
Mean normalized brain volume (SD), cm3 1553.9 (90.5) 1599.5 (90.6) 1547.5 (91.8) 1610 (87.4) 1410.4 (91.5) 1491.7 (68.1)
  1. Data reported as mean (standard deviation) and number (percentage) for continuous and categorical variables, respectively (unless otherwise specified). Characteristics presented in italics are those that present a significant difference between respondent and non-respondent (p < 0.05)
  2. NR non-responders (patients with a response score > − 0.31), R responders (patients with a response score ≤ − 0.31), EDSS Expanded Disability Status Scale, GD+ gadolinium-enhancing