ID

19656

Descripción

Safety and Efficacy Study of Femara(Letrozole) as an Extended Adjuvant Treatment in Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01249456

Link

https://clinicaltrials.gov/show/NCT01249456

Palabras clave

Versiones (1)
  1. 19/1/17 19/1/17 -
Subido en

19 de enero de 2017

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.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

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

Eligibility Breast Cancer NCT01249456

Inglés

Eligibility Breast Cancer NCT01249456

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent form
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
postmenopausal patients who had had a histologically or cytologically confirmed breast cancer removed at the time of diagnosis with no evidence of metastases and who had completed over 5 years of adjuvant therapy with tamoxifen or toremifen before entering the study
Descripción

Postmenopausal state | Breast Carcinoma Removed | Neoplasm Metastasis Absent | Adjuvant therapy Completed | Tamoxifen | Toremifene

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0849355
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0677850
UMLS CUI [4,2]
C0205197
UMLS CUI [5]
C0039286
UMLS CUI [6]
C0076836
age ≥50 years with cessation of menses and age ＜50 years postmenopausal status defined by one of the following:
Descripción

Age Amenorrhea | Age Postmenopausal state

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0002453
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C0232970
fsh level ＞ 30-40 iu/l
Descripción

Follicle stimulating hormone measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0202022
cessation of menses over the past 1 year
Descripción

Amenorrhea Duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0002453
UMLS CUI [1,2]
C0449238
are/become amenorrheic due to either chemotherapy or lhrh, are/become amenorrheic due to surgical ovarian ablation
Descripción

Amenorrhea Due to Chemotherapy | Amenorrhea Due to Luteinizing Hormone-releasing Hormone Agonist | Amenorrhea Due to Ovarian ablation Surgical

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0002453
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0392920
UMLS CUI [2,1]
C0002453
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C1518041
UMLS CUI [3,1]
C0002453
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0677922
UMLS CUI [3,4]
C0543467
the tumor was to be er and/or pgr-positive or the receptor status could have been unknown
Descripción

Estrogen receptor positive tumor | Progesterone receptor positive tumor | estrogen receptor status unknown | progesterone receptor status unknown

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1562312
UMLS CUI [2]
C1562928
UMLS CUI [3]
C0279758
UMLS CUI [4]
C0279768
no evidence of recurrence of the disease at entry
Descripción

Disease recurrence Evidence

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679254
UMLS CUI [1,2]
C3887511
patient must be accessible for follow-up
Descripción

Patient Available Follow-up

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C3274571
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
those patients known to have had receptor-negative primary tumors
Descripción

Hormone receptor negative neoplasm Primary

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2584453
UMLS CUI [1,2]
C0205225
any concurrent malignancy
Descripción

Malignant Neoplasms

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
patients who previously received hormone replacement therapy (hrt) during 5 years of adjuvant therapy with tamoxifen or toremifen
Descripción

Hormone replacement therapy | Adjuvant therapy | Tamoxifen | Toremifene

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2]
C0677850
UMLS CUI [3]
C0039286
UMLS CUI [4]
C0076836
patients who are currently receiving other aromatase inhibitors, or chemotherapy
Descripción

Aromatase Inhibitors | Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0593802
UMLS CUI [2]
C0392920
patients who have serious cardiovascular or hepatic disease with significantly abnormal daily function and/or laboratory results
Descripción

Cardiovascular Disease Serious | Liver disease Serious | Abnormal cardiovascular function Daily Significant | Liver function Abnormal Daily Significant | Laboratory Results Abnormal

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0232090
UMLS CUI [3,2]
C0332173
UMLS CUI [3,3]
C0750502
UMLS CUI [4,1]
C0232741
UMLS CUI [4,2]
C0205161
UMLS CUI [4,3]
C0332173
UMLS CUI [4,4]
C0750502
UMLS CUI [5,1]
C1254595
UMLS CUI [5,2]
C0205161
life expectancy ＜ 12 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
Volver a la parte superior de la página

