ID

31218

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00976456

Nyckelord

Versioner (1)
  1. 30/07/18 30/07/18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

30 luglio 2018

DOI

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Creative Commons BY 4.0
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Eligibility Non-squamous Non-small Cell Lung Cancer NCT00976456

Engelsk

Eligibility Non-squamous Non-small Cell Lung Cancer NCT00976456

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

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

Datatyp

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
Beskrivning

Age

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

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

Datatyp

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
Beskrivning

Hemoptysis

Datatyp

boolean

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

Tumor Invasion Blood Vessels Major Imaging

Datatyp

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
Beskrivning

Therapeutic radiology procedure

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Wound, non-healed | Peptic Ulcer | Fracture

Datatyp

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
Beskrivning

Abdominal fistula | Gastrointestinal perforation | Abdominal Abscess

Datatyp

boolean

Alias
UMLS CUI [1]
C1879311
UMLS CUI [2]
C0151664
UMLS CUI [3]
C0243001
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Similar models

Eligibility Non-squamous Non-small Cell Lung Cancer NCT00976456

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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