Age
Item
male or female patients aged equal or above 18 years.
boolean
C0001779 (UMLS CUI [1])
Hepatocellular Carcinoma by BCLC Stage | Therapeutic procedure Established failed | Excision | Transplantation of liver | Local Ablation Therapy | Chemoembolization | Sorafenib Systemic
Item
bclc stage category a, b or c that cannot benefit from treatments of established efficacy with higher priority such as resection, liver transplantation, local ablation, chemoembolization or systemic sorafenib.
boolean
C3898888 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0443211 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0728940 (UMLS CUI [3])
C0023911 (UMLS CUI [4])
C0547070 (UMLS CUI [5])
C0796679 (UMLS CUI [6])
C1516119 (UMLS CUI [7,1])
C0205373 (UMLS CUI [7,2])
Liver function Child-Pugh Classification
Item
liver function status child-pugh class a.
boolean
C0232741 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Sorafenib Therapeutic procedure failed | Disease Progression Radiology
Item
failure to prior treatment with sorafenib (defined as radiological progression under sorafenib therapy)
boolean
C1516119 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2,1])
C0043299 (UMLS CUI [2,2])
Local Therapy Completed | Therapeutic procedure Local-Regional Completed | Operative Surgical Procedures | Therapeutic radiology procedure | Arterial embolization Hepatic | Chemoembolization | Radiofrequency ablation | Percutaneous ethanol injection therapy | Cryoablation | BAY 73-4506
Item
local or loco-regional therapy (eg, surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed = 4 weeks before first dose of bay73-4506.
boolean
C1517925 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1947913 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0543467 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C3163695 (UMLS CUI [5,1])
C0205054 (UMLS CUI [5,2])
C0796679 (UMLS CUI [6])
C0850292 (UMLS CUI [7])
C1535909 (UMLS CUI [8])
C0010408 (UMLS CUI [9])
C2703114 (UMLS CUI [10])
ECOG performance status
Item
ecog ps of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Systemic therapy | Molecular Targeted Therapy Liver carcinoma | Exception Sorafenib | Prior Chemotherapy allowed
Item
prior systemic treatment with molecular targeted agents for hcc, except sorafenib. prior chemotherapy treatment is allowed.
boolean
C1515119 (UMLS CUI [1])
C2699893 (UMLS CUI [2,1])
C2239176 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1516119 (UMLS CUI [3,2])
C1514457 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Metastatic malignant neoplasm to brain | Metastatic malignant neoplasm to brain Symptomatic | Meningeal Carcinomatosis | Meningeal Carcinomatosis Symptomatic | CNS disorder Absent CT head | CNS disorder Absent MRI of head | Symptoms Suggestive of CNS disorder | Symptoms Consistent with CNS disorder
Item
known history or symptomatic metastatic brain or meningeal tumors (head ct or mri at screening to confirm the absence of central nervous system [cns] disease if patient has symptoms suggestive or consistent with cns disease).
boolean
C0220650 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0220654 (UMLS CUI [3])
C0220654 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C0007682 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0202691 (UMLS CUI [5,3])
C0007682 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0412674 (UMLS CUI [6,3])
C1457887 (UMLS CUI [7,1])
C0332299 (UMLS CUI [7,2])
C0007682 (UMLS CUI [7,3])
C1457887 (UMLS CUI [8,1])
C0332290 (UMLS CUI [8,2])
C0007682 (UMLS CUI [8,3])
Congestive heart failure New York Heart Association Classification
Item
congestive heart failure nyha>/= class 2
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Angina, Unstable | Angina symptom At rest | New onset angina | Myocardial Infarction
Item
unstable angina (angina symptoms at rest, new onset angina within the last 3 months) or myocardial infarction (mi) within the past 6 months before start of study medication.
boolean
C0002965 (UMLS CUI [1])
C0858277 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
C0340289 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
Cardiac Arrhythmia Requirement Anti-Arrhythmia Agents | Adrenergic beta-1 Receptor Antagonists allowed | Digoxin allowed
Item
cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
boolean
C0003811 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003195 (UMLS CUI [1,3])
C0304516 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0012265 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure | Disease Management Optimal
Item
uncontrolled hypertension (systolic blood pressure > 150 mmhg or diastolic pressure > 90 mmhg despite optimal medical management).
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0376636 (UMLS CUI [4,1])
C2698651 (UMLS CUI [4,2])
Thrombotic episodes Arterial | Thrombotic episodes Venous | Embolism Arterial | Embolism Venous | Cerebrovascular accident | Transient Ischemic Attack | Deep Vein Thrombosis | Pulmonary Embolism
Item
arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study treatment.
boolean
C2674163 (UMLS CUI [1,1])
C0221464 (UMLS CUI [1,2])
C2674163 (UMLS CUI [2,1])
C0348013 (UMLS CUI [2,2])
C0013922 (UMLS CUI [3,1])
C0221464 (UMLS CUI [3,2])
C0013922 (UMLS CUI [4,1])
C0348013 (UMLS CUI [4,2])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0149871 (UMLS CUI [7])
C0034065 (UMLS CUI [8])