ID

14824

Description

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

Keywords

  1. 4/29/16 4/29/16 -
Uploaded on

April 29, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Advanced Hepatocellular Carcinoma NCT00517920

Eligibility Advanced Hepatocellular Carcinoma NCT00517920

Inclusion Criteria
Description

Inclusion Criteria

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

age

Data type

boolean

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

subject must be diagnosed with unresectable or metastatic hcc

Data type

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
Description

measurable lesion

Data type

boolean

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

ecog

Data type

boolean

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

malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
Exclusion Criteria
Description

Exclusion Criteria

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

vegf/pdgf/tki therapy

Data type

boolean

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

Child-Pugh score class C

Data type

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
Description

proteinuria

Data type

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
Description

hypertension

Data type

boolean

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

left ventricular ejection fraction

Data type

boolean

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

anticoagulation therapy

Data type

boolean

Alias
UMLS CUI [1]
C0003281

Similar models

Eligibility Advanced Hepatocellular Carcinoma NCT00517920

Name
Type
Description | Question | Decode (Coded Value)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial