ID

16283

Description

Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00093002

Link

https://clinicaltrials.gov/show/NCT00093002

Keywords

  1. 7/9/16 7/9/16 -
Uploaded on

July 9, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00093002

Eligibility Breast Cancer NCT00093002

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal women defined as women who have stopped having menstrual periods
Description

postmenopausal women

Data type

boolean

Alias
UMLS CUI [1]
C0232970
written informed consent to participate in the trial
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
biopsy confirmation of invasive breast cancer
Description

Biopsy result

Data type

boolean

Alias
UMLS CUI [1,1]
C0405352
UMLS CUI [1,2]
C0853879
evidence of hormone sensitivity
Description

Hormone status

Data type

boolean

Alias
UMLS CUI [1]
C0920555
willingness to undergo biopsies
Description

willingness to undergo biopsies

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0405352
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any previous treatment for breast cancer
Description

previous treatment

Data type

boolean

Alias
UMLS CUI [1]
C1511300
unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
Description

ID.7

Data type

boolean

any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
Description

Comorbidities

Data type

boolean

Alias
UMLS CUI [1]
C0009488
the presence of more than one primary tumor
Description

Number of primary tumors

Data type

boolean

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C0677930
history of hypersensitivity to castor oil
Description

hypersensitivity to castor oil

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0007343
history of known bleeding disorders
Description

bleeding disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005779

Similar models

Eligibility Breast Cancer NCT00093002

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
postmenopausal women
Item
postmenopausal women defined as women who have stopped having menstrual periods
boolean
C0232970 (UMLS CUI [1])
written informed consent
Item
written informed consent to participate in the trial
boolean
C0021430 (UMLS CUI [1])
Biopsy result
Item
biopsy confirmation of invasive breast cancer
boolean
C0405352 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
Hormone status
Item
evidence of hormone sensitivity
boolean
C0920555 (UMLS CUI [1])
willingness to undergo biopsies
Item
willingness to undergo biopsies
boolean
C0021430 (UMLS CUI [1,1])
C0405352 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
previous treatment
Item
any previous treatment for breast cancer
boolean
C1511300 (UMLS CUI [1])
ID.7
Item
unwillingness to stop taking any drug known to affect sex hormonal status or a patient in which it would be inappropriate to stop.
boolean
Comorbidities
Item
any severe concurrent condition that would preclude surgery or that would jeopardize compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled diabetes mellitus
boolean
C0009488 (UMLS CUI [1])
Number of primary tumors
Item
the presence of more than one primary tumor
boolean
C0449788 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
hypersensitivity to castor oil
Item
history of hypersensitivity to castor oil
boolean
C0020517 (UMLS CUI [1,1])
C0007343 (UMLS CUI [1,2])
bleeding disorders
Item
history of known bleeding disorders
boolean
C0005779 (UMLS CUI [1])

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