ID

33954

Descripción

First-line Treatment With Icotinib in Elder NSCLC EGFR Mutated Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01646450

Link

https://clinicaltrials.gov/show/NCT01646450

Palabras clave

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

See clinicaltrials.gov

Subido en

9 de enero de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT01646450

Inglés

Eligibility Non-Small Cell Lung Cancer NCT01646450

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
recurrent or progressive non-small cell lung cancer stage iv or iiib patients.
Descripción

Non-small cell lung cancer recurrent TNM clinical staging | Non-Small Cell Lung Carcinoma Progressive TNM clinical staging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0278517
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205329
UMLS CUI [2,3]
C3258246
positive egfr mutation.
Descripción

EGFR gene mutation Positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3266992
UMLS CUI [1,2]
C1514241
no previous systemic anticancer therapy.
Descripción

Absence Cancer treatment Systemic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0920425
UMLS CUI [1,3]
C0205373
male and female patients aged over 70 years.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
measurable lesion according to recist with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
Descripción

Measurable lesion | Measurable lesion Quantity Therapeutic radiology procedure Absent | Exception Disease Progression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1522449
UMLS CUI [2,4]
C0332197
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0242656
provision of written informed consent.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
Descripción

Lung Diseases, Interstitial

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0206062
known severe hypersensitivity to icotinib or any of the excipients of this product.
Descripción

Severe allergy Icotinib | Severe allergy Excipient Icotinib

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C2604307
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0015237
UMLS CUI [2,3]
C2604307
evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
Descripción

Disease Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C3640815
UMLS CUI [2,1]
C0587081
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C3640815
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT01646450

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-small cell lung cancer recurrent TNM clinical staging | Non-Small Cell Lung Carcinoma Progressive TNM clinical staging
Item
recurrent or progressive non-small cell lung cancer stage iv or iiib patients.
boolean
C0278517 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
EGFR gene mutation Positive
Item
positive egfr mutation.
boolean
C3266992 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
Absence Cancer treatment Systemic
Item
no previous systemic anticancer therapy.
boolean
C0332197 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0205373 (UMLS CUI [1,3])
Age
Item
male and female patients aged over 70 years.
boolean
C0001779 (UMLS CUI [1])
Measurable lesion | Measurable lesion Quantity Therapeutic radiology procedure Absent | Exception Disease Progression
Item
measurable lesion according to recist with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
boolean
C1513041 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0242656 (UMLS CUI [3,2])
Informed Consent
Item
provision of written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Lung Diseases, Interstitial
Item
evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
boolean
C0206062 (UMLS CUI [1])
Severe allergy Icotinib | Severe allergy Excipient Icotinib
Item
known severe hypersensitivity to icotinib or any of the excipients of this product.
boolean
C2945656 (UMLS CUI [1,1])
C2604307 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
C2604307 (UMLS CUI [2,3])
Disease Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable
Item
evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
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