Similar models

Eligibility Breast Cancer NCT01249456

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent form
boolean
C0021430 (UMLS CUI [1])
Postmenopausal state | Breast Carcinoma Removed | Neoplasm Metastasis Absent | Adjuvant therapy Completed | Tamoxifen | Toremifene
Item
postmenopausal patients who had had a histologically or cytologically confirmed breast cancer removed at the time of diagnosis with no evidence of metastases and who had completed over 5 years of adjuvant therapy with tamoxifen or toremifen before entering the study
boolean
C0232970 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0849355 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0677850 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0039286 (UMLS CUI [5])
C0076836 (UMLS CUI [6])
Age Amenorrhea | Age Postmenopausal state
Item
age ≥50 years with cessation of menses and age ＜50 years postmenopausal status defined by one of the following:
boolean
C0001779 (UMLS CUI [1,1])
C0002453 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
Follicle stimulating hormone measurement
Item
fsh level ＞ 30-40 iu/l
boolean
C0202022 (UMLS CUI [1])
Amenorrhea Duration
Item
cessation of menses over the past 1 year
boolean
C0002453 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Amenorrhea Due to Chemotherapy | Amenorrhea Due to Luteinizing Hormone-releasing Hormone Agonist | Amenorrhea Due to Ovarian ablation Surgical
Item
are/become amenorrheic due to either chemotherapy or lhrh, are/become amenorrheic due to surgical ovarian ablation
boolean
C0002453 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0002453 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1518041 (UMLS CUI [2,3])
C0002453 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0677922 (UMLS CUI [3,3])
C0543467 (UMLS CUI [3,4])
Estrogen receptor positive tumor | Progesterone receptor positive tumor | estrogen receptor status unknown | progesterone receptor status unknown
Item
the tumor was to be er and/or pgr-positive or the receptor status could have been unknown
boolean
C1562312 (UMLS CUI [1])
C1562928 (UMLS CUI [2])
C0279758 (UMLS CUI [3])
C0279768 (UMLS CUI [4])
Disease recurrence Evidence
Item
no evidence of recurrence of the disease at entry
boolean
C0679254 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
Patient Available Follow-up
Item
patient must be accessible for follow-up
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hormone receptor negative neoplasm Primary
Item
those patients known to have had receptor-negative primary tumors
boolean
C2584453 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Malignant Neoplasms
Item
any concurrent malignancy
boolean
C0006826 (UMLS CUI [1])
Hormone replacement therapy | Adjuvant therapy | Tamoxifen | Toremifene
Item
patients who previously received hormone replacement therapy (hrt) during 5 years of adjuvant therapy with tamoxifen or toremifen
boolean
C0282402 (UMLS CUI [1])
C0677850 (UMLS CUI [2])
C0039286 (UMLS CUI [3])
C0076836 (UMLS CUI [4])
Aromatase Inhibitors | Chemotherapy
Item
patients who are currently receiving other aromatase inhibitors, or chemotherapy
boolean
C0593802 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Cardiovascular Disease Serious | Liver disease Serious | Abnormal cardiovascular function Daily Significant | Liver function Abnormal Daily Significant | Laboratory Results Abnormal
Item
patients who have serious cardiovascular or hepatic disease with significantly abnormal daily function and/or laboratory results
boolean
C0007222 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0232090 (UMLS CUI [3,1])
C0332173 (UMLS CUI [3,2])
C0750502 (UMLS CUI [3,3])
C0232741 (UMLS CUI [4,1])
C0205161 (UMLS CUI [4,2])
C0332173 (UMLS CUI [4,3])
C0750502 (UMLS CUI [4,4])
C1254595 (UMLS CUI [5,1])
C0205161 (UMLS CUI [5,2])
Life Expectancy
Item
life expectancy ＜ 12 months
boolean
C0023671 (UMLS CUI [1])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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