ID

19744

Beskrivning

A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC); ODM derived from: https://clinicaltrials.gov/show/NCT00300885

Länk

https://clinicaltrials.gov/show/NCT00300885

Nyckelord

Versioner (1)
  1. 2017-01-25 2017-01-25 -
Uppladdad den

25 januari 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small Cell Lung NCT00300885

Engelsk

Eligibility Carcinoma, Non-Small Cell Lung NCT00300885

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
stage iiib (with effusion) or stage iv nsclc any histology
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging Effusion | Non-Small Cell Lung Carcinoma TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [1,3]
C0013687
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C3258246
no prior chemotherapy
Beskrivning

Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
eastern cooperative oncology group (ecog) performance status of 0 or 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
greater than or equal to 18 years of age
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy at least 12 weeks
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
adequate bone marrow, liver and renal function
Beskrivning

Bone Marrow function | Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior systemic anti cancer therapy
Beskrivning

cancer treatment Systemic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
known brain metastasis. patients with neurological symptoms should undergo at computed tomography (ct) scan/magnetic resonance imaging (mri) of the brain to exclude brain metastasis
Beskrivning

Metastatic malignant neoplasm to brain | Neurologic Symptoms CT of brain | MRI brain procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0235031
UMLS CUI [2,2]
C0412585
UMLS CUI [3]
C0412675
pulmonary hemorrhage/bleeding event > common terminology criteria for adverse events (ctcae) grade 2 within 4 weeks of first dose of study drug
Beskrivning

Pulmonary hemorrhage CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0151701
UMLS CUI [1,2]
C1516728
thrombotic or embolic events including transient ischemic attack (tia) within the past 6 months
Beskrivning

Thrombosis | Embolism | Transient Ischemic Attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0040053
UMLS CUI [2]
C0013922
UMLS CUI [3]
C0007787
uncontrolled hypertension
Beskrivning

Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
any other hemorrhage/bleeding event > ctcae grade 3 within 4 weeks of first dose of study drug
Beskrivning

Hemorrhage CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1516728
major surgery within 4 weeks
Beskrivning

major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
evidence or history of bleeding diathesis or coagulopathy
Beskrivning

Bleeding tendency | Blood Coagulation Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
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Similar models

Eligibility Carcinoma, Non-Small Cell Lung NCT00300885

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging Effusion | Non-Small Cell Lung Carcinoma TNM clinical staging
Item
stage iiib (with effusion) or stage iv nsclc any histology
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0013687 (UMLS CUI [1,3])
C0007131 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Chemotherapy
Item
no prior chemotherapy
boolean
C0392920 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Age
Item
greater than or equal to 18 years of age
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy at least 12 weeks
boolean
C0023671 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
cancer treatment Systemic
Item
prior systemic anti cancer therapy
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain | Neurologic Symptoms CT of brain | MRI brain procedure
Item
known brain metastasis. patients with neurological symptoms should undergo at computed tomography (ct) scan/magnetic resonance imaging (mri) of the brain to exclude brain metastasis
boolean
C0220650 (UMLS CUI [1])
C0235031 (UMLS CUI [2,1])
C0412585 (UMLS CUI [2,2])
C0412675 (UMLS CUI [3])
Pulmonary hemorrhage CTCAE Grades
Item
pulmonary hemorrhage/bleeding event > common terminology criteria for adverse events (ctcae) grade 2 within 4 weeks of first dose of study drug
boolean
C0151701 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Thrombosis | Embolism | Transient Ischemic Attack
Item
thrombotic or embolic events including transient ischemic attack (tia) within the past 6 months
boolean
C0040053 (UMLS CUI [1])
C0013922 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Hemorrhage CTCAE Grades
Item
any other hemorrhage/bleeding event > ctcae grade 3 within 4 weeks of first dose of study drug
boolean
C0019080 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
major surgery
Item
major surgery within 4 weeks
boolean
C0679637 (UMLS CUI [1])
Bleeding tendency | Blood Coagulation Disorder
Item
evidence or history of bleeding diathesis or coagulopathy
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
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