ID

16223

Description

Fulvestrant in Premenopausal Women With Hormone Receptor-Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00146601

Link

https://clinicaltrials.gov/show/NCT00146601

Keywords

  1. 7/6/16 7/6/16 -
Uploaded on

July 6, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00146601

Eligibility Breast Cancer NCT00146601

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed invasive breast cancer, with stage iv disease.
Description

Invasive carcinoma of breast | Stage level 4

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2]
C0441772
tumors must be positive for estrogen receptors, progesterone receptors, or both.
Description

Estrogen receptor positive | progesterone receptor positive | Estrogen receptor positive progesterone receptor positive

Data type

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0279759
UMLS CUI [3,1]
C0279754
UMLS CUI [3,2]
C0279759
patients must be premenopausal.
Description

Premenopausal

Data type

boolean

Alias
UMLS CUI [1]
C0279752
prior anti-estrogen therapy (with or without ovarian suppression)
Description

Antioestrogen therapy | Ovarian suppression | Antioestrogen therapy Ovarian suppression

Data type

boolean

Alias
UMLS CUI [1]
C0854638
UMLS CUI [2]
C0677922
UMLS CUI [3,1]
C0854638
UMLS CUI [3,2]
C0677922
platelet count > 100,000/mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
age older than 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hormonal treatment for metastatic disease
Description

Hormone Therapy Metastatic Neoplasm

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C2939420
pregnant or breast-feeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
concurrent hormonal therapy or chemotherapy
Description

Hormone Therapy | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
UMLS CUI [2]
C0392920
prior fulvestrant therapy
Description

fulvestrant

Data type

boolean

Alias
UMLS CUI [1]
C0935916
more than three prior chemotherapy regimens for metastatic disease
Description

Chemotherapy Regimen Metastatic Neoplasm

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C2939420
concurrent, long-term anticoagulation therapy
Description

Anticoagulation Therapy Long-term

Data type

boolean

Alias
UMLS CUI [1,1]
C0003281
UMLS CUI [1,2]
C0443252
severe, uncontrolled intercurrent illness
Description

Intercurrent disease Severe Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0277557
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0205318
history of hypersensitivity to castor oil
Description

Hypersensitivity Castor Oil

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0007343

Similar models

Eligibility Breast Cancer NCT00146601

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast | Stage level 4
Item
histologically or cytologically confirmed invasive breast cancer, with stage iv disease.
boolean
C0853879 (UMLS CUI [1])
C0441772 (UMLS CUI [2])
Estrogen receptor positive | progesterone receptor positive | Estrogen receptor positive progesterone receptor positive
Item
tumors must be positive for estrogen receptors, progesterone receptors, or both.
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
C0279754 (UMLS CUI [3,1])
C0279759 (UMLS CUI [3,2])
Premenopausal
Item
patients must be premenopausal.
boolean
C0279752 (UMLS CUI [1])
Antioestrogen therapy | Ovarian suppression | Antioestrogen therapy Ovarian suppression
Item
prior anti-estrogen therapy (with or without ovarian suppression)
boolean
C0854638 (UMLS CUI [1])
C0677922 (UMLS CUI [2])
C0854638 (UMLS CUI [3,1])
C0677922 (UMLS CUI [3,2])
Platelet Count measurement
Item
platelet count > 100,000/mm3
boolean
C0032181 (UMLS CUI [1])
Age
Item
age older than 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hormone Therapy Metastatic Neoplasm
Item
hormonal treatment for metastatic disease
boolean
C0279025 (UMLS CUI [1,1])
C2939420 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Postmenopausal state
Item
postmenopausal
boolean
C0232970 (UMLS CUI [1])
Hormone Therapy | Chemotherapy
Item
concurrent hormonal therapy or chemotherapy
boolean
C0279025 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
fulvestrant
Item
prior fulvestrant therapy
boolean
C0935916 (UMLS CUI [1])
Chemotherapy Regimen Metastatic Neoplasm
Item
more than three prior chemotherapy regimens for metastatic disease
boolean
C0392920 (UMLS CUI [1,1])
C2939420 (UMLS CUI [1,2])
Anticoagulation Therapy Long-term
Item
concurrent, long-term anticoagulation therapy
boolean
C0003281 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
Intercurrent disease Severe Uncontrolled
Item
severe, uncontrolled intercurrent illness
boolean
C0277557 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Hypersensitivity Castor Oil
Item
history of hypersensitivity to castor oil
boolean
C0020517 (UMLS CUI [1,1])
C0007343 (UMLS CUI [1,2])

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