8 experienced clinical decompensation compared to 16 (67%) of 23

8 experienced clinical decompensation compared to 16 (6.7%) of 238 with baseline AST/ALT ratio ≤0.8 (Table 2). Within each stratum of baseline AST/ALT ratio, patients who had severe worsening (>15% increase between month 24 and baseline) had a higher rate of clinical decompensation. The cumulative incidence of clinical decompensation at 3, 5, and 7 years is shown in Supporting Table 2C. Forty-eight (18.3%) of 263 patients

with baseline total bilirubin >0.7 mg/dL experienced clinical decompensation compared to 12 (5.8%) of 207 with baseline total bilirubin ≤0.7 mg/dL (Table 2). Within each stratum of baseline total bilirubin, patients who had severe worsening (>15% increase between month 24 and baseline) had a

higher rate of clinical decompensation. The cumulative incidence of clinical decompensation at 3, 5, and 7 years is shown in Supporting Table 2C. Forty-three (16.5%) of 261 patients with baseline albumin see more ≤3.9 mg/dL experienced clinical decompensation compared to 17 (8.1%) of 209 with baseline albumin >3.9 mg/dL (Table 2). Within each stratum GDC-0449 clinical trial of baseline albumin, patients who had severe worsening (>15% decrease between month 24 and baseline) had a higher rate of clinical decompensation. The cumulative incidence of clinical decompensation at 3, 5, and 7 years is shown in Supporting Table 2C. A multivariate model including baseline platelet count, AST/ALT ratio, bilirubin, and albumin (Model IA) showed that each of these four baseline laboratory values independently predicted the occurrence of clinical decompensation (Table 3A). A model including changes in values of these four laboratory tests between month 24 and baseline (Model IIA) found that severe worsening (>15% change) but not mild worsening (5%-15% change) of platelet count, bilirubin, as well as albumin were independent predictors of clinical

decompensation, whereas changes in 上海皓元医药股份有限公司 AST/ALT ratio were not. Inclusion of both baseline laboratory values and changes in laboratory values (Model IIIA) showed that baseline platelet, AST/ALT ratio, and bilirubin; and severe worsening of platelet count, bilirubin, and albumin were independent predictors of clinical decompensation. Model IIIA has the lowest AIC (621), indicating that it has a better fit than Model IA (AIC: 651) and Model IIA (AIC: 655). Addition of age, gender, and race did not improve the fit of any of these models. The duration of follow-up was similar among the three categories of change for each variable irrespective of whether the variable was normal or abnormal at baseline and did not impact the accuracy of the model. To address the issue whether a longer observation period would have any effect on the accuracy of the model, we used change in laboratory values from baseline to month 48 (Table 2B), and compared the results with those obtained using change in laboratory values from baseline to month 24.