22 Multivariable logistic regression analysis for transplant-free

survival was performed on selected baseline variables from the univariate analyses, continuous variables were assessed for linearity in the log-odds with the Loess procedure, and analysis for interaction Regorafenib and colinearity was done for all covariates. The final multivariable model was assessed using the Hosmer-Lemeshow goodness-of-fit test. Statistical significance was defined as a two-sided P < 0.05. Analyses were performed using SAS (version 9.1.03; SAS Institute, Inc., Cary, NC). Of the 1198 ALF subjects, 136 were considered by the site investigator to have DILI; three subjects were subsequently rejected as “indeterminate” cases, leaving 133 (11.1%). Overall, 94 (70.6%) of the DILI ALF patients were women.

The average age of the DILI subjects was 43.8 years ± 14.1 SD (range, 17-73 years). Twenty (15.0%) subjects were ≥60 years, Vemurafenib cell line and eight (6.0%) were ≥65 years. A positive alcohol history was obtained in 38 subjects but quantification was only possible in 18, of whom eight admitted to using ≥30 g daily. One patient had chronic hepatitis B and four were treated for human immunodeficiency virus (HIV) infection. The racial/ethnic makeup of the 133 subjects was: white 76 (57.1%); African American 21 (15.8%); Hispanic 20 (15.0%); and 16 (12.0%) others (Supporting Table 1) On average, the subjects were overweight (median body mass index [BMI], 28.7 kg/m2; IQR, 24.6-32.8), 43.4% seriously so (BMI ≥ 30), and 17.9% were obese (BMI ≥ 35). At enrollment, shock was uncommon and only 19 (14.2%) subjects had a mean arterial

pressure ≤70 mm Hg. The average coma grade was 2.2 ± 1.1; more than two-thirds of the subjects (91; 68.4%) had advanced coma (grade ≥ 2). Peripheral MCE edema was common (43.4% subjects); clinically-detectable ascites was observed in 24.6% of subjects, and deep jaundice was typical. Laboratory results at enrollment (Supporting Table 2A,B) were widely dispersed. There was mild leukocytosis (mean white blood count, 13.5 × 106/μL). White-cell differential counts were recorded in 93 subjects; eight (8.6%) had a relative eosinophilia (≥5%) and 10 (10.8%) had an absolute eosinophilia (≥400/μL). Mean bilirubin was 20.8 mg/dL ± 11.5, but aspartate aminotransferase and ALT were only moderately elevated (medians 551 IU/L and 574 IU/L, respectively). Alkaline phosphatase elevations were modest, albumin was moderately depressed (median, 2.4 g/dL; IQR, 2.1-2.7), and INR was substantially deranged (median, 2.6; IQR, 1.9-4.1). Overall, renal function appeared intact (median creatinine 1.2 mg/dL; IQR, 0.8-2.8) but 60 subjects (45.1%) had some and often severe renal impairment (serum creatinine ≥ 1.5 mg/dL; range, 1.5-9.3; IQR, 2.0-4.3). Marked creatinine elevations were associated with high levels of creatinine kinase but the latter were measured infrequently. MELD scores were high and similar among racial/ethnic groups and genders.