age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread
Item
Unresectable, multinodular asymptomatic tumor without vascular invasion or extrahepatic spread
boolean
C0205416 (UMLS CUI 2011AA)
56152004 (SNOMED CT 2011_0131)
C0231221 (UMLS CUI 2011AA)
84387000 (SNOMED CT 2011_0131)
C1336869 (UMLS CUI 2011AA)
C1264755 (UMLS CUI 2011AA)
127494000 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1517058 (UMLS CUI 2011AA)
C0332261 (UMLS CUI 2011AA)
410677005, 410676001 (SNOMED CT 2011_0131)
Confirmed Diagnosis of HCC:
Item
Confirmed Diagnosis of HCC:
boolean
C0750484 (UMLS CUI 2011AA)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C2239176 (UMLS CUI 2011AA)
10049010 (MedDRA 14.1)
Cirrhotic subjects: Clinical diagnosis by AASLD criteria
Item
Cirrhotic subjects: Clinical diagnosis by AASLD criteria
boolean
C0439686 (UMLS CUI 2011AA)
255417007 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C0332140 (UMLS CUI 2011AA)
39154008 (SNOMED CT 2011_0131)
C0596070 (UMLS CUI 2011AA)
C0037459 (UMLS CUI 2011AA)
C0947630 (UMLS CUI 2011AA)
MTHU008392 (LOINC Version 232)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
CL414621 (UMLS CUI 2011AA)
HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter.
Item
HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter.
boolean
C2239176 (UMLS CUI 2011AA)
10049010 (MedDRA 14.1)
C0439686 (UMLS CUI 2011AA)
255417007 (SNOMED CT 2011_0131)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C1704788 (UMLS CUI 2011AA)
C0079595 (UMLS CUI 2011AA)
278395004 (SNOMED CT 2011_0131)
10068979 (MedDRA 14.1)
C0040405 (UMLS CUI 2011AA)
10011603 (MedDRA 14.1)
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C0041618 (UMLS CUI 2011AA)
16310003 (SNOMED CT 2011_0131)
10065594 (MedDRA 14.1)
MTHU000076 (LOINC Version 232)
12 (HL7 V3 2006_05)
C0493823 (UMLS CUI 2011AA)
356442006 (SNOMED CT 2011_0131)
Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.
Item
Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.
boolean
C0085172 (UMLS CUI 2011AA)
C0750484 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C0030705 (UMLS CUI 2011AA)
116154003 (SNOMED CT 2011_0131)
C2919401 (UMLS CUI 2011AA)
444734003 (SNOMED CT 2011_0131)
Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory
Item
Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory
boolean
C0205462 (UMLS CUI 2011AA)
67151002 (SNOMED CT 2011_0131)
C0205471 (UMLS CUI 2011AA)
40413002 (SNOMED CT 2011_0131)
C0750484 (UMLS CUI 2011AA)
C1514873 (UMLS CUI 2011AA)
C0750557 (UMLS CUI 2011AA)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0023890 (UMLS CUI 2011AA)
19943007 (SNOMED CT 2011_0131)
10019641 (MedDRA 14.1)
K74.60 (ICD-10-CM Version 2010)
Documentation of original biopsy for diagnosis is acceptable
Item
Documentation of original biopsy for diagnosis is acceptable
boolean
C0920316 (UMLS CUI 2011AA)
C0205313 (UMLS CUI 2011AA)
19535007 (SNOMED CT 2011_0131)
C0005558 (UMLS CUI 2011AA)
86273004 (SNOMED CT 2011_0131)
10004720 (MedDRA 14.1)
MTHU028106 (LOINC Version 232)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1879533 (UMLS CUI 2011AA)
Child Pugh class A without ascites
Item
Child Pugh class A without ascites
boolean
C4050412 (UMLS CUI 2011AA)
C0456387 (UMLS CUI 2011AA)
277046005 (SNOMED CT 2011_0131)
C1706281 (UMLS CUI 2011AA)
422097006 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0003962 (UMLS CUI 2011AA)
389026000 (SNOMED CT 2011_0131)
10003445 (MedDRA 14.1)
R18 (ICD-10-CM Version 2010)
789.5 (ICD-9-CM Version 2011)
E10502 (CTCAE 1105E)
Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
Item
Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
boolean
C0205411 (UMLS CUI 2011AA)
88323005 (SNOMED CT 2011_0131)
C0005953 (UMLS CUI 2011AA)
14016003 (SNOMED CT 2011_0131)
MTHU016536 (LOINC Version 232)
C0542341 (UMLS CUI 2011AA)
246464006 (SNOMED CT 2011_0131)
C0232741 (UMLS CUI 2011AA)
79036002 (SNOMED CT 2011_0131)
C0232804 (UMLS CUI 2011AA)
11953005 (SNOMED CT 2011_0131)
C1516048 (UMLS CUI 2011AA)
C1880016 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0034656 (UMLS CUI 2011AA)
Patients on a liver transplantation list or with advanced liver disease as defined below:
Item
Patients on a liver transplantation list or with advanced liver disease as defined below:
boolean
C0023911 (UMLS CUI 2011AA)
18027006 (SNOMED CT 2011_0131)
10024714 (MedDRA 14.1)
50.5 (ICD-9-CM Version 2011)
C0745732 (UMLS CUI 2011AA)
C0205179 (UMLS CUI 2011AA)
86005002 (SNOMED CT 2011_0131)
C0023895 (UMLS CUI 2011AA)
235856003 (SNOMED CT 2011_0131)
10024670 (MedDRA 14.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
Child Pugh B and C
Item
Child Pugh B and C
boolean
C4050412 (UMLS CUI 2011AA)
C0456387 (UMLS CUI 2011AA)
277046005 (SNOMED CT 2011_0131)
C0439105 (UMLS CUI 2011AA)
421151005 (SNOMED CT 2011_0131)
C0439106 (UMLS CUI 2011AA)
257962003 (SNOMED CT 2011_0131)
Active gastrointestinal bleeding
Item
Active gastrointestinal bleeding
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0017181 (UMLS CUI 2011AA)
74474003 (SNOMED CT 2011_0131)
10017955 (MedDRA 14.1)
K92.2 (ICD-10-CM Version 2010)
578 (ICD-9-CM Version 2011)
Encephalopathy
Item
Encephalopathies
boolean
C0085584 (UMLS CUI 2011AA)
81308009 (SNOMED CT 2011_0131)
10014625 (MedDRA 14.1)
G93.40 (ICD-10-CM Version 2010)
348.30 (ICD-9-CM Version 2011)
E12652 (CTCAE 1105E)
Ascites
Item
Ascites
boolean
C0003962 (UMLS CUI 2011AA)
389026000 (SNOMED CT 2011_0131)
10003445 (MedDRA 14.1)
R18 (ICD-10-CM Version 2010)
789.5 (ICD-9-CM Version 2011)
E10502 (CTCAE 1105E)
Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.
Item
Lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI) or cryoablation can not be selected as the target lesions.
boolean
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C1514463 (UMLS CUI 2011AA)
CL426184 (UMLS CUI 2011AA)
C0728940 (UMLS CUI 2011AA)
65801008 (SNOMED CT 2011_0131)
C2239176 (UMLS CUI 2011AA)
10049010 (MedDRA 14.1)
CL382653 (UMLS CUI 2011AA)
C1880568 (UMLS CUI 2011AA)
C0010408 (UMLS CUI 2011AA)
281609006, 427357007 (SNOMED CT 2011_0131)
10066082 (MedDRA 14.1)