ID

17916

Descripción

The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00065325

Link

https://clinicaltrials.gov/show/NCT00065325

Palabras clave

  1. 9/10/16 9/10/16 -
Subido en

9 de octubre de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :


Sin comentarios

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Locally Advanced Breast Cancer NCT00065325

Eligibility Locally Advanced Breast Cancer NCT00065325

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
biopsy confirmation of breast cancer
Descripción

Breast Carcinoma | Biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2]
C0005558
breast cancer has continued to grow after having received treatment with an aromatase inhibitor
Descripción

Therapeutic procedure Breast Carcinoma | Aromatase Inhibitor | Disease Progression

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0593802
UMLS CUI [3]
C0242656
postmenopausal women defined as a women who has stopped having menstrual periods
Descripción

Postmenopausal state | Periods have stopped

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0425957
evidence of hormone sensitivity
Descripción

hormone sensitivity Evidence of

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0920555
UMLS CUI [1,2]
C0332120
written informed consent to participate in the trial
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with faslodex (fulvestrant) or aromasin (exemestane)
Descripción

Faslodex | fulvestrant | Aromasin | exemestane

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0701491
UMLS CUI [2]
C0935916
UMLS CUI [3]
C0876723
UMLS CUI [4]
C0851344
any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor
Descripción

Hormone Therapy Other medical condition Changing | Non-Steroidal Aromatase Inhibitor

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C3843040
UMLS CUI [1,3]
C0392747
UMLS CUI [2]
C1518386
treatment with an investigational or non-approved drug within one month
Descripción

Investigational New Drugs | Illicit Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0086190
an existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
Descripción

Disease Serious Preventing participation | Disease Serious Preventing Protocol Compliance | Condition Preventing participation | Condition Preventing Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C0679823
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C1292733
UMLS CUI [2,4]
C0525058
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0679823
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0525058
a history of allergies to any active or inactive ingredients of faslodex or exemestane (i.e. castor oil or mannitol)
Descripción

Hypersensitivity Faslodex Ingredient | Hypersensitivity exemestane Ingredient | Hypersensitivity Castor Oil | Hypersensitivity Mannitol

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0701491
UMLS CUI [1,3]
C1550600
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0851344
UMLS CUI [2,3]
C1550600
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0007343
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0024730

Similar models

Eligibility Locally Advanced Breast Cancer NCT00065325

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma | Biopsy
Item
biopsy confirmation of breast cancer
boolean
C0678222 (UMLS CUI [1])
C0005558 (UMLS CUI [2])
Therapeutic procedure Breast Carcinoma | Aromatase Inhibitor | Disease Progression
Item
breast cancer has continued to grow after having received treatment with an aromatase inhibitor
boolean
C0087111 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0593802 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
Postmenopausal state | Periods have stopped
Item
postmenopausal women defined as a women who has stopped having menstrual periods
boolean
C0232970 (UMLS CUI [1])
C0425957 (UMLS CUI [2])
hormone sensitivity Evidence of
Item
evidence of hormone sensitivity
boolean
C0920555 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Informed Consent
Item
written informed consent to participate in the trial
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Faslodex | fulvestrant | Aromasin | exemestane
Item
previous treatment with faslodex (fulvestrant) or aromasin (exemestane)
boolean
C0701491 (UMLS CUI [1])
C0935916 (UMLS CUI [2])
C0876723 (UMLS CUI [3])
C0851344 (UMLS CUI [4])
Hormone Therapy Other medical condition Changing | Non-Steroidal Aromatase Inhibitor
Item
any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor
boolean
C0279025 (UMLS CUI [1,1])
C3843040 (UMLS CUI [1,2])
C0392747 (UMLS CUI [1,3])
C1518386 (UMLS CUI [2])
Investigational New Drugs | Illicit Drugs
Item
treatment with an investigational or non-approved drug within one month
boolean
C0013230 (UMLS CUI [1])
C0086190 (UMLS CUI [2])
Disease Serious Preventing participation | Disease Serious Preventing Protocol Compliance | Condition Preventing participation | Condition Preventing Protocol Compliance
Item
an existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C0679823 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1292733 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0679823 (UMLS CUI [3,3])
C0348080 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Hypersensitivity Faslodex Ingredient | Hypersensitivity exemestane Ingredient | Hypersensitivity Castor Oil | Hypersensitivity Mannitol
Item
a history of allergies to any active or inactive ingredients of faslodex or exemestane (i.e. castor oil or mannitol)
boolean
C0020517 (UMLS CUI [1,1])
C0701491 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0851344 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0007343 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0024730 (UMLS CUI [4,2])

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial