ID

38085

Descripción

An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic or Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01725386

Link

https://clinicaltrials.gov/show/NCT01725386

Palabras clave

Versiones (1)
  1. 16/9/19 16/9/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

16 de septiembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01725386

Inglés

Eligibility Breast Cancer NCT01725386

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult female patients, >/= 18 years of age
Descripción

Adult | Gender | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
cytolologic/histopathologic confirmed diagnosis of metastatic breast cancer
Descripción

Secondary malignant neoplasm of female breast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0346993
prescribed xeloda as in routine clinical practice
Descripción

Xeloda prescribed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0724419
UMLS CUI [1,2]
C0278329
informed consent signed
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
participation in any other clinical trial
Descripción

Study Subject Participation Status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
history of severe and unexpected reactions to fluoropyrimidine therapy
Descripción

Severe reaction Unexpected Fluoropyrimidine

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3242604
UMLS CUI [1,2]
C4055646
UMLS CUI [1,3]
C0596581
hypersensitivity to capecitabine or to any of the excipients of fluorouracil
Descripción

Hypersensitivity Capecitabine | Hypersensitivity Fluorouracil Excipient

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0671970
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0016360
UMLS CUI [2,3]
C0015237
known dihydropyrimidine dehydrogenase (dpd) deficiency
Descripción

Dihydropyrimidine Dehydrogenase Deficiency

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1959620
pregnant or lactating women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
severe leucopenia, neutropenia, or thrombocytopenia
Descripción

Leukopenia Severe | Neutropenia Severe | Thrombocytopenia Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023530
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0027947
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0040034
UMLS CUI [3,2]
C0205082
severe hepatic impairment
Descripción

Hepatic impairment Severe

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205082
severe renal impairment (creatinine clearance below 30 ml/min)
Descripción

Renal Insufficiency Severe | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0201976
treatment with sorivudine or its chemically related analogues, such as brivudine
Descripción

sorivudine | Sorivudine Analogue | brivudine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0207628
UMLS CUI [2,1]
C0207628
UMLS CUI [2,2]
C0243071
UMLS CUI [3]
C0163272
refusal to give consent
Descripción

Informed Consent Refused

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
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Similar models

Eligibility Breast Cancer NCT01725386

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Gender | Age
Item
adult female patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Secondary malignant neoplasm of female breast
Item
cytolologic/histopathologic confirmed diagnosis of metastatic breast cancer
boolean
C0346993 (UMLS CUI [1])
Xeloda prescribed
Item
prescribed xeloda as in routine clinical practice
boolean
C0724419 (UMLS CUI [1,1])
C0278329 (UMLS CUI [1,2])
Informed Consent
Item
informed consent signed
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
participation in any other clinical trial
boolean
C2348568 (UMLS CUI [1])
Severe reaction Unexpected Fluoropyrimidine
Item
history of severe and unexpected reactions to fluoropyrimidine therapy
boolean
C3242604 (UMLS CUI [1,1])
C4055646 (UMLS CUI [1,2])
C0596581 (UMLS CUI [1,3])
Hypersensitivity Capecitabine | Hypersensitivity Fluorouracil Excipient
Item
hypersensitivity to capecitabine or to any of the excipients of fluorouracil
boolean
C0020517 (UMLS CUI [1,1])
C0671970 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0016360 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Dihydropyrimidine Dehydrogenase Deficiency
Item
known dihydropyrimidine dehydrogenase (dpd) deficiency
boolean
C1959620 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Leukopenia Severe | Neutropenia Severe | Thrombocytopenia Severe
Item
severe leucopenia, neutropenia, or thrombocytopenia
boolean
C0023530 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0027947 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0040034 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Hepatic impairment Severe
Item
severe hepatic impairment
boolean
C0948807 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Renal Insufficiency Severe | Creatinine measurement, serum
Item
severe renal impairment (creatinine clearance below 30 ml/min)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
sorivudine | Sorivudine Analogue | brivudine
Item
treatment with sorivudine or its chemically related analogues, such as brivudine
boolean
C0207628 (UMLS CUI [1])
C0207628 (UMLS CUI [2,1])
C0243071 (UMLS CUI [2,2])
C0163272 (UMLS CUI [3])
Informed Consent Refused
Item
refusal to give consent
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
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