ID

14824

Beschreibung

Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC); ODM derived from: https://clinicaltrials.gov/show/NCT00517920

Link

https://clinicaltrials.gov/show/NCT00517920

Stichworte

  1. 29.04.16 29.04.16 -
Hochgeladen am

29. April 2016

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Advanced Hepatocellular Carcinoma NCT00517920

Eligibility Advanced Hepatocellular Carcinoma NCT00517920

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject must be greater than or equal to 18 years of age
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
subject must be diagnosed with unresectable or metastatic hcc
Beschreibung

subject must be diagnosed with unresectable or metastatic hcc

Datentyp

boolean

Alias
UMLS CUI [1]
C1336869
UMLS CUI [2]
C2239176
subjects must have a measurable lesion by recist on ct scan in at least one site which has not received radiation
Beschreibung

measurable lesion

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
subject has an eastern cooperative oncology group (ecog) performance status of 0-2
Beschreibung

ecog

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
no other active malignancy within the past 5 years
Beschreibung

malignancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has received targeted vegf/pdgf/tki therapy. prior avastin is allowed
Beschreibung

vegf/pdgf/tki therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0078058
UMLS CUI [2]
C0032200
subject has child-pugh grade class c hepatic impairment
Beschreibung

Child-Pugh score class C

Datentyp

boolean

Alias
UMLS CUI [1]
C4039103
the subject has proteinuria common toxicity criteria (ctc) grade > 1 as measured by routine urinalysis or 24 hour urine collection during screening assessment
Beschreibung

proteinuria

Datentyp

boolean

Alias
UMLS CUI [1]
C0033687
subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 100 mmhg or systolic blood pressure > 150 mmhg. subjects may be re-screened if blood pressure is shown to be controlled with or without intervention
Beschreibung

hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C2704328
the subject has a documented left ventricular ejection fraction < 50%
Beschreibung

left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
subject is receiving therapeutic anticoagulation therapy
Beschreibung

anticoagulation therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0003281

Ähnliche Modelle

Eligibility Advanced Hepatocellular Carcinoma NCT00517920

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
age
Item
subject must be greater than or equal to 18 years of age
boolean
C0001779 (UMLS CUI [1])
subject must be diagnosed with unresectable or metastatic hcc
Item
subject must be diagnosed with unresectable or metastatic hcc
boolean
C1336869 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
measurable lesion
Item
subjects must have a measurable lesion by recist on ct scan in at least one site which has not received radiation
boolean
C1513041 (UMLS CUI [1])
ecog
Item
subject has an eastern cooperative oncology group (ecog) performance status of 0-2
boolean
C1520224 (UMLS CUI [1])
malignancy
Item
no other active malignancy within the past 5 years
boolean
C0006826 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
vegf/pdgf/tki therapy
Item
subject has received targeted vegf/pdgf/tki therapy. prior avastin is allowed
boolean
C0078058 (UMLS CUI [1])
C0032200 (UMLS CUI [2])
Child-Pugh score class C
Item
subject has child-pugh grade class c hepatic impairment
boolean
C4039103 (UMLS CUI [1])
proteinuria
Item
the subject has proteinuria common toxicity criteria (ctc) grade > 1 as measured by routine urinalysis or 24 hour urine collection during screening assessment
boolean
C0033687 (UMLS CUI [1])
hypertension
Item
subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure > 100 mmhg or systolic blood pressure > 150 mmhg. subjects may be re-screened if blood pressure is shown to be controlled with or without intervention
boolean
C0020538 (UMLS CUI [1])
C2704328 (UMLS CUI [2])
left ventricular ejection fraction
Item
the subject has a documented left ventricular ejection fraction < 50%
boolean
C0428772 (UMLS CUI [1])
anticoagulation therapy
Item
subject is receiving therapeutic anticoagulation therapy
boolean
C0003281 (UMLS CUI [1])

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