ID

16167

Beschrijving

Trial of Vinflunine Plus Capecitabine in Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01095003

Link

https://clinicaltrials.gov/show/NCT01095003

Trefwoorden

  1. 03-07-16 03-07-16 -
Geüploaded op

3 juli 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Advanced Breast Cancer NCT01095003

Eligibility Advanced Breast Cancer NCT01095003

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients
Beschrijving

female patients

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
21 years of age or older
Beschrijving

age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
histologically/cytologically confirmed carcinoma of the breast
Beschrijving

carcinoma of the breast

Datatype

boolean

Alias
UMLS CUI [1]
C0678222
documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy
Beschrijving

metastatic disease

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
either one, two or three prior chemotherapy regimens
Beschrijving

chemotherapy regimen

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
prior treatments including both an anthracycline and a taxane and patient no longer candidate for these drugs
Beschrijving

anthracycline and a taxane

Datatype

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2]
C0215136
measurable or non-measurable disease according to recist 1.1
Beschrijving

measurable disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
karnofsky performance score of at least 70 %
Beschrijving

karnofsky performance score

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
adequate haematological, hepatic and renal functions
Beschrijving

hepatic and renal function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
ecg without clinically relevant abnormality
Beschrijving

ecg

Datatype

boolean

Alias
UMLS CUI [1]
C1623258
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known or clinical evidence of brain metastasis or leptomeningeal involvement
Beschrijving

brain metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
pulmonary lymphangitis or symptomatic pleural effusion
Beschrijving

lymphangitis

Datatype

boolean

Alias
UMLS CUI [1]
C0024225
any serious, concurrent uncontrolled medical disorder
Beschrijving

medical disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0236748
history of second primary malignancy
Beschrijving

second primary malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0751623
preexisting motor/sensory peripheral neuropathy
Beschrijving

peripheral neuropathy

Datatype

boolean

Alias
UMLS CUI [1]
C0031117
known history of hiv infection
Beschrijving

hiv infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
prior therapy with capecitabine and/or vinca-alkaloids
Beschrijving

capecitabine

Datatype

boolean

Alias
UMLS CUI [1]
C0671970
history of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or contra indication to any of these drugs
Beschrijving

hypersensitivity to vinca alkaloids

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042672
known or suspected dihydropyrimidine dehydrogenase (dpd) deficiency
Beschrijving

dihydropyrimidine dehydrogenase (dpd) deficiency

Datatype

boolean

Alias
UMLS CUI [1]
C1959620
pregnancy or breast feeding
Beschrijving

pregnancy or breast feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Advanced Breast Cancer NCT01095003

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
female patients
Item
female patients
boolean
C0079399 (UMLS CUI [1])
age
Item
21 years of age or older
boolean
C0001779 (UMLS CUI [1])
carcinoma of the breast
Item
histologically/cytologically confirmed carcinoma of the breast
boolean
C0678222 (UMLS CUI [1])
metastatic disease
Item
documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy
boolean
C0027627 (UMLS CUI [1])
chemotherapy regimen
Item
either one, two or three prior chemotherapy regimens
boolean
C0392920 (UMLS CUI [1])
anthracycline and a taxane
Item
prior treatments including both an anthracycline and a taxane and patient no longer candidate for these drugs
boolean
C0282564 (UMLS CUI [1])
C0215136 (UMLS CUI [2])
measurable disease
Item
measurable or non-measurable disease according to recist 1.1
boolean
C1513041 (UMLS CUI [1])
karnofsky performance score
Item
karnofsky performance score of at least 70 %
boolean
C0206065 (UMLS CUI [1])
hepatic and renal function
Item
adequate haematological, hepatic and renal functions
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
ecg
Item
ecg without clinically relevant abnormality
boolean
C1623258 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
brain metastasis
Item
known or clinical evidence of brain metastasis or leptomeningeal involvement
boolean
C0220650 (UMLS CUI [1])
lymphangitis
Item
pulmonary lymphangitis or symptomatic pleural effusion
boolean
C0024225 (UMLS CUI [1])
medical disorder
Item
any serious, concurrent uncontrolled medical disorder
boolean
C0236748 (UMLS CUI [1])
second primary malignancy
Item
history of second primary malignancy
boolean
C0751623 (UMLS CUI [1])
peripheral neuropathy
Item
preexisting motor/sensory peripheral neuropathy
boolean
C0031117 (UMLS CUI [1])
hiv infection
Item
known history of hiv infection
boolean
C0019693 (UMLS CUI [1])
capecitabine
Item
prior therapy with capecitabine and/or vinca-alkaloids
boolean
C0671970 (UMLS CUI [1])
hypersensitivity to vinca alkaloids
Item
history of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or contra indication to any of these drugs
boolean
C0020517 (UMLS CUI [1,1])
C0042672 (UMLS CUI [1,2])
dihydropyrimidine dehydrogenase (dpd) deficiency
Item
known or suspected dihydropyrimidine dehydrogenase (dpd) deficiency
boolean
C1959620 (UMLS CUI [1])
pregnancy or breast feeding
Item
pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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