Information:
Error:
ID
42118
Description
Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01405573
Link
https://clinicaltrials.gov/show/NCT01405573
Keywords
Versions (2)
- 5/27/16 5/27/16 -
- 4/10/21 4/10/21 - Ahmed Rafee, MD
Copyright Holder
folgt
Uploaded on
April 10, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility Advanced Adult Hepatocellular Carcinoma NCT01405573
Eligibility Advanced Adult Hepatocellular Carcinoma NCT01405573
- StudyEvent: Eligibility
Similar models
Eligibility Advanced Adult Hepatocellular Carcinoma NCT01405573
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
hepatic cell carcinoma
Item
patients with diagnosis of hepatic cell carcinoma (hcc) according to the aasld- easl criteria
boolean
C2239176 (UMLS CUI [1])
age
Item
age >18 years
boolean
C0001779 (UMLS CUI [1])
locoregional hcc
Item
advanced stage of disease defined as hcc not eligible for locoregional treatments (ab initio or following progression after such treatments)
boolean
C0027643 (UMLS CUI [1])
child-pugh class b
Item
liver function classified as child-pugh class b
boolean
C3831116 (UMLS CUI [1])
ecog
Item
ecog performance status < or = 2
boolean
C1520224 (UMLS CUI [1])
life expectancy
Item
life expectancy of at least 2 months
boolean
C0023671 (UMLS CUI [1])
contraception
Item
adequate contraception for fertile male and female patients
boolean
C0420837 (UMLS CUI [1])
informed consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
sorafenib
Item
prior exposure to sorafenib or antiangiogenesis drugs
boolean
C1516119 (UMLS CUI [1])
C0596087 (UMLS CUI [2])
C0596087 (UMLS CUI [2])
concomitant diseases
Item
concomitant diseases that contraindicate the use of sorafenib
boolean
C0150941 (UMLS CUI [1])
gastro-intestinal bleeding
Item
gastro-intestinal bleeding in the previous 30 days
boolean
C0017181 (UMLS CUI [1])
renal function, hemoglobin
Item
altered renal function(creatinine > 1.5 x uln), or haematological function (platelet count < 60 x 10^9/l, hemoglobin < 9 g/dl)
boolean
C0518015 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232804 (UMLS CUI [2])
active infections
Item
serious active infections (> grade 2 ctcae version 3.0)
boolean
C0009450 (UMLS CUI [1])
congestive heart failure
Item
congestive heart failure, history of congestive heart failure, unstable angina pectoris, myocardial infarct or significant valvular heart disease or uncontrolled heart arrhythmia
boolean
C0018802 (UMLS CUI [1])
patients who are unable or unwilling to participate in the study
Item
patients who are unable or unwilling to participate in the study
boolean
C2348568 (UMLS CUI [1])
pregnant or lactating females
Item
pregnant or lactating females
boolean
C0549206 (UMLS CUI [1])
C2828358 (UMLS CUI [2])
C2828358 (UMLS CUI [2])
hepatic encephalopathy
Item
hepatic encephalopathy of any grade
boolean
C0019151 (UMLS CUI [1])