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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