ID

31218

Description

Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00976456

Link

https://clinicaltrials.gov/show/NCT00976456

Keywords

Versions (1)
  1. 7/30/18 7/30/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 30, 2018

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 :

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

Eligibility Non-squamous Non-small Cell Lung Cancer NCT00976456

English

Eligibility Non-squamous Non-small Cell Lung Cancer NCT00976456

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage iiib and iv nsclc, excluded squamous cell nsclc
Description

Non-Small Cell Lung Carcinoma TNM clinical staging | Squamous Cell Non-Small Cell Lung Carcinoma Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0221910
UMLS CUI [2,2]
C0007131
UMLS CUI [2,3]
C0332196
age ≥ 65 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component
Description

Non-small cell carcinoma Small Cell Carcinoma Mixed | Adenosquamous carcinoma Component Squamous Mixed

Data type

boolean

Alias
UMLS CUI [1,1]
C1266002
UMLS CUI [1,2]
C0262584
UMLS CUI [1,3]
C0205430
UMLS CUI [2,1]
C0206623
UMLS CUI [2,2]
C1705248
UMLS CUI [2,3]
C1182670
UMLS CUI [2,4]
C0205430
history of haemoptysis
Description

Hemoptysis

Data type

boolean

Alias
UMLS CUI [1]
C0019079
evidence of tumour invading major blood vessels on imaging
Description

Tumor Invasion Blood Vessels Major Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C1269955
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C0205164
UMLS CUI [1,4]
C0011923
radiotherapy within 28 days prior to enrolment
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
patients who are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
Description

Unable to discontinue Aspirin | Unable to discontinue Non-Steroidal Anti-Inflammatory Agents | Exception Aspirin U/day Time Period | Exception Piroxicam Time Period

Data type

boolean

Alias
UMLS CUI [1,1]
C1548265
UMLS CUI [1,2]
C0004057
UMLS CUI [2,1]
C1548265
UMLS CUI [2,2]
C0003211
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0004057
UMLS CUI [3,3]
C0456683
UMLS CUI [3,4]
C1948053
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0031990
UMLS CUI [4,3]
C1948053
current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. prophylactic use of anticoagulants is allowed
Description

Oral anticoagulants Dosage Full | Anticoagulants Parenteral | Fibrinolytic Agents | Anticoagulants Prophylactic allowed

Data type

boolean

Alias
UMLS CUI [1,1]
C0354604
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0443225
UMLS CUI [2,1]
C0003280
UMLS CUI [2,2]
C1518896
UMLS CUI [3]
C0016018
UMLS CUI [4,1]
C0003280
UMLS CUI [4,2]
C0199176
UMLS CUI [4,3]
C0683607
clinically significant (i.e. active) cardiovascular disease for example cva (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, chf nyha class ≥ii, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication
Description

Cardiovascular Disease | Cerebrovascular accident | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations | Cardiac Arrhythmia Serious Interferes with Study Protocol | Cardiac Arrhythmia Serious Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C1275491
UMLS CUI [6,1]
C0003811
UMLS CUI [6,2]
C0205404
UMLS CUI [6,3]
C1514873
UMLS CUI [6,4]
C0013227
UMLS CUI [7,1]
C0003811
UMLS CUI [7,2]
C0205404
UMLS CUI [7,3]
C0521102
UMLS CUI [7,4]
C2348563
UMLS CUI [8,1]
C0003811
UMLS CUI [8,2]
C0205404
UMLS CUI [8,3]
C0205318
non-healing wound, active peptic ulcer or bone fracture
Description

Wound, non-healed | Peptic Ulcer | Fracture

Data type

boolean

Alias
UMLS CUI [1]
C0750433
UMLS CUI [2]
C0030920
UMLS CUI [3]
C0016658
history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
Description

Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess

Data type

boolean

Alias
UMLS CUI [1]
C1879311
UMLS CUI [2]
C0151664
UMLS CUI [3]
C0243001
Back to the top of the page

Similar models

Eligibility Non-squamous Non-small Cell Lung Cancer NCT00976456

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Squamous Cell Non-Small Cell Lung Carcinoma Excluded
Item
stage iiib and iv nsclc, excluded squamous cell nsclc
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0221910 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
Age
Item
age ≥ 65 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog 0-2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Non-small cell carcinoma Small Cell Carcinoma Mixed | Adenosquamous carcinoma Component Squamous Mixed
Item
mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component
boolean
C1266002 (UMLS CUI [1,1])
C0262584 (UMLS CUI [1,2])
C0205430 (UMLS CUI [1,3])
C0206623 (UMLS CUI [2,1])
C1705248 (UMLS CUI [2,2])
C1182670 (UMLS CUI [2,3])
C0205430 (UMLS CUI [2,4])
Hemoptysis
Item
history of haemoptysis
boolean
C0019079 (UMLS CUI [1])
Tumor Invasion Blood Vessels Major Imaging
Item
evidence of tumour invading major blood vessels on imaging
boolean
C1269955 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0011923 (UMLS CUI [1,4])
Therapeutic radiology procedure
Item
radiotherapy within 28 days prior to enrolment
boolean
C1522449 (UMLS CUI [1])
Unable to discontinue Aspirin | Unable to discontinue Non-Steroidal Anti-Inflammatory Agents | Exception Aspirin U/day Time Period | Exception Piroxicam Time Period
Item
patients who are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
boolean
C1548265 (UMLS CUI [1,1])
C0004057 (UMLS CUI [1,2])
C1548265 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0004057 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
C1948053 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0031990 (UMLS CUI [4,2])
C1948053 (UMLS CUI [4,3])
Oral anticoagulants Dosage Full | Anticoagulants Parenteral | Fibrinolytic Agents | Anticoagulants Prophylactic allowed
Item
current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. prophylactic use of anticoagulants is allowed
boolean
C0354604 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443225 (UMLS CUI [1,3])
C0003280 (UMLS CUI [2,1])
C1518896 (UMLS CUI [2,2])
C0016018 (UMLS CUI [3])
C0003280 (UMLS CUI [4,1])
C0199176 (UMLS CUI [4,2])
C0683607 (UMLS CUI [4,3])
Cardiovascular Disease | Cerebrovascular accident | Myocardial Infarction | Angina, Unstable | Congestive heart failure New York Heart Association Classification | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations | Cardiac Arrhythmia Serious Interferes with Study Protocol | Cardiac Arrhythmia Serious Uncontrolled
Item
clinically significant (i.e. active) cardiovascular disease for example cva (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, chf nyha class ≥ii, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication
boolean
C0007222 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0003811 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
C1514873 (UMLS CUI [6,3])
C0013227 (UMLS CUI [6,4])
C0003811 (UMLS CUI [7,1])
C0205404 (UMLS CUI [7,2])
C0521102 (UMLS CUI [7,3])
C2348563 (UMLS CUI [7,4])
C0003811 (UMLS CUI [8,1])
C0205404 (UMLS CUI [8,2])
C0205318 (UMLS CUI [8,3])
Wound, non-healed | Peptic Ulcer | Fracture
Item
non-healing wound, active peptic ulcer or bone fracture
boolean
C0750433 (UMLS CUI [1])
C0030920 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess
Item
history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
boolean
C1879311 (UMLS CUI [1])
C0151664 (UMLS CUI [2])
C0243001 (UMLS CUI [3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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