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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