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ID
18400
Descrição
Trial of Docetaxel Versus Vinorelbine as 1st Line Treatment in Elderly Patients With Non-Small-Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00441922
Link
https://clinicaltrials.gov/show/NCT00441922
Palavras-chave
Versões (1)
- 03/11/2016 03/11/2016 -
Transferido a
3 de novembro de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT00441922
Eligibility Non Small Cell Lung Cancer NCT00441922
- StudyEvent: Eligibility
Similar models
Eligibility Non Small Cell Lung Cancer NCT00441922
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Non-Small Cell Lung Carcinoma
Item
histologically- or cytologically- confirmed non-small-cell lung cancer
boolean
C0007131 (UMLS CUI [1])
TNM clinical staging
Item
stage iiib/iv
boolean
C3258246 (UMLS CUI [1])
Prior Chemotherapy
Item
no prior chemotherapy
boolean
C1514457 (UMLS CUI [1])
Measurable Disease 2-Dimensional | Therapeutic radiology procedure Measurable Disease
Item
existence of two-dimensional measurable disease. the measurable disease should not have been irradiated
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1513041 (UMLS CUI [2,2])
C1705052 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C1513041 (UMLS CUI [2,2])
Life Expectancy
Item
life expectancy of more than 3 months
boolean
C0023671 (UMLS CUI [1])
Age
Item
age ≥ 65 years
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
performance status (who) ≤ 3
boolean
C1298650 (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 > 9 gr/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])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
adequate liver (bilirubin < 1.5 times upper limit of normal and sgot/sgpt < 2 times upper limit of normal), and renal function (creatinine < 2 mg/dl)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Mental disorder Excludes Protocol Compliance | social situation Excludes Protocol Compliance
Item
psychiatric illness or social situation that would preclude study compliance.
boolean
C0004936 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Comorbidity Uncontrolled
Item
other concurrent uncontrolled illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,2])
invasive cancer | Skin carcinoma
Item
other invasive malignancy within the past 5 years except nonmelanoma skin cancer
boolean
C0677898 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0699893 (UMLS CUI [2])
CNS metastases Presence | Therapeutic radiology procedure CNS metastases | CNS metastases Stable
Item
no absence or irradiated and stable central nervous system metastatic disease.
boolean
C0686377 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
C0686377 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0150312 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
C0686377 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
Caregiver Absence
Item
no presence of a reliable care giver
boolean
C0085537 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,2])
Investigational New Drugs
Item
other concurrent investigational agents
boolean
C0013230 (UMLS CUI [1])