Time to Pre-transplant mortality
Time (in days) to mortality while enrolled before transplant (survival framework)
Graft Failure as assessed by Time to first occurrence of mortality or re-transplant or return to maintenance dialysis
Time (in days) to mortality or re-transplant or return to maintenance dialysis (survival framework)
1-year acute liver rejection
Proportion of recipients who experience acute rejection as measured by biopsy using Banff 2016 comprehensive Update for antibody mediated rejection and Banff 1997 criteria for acute cellular rejection, liver.
2-year acute liver rejection
Proportion of recipients who experience acute rejection as measured by biopsy using Banff 2016 comprehensive Update for antibody mediated rejection and Banff 1997 criteria for acute cellular rejection, liver.
3-year acute liver rejection
Proportion of recipients who experience acute rejection as measured by biopsy using Banff 2016 comprehensive Update for antibody mediated rejection and Banff 1997 criteria for acute cellular rejection, liver.
Number of graft rejections in liver transplant
Cumulative incidence of acute rejection (survival framework) as measured by biopsy using Banff 2016 comprehensive Update for antibody mediated rejection and Banff 1997 criteria for acute cellular rejection, liver.
6-month acute kidney rejection in simultaneous liver/kidney transplant recipients
Proportion of recipients who experience acute rejection as measured by biopsy using Banff 2015 criteria: Borderline changes: 'Suspicious' for acute T-cell mediated rejection.This category is used when no intimal arteritis is present, but there are foci of mild tubulitis (t1, t2, or t3) with minor interstitial infiltration (i0 or i1) or interstitial infiltration (i2, i3) with mild (t1) tubulitis. Acute T-cell mediated rejection:Grade from IA defined as cases with significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2) to III defined as cases with 'transmural' arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3)
1-year acute kidney rejection in simultaneous liver/kidney transplant recipients only
Proportion of recipients who experience acute rejection as measured by biopsy using Banff 2015 criteria: Borderline changes: 'Suspicious' for acute T-cell mediated rejection.This category is used when no intimal arteritis is present, but there are foci of mild tubulitis (t1, t2, or t3) with minor interstitial infiltration (i0 or i1) or interstitial infiltration (i2, i3) with mild (t1) tubulitis. Acute T-cell mediated rejection:Grade from IA defined as cases with significant interstitial infiltration (>25% of parenchyma affected, i2 or i3) and foci of moderate tubulitis (t2) to III defined as cases with 'transmural' arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic inflammation (v3)
Number of Non-alcoholic fatty liver (NAFL)
Cumulative incidence of NAFL as measured by biopsy and transient elastography with controlled attenuation parameter for steatosis
Number of steatohepatitis (NASH)
Cumulative incidence of NASH as measured by biopsy and transient elastography with controlled attenuation parameter for steatosis
Trajectory of recipient Cluster of Differentiation (CD4) count over time
Analysis of repeated measures of CD4 (cells/mm3) count (longitudinal model)
Trajectory of recipient plasma HIV RNA over time
Analysis of repeated measures of plasma HIV RNA (copies/mL) longitudinal model
Graft function as assessed by Fibrosis-4 index
Mean calculated fibrosis-4 index (Age (years) + AST/platelet count (109/L) x √ALT) Fibrosis 4 index estimates the amount of scar or fibrosis in the liver without requiring a biopsy. Using a lower cutoff value of 1.45, a Fibrosis-4 score <1.45 had a negative predictive value of 90% for advanced fibrosis. In contrast, a Fibrosis-4 >3.25 would have a 97% specificity and a positive predictive value of 65% for advanced fibrosis. In the patient cohort in which this formula was first validated, at least 70% patients had values <1.45 or >3.25.
Graft function as assessed by Fibrosis-4 index
Mean calculated fibrosis-4 index (Age (years) + AST/platelet count (109/L) x √ALT) Fibrosis 4 index estimates the amount of scar or fibrosis in the liver without requiring a biopsy. Using a lower cutoff value of 1.45, a Fibrosis-4 score <1.45 had a negative predictive value of 90% for advanced fibrosis. In contrast, a Fibrosis-4 >3.25 would have a 97% specificity and a positive predictive value of 65% for advanced fibrosis. In the patient cohort in which this formula was first validated, at least 70% patients had values <1.45 or >3.25.
Graft function as assessed by Fibrosis-4 index
Mean calculated fibrosis-4 index (Age (years) + AST/platelet count (109/L) x √ALT) Fibrosis 4 index estimates the amount of scar or fibrosis in the liver without requiring a biopsy. Using a lower cutoff value of 1.45, a Fibrosis-4 score <1.45 had a negative predictive value of 90% for advanced fibrosis. In contrast, a Fibrosis-4 >3.25 would have a 97% specificity and a positive predictive value of 65% for advanced fibrosis. In the patient cohort in which this formula was first validated, at least 70% patients had values <1.45 or >3.25.
Graft function as assessed by Fibrosis-4 index
Mean calculated fibrosis-4 index (Age (years) + AST/platelet count (109/L) x √ALT) Fibrosis 4 index estimates the amount of scar or fibrosis in the liver without requiring a biopsy. Using a lower cutoff value of 1.45, a Fibrosis-4 score <1.45 had a negative predictive value of 90% for advanced fibrosis. In contrast, a Fibrosis-4 >3.25 would have a 97% specificity and a positive predictive value of 65% for advanced fibrosis. In the patient cohort in which this formula was first validated, at least 70% patients had values <1.45 or >3.25.
Graft function as assessed by incidence of fibrosis
Cumulative incidence of advanced fibrosis (stage F3 or greater as defined by metavir fibrosis score) as measured on biopsy. The fibrosis score is assessed on a five point scale (F0 = no fibrosis, F1 = portal fibrosis without septa, F2 = few septa, F3 = numerous septa without cirrhosis, F4 = cirrhosis).
Graft function as assessed by liver stiffness
Mean calculated liver stiffness by transient elastography (kPA)
Graft function as assessed by liver stiffness
Mean calculated liver stiffness by transient elastography (kPA)
Graft function as assessed by liver stiffness
Mean calculated liver stiffness by transient elastography (kPA)
Average graft function as assessed by aspartate aminotransferase (AST)
Mean calculated AST (U/L)
Average graft function as assessed by AST
Mean calculated AST (U/L)
Average graft function as assessed by AST
Mean calculated AST (U/L)
Average graft function as assessed by AST
Mean calculated AST (U/L)
Average graft function as assessed by alanine aminotransferase (ALT)
Mean calculated ALT (U/L)
Average graft function as assessed by ALT
Mean calculated ALT (U/L)
Average Graft function as assessed by ALT
Mean calculated ALT (U/L)
Average graft function as assessed by ALT
Mean calculated ALT (U/L)
Average graft function as assessed by bilirubin
Mean calculated bilirubin (mg/dL)
Average graft function as assessed by bilirubin
Mean calculated bilirubin (mg/dL)
Average graft function as assessed by bilirubin
Mean calculated bilirubin (mg/dL)
Average graft function as assessed by Bilirubin
Mean calculated bilirubin (mg/dL)
Graft function as assessed by Mean calculated Model for End Stage Liver Disease (MELD) score
Mean calculated MELD score. MELD score indicates the severity of liver disease, with scores ranging from 0-40. The higher the score the more severe the disease
Graft function as assessed by Mean calculated MELD score
Mean calculated MELD score. MELD score indicates the severity of liver disease, with scores ranging from 0-40. The higher the score the more severe the disease
Graft function as assessed by Mean calculated MELD score
Mean calculated MELD score. MELD score indicates the severity of liver disease, with scores ranging from 0-40. The higher the score the more severe the disease
Graft function as assessed by Mean calculated MELD score
Mean calculated MELD score. MELD score indicates the severity of liver disease, with scores ranging from 0-40. The higher the score the more severe the disease
Graft function as assessed by AST to Platelet Ratio (APRI) index
Mean calculated APRI index [( AST / upper limits of normal (ULN) AST ) x 100] / Platelets (109/L)] An APRI score greater than 1.0 has a sensitivity of 76% and specificity of 72% for predicting cirrhosis. In addition, APRI score greater than 0.7 has a sensitivity of 77% and specificity of 72% for predicting significant hepatic fibrosis.For detection of cirrhosis, using an APRI cutoff score of 2.0 is more specific (91%) but less sensitive (46%). The lower the APRI score (less than 0.5), the greater the negative predictive value (and ability to rule out cirrhosis) and the higher the value (greater than 1.5) the greater the positive predictive value (and ability to rule in cirrhosis); midrange values are less helpful.
