ID

26211

Descrição

A Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00669591

Link

https://clinicaltrials.gov/show/NCT00669591

Palavras-chave

  1. 11/10/2017 11/10/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

11 de outubro de 2017

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00669591

Eligibility Breast Cancer NCT00669591

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult females over age 18 with life expectancy of at least 3 months
Descrição

Adult | Gender | Age | Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0023671
histologically or cytologically confirmed locally advanced or metastatic breast cancer
Descrição

Locally advanced breast cancer | Secondary malignant neoplasm of female breast

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0346993
one and only one prior chemotherapy regimen (no prior docetaxel)
Descrição

Prior Chemotherapy Quantity | Docetaxel Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0246415
UMLS CUI [2,2]
C0332197
measurable disease (at least one target lesion)at least 2 cm in longest diameter (1 cm by spiral ct)
Descrição

Measurable Disease Longest Diameter | Measurable Disease Longest Diameter Spiral CT | Target Lesion Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0552406
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0552406
UMLS CUI [2,3]
C0860888
UMLS CUI [3,1]
C2986546
UMLS CUI [3,2]
C1265611
adequate hematologic, renal, and hepatic function;
Descrição

Hematologic function | Renal function | Liver function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
known history of bleeding diathesis or coagulopathy
Descrição

Bleeding tendency | Blood Coagulation Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
any current evidence of clinically significant bleeding
Descrição

Hemorrhage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019080
any history of thromboembolic events
Descrição

Thromboembolism

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0040038
concurrent hormone therapy
Descrição

Hormone Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0279025
prior immunotherapy or radiotherapy to an area of measurable disease unless disease has recurred after radiotherapy
Descrição

Immunotherapy Measurable Disease | Therapeutic radiology procedure Measurable Disease | Exception Recurrent disease Post Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C1513041
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1513041
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0277556
UMLS CUI [3,3]
C0687676
UMLS CUI [3,4]
C1522449

Similar models

Eligibility Breast Cancer NCT00669591

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Gender | Age | Life Expectancy
Item
adult females over age 18 with life expectancy of at least 3 months
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0023671 (UMLS CUI [4])
Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
histologically or cytologically confirmed locally advanced or metastatic breast cancer
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
Prior Chemotherapy Quantity | Docetaxel Absent
Item
one and only one prior chemotherapy regimen (no prior docetaxel)
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0246415 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Measurable Disease Longest Diameter | Measurable Disease Longest Diameter Spiral CT | Target Lesion Quantity
Item
measurable disease (at least one target lesion)at least 2 cm in longest diameter (1 cm by spiral ct)
boolean
C1513041 (UMLS CUI [1,1])
C0552406 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0552406 (UMLS CUI [2,2])
C0860888 (UMLS CUI [2,3])
C2986546 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Hematologic function | Renal function | Liver function
Item
adequate hematologic, renal, and hepatic function;
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Bleeding tendency | Blood Coagulation Disorders
Item
known history of bleeding diathesis or coagulopathy
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
Hemorrhage
Item
any current evidence of clinically significant bleeding
boolean
C0019080 (UMLS CUI [1])
Thromboembolism
Item
any history of thromboembolic events
boolean
C0040038 (UMLS CUI [1])
Hormone Therapy
Item
concurrent hormone therapy
boolean
C0279025 (UMLS CUI [1])
Immunotherapy Measurable Disease | Therapeutic radiology procedure Measurable Disease | Exception Recurrent disease Post Therapeutic radiology procedure
Item
prior immunotherapy or radiotherapy to an area of measurable disease unless disease has recurred after radiotherapy
boolean
C0021083 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1513041 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0277556 (UMLS CUI [3,2])
C0687676 (UMLS CUI [3,3])
C1522449 (UMLS CUI [3,4])

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