ID

42118

Beskrivning

Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01405573

Länk

https://clinicaltrials.gov/show/NCT01405573

Nyckelord

  1. 2016-05-27 2016-05-27 -
  2. 2021-04-10 2021-04-10 - Ahmed Rafee, MD
Rättsinnehavare

folgt

Uppladdad den

10 april 2021

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Advanced Adult Hepatocellular Carcinoma NCT01405573

Eligibility Advanced Adult Hepatocellular Carcinoma NCT01405573

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with diagnosis of hepatic cell carcinoma (hcc) according to the aasld- easl criteria
Beskrivning

hepatic cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C2239176
age >18 years
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
advanced stage of disease defined as hcc not eligible for locoregional treatments (ab initio or following progression after such treatments)
Beskrivning

locoregional hcc

Datatyp

boolean

Alias
UMLS CUI [1]
C0027643
liver function classified as child-pugh class b
Beskrivning

child-pugh class b

Datatyp

boolean

Alias
UMLS CUI [1]
C3831116
ecog performance status < or = 2
Beskrivning

ecog

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of at least 2 months
Beskrivning

life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
adequate contraception for fertile male and female patients
Beskrivning

contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0420837
signed informed consent
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior exposure to sorafenib or antiangiogenesis drugs
Beskrivning

sorafenib

Datatyp

boolean

Alias
UMLS CUI [1]
C1516119
UMLS CUI [2]
C0596087
concomitant diseases that contraindicate the use of sorafenib
Beskrivning

concomitant diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0150941
gastro-intestinal bleeding in the previous 30 days
Beskrivning

gastro-intestinal bleeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0017181
altered renal function(creatinine > 1.5 x uln), or haematological function (platelet count < 60 x 10^9/l, hemoglobin < 9 g/dl)
Beskrivning

renal function, hemoglobin

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0232804
serious active infections (> grade 2 ctcae version 3.0)
Beskrivning

active infections

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
congestive heart failure, history of congestive heart failure, unstable angina pectoris, myocardial infarct or significant valvular heart disease or uncontrolled heart arrhythmia
Beskrivning

congestive heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0018802
patients who are unable or unwilling to participate in the study
Beskrivning

patients who are unable or unwilling to participate in the study

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
pregnant or lactating females
Beskrivning

pregnant or lactating females

Datatyp

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C2828358
hepatic encephalopathy of any grade
Beskrivning

hepatic encephalopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0019151

Similar models

Eligibility Advanced Adult Hepatocellular Carcinoma NCT01405573

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
sorafenib
Item
prior exposure to sorafenib or antiangiogenesis drugs
boolean
C1516119 (UMLS CUI [1])
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])
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])
hepatic encephalopathy
Item
hepatic encephalopathy of any grade
boolean
C0019151 (UMLS CUI [1])

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