Graft function as assessed by AST to Platelet Ratio (APRI) index
Mean calculated APRI index [( AST / ULN AST ) x 100] / Platelets (109/L)] An APRI score greater than 1.0 has a sensitivity of 76% and specificity of 72% for predicting cirrhosis. In addition, APRI score greater than 0.7 has a sensitivity of 77% and specificity of 72% for predicting significant hepatic fibrosis.For detection of cirrhosis, using an APRI cutoff score of 2.0 is more specific (91%) but less sensitive (46%). The lower the APRI score (less than 0.5), the greater the negative predictive value (and ability to rule out cirrhosis) and the higher the value (greater than 1.5) the greater the positive predictive value (and ability to rule in cirrhosis); midrange values are less helpful.
Graft function as assessed by AST to Platelet Ratio (APRI) index
Mean calculated APRI index [( AST / ULN AST ) x 100] / Platelets (109/L)] An APRI score greater than 1.0 has a sensitivity of 76% and specificity of 72% for predicting cirrhosis. In addition, APRI score greater than 0.7 has a sensitivity of 77% and specificity of 72% for predicting significant hepatic fibrosis.For detection of cirrhosis, using an APRI cutoff score of 2.0 is more specific (91%) but less sensitive (46%). The lower the APRI score (less than 0.5), the greater the negative predictive value (and ability to rule out cirrhosis) and the higher the value (greater than 1.5) the greater the positive predictive value (and ability to rule in cirrhosis); midrange values are less helpful.
Graft function as assessed by AST to Platelet Ratio (APRI) index
Mean calculated APRI index [( AST / ULN AST ) x 100] / Platelets (109/L)] An APRI score greater than 1.0 has a sensitivity of 76% and specificity of 72% for predicting cirrhosis. In addition, APRI score greater than 0.7 has a sensitivity of 77% and specificity of 72% for predicting significant hepatic fibrosis.For detection of cirrhosis, using an APRI cutoff score of 2.0 is more specific (91%) but less sensitive (46%). The lower the APRI score (less than 0.5), the greater the negative predictive value (and ability to rule out cirrhosis) and the higher the value (greater than 1.5) the greater the positive predictive value (and ability to rule in cirrhosis); midrange values are less helpful.
Metabolic Outcome as assessed by Body mass index (BMI)
Mean calculated BMI (weight in kilograms/height in meters squared)
Metabolic Outcome as assessed by Body mass index (BMI)
Mean calculated BMI(weight in kilograms/height in meters squared)
Metabolic Outcome as assessed by Body mass index (BMI)
Mean calculated BMI(weight in kilograms/height in meters squared)
Metabolic Outcome as assessed by Body mass index (BMI)
Mean calculated BMI(weight in kilograms/height in meters squared)
Average hemoglobin a1c among participants at 1 year
Mean calculated hemoglobin a1c (mg/dL)
Average hemoglobin a1c among participants at 2 years
Mean calculated hemoglobin a1c (mg/dL)
Average hemoglobin a1c among participants at 3 years
Mean calculated hemoglobin a1c (mg/dL)
Average hemoglobin a1c among participants at 4 years
Mean calculated hemoglobin a1c (mg/dL)
Number of HIV breakthroughs
Measured by local sites' Clinical Laboratory Improvement Amendments (CLIA) certified lab with episode of HIV breakthrough defined as 2 consecutive plasma HIV viral loads >200 copies/mL or one HIV viral load >1000 copies/mL after a period of virologic control post-transplant
Number of opportunistic infections
Cumulative incidence of opportunistic infections
Number of X4 tropic virus breakthroughs
Measured by sending virus at time of breakthrough for HIV co-receptor assay
Number of vascular complications
Number of vascular complications within 1 year of transplant, e.g. thrombosis, aneurysm
Number of surgical complications
Number of surgical complications within 1 year of transplant, e.g. delayed closure, wound dehiscence
Number of viral-related malignancies
Number of malignancies as determined by local pathology
Hepatitis C (HCV) sustained viral response post-transplant
Proportion of HCV RNA positive recipients that achieve a sustained virologic response week 12 post-treatment (<15 IU/mL) with direct acting antivirals
Number of the formation of de novo donor-specific human leukocyte antigen(HLA) antibodies
Proportion of participants with a de novo donor-specific HLA antibody as measured and reported by local sites' lab
Time to first occurrence of all-cause-mortality or graft failure or renal allograft rejection or HIV breakthrough or HIV virologic failure or AIDS defining illness as a composite measure
Time to first of any of these events: all-cause-mortality or graft failure or renal allograft rejection or HIV breakthrough or HIV virologic failure or AIDS defining illness