Table 1 Description of cohort, sample sizes and clinical data used in the study.
Baseline analysis set | Follow up analysis set | Full analysis set | |
|---|---|---|---|
(N = 231) | (N = 72) | (N = 305) | |
Age (years) | |||
Median (IQR) | 56 (46.5 to 63) | 56.5 (47 to 61) | 56 (47 to 63) |
Mean (SD) | 53.2 (12.2) | 53.5 (11.3) | 53.4 (12) |
Race | |||
American indian or alaska native | 1/231 (0.4%) | 0/72 (0%) | 1/305 (0.3%) |
Asian | 25/231 (10.8%) | 8/72 (11.1%) | 38/305 (12.5%) |
Black or african american | 2/231 (0.9%) | 0/72 (0%) | 4/305 (1.3%) |
Native hawaiian or other pacific islander | 1/231 (0.4%) | 0/72 (0%) | 1/305 (0.3%) |
Not reported | 9/231 (3.9%) | 3/72 (4.2%) | 9/305 (3%) |
White | 193/231 (83.5%) | 61/72 (84.7%) | 252/305 (82.6%) |
Ethnicity | |||
Hispanic or latino | 39/231 (16.9%) | 16/72 (22.2%) | 54/305 (17.7%) |
Not hispanic or latino | 191/231 (82.7%) | 56/72 (77.8%) | 249/305 (81.6%) |
Not reported | 1/231 (0.4%) | 0/72 (0%) | 2/305 (0.7%) |
Sex | |||
F | 125/231 (54.1%) | 41/72 (56.9%) | 171/305 (56.1%) |
M | 106/231 (45.9%) | 31/72 (43.1%) | 134/305 (43.9%) |
Randomization | |||
PF-05221304 10 mg | 53/231 (22.9%) | 0/72 (0%) | 62/305 (20.3%) |
PF-05221304 2 mg | 50/231 (21.6%) | 0/72 (0%) | 63/305 (20.7%) |
PF-05221304 25 mg | 42/231 (18.2%) | 32/72 (44.4%) | 58/305 (19%) |
PF-05221304 50 mg | 40/231 (17.3%) | 0/72 (0%) | 61/305 (20%) |
Placebo | 46/231 (19.9%) | 40/72 (55.6%) | 61/305 (20%) |
Diabetes status | |||
Non-T2DM | 137/231 (59.3%) | 39/72 (54.2%) | 181/305 (59.3%) |
T2DM | 94/231 (40.7%) | 33/72 (45.8%) | 124/305 (40.7%) |
NASH status | |||
Subjects with biopsy-proven or presumed NASH | 171/231 (74%) | 51/72 (70.8%) | 208/305 (68.2%) |
Subjects with NAFLD with minimal inflammation/fibrosis | 60/231 (26%) | 21/72 (29.2%) | 97/305 (31.8%) |
