--- a +++ b/clusters/9knumclustersv2/clust_134.txt @@ -0,0 +1,71 @@ +Child-Pugh score A within days prior to study entry +Patient with a Child-Pugh score B or C +Child-Pugh Score or +Child-Pugh score A +Patient with a Child-Pugh score B or C +Child-Pugh score A or B +Patients with chronic liver disease with a Child-Pugh score B or C +Child Pugh score A, A, B or B +Child Pugh score B or C +Child-Pugh Score class A +Patient with a Child-Pugh score B or C +Child-Pugh score of A +Childs-Pugh cirrhotic status A or B with a maximum score of +Patient with a Child-Pugh score B or C +COHORT B, GROUP : HEPATOCELLULAR CARCINOMA: Child-Pugh score > +Documented Child-Pugh score of B or C for hepatocellular carcinoma patients with known underlying liver dysfunction +Child-Pugh score A +Child-Pugh score of A. A score of B is allowed without severe ascites or without hepatic encephalopathy. +Child Pugh A score or liver function +Subjects must have a Child-Turcotte-Pugh (CTP) score =< to be eligible +Child-Pugh score of A +Subjects with severe hepatic insufficiency Child-Pugh score > +Subject with a Child-Pugh score B or C. +Patient with a Child-Pugh score B or C +Have a Child-Pugh A liver score within days of first dose of study drug +Child-Pugh cirrhotic status A or B with a score of +Patients with severe chronic liver disease (Child-Pugh score > ) +Child-Pugh score or greater +Patient with a Child-Pugh score B or C +Child-Pugh score of A +Child-Pugh score must be A to B. +Subject has hepatic decompensation (Child-Pugh score > [class B and C]) +The Child Pugh score must be or (Child Pugh class A) +Child Pugh score A or B +Child-Pugh score A +Adequate hepatic function for squamous cell NSCLC patients, as defined per protocol. For HCC patients: Child-Pugh score ? and Model for End-Stage Liver Disease (MELD) score? +Adequate hepatic function for squamous cell NSCLC patients, as defined per protocol. For HCC patients: Child-Pugh score ? and Model for End-Stage Liver Disease (MELD) score? +Has hepatic decompensation (Child-Pugh score > ; = class B and C) +Patient with severe liver impairment (Child Pugh score B/C) +ARM B: Child Pugh Score A +Subjects with known hepatic insufficiency (i.e. Child-Pugh score A [mild], Child-Pugh score B [moderate] or Child-Pugh score C [severe]) according to Child-Pugh criteria +Patient with a Child-Pugh score B or C +Child-Pugh score of A or B with =< points and meeting laboratory eligibility for all parameters +Child-Pugh Score of A. +Patients with Child pugh score B or C +Subject has Child-Pugh score of ?, i.e., Child-Pugh A (Appendix ); +Patient with a Child-Pugh score B or C +Dose Escalation Phase: Child-Pugh score of points or less. Cohort : Child-Pugh Class B (B-B). For all other cohorts Child-Pugh score of points or less +Child Pugh score ? points +Child-Pugh score A +Child-Pugh score of - (Class C) +Patient with Child-Pugh score B or C +Child Pugh score =< +Child-Pugh score =< (Child A-B) +Child Pugh score =< +Serum albumin of at least . g/dL Note: Laboratories in combination must still be Child Pugh score less than Other laboratory parameters: +For patients with hepatocellular carcinoma only, Child-Pugh Class A (score -) disease. Score for hepatic encephalopathy must be ; the score for ascites must be no greater than and clinically irrelevant; for the determination of the Child-Pugh Class. +Hepatic function with a score of < points according to the Child-Pugh System +Subjects with impaired hepatic function will be grouped according to Child-Pugh classification score +Child-Pugh Score A (-) +Significant liver dysfunction determined as Child-Pugh score B or C +ECOG PS or ; Child-Pugh Cirrhotic Status A or B with a score of ; +Hepatic function with a score of - points according to the Child-Pugh System +Subjects with severe hepatic insufficiency (Child Pugh score > ) +Severe liver impairment (Child-Pugh score > ) +Child-Pugh Score of up to B +Child-Pugh score of up to B +Child-Pugh score A +Child-Pugh score < (Child-Pugh Class A). +Moderate or severe hepatic insufficiency Child-Pugh score > +Child-Pugh score ?