Information:
Error:
ID
38085
Description
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
Keywords
Versions (1)
- 9/16/19 9/16/19 -
Copyright Holder
See clinicaltrials.gov
Uploaded on
September 16, 2019
DOI
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License
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01725386
Eligibility Breast Cancer NCT01725386
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT01725386
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Adult | Gender | Age
Item
adult female patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
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])
C0278329 (UMLS CUI [1,2])
Informed Consent
Item
informed consent signed
boolean
C0021430 (UMLS CUI [1])
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])
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])
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])
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])
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])
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])
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])
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])
C1705116 (UMLS CUI [1,2])