ID

20416

Beschrijving

Trial of Paclitaxel, Bevacizumab, and Enzastaurin Versus Paclitaxel, Bevacizumab and Placebo for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00536939

Link

https://clinicaltrials.gov/show/NCT00536939

Trefwoorden

  1. 22-02-17 22-02-17 -
Geüploaded op

22 februari 2017

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00536939

Eligibility Breast Cancer NCT00536939

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have signed an inform consent document
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
have histologic or cytologic diagnosis of breast cancer with evidence of unresectable locally recurrent or metastatic disease
Beschrijving

Breast Carcinoma; histological diagnosis; Cancer diagnosis based on cytological evidence | Unresectable Malignant Neoplasm | Recurrent disease | Metastatic Neoplasm

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0679557
UMLS CUI [1,3]
C1298647
UMLS CUI [2]
C1336869
UMLS CUI [3]
C0277556
UMLS CUI [4]
C2939420
have not received any prior chemotherapy for locally recurrent or metastatic disease
Beschrijving

Prior Chemotherapy | Locally Recurrent Malignant Neoplasm | Metastatic Neoplasm

Datatype

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C2986682
UMLS CUI [3]
C2939420
have not had adjuvant or neoadjuvant taxane therapy within 12 months prior to assignment to study treatment
Beschrijving

adjuvant or neoadjuvant taxane therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C3541958
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0677850
UMLS CUI [1,4]
C1514457
age 18 years or older at time of informed consent
Beschrijving

age, informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
have any clinical evidence of central nervous system (cns) metastases
Beschrijving

cns metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
have a history of seizure
Beschrijving

have a history of seizure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0036572
UMLS CUI [1,2]
C0262926
have had a major surgical procedure within 4 weeks prior to assignment to study treatment
Beschrijving

surgical procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0543467
have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days prior to assignment to study treatment
Beschrijving

Minor Surgical Procedures | Vascular Access Device Placement | Fine needle aspiration biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0038904
UMLS CUI [2]
C1519955
UMLS CUI [3]
C1510483
have symptomatic peripheral vascular disease
Beschrijving

symptomatic peripheral vascular disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0231220

Similar models

Eligibility Breast Cancer NCT00536939

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
must have signed an inform consent document
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma; histological diagnosis; Cancer diagnosis based on cytological evidence | Unresectable Malignant Neoplasm | Recurrent disease | Metastatic Neoplasm
Item
have histologic or cytologic diagnosis of breast cancer with evidence of unresectable locally recurrent or metastatic disease
boolean
C0678222 (UMLS CUI [1,1])
C0679557 (UMLS CUI [1,2])
C1298647 (UMLS CUI [1,3])
C1336869 (UMLS CUI [2])
C0277556 (UMLS CUI [3])
C2939420 (UMLS CUI [4])
Prior Chemotherapy | Locally Recurrent Malignant Neoplasm | Metastatic Neoplasm
Item
have not received any prior chemotherapy for locally recurrent or metastatic disease
boolean
C1514457 (UMLS CUI [1])
C2986682 (UMLS CUI [2])
C2939420 (UMLS CUI [3])
adjuvant or neoadjuvant taxane therapy
Item
have not had adjuvant or neoadjuvant taxane therapy within 12 months prior to assignment to study treatment
boolean
C3541958 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0677850 (UMLS CUI [1,3])
C1514457 (UMLS CUI [1,4])
age, informed consent
Item
age 18 years or older at time of informed consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
cns metastases
Item
have any clinical evidence of central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
have a history of seizure
Item
have a history of seizure
boolean
C0036572 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
surgical procedure
Item
have had a major surgical procedure within 4 weeks prior to assignment to study treatment
boolean
C0543467 (UMLS CUI [1])
Minor Surgical Procedures | Vascular Access Device Placement | Fine needle aspiration biopsy
Item
have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days prior to assignment to study treatment
boolean
C0038904 (UMLS CUI [1])
C1519955 (UMLS CUI [2])
C1510483 (UMLS CUI [3])
symptomatic peripheral vascular disease
Item
have symptomatic peripheral vascular disease
boolean
C0085096 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])

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