ID

31120

Description

Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00687817

Link

https://clinicaltrials.gov/show/NCT00687817

Keywords

Versions (1)
  1. 7/21/18 7/21/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 21, 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-small Cell Lung Cancer NCT00687817

English

Eligibility Non-small Cell Lung Cancer NCT00687817

1 forms  
Criteria
Description

Criteria

adults over age 18 years of age with a life expectancy of at least 3 months
Description

Adult | Age | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0023671
histologically or cytologically confirmed non-small cell lung cancer at stage iiib (with pleural effusion), stage iv, or recurrence
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0032227
UMLS CUI [3]
C0278517
measurable disease on cross sectional imaging at least 2 cm in longest diameter (1 cm if measured by spiral ct)
Description

Measurable Disease Cross-sectional imaging | Longest Diameter | Longest Diameter Spiral CT

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C3824793
UMLS CUI [2]
C0552406
UMLS CUI [3,1]
C0552406
UMLS CUI [3,2]
C0860888
adequate hematologic (anc ≥ 1500 cells/µl; hemoglobin ≥9 g/dl; platelets ≥100,000/µl and ≤500,000/µl ), renal (serum creatinine ≤ 1.5 mg/dl or calculated creatinine clearance ≥ 60 ml/min), and hepatic function (bilirubin ≤ 1.5 x uln, alt ≤ 3 x uln, ast ≤ 3 x uln)
Description

Hematologic function | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0518015
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0232804
UMLS CUI [6]
C0201976
UMLS CUI [7]
C2711451
UMLS CUI [8]
C0232741
UMLS CUI [9]
C1278039
UMLS CUI [10]
C0201836
UMLS CUI [11]
C0201899
d-dimer ≤ 2 x uln
Description

D-Dimer Measurement

Data type

boolean

Alias
UMLS CUI [1]
C2826333
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
small cell or mixed histology
Description

Cells Small Histology | Histology Mixed

Data type

boolean

Alias
UMLS CUI [1,1]
C0007634
UMLS CUI [1,2]
C0700321
UMLS CUI [1,3]
C4048239
UMLS CUI [2,1]
C4048239
UMLS CUI [2,2]
C0205430
known history of bleeding diathesis or coagulopathy
Description

Bleeding tendency | Blood Coagulation Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
any current evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or gi bleeding
Description

Hemorrhage | Gross hematuria | Hemoptysis | Gastrointestinal Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0019080
UMLS CUI [2]
C0473237
UMLS CUI [3]
C0019079
UMLS CUI [4]
C0017181
any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism)
Description

Thromboembolism | Deep Vein Thrombosis | Pulmonary Thromboembolisms

Data type

boolean

Alias
UMLS CUI [1]
C0040038
UMLS CUI [2]
C0149871
UMLS CUI [3]
C0524702
prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
Description

Prior Chemotherapy Area Measurable Disease | Prior Immunotherapy Area Measurable Disease | Prior radiation therapy Area Measurable Disease | Exception Recurrent disease Post Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0205146
UMLS CUI [1,3]
C1513041
UMLS CUI [2,1]
C1514461
UMLS CUI [2,2]
C0205146
UMLS CUI [2,3]
C1513041
UMLS CUI [3,1]
C0279134
UMLS CUI [3,2]
C0205146
UMLS CUI [3,3]
C1513041
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0277556
UMLS CUI [4,3]
C0687676
UMLS CUI [4,4]
C1522449
radiotherapy within 2 weeks preceding study day 1
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
symptomatic or clinically active cns disease or metastatic lesions
Description

CNS disorder Symptomatic | CNS disorder | Metastatic Lesion

Data type

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0007682
UMLS CUI [3]
C1513183
major surgery within 4 weeks of study day 1
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
Description

Comorbidity Uncontrolled | Diabetes Mellitus | Hypertensive disease | Thyroid Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0011849
UMLS CUI [3]
C0020538
UMLS CUI [4]
C0040128
any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
Description

Angina Pectoris | Coronary Artery Disease | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0002962
UMLS CUI [2]
C1956346
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
a history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin. anti-platelet agents are prohibited during the study.
Description

Condition Requirement Antiplatelet therapy | Exception Aspirin Cardiovascular event prophylaxis | Antiplatelet Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1096021
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0004057
UMLS CUI [2,3]
C1610618
UMLS CUI [3]
C0085826
requirement for chronic daily treatment with nsaids, anti-platelet drugs, or steroids
Description

Non-Steroidal Anti-Inflammatory Agents Daily chronic | Antiplatelet Agents Daily chronic | Steroids Daily chronic

Data type

boolean

Alias
UMLS CUI [1,1]
C0003211
UMLS CUI [1,2]
C0332173
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0085826
UMLS CUI [2,2]
C0332173
UMLS CUI [2,3]
C0205191
UMLS CUI [3,1]
C0038317
UMLS CUI [3,2]
C0332173
UMLS CUI [3,3]
C0205191
Back to the top of the page

