ID

41195

Beskrivning

Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01109524

Länk

https://clinicaltrials.gov/show/NCT01109524

Nyckelord

Versioner (1)
  1. 2020-07-10 2020-07-10 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

10 juli 2020

DOI

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Creative Commons BY 4.0
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Eligibility Lung Neoplasms NCT01109524

Engelsk

Eligibility Lung Neoplasms NCT01109524

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
non-small cell lung cancer (nsclc), stage iv (per the american joint committee on cancer (ajcc) staging manual, seventh edition) or recurrent disease following surgery and/or radiation therapy
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging | Recurrent disease | Status post Operative Surgical Procedures | Status post Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0277556
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0543467
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C1522449
evaluable or measurable disease
Beskrivning

Evaluable Disease | Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1516986
UMLS CUI [2]
C1513041
eastern cooperative oncology group (ecog) performance status of 0, 1 or 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled central nervous system (cns) metastasis.
Beskrivning

CNS metastases Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
previous exposure to monoclonal antibodies, signal transduction inhibitors or epidermal growth factor receptor (egfr) targeting therapy
Beskrivning

Exposure to Monoclonal Antibodies | Signal Transduction Inhibitor | EGFR targeted therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0003250
UMLS CUI [2]
C1519313
UMLS CUI [3]
C4733187
concurrent malignancy
Beskrivning

Cancer Other

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
prior chemotherapy for nsclc
Beskrivning

Prior Chemotherapy Non-Small Cell Lung Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0007131
pre-existing ascites grade ≥ 2 or pericardial effusion grade ≥ 2
Beskrivning

Ascites Pre-existing CTCAE Grades | Pericardial effusion CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
UMLS CUI [2,1]
C0031039
UMLS CUI [2,2]
C1516728
superior vena cava syndrome contra-indicating hydration
Beskrivning

Superior Vena Cava Syndrome | Hydration Therapy Contraindicated

Datatyp

boolean

Alias
UMLS CUI [1]
C0038833
UMLS CUI [2,1]
C1881074
UMLS CUI [2,2]
C1444657
white blood cells (wbc) < 3,000/mm³
Beskrivning

White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophile count (anc) < 1,500/mm³
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
platelet < 100,000/mm³
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin (hgb) < 9.0 g/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
total bilirubin > 1.5 x upper limit of normal (uln).
Beskrivning

SERUM TOTAL BILIRUBIN ELEVATED

Datatyp

boolean

Alias
UMLS CUI [1]
C0595866
aspartate aminotransferase (ast) or alanine-aminotransferase (alt) > 5.0 x uln.
Beskrivning

Aspartate Aminotransferase Increased | Alanine Aminotransferase Increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
serum creatinine >1.25 x uln and calculated creatinine clearance <60ml/min
Beskrivning

Serum creatinine raised | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1]
C0700225
UMLS CUI [2]
C2711451
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Similar models

Eligibility Lung Neoplasms NCT01109524

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Recurrent disease | Status post Operative Surgical Procedures | Status post Therapeutic radiology procedure
Item
non-small cell lung cancer (nsclc), stage iv (per the american joint committee on cancer (ajcc) staging manual, seventh edition) or recurrent disease following surgery and/or radiation therapy
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C1522449 (UMLS CUI [4,2])
Evaluable Disease | Measurable Disease
Item
evaluable or measurable disease
boolean
C1516986 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CNS metastases Uncontrolled
Item
uncontrolled central nervous system (cns) metastasis.
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Exposure to Monoclonal Antibodies | Signal Transduction Inhibitor | EGFR targeted therapy
Item
previous exposure to monoclonal antibodies, signal transduction inhibitors or epidermal growth factor receptor (egfr) targeting therapy
boolean
C0332157 (UMLS CUI [1,1])
C0003250 (UMLS CUI [1,2])
C1519313 (UMLS CUI [2])
C4733187 (UMLS CUI [3])
Cancer Other
Item
concurrent malignancy
boolean
C1707251 (UMLS CUI [1])
Prior Chemotherapy Non-Small Cell Lung Carcinoma
Item
prior chemotherapy for nsclc
boolean
C1514457 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
Ascites Pre-existing CTCAE Grades | Pericardial effusion CTCAE Grades
Item
pre-existing ascites grade ≥ 2 or pericardial effusion grade ≥ 2
boolean
C0003962 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0031039 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Superior Vena Cava Syndrome | Hydration Therapy Contraindicated
Item
superior vena cava syndrome contra-indicating hydration
boolean
C0038833 (UMLS CUI [1])
C1881074 (UMLS CUI [2,1])
C1444657 (UMLS CUI [2,2])
White Blood Cell Count procedure
Item
white blood cells (wbc) < 3,000/mm³
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophile count (anc) < 1,500/mm³
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet < 100,000/mm³
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin (hgb) < 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
SERUM TOTAL BILIRUBIN ELEVATED
Item
total bilirubin > 1.5 x upper limit of normal (uln).
boolean
C0595866 (UMLS CUI [1])
Aspartate Aminotransferase Increased | Alanine Aminotransferase Increased
Item
aspartate aminotransferase (ast) or alanine-aminotransferase (alt) > 5.0 x uln.
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Serum creatinine raised | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
serum creatinine >1.25 x uln and calculated creatinine clearance <60ml/min
boolean
C0700225 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Tillbaka till toppen 

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