Informações:
Falhas:
ID
16387
Descrição
Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00431795
Link
https://clinicaltrials.gov/show/NCT00431795
Palavras-chave
Versões (1)
- 14/07/2016 14/07/2016 -
Transferido a
14 de julho de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00431795
Eligibility Breast Cancer NCT00431795
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT00431795
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
age 18-75 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin
Item
adequate bone marrow function (absolute neutrophil count >1000/mm^3, platelet count>100000/mm^3, hemoglobin>9gr/mm^3)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0019046 (UMLS CUI [4])
Breast adenocarcinoma
Item
histologically- or cytologically- confirmed breast adenocarcinoma
boolean
C0858252 (UMLS CUI [1])
Anthracycline Antibiotics | Therapeutic procedure Advanced breast cancer
Item
no prior anthracycline-based chemotherapy as treatment of advanced breast cancer
boolean
C0003234 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3495917 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,1])
C3495917 (UMLS CUI [2,2])
Prior Chemotherapy | Doxorubicin Adjuvant | Epirubicin Adjuvant
Item
no prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting
boolean
C1514457 (UMLS CUI [1])
C0013089 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C0014582 (UMLS CUI [3,1])
C1522673 (UMLS CUI [3,2])
C0013089 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C0014582 (UMLS CUI [3,1])
C1522673 (UMLS CUI [3,2])
Interval Minimum Since cancer treatment
Item
at least 4 weeks interval since prior anticancer treatment
boolean
C1272706 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
C1711239 (UMLS CUI [1,3])
C0920425 (UMLS CUI [1,4])
C1524031 (UMLS CUI [1,2])
C1711239 (UMLS CUI [1,3])
C0920425 (UMLS CUI [1,4])
Measurable lesion Quantity | Secondary malignant neoplasm of bone | Ascites | Pleural effusion
Item
measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0032227 (UMLS CUI [4])
C1265611 (UMLS CUI [1,2])
C0153690 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0032227 (UMLS CUI [4])
Life Expectancy
Item
life expectancy > 3 months
boolean
C0023671 (UMLS CUI [1])
Informed consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
Congestive heart failure | Cardiac Arrhythmia Serious | Myocardial Infarction
Item
documented history of congestive heart failure (chf), serious arrhythmia, or myocardial infarction (within 6 months)
boolean
C0018802 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0003811 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
invasive cancer | Skin carcinoma | Acute infection
Item
other invasive malignancy except nonmelanoma skin cancer or acute infection.
boolean
C0677898 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0275518 (UMLS CUI [3])
C0699893 (UMLS CUI [2])
C0275518 (UMLS CUI [3])
Radiation Measurable Disease | Metastatic malignant neoplasm to brain
Item
radiation of measurable disease (except brain metastases)
boolean
C0851346 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2])
C1513041 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2])
Metastatic malignant neoplasm to brain Progressive
Item
progressive brain metastases according to clinical or radiological criteria.
boolean
C0220650 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0205329 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Without prior radiation therapy
Item
brain metastases without prior radiation therapy
boolean
C0220650 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0279134 (UMLS CUI [1,3])
C0332288 (UMLS CUI [1,2])
C0279134 (UMLS CUI [1,3])