Similar models

Eligibility Non-small Cell Lung Cancer NCT00687817

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Adult | Age | Life Expectancy
Item
adults over age 18 years of age with a life expectancy of at least 3 months
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Non-Small Cell Lung Carcinoma TNM clinical staging | Pleural effusion | Non-small cell lung cancer recurrent
Item
histologically or cytologically confirmed non-small cell lung cancer at stage iiib (with pleural effusion), stage iv, or recurrence
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
C0278517 (UMLS CUI [3])
Measurable Disease Cross-sectional imaging | Longest Diameter | Longest Diameter Spiral CT
Item
measurable disease on cross sectional imaging at least 2 cm in longest diameter (1 cm if measured by spiral ct)
boolean
C1513041 (UMLS CUI [1,1])
C3824793 (UMLS CUI [1,2])
C0552406 (UMLS CUI [2])
C0552406 (UMLS CUI [3,1])
C0860888 (UMLS CUI [3,2])
Hematologic function | Absolute neutrophil count | Hemoglobin measurement | Platelet Count measurement | Renal function | Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula | Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
adequate hematologic (anc ≥ 1500 cells/µl; hemoglobin ≥9 g/dl; platelets ≥100,000/µl and ≤500,000/µl ), renal (serum creatinine ≤ 1.5 mg/dl or calculated creatinine clearance ≥ 60 ml/min), and hepatic function (bilirubin ≤ 1.5 x uln, alt ≤ 3 x uln, ast ≤ 3 x uln)
boolean
C0221130 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C2711451 (UMLS CUI [7])
C0232741 (UMLS CUI [8])
C1278039 (UMLS CUI [9])
C0201836 (UMLS CUI [10])
C0201899 (UMLS CUI [11])
D-Dimer Measurement
Item
d-dimer ≤ 2 x uln
boolean
C2826333 (UMLS CUI [1])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Cells Small Histology | Histology Mixed
Item
small cell or mixed histology
boolean
C0007634 (UMLS CUI [1,1])
C0700321 (UMLS CUI [1,2])
C4048239 (UMLS CUI [1,3])
C4048239 (UMLS CUI [2,1])
C0205430 (UMLS CUI [2,2])
Bleeding tendency | Blood Coagulation Disorder
Item
known history of bleeding diathesis or coagulopathy
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
Hemorrhage | Gross hematuria | Hemoptysis | Gastrointestinal Hemorrhage
Item
any current evidence of clinically significant bleeding defined as gross hematuria, hemoptysis, or gi bleeding
boolean
C0019080 (UMLS CUI [1])
C0473237 (UMLS CUI [2])
C0019079 (UMLS CUI [3])
C0017181 (UMLS CUI [4])
Thromboembolism | Deep Vein Thrombosis | Pulmonary Thromboembolisms
Item
any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism)
boolean
C0040038 (UMLS CUI [1])
C0149871 (UMLS CUI [2])
C0524702 (UMLS CUI [3])
Prior Chemotherapy Area Measurable Disease | Prior Immunotherapy Area Measurable Disease | Prior radiation therapy Area Measurable Disease | Exception Recurrent disease Post Therapeutic radiology procedure
Item
prior chemotherapy, immunotherapy or radiotherapy to an area of measurable disease unless disease had recurred after radiotherapy
boolean
C1514457 (UMLS CUI [1,1])
C0205146 (UMLS CUI [1,2])
C1513041 (UMLS CUI [1,3])
C1514461 (UMLS CUI [2,1])
C0205146 (UMLS CUI [2,2])
C1513041 (UMLS CUI [2,3])
C0279134 (UMLS CUI [3,1])
C0205146 (UMLS CUI [3,2])
C1513041 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0277556 (UMLS CUI [4,2])
C0687676 (UMLS CUI [4,3])
C1522449 (UMLS CUI [4,4])
Therapeutic radiology procedure
Item
radiotherapy within 2 weeks preceding study day 1
boolean
C1522449 (UMLS CUI [1])
CNS disorder Symptomatic | CNS disorder | Metastatic Lesion
Item
symptomatic or clinically active cns disease or metastatic lesions
boolean
C0007682 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0007682 (UMLS CUI [2])
C1513183 (UMLS CUI [3])
Major surgery
Item
major surgery within 4 weeks of study day 1
boolean
C0679637 (UMLS CUI [1])
Comorbidity Uncontrolled | Diabetes Mellitus | Hypertensive disease | Thyroid Diseases
Item
uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease)
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0011849 (UMLS CUI [2])
C0020538 (UMLS CUI [3])
C0040128 (UMLS CUI [4])
Angina Pectoris | Coronary Artery Disease | Cerebrovascular accident | Transient Ischemic Attack
Item
any history of angina pectoris, coronary artery disease or cerebrovascular accident, or transient ischemic attack
boolean
C0002962 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
Condition Requirement Antiplatelet therapy | Exception Aspirin Cardiovascular event prophylaxis | Antiplatelet Agents
Item
a history of any condition requiring anti-platelet therapy with the exception of general cardiovascular prophylaxis with aspirin. anti-platelet agents are prohibited during the study.
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1096021 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C1610618 (UMLS CUI [2,3])
C0085826 (UMLS CUI [3])
Non-Steroidal Anti-Inflammatory Agents Daily chronic | Antiplatelet Agents Daily chronic | Steroids Daily chronic
Item
requirement for chronic daily treatment with nsaids, anti-platelet drugs, or steroids
boolean
C0003211 (UMLS CUI [1,1])
C0332173 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0085826 (UMLS CUI [2,1])
C0332173 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
C0038317 (UMLS CUI [3,1])
C0332173 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
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