ID

38490

Description

Sequential Use of Low-dose Sunitinib With Chemotherapy in Advanced NSCLC After Failure of Conventional Regimen; ODM derived from: https://clinicaltrials.gov/show/NCT01850147

Link

https://clinicaltrials.gov/show/NCT01850147

Keywords

Versions (1)
  1. 10/22/19 10/22/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 22, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

  • Newest
  • Oldest
  • Popular
  • Newest
    • Newest
    • Oldest
    • Popular

No comments

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Cancer NCT01850147

English

Eligibility Cancer NCT01850147

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT01850147
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytologic diagnosis of stage iiib/iv nsclc
Description

Non-Small Cell Lung Carcinoma TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
ecog ps: 0,1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
unidimensional or bi-dimensional measurable disease
Description

Measurable Disease Linear | Measurable Disease 2-Dimensional

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1705052
receive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 egf/egfr inhibitor
Description

First line Chemotherapy Platinum-Based | Second line Chemotherapy | EGFR inhibitor Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1514162
UMLS CUI [2,1]
C1710038
UMLS CUI [2,2]
C0392920
UMLS CUI [3,1]
C1443775
UMLS CUI [3,2]
C1265611
evidence of disease progression
Description

Disease Progression

Data type

boolean

Alias
UMLS CUI [1]
C0242656
life expectancy >12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
neutrophils > 1.5 109/l, platelets > 100 109/l, hemoglobin > 9g/dl, total bilirubin < 1.5 unl, ast (sgot) and alt (sgpt) < 2.5 unl, alkaline phosphatases < 5 unl, creatinine < 1 unl
Description

Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0200633
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201850
UMLS CUI [8]
C0201976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pre-existing hemoptysis of a severity > grade 3 by nci ctcae criteria within 4 weeks prior to study entry
Description

Hemoptysis Pre-existing CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0019079
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
uncontrolled hypertension
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
chf, angina or arrhythmias
Description

Congestive heart failure | Angina Pectoris | Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0003811
lvef < 1 unl
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
existing a second malignancy within 5 years
Description

Second Primary Cancer

Data type

boolean

Alias
UMLS CUI [1]
C0751623
infected with hiv
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
Back to the top of the page

Similar models

Eligibility Cancer NCT01850147

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT01850147
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging
Item
histologic or cytologic diagnosis of stage iiib/iv nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
ECOG performance status
Item
ecog ps: 0,1
boolean
C1520224 (UMLS CUI [1])
Measurable Disease Linear | Measurable Disease 2-Dimensional
Item
unidimensional or bi-dimensional measurable disease
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C1705052 (UMLS CUI [2,2])
First line Chemotherapy Platinum-Based | Second line Chemotherapy | EGFR inhibitor Quantity
Item
receive prior treatment including first-line platinum-based chemotherapy, standard second-line chemotherapy and 1 egf/egfr inhibitor
boolean
C1708063 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1514162 (UMLS CUI [1,3])
C1710038 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C1443775 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Disease Progression
Item
evidence of disease progression
boolean
C0242656 (UMLS CUI [1])
Life Expectancy
Item
life expectancy >12 weeks
boolean
C0023671 (UMLS CUI [1])
Neutrophil count | Platelet Count measurement | Hemoglobin measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Creatinine measurement, serum
Item
neutrophils > 1.5 109/l, platelets > 100 109/l, hemoglobin > 9g/dl, total bilirubin < 1.5 unl, ast (sgot) and alt (sgpt) < 2.5 unl, alkaline phosphatases < 5 unl, creatinine < 1 unl
boolean
C0200633 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
C0201976 (UMLS CUI [8])
Item Group
C0680251 (UMLS CUI)
Hemoptysis Pre-existing CTCAE Grades
Item
pre-existing hemoptysis of a severity > grade 3 by nci ctcae criteria within 4 weeks prior to study entry
boolean
C0019079 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Congestive heart failure | Angina Pectoris | Cardiac Arrhythmia
Item
chf, angina or arrhythmias
boolean
C0018802 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0003811 (UMLS CUI [3])
Left ventricular ejection fraction
Item
lvef < 1 unl
boolean
C0428772 (UMLS CUI [1])
Second Primary Cancer
Item
existing a second malignancy within 5 years
boolean
C0751623 (UMLS CUI [1])
HIV Infection
Item
infected with hiv
boolean
C0019693 (UMLS CUI [1])
Back to the top of the page 

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial