ID

44260

Descripción

A Study in Non-squamous Non Small Cell Lung Cancer in Asian Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01020786

Link

https://clinicaltrials.gov/show/NCT01020786

Palabras clave

Versiones (2)
  1. 15/7/18 15/7/18 -
  2. 20/9/21 20/9/21 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Non Small Cell Lung Cancer NCT01020786

Inglés

Eligibility Non Small Cell Lung Cancer NCT01020786

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
non-squamous cell non small cell lung cancer (nsclc) disease
Descripción

Non-Squamous Non-Small Cell Lung Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C4324656
clinical stage iiib/iv or recurrent disease after surgery
Descripción

TNM clinical staging | Recurrent disease Post Operative Surgical Procedures

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3258246
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0543467
no prior systemic chemotherapy, immunotherapy, targeted therapy or biological therapy, including adjuvant therapy
Descripción

Systemic Chemotherapy Absent | Immunotherapy Absent | Targeted Therapy Absent | Biological treatment Absent | Adjuvant therapy Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0021083
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C2985566
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1531518
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0677850
UMLS CUI [5,2]
C0332197
prior radiation therapy is allowed to less than 25% of the bone marrow
Descripción

Prior radiation therapy Bone Marrow Percentage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
measurable disease as defined by response evaluation criteria in solid tumors (recist)
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
the eastern cooperative oncology group (ecog) performance status 0 or 1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
adequate organ function
Descripción

Organ function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
estimated life expectancy of at least 12 weeks
Descripción

Life Expectancy Estimated

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0750572
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically significant third-space fluid collections
Descripción

Fluid Space Third Clinical Significance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005889
UMLS CUI [1,2]
C1883067
UMLS CUI [1,3]
C0205437
UMLS CUI [1,4]
C2826293
central nervous system disease other than stable and treated brain metastasis
Descripción

CNS disorder | Exception Metastatic malignant neoplasm to brain Treated Stable

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0220650
UMLS CUI [2,3]
C1522326
UMLS CUI [2,4]
C0205360
more than 3 weeks interval between the surgery and enrollment request date
Descripción

Interval Operative Surgical Procedures Enrollment

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C1516879
unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (nsaids), for a 5 days period
Descripción

Aspirin Unable to discontinue | Non-Steroidal Anti-Inflammatory Agents Unable to discontinue

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C1548265
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C1548265
unable or unwilling to take folic acid or vitamin b12 supplementation
Descripción

Folic Acid Intake Unable | Vitamin B12 supplementation Unable | Folic Acid Intake Unwilling | Vitamin B12 supplementation Unwilling

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0016410
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C4524262
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C0016410
UMLS CUI [3,2]
C1512806
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C4524262
UMLS CUI [4,2]
C0558080
unable to take corticosteroids.
Descripción

Adrenal Cortex Hormones Intake Unable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1512806
UMLS CUI [1,3]
C1299582
serious concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol
Descripción

Comorbidity Serious compromises Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C2945640
UMLS CUI [1,4]
C0525058
currently have and historically had interstitial pneumonitis (interstitial pneumonia) or pulmonary fibrosis manifested as opacity on chest x-ray or computed tomography (ct)
Descripción

Interstitial Pneumonia Chest X-ray | Pulmonary Fibrosis Chest X-ray | Interstitial Pneumonia Chest CT | Pulmonary Fibrosis Chest CT

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0206061
UMLS CUI [1,2]
C0039985
UMLS CUI [2,1]
C0034069
UMLS CUI [2,2]
C0039985
UMLS CUI [3,1]
C0206061
UMLS CUI [3,2]
C0202823
UMLS CUI [4,1]
C0034069
UMLS CUI [4,2]
C0202823
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Similar models

Eligibility Non Small Cell Lung Cancer NCT01020786

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Non-Squamous Non-Small Cell Lung Carcinoma
Item
non-squamous cell non small cell lung cancer (nsclc) disease
boolean
C4324656 (UMLS CUI [1])
TNM clinical staging | Recurrent disease Post Operative Surgical Procedures
Item
clinical stage iiib/iv or recurrent disease after surgery
boolean
C3258246 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
Systemic Chemotherapy Absent | Immunotherapy Absent | Targeted Therapy Absent | Biological treatment Absent | Adjuvant therapy Absent
Item
no prior systemic chemotherapy, immunotherapy, targeted therapy or biological therapy, including adjuvant therapy
boolean
C1883256 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C2985566 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1531518 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0677850 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Prior radiation therapy Bone Marrow Percentage
Item
prior radiation therapy is allowed to less than 25% of the bone marrow
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
Measurable Disease
Item
measurable disease as defined by response evaluation criteria in solid tumors (recist)
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
the eastern cooperative oncology group (ecog) performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
Life Expectancy Estimated
Item
estimated life expectancy of at least 12 weeks
boolean
C0023671 (UMLS CUI [1,1])
C0750572 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Fluid Space Third Clinical Significance
Item
clinically significant third-space fluid collections
boolean
C0005889 (UMLS CUI [1,1])
C1883067 (UMLS CUI [1,2])
C0205437 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,4])
CNS disorder | Exception Metastatic malignant neoplasm to brain Treated Stable
Item
central nervous system disease other than stable and treated brain metastasis
boolean
C0007682 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Interval Operative Surgical Procedures Enrollment
Item
more than 3 weeks interval between the surgery and enrollment request date
boolean
C1272706 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C1516879 (UMLS CUI [1,3])
Aspirin Unable to discontinue | Non-Steroidal Anti-Inflammatory Agents Unable to discontinue
Item
unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (nsaids), for a 5 days period
boolean
C0004057 (UMLS CUI [1,1])
C1548265 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2,1])
C1548265 (UMLS CUI [2,2])
Folic Acid Intake Unable | Vitamin B12 supplementation Unable | Folic Acid Intake Unwilling | Vitamin B12 supplementation Unwilling
Item
unable or unwilling to take folic acid or vitamin b12 supplementation
boolean
C0016410 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C4524262 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0016410 (UMLS CUI [3,1])
C1512806 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C4524262 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
Adrenal Cortex Hormones Intake Unable
Item
unable to take corticosteroids.
boolean
C0001617 (UMLS CUI [1,1])
C1512806 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Comorbidity Serious compromises Protocol Compliance
Item
serious concomitant disorder that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C2945640 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
Interstitial Pneumonia Chest X-ray | Pulmonary Fibrosis Chest X-ray | Interstitial Pneumonia Chest CT | Pulmonary Fibrosis Chest CT
Item
currently have and historically had interstitial pneumonitis (interstitial pneumonia) or pulmonary fibrosis manifested as opacity on chest x-ray or computed tomography (ct)
boolean
C0206061 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0034069 (UMLS CUI [2,1])
C0039985 (UMLS CUI [2,2])
C0206061 (UMLS CUI [3,1])
C0202823 (UMLS CUI [3,2])
C0034069 (UMLS CUI [4,1])
C0202823 (UMLS CUI [4,2])
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