Table 1 Baseline patient characteristics
From: Validation of NASH-CHECK: a novel patient-reported outcome measure for nonalcoholic steatohepatitis
Baseline characteristics | Part B sample (n = 104) | Part C sample (n = 149) | Combined Part B and Part C sample (n = 253) |
|---|---|---|---|
Gender, n (%) | |||
Male | 47 (45.2) | 52 (34.9) | 99 (39.1) |
Female | 57 (54.8) | 97 (65.1) | 154 (60.9) |
Age, years | |||
Mean (SD), min–max | 51.2 (12.7), 19.0–79.0 | 54.9 (10.9), 25.0–79.0 | 53.4 (11.8), 19.0–79.0 |
Race, n (%) | |||
Caucasian | 60 (58.3) | 111 (74.5) | 171 (67.9) |
Not Caucasian | 43 (41.7) | 38 (25.5) | 81 (32.1) |
Ethnicity, n (%) | |||
Hispanic or Latino | 22 (25.3) | 48 (36.9) | 70 (32.3) |
Not Hispanic or Latino | 65 (74.7) | 82 (63.1) | 147 (67.7) |
BMI | |||
Mean (SD), min–max | 32.5 (6.1), 20.9–49.3 | 34.9 (6.1), 24.0–53.4 | 33.9 (6.2), 20.9–53.4 |
T2DM, n (%) | |||
Yes | 68 (65.4) | 85 (58.6) | 153 (61.4) |
No | 36 (34.6) | 60 (41.4) | 96 (38.6) |
Liver biopsy fibrosis grade, n (%) | |||
F2 | − | 63 (42.3) | 63 (42.3) |
F3 | − | 86 (57.7) | 86 (57.7) |
Additional clinical assessments, Mean (SD), min–max | |||
NAFLD fibrosis score | − 1.3 (1.4), − 5.4–1.2 | − 0.7 (1.2), − 4.2–1.7 | − 0.9 (1.3), − 5.4–1.7 |
ELF score | 9.4 (1.1), 3.3–11.7 | 9.9 (0.9), 8.2–13.1 | 9.7 (1.0), 3.3–13.1 |
NAS | 4.6 (1.3), 1.0–7.0 | 6.0 (0.6), 4.0–7.0 | 5.6 (1.0), 1.0–7.0 |
ALT level, U/L | 79.9 (41.1), 25.0–248.0 | 70.3 (38.7), 26.0–275.0 | 74.2 (39.9), 25.0–275.0 |
AST level, U/L | 57.5 (32.6), 16.5–224.0 | 56.2 (28.2), 21.0–227.5 | 56.7 (30.0), 16.5–227.5 |
GGT level, U/L | 73.3 (58.0), 12.0–385.0 | 67.4 (49.6), 15.5–400.5 | 69.8 (53.2), 12.0–400.5 |
Hepatic fat a | 20.0 (6.9), 10.2–36.7 | 18.9 (7.1), 10.2–42.8 | 19.3 (7.0), 10.2–42.